Trial Outcomes & Findings for Safety and Efficacy of Andecaliximab (GS-5745) in Adults With Moderately to Severely Active Ulcerative Colitis (NCT NCT02520284)
NCT ID: NCT02520284
Last Updated: 2019-04-10
Results Overview
EBS clinical remission was defined as an endoscopic subscore of 0 or 1 (endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]); rectal bleeding subscore of 0 (rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes); and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1 (stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal).
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
165 participants
Primary outcome timeframe
Week 8
Results posted on
2019-04-10
Participant Flow
Participants were enrolled at study sites in South Africa, Europe, North America, and Asia Pacific. The first participant was screened on 15 September 2015. The last study visit occurred on 22 November 2016.
241 participants were screened.
Participant milestones
| Measure |
Andecaliximab Every 2 Weeks
Blinded Induction Phase: Participants received andecaliximab 150 mg administered via subcutaneous (SC) injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.
Blinded Maintenance Phase: Participants who achieved endoscopy, rectal bleeding, and stool frequency (EBS) clinical remission and/or Mayo Clinical Score (MCS) response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.
|
Andecaliximab Weekly
Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.
|
Placebo
Blinded Induction Phase: Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.
|
|---|---|---|---|
|
Blinded Induction Phase: Up to Week 8
STARTED
|
54
|
56
|
55
|
|
Blinded Induction Phase: Up to Week 8
COMPLETED
|
52
|
52
|
53
|
|
Blinded Induction Phase: Up to Week 8
NOT COMPLETED
|
2
|
4
|
2
|
|
Blinded Maintenance Phase: Up to Week 51
STARTED
|
20
|
16
|
18
|
|
Blinded Maintenance Phase: Up to Week 51
COMPLETED
|
0
|
0
|
0
|
|
Blinded Maintenance Phase: Up to Week 51
NOT COMPLETED
|
20
|
16
|
18
|
|
Open-Label MaintenancePhase: Upto Week51
STARTED
|
32
|
35
|
34
|
|
Open-Label MaintenancePhase: Upto Week51
COMPLETED
|
0
|
0
|
0
|
|
Open-Label MaintenancePhase: Upto Week51
NOT COMPLETED
|
32
|
35
|
34
|
Reasons for withdrawal
| Measure |
Andecaliximab Every 2 Weeks
Blinded Induction Phase: Participants received andecaliximab 150 mg administered via subcutaneous (SC) injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.
Blinded Maintenance Phase: Participants who achieved endoscopy, rectal bleeding, and stool frequency (EBS) clinical remission and/or Mayo Clinical Score (MCS) response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.
|
Andecaliximab Weekly
Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.
|
Placebo
Blinded Induction Phase: Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.
|
|---|---|---|---|
|
Blinded Induction Phase: Up to Week 8
Adverse Event
|
1
|
3
|
0
|
|
Blinded Induction Phase: Up to Week 8
Withdrew Consent
|
1
|
1
|
1
|
|
Blinded Induction Phase: Up to Week 8
Study Terminated by Sponsor
|
0
|
0
|
1
|
|
Blinded Maintenance Phase: Up to Week 51
Study Terminated by Sponsor
|
17
|
11
|
15
|
|
Blinded Maintenance Phase: Up to Week 51
Disease Worsening
|
2
|
2
|
3
|
|
Blinded Maintenance Phase: Up to Week 51
Adverse Event
|
1
|
1
|
0
|
|
Blinded Maintenance Phase: Up to Week 51
Disposition Error
|
0
|
2
|
0
|
|
Open-Label MaintenancePhase: Upto Week51
Study Terminated by Sponsor
|
25
|
29
|
28
|
|
Open-Label MaintenancePhase: Upto Week51
Withdrew Consent
|
3
|
4
|
2
|
|
Open-Label MaintenancePhase: Upto Week51
Adverse Event
|
2
|
1
|
3
|
|
Open-Label MaintenancePhase: Upto Week51
Investigator's Discretion
|
2
|
1
|
1
|
Baseline Characteristics
Safety and Efficacy of Andecaliximab (GS-5745) in Adults With Moderately to Severely Active Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Andecaliximab Every 2 Weeks
n=54 Participants
Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.
|
Andecaliximab Weekly
n=56 Participants
Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.
|
Placebo
n=55 Participants
Blinded Induction Phase: Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 14.1 • n=93 Participants
|
43 years
STANDARD_DEVIATION 13.2 • n=4 Participants
|
43 years
STANDARD_DEVIATION 12.8 • n=27 Participants
|
43 years
STANDARD_DEVIATION 13.3 • n=483 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
61 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
104 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
48 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
141 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · Not Permitted
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
54 Participants
n=93 Participants
|
56 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
161 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Permitted
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Region of Enrollment
Romania
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Region of Enrollment
Hungary
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
61 Participants
n=483 Participants
|
|
Region of Enrollment
Czechia
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Region of Enrollment
Ukraine
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Region of Enrollment
United Kingdom
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Region of Enrollment
Switzerland
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Region of Enrollment
Russia
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Region of Enrollment
New Zealand
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Region of Enrollment
South Korea
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Region of Enrollment
Latvia
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Region of Enrollment
Netherlands
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Region of Enrollment
Belgium
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Region of Enrollment
Ireland
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Region of Enrollment
Taiwan
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Region of Enrollment
Poland
|
11 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
23 Participants
n=483 Participants
|
|
Region of Enrollment
Italy
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Region of Enrollment
South Africa
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Region of Enrollment
Slovakia
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Region of Enrollment
Australia
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Region of Enrollment
Bulgaria
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: Full Analysis Set included all randomized participants who received at least 1 dose of study drug in the Blinded Induction Phase (Cohort 1).
EBS clinical remission was defined as an endoscopic subscore of 0 or 1 (endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]); rectal bleeding subscore of 0 (rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes); and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1 (stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal).
Outcome measures
| Measure |
Andecaliximab Every 2 Weeks
n=54 Participants
Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.
|
Andecaliximab Weekly
n=56 Participants
Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.
|
Placebo
n=55 Participants
Blinded Induction Phase: Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.
|
|---|---|---|---|
|
For Cohort 1, Percentage of Participants With EBS Clinical Remission at Week 8
|
7.4 percentage of participants
Interval 2.1 to 17.9
|
1.8 percentage of participants
Interval 0.0 to 9.6
|
7.3 percentage of participants
Interval 2.0 to 17.6
|
SECONDARY outcome
Timeframe: Week 8Population: Participants in the Full Analysis Set were analyzed.
The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and physician's global assessment (PGA). The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. The MCS remission was defined as a MCS of ≤ 2 points and no individual subscore \> 1 point. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating disease worsening.
Outcome measures
| Measure |
Andecaliximab Every 2 Weeks
n=54 Participants
Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.
|
Andecaliximab Weekly
n=56 Participants
Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.
|
Placebo
n=55 Participants
Blinded Induction Phase: Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.
|
|---|---|---|---|
|
For Cohort 1, Percentage of Participants With MCS Remission at Week 8
|
7.4 percentage of participants
Interval 2.1 to 17.9
|
1.8 percentage of participants
Interval 0.0 to 9.6
|
7.3 percentage of participants
Interval 2.0 to 17.6
|
SECONDARY outcome
Timeframe: Week 8Population: Participants in the Full Analysis Set were analyzed.
The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and PGA. The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating disease worsening. The MCS response was defined as a MCS reduction of ≥ 3 points and at least 30% from baseline, with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of 0 or 1.
Outcome measures
| Measure |
Andecaliximab Every 2 Weeks
n=54 Participants
Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.
|
Andecaliximab Weekly
n=56 Participants
Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.
|
Placebo
n=55 Participants
Blinded Induction Phase: Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.
|
|---|---|---|---|
|
For Cohort 1, Percentage of Participants With MCS Response at Week 8
|
46.3 percentage of participants
Interval 32.6 to 60.4
|
30.4 percentage of participants
Interval 18.8 to 44.1
|
30.9 percentage of participants
Interval 19.1 to 44.8
|
SECONDARY outcome
Timeframe: Week 8Population: Participants in the Full Analysis Set were analyzed.
Endoscopic remission was defined as endoscopic subscore of 0. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).
Outcome measures
| Measure |
Andecaliximab Every 2 Weeks
n=54 Participants
Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.
|
Andecaliximab Weekly
n=56 Participants
Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.
|
Placebo
n=55 Participants
Blinded Induction Phase: Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.
|
|---|---|---|---|
|
For Cohort 1, Percentage of Participants With Endoscopic Remission at Week 8
|
3.7 percentage of participants
Interval 0.5 to 12.7
|
0.0 percentage of participants
Interval 0.0 to 6.4
|
5.5 percentage of participants
Interval 1.1 to 15.1
|
SECONDARY outcome
Timeframe: Week 8Population: Participants in the Full Analysis Set were analyzed.
Endoscopic response was defined as endoscopic subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).
Outcome measures
| Measure |
Andecaliximab Every 2 Weeks
n=54 Participants
Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.
|
Andecaliximab Weekly
n=56 Participants
Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.
|
Placebo
n=55 Participants
Blinded Induction Phase: Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.
|
|---|---|---|---|
|
For Cohort 1, Percentage of Participants With Endoscopic Response at Week 8
|
18.5 percentage of participants
Interval 9.3 to 31.4
|
7.1 percentage of participants
Interval 2.0 to 17.3
|
14.5 percentage of participants
Interval 6.5 to 26.7
|
SECONDARY outcome
Timeframe: Week 8Population: Participants in the Full Analysis Set who did not meet the mucosal healing definition at baseline were analyzed.
Mucosal healing was defined as elimination of ulcers/erosion, elimination of crypt destruction, elimination of intraepithelial neutrophils, elimination of lamina propria neutrophils, and reduction in lamina propria chronic inflammatory cells to at most a mild increase. When measured by the Geboes histologic scoring system, it was the selection of the following combined scores of ≤ 3 for Grade 0 (Structural Architectural Change), ≤ 1 for Grade 1 (Chronic Inflammatory Infiltrate), ≤ 3 for Grade 2A (Lamina Propria Eosinophils), and 0 for Grade 2B (Lamina Propria Neutrophils), Grade 3 (Neutrophils in Epithelium), Grade 4 (Crypt Destruction), and Grade 5 (Erosion or Ulceration). Total Geboes histologic score ranged from 0 to 22, with higher scores indicating greater disease severity.
Outcome measures
| Measure |
Andecaliximab Every 2 Weeks
n=50 Participants
Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.
|
Andecaliximab Weekly
n=51 Participants
Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.
|
Placebo
n=50 Participants
Blinded Induction Phase: Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.
|
|---|---|---|---|
|
For Cohort 1, Percentage of Participants With Mucosal Healing as Determined by the Geboes Histologic Scoring System at Week 8
|
18.0 percentage of participants
Interval 8.6 to 31.4
|
13.7 percentage of participants
Interval 5.7 to 26.3
|
22.0 percentage of participants
Interval 11.5 to 36.0
|
SECONDARY outcome
Timeframe: Week 8Population: Participants in the Full Analysis Set were analyzed.
The MCS remission (alternative definition) was defined as a rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and PGA subscore (range: 0 to 3 with higher score indicating the severe disease) of 0, and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]) of 0 or 1 for an overall MCS of ≤ 1. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating disease worsening.
Outcome measures
| Measure |
Andecaliximab Every 2 Weeks
n=54 Participants
Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.
|
Andecaliximab Weekly
n=56 Participants
Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.
|
Placebo
n=55 Participants
Blinded Induction Phase: Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.
Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.
Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.
|
|---|---|---|---|
|
For Cohort 1, Percentage of Participants With MCS Remission (Alternative Definition) at Week 8
|
1.9 percentage of participants
Interval 0.0 to 9.9
|
0.0 percentage of participants
Interval 0.0 to 6.4
|
0.0 percentage of participants
Interval 0.0 to 6.5
|
Adverse Events
Blinded Induction Phase: Andecaliximab Every 2 Weeks
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Blinded Induction Phase: Andecaliximab Every Weeks
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
Blinded Induction Phase: Placebo
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Blinded Maintenance Phase: Andecaliximab Every 2 Weeks
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Blinded Maintenance Phase: Andecaliximab Every Week
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Blinded Maintenance Phase: Placebo
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Open-Label Maintenance Phase From Andecaliximab Every 2 Weeks
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Open-Label Maintenance Phase From Andecaliximab Every Week
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Open-Label Maintenance Phase From Placebo
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Blinded Induction Phase: Andecaliximab Every 2 Weeks
n=54 participants at risk
Adverse events reported in this group occurred during the Blinded Induction Phase. Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.
|
Blinded Induction Phase: Andecaliximab Every Weeks
n=56 participants at risk
Adverse events reported in this group occurred during the Blinded Induction Phase. Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.
|
Blinded Induction Phase: Placebo
n=55 participants at risk
Adverse events reported in this group occurred during the Blinded Induction Phase. Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.
|
Blinded Maintenance Phase: Andecaliximab Every 2 Weeks
n=20 participants at risk
Adverse events reported in this group occurred during the Blinded Maintenance Phase. Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.
|
Blinded Maintenance Phase: Andecaliximab Every Week
n=16 participants at risk
Adverse events reported in this group occurred during the Blinded Maintenance Phase. Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.
|
Blinded Maintenance Phase: Placebo
n=18 participants at risk
Adverse events reported in this group occurred during the Blinded Maintenance Phase. Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.
|
Open-Label Maintenance Phase From Andecaliximab Every 2 Weeks
n=32 participants at risk
Adverse events reported in this group occurred during the Open-Label Maintenance Phase. Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.
|
Open-Label Maintenance Phase From Andecaliximab Every Week
n=35 participants at risk
Adverse events reported in this group occurred during the Open-Label Maintenance Phase. Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.
|
Open-Label Maintenance Phase From Placebo
n=34 participants at risk
Adverse events reported in this group occurred during the Open-Label Maintenance Phase. Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
3.1%
1/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
2.9%
1/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
2.9%
1/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
2.9%
1/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Infections and infestations
Anal abscess
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
2.9%
1/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
2.9%
1/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
2.9%
1/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
Other adverse events
| Measure |
Blinded Induction Phase: Andecaliximab Every 2 Weeks
n=54 participants at risk
Adverse events reported in this group occurred during the Blinded Induction Phase. Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.
|
Blinded Induction Phase: Andecaliximab Every Weeks
n=56 participants at risk
Adverse events reported in this group occurred during the Blinded Induction Phase. Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.
|
Blinded Induction Phase: Placebo
n=55 participants at risk
Adverse events reported in this group occurred during the Blinded Induction Phase. Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.
|
Blinded Maintenance Phase: Andecaliximab Every 2 Weeks
n=20 participants at risk
Adverse events reported in this group occurred during the Blinded Maintenance Phase. Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.
|
Blinded Maintenance Phase: Andecaliximab Every Week
n=16 participants at risk
Adverse events reported in this group occurred during the Blinded Maintenance Phase. Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.
|
Blinded Maintenance Phase: Placebo
n=18 participants at risk
Adverse events reported in this group occurred during the Blinded Maintenance Phase. Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.
|
Open-Label Maintenance Phase From Andecaliximab Every 2 Weeks
n=32 participants at risk
Adverse events reported in this group occurred during the Open-Label Maintenance Phase. Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.
|
Open-Label Maintenance Phase From Andecaliximab Every Week
n=35 participants at risk
Adverse events reported in this group occurred during the Open-Label Maintenance Phase. Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.
|
Open-Label Maintenance Phase From Placebo
n=34 participants at risk
Adverse events reported in this group occurred during the Open-Label Maintenance Phase. Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.4%
4/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
7.1%
4/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
3.6%
2/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
15.0%
3/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
2.9%
1/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
8.8%
3/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Eye disorders
Dry eye
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
2.9%
1/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
3.1%
1/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
1/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
3.6%
2/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
9.1%
5/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
2.9%
1/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Gastrointestinal disorders
Colitis ulcerative
|
3.7%
2/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.4%
3/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
10.0%
2/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
22.2%
4/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
3.1%
1/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
2.9%
1/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
8.8%
3/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Gastrointestinal disorders
Dyschezia
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Gastrointestinal disorders
Haematochezia
|
1.9%
1/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Gastrointestinal disorders
Mouth ulceration
|
3.7%
2/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
3.6%
2/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Gastrointestinal disorders
Nausea
|
3.7%
2/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.4%
3/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.5%
3/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
2/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.9%
1/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
2.9%
1/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
General disorders
Fatigue
|
1.9%
1/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.5%
3/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
2/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
2.9%
1/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
General disorders
Feeling hot
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
General disorders
Influenza like illness
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
General disorders
Injection site bruising
|
1.9%
1/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
7.1%
4/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
3.1%
1/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
General disorders
Injection site erythema
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
3.1%
1/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
General disorders
Injection site hypersensitivity
|
1.9%
1/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
General disorders
Peripheral swelling
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
3.1%
1/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
2.9%
1/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
General disorders
Pyrexia
|
1.9%
1/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
7.1%
4/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
General disorders
Thirst
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Infections and infestations
Cellulitis
|
1.9%
1/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Infections and infestations
Folliculitis
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.9%
2/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Infections and infestations
Nasopharyngitis
|
3.7%
2/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
3.6%
2/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
3.6%
2/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
12.5%
2/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
11.1%
2/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
3.1%
1/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
2.9%
1/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.4%
3/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
2.9%
1/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
2.9%
1/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Infections and infestations
Urinary tract infection
|
3.7%
2/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
3.6%
2/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
2.9%
1/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
3.6%
2/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Injury, poisoning and procedural complications
Radius fracture
|
1.9%
1/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Investigations
Blood creatine phosphokinase increased
|
1.9%
1/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
3.6%
2/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Investigations
Lymphocyte count decreased
|
1.9%
1/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
7.1%
4/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
12.5%
2/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
3.1%
1/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Metabolism and nutrition disorders
Iron deficiency
|
1.9%
1/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
2.9%
1/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
1/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.4%
3/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.5%
3/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
18.8%
3/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
16.7%
3/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.7%
2/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
2.9%
1/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
1/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.4%
3/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
3.6%
2/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
2.9%
1/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
3.6%
2/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
11.1%
2/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
3.1%
1/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
11.1%
2/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Nervous system disorders
Headache
|
3.7%
2/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
7.1%
4/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
12.5%
2/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
3.1%
1/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Nervous system disorders
Lethargy
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Psychiatric disorders
Depression
|
1.9%
1/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
2.9%
1/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
1/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.4%
3/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
12.5%
2/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
3.1%
1/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
1.9%
1/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
12.5%
2/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
2.9%
1/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.9%
1/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
3.6%
2/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.9%
1/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
1/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.0%
1/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
5.6%
1/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
3.1%
1/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
|
Vascular disorders
Hypertension
|
0.00%
0/54 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
1.8%
1/56 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/55 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/20 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
6.2%
1/16 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/18 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/32 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/35 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
0.00%
0/34 • Blinded Induction Phase: First dose of study drug to Week 8; Blinded Maintenance Phase: First dose of study drug up to approximately 39 weeks plus 30 days; Open-Label Maintenance Phase: First dose of open-label andecaliximab up to approximately 41 weeks plus 30 days
Safety Analysis Set included all participants who received at least 1 dose of study drug in the Blinded Induction Phase. Safety data was summarized by the study periods (Blinded Induction Phase, Blinded Maintenance Phase, and Open-Label Maintenance Phase).
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER