Trial Outcomes & Findings for This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines (NCT NCT03926611)
NCT ID: NCT03926611
Last Updated: 2022-04-29
Results Overview
UAS7 score change (LS mean Change) from baseline at Week 4 estimated with a mixed-effect repeated measurement analysis of UAS7 score change from baseline (FAS) The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. The maximum UAS7 value is 42. A higher score indicates worse disease. A negative change score (week 4 score minus Baseline score) indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
311 participants
Primary outcome timeframe
Baseline, Week 4
Results posted on
2022-04-29
Participant Flow
311 participants enrolled at 82 investigative sites in 17 countries. This Randomized Set included all randomized subjects, regardless of whether or not they actually received study medication. Subjects were analyzed according to the treatment assigned at randomization.
Informed consent was obtained from each subject in writing at screening before any study specific procedure was performed. The study was explained to the subject by the investigator or designee, who answered any questions, and written information was also provided. Re-screening was allowed once and if a subject was re-screened, then the subject had to sign a new informed consent form. .
Participant milestones
| Measure |
LOU064 Arm 1
10 mg LOU064 qd capsule once daily
|
LOU064 Arm 2
35 mg capsule qd LOU064 once daily
|
LOU064 Arm 3
100 mg capsule qd LOU064 once daily
|
LOU064 Arm 4
10 mg capsule LOU064 bid
|
LOU064 Arm 5
25 mg capsule LOU064 bid
|
LOU064 Arm 6
100 mg capsule LOU064 bid
|
Placebo Arm
Took matching placebo twice daily
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
44
|
44
|
47
|
44
|
44
|
45
|
43
|
|
Overall Study
Randomized Set (RAN)
|
44
|
44
|
47
|
44
|
44
|
45
|
43
|
|
Overall Study
Full Analysis Set (FAS)
|
44
|
44
|
47
|
44
|
43
|
45
|
42
|
|
Overall Study
Safety Set (SAF)
|
44
|
44
|
47
|
44
|
43
|
45
|
42
|
|
Overall Study
COMPLETED
|
41
|
41
|
45
|
40
|
40
|
36
|
38
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
2
|
4
|
4
|
9
|
5
|
Reasons for withdrawal
| Measure |
LOU064 Arm 1
10 mg LOU064 qd capsule once daily
|
LOU064 Arm 2
35 mg capsule qd LOU064 once daily
|
LOU064 Arm 3
100 mg capsule qd LOU064 once daily
|
LOU064 Arm 4
10 mg capsule LOU064 bid
|
LOU064 Arm 5
25 mg capsule LOU064 bid
|
LOU064 Arm 6
100 mg capsule LOU064 bid
|
Placebo Arm
Took matching placebo twice daily
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
3
|
1
|
3
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
1
|
1
|
1
|
1
|
|
Overall Study
Technical problems
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
0
|
0
|
1
|
3
|
|
Overall Study
Covid-19 pandemic
|
0
|
0
|
1
|
0
|
1
|
2
|
0
|
Baseline Characteristics
This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines
Baseline characteristics by cohort
| Measure |
LOU064 Arm 1
n=44 Participants
10 mg LOU064 qd capsule once daily
|
LOU064 Arm 2
n=44 Participants
35 mg capsule qd LOU064 once daily
|
LOU064 Arm 3
n=47 Participants
100 mg capsule qd LOU064 once daily
|
LOU064 Arm 4
n=44 Participants
10 mg capsule LOU064 bid
|
LOU064 Arm 5
n=44 Participants
25 mg capsule LOU064 bid
|
LOU064 Arm 6
n=45 Participants
100 mg capsule LOU064 bid
|
Placebo Arm
n=43 Participants
Participants took matching placebo twice daily
|
Total
n=311 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
41 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
279 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
32 Participants
n=24 Participants
|
|
Age, Continuous
|
42.5 Years
STANDARD_DEVIATION 16.04 • n=5 Participants
|
44.0 Years
STANDARD_DEVIATION 16.47 • n=7 Participants
|
45.2 Years
STANDARD_DEVIATION 13.40 • n=5 Participants
|
46.1 Years
STANDARD_DEVIATION 15.21 • n=4 Participants
|
47.4 Years
STANDARD_DEVIATION 14.62 • n=21 Participants
|
44.9 Years
STANDARD_DEVIATION 13.76 • n=8 Participants
|
45.1 Years
STANDARD_DEVIATION 15.24 • n=8 Participants
|
45.0 Years
STANDARD_DEVIATION 14.90 • n=24 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
25 Participants
n=8 Participants
|
222 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
89 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
36 Participants
n=8 Participants
|
35 Participants
n=8 Participants
|
256 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
50 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: Full Analysis Set (FAS) included all randomized subjects. Following intent-to-treat principle, subjects were analyzed according to the treatment and strata assigned to at randomization.
UAS7 score change (LS mean Change) from baseline at Week 4 estimated with a mixed-effect repeated measurement analysis of UAS7 score change from baseline (FAS) The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. The maximum UAS7 value is 42. A higher score indicates worse disease. A negative change score (week 4 score minus Baseline score) indicates improvement.
Outcome measures
| Measure |
LOU064 Arm 1
n=44 Participants
10 mg LOU064 q.d. capsule once daily
|
LOU064 Arm 2
n=44 Participants
35 mg capsule q.d. LOU064 once daily
|
LOU064 Arm 3
n=47 Participants
100 mg capsule q.d. LOU064 once daily
|
LOU064 Arm 4
n=44 Participants
10 mg capsule LOU064 bid
|
LOU064 Arm 5
n=43 Participants
25 mg capsule LOU064 bid
|
LOU064 Arm 6
n=45 Participants
100 mg capsule LOU064 bid
|
Placebo Arm
n=42 Participants
Participants took matching placebo twice daily
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 4
|
-19.10 Scores on a scale
Standard Error 1.686
|
-19.08 Scores on a scale
Standard Error 1.690
|
-14.65 Scores on a scale
Standard Error 1.624
|
-15.99 Scores on a scale
Standard Error 1.686
|
-20.02 Scores on a scale
Standard Error 1.708
|
-18.06 Scores on a scale
Standard Error 1.691
|
-5.44 Scores on a scale
Standard Error 1.739
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set (FAS) included all randomized subjects. Following intent-to-treat principle, subjects were analyzed according to the treatment and strata assigned to at randomization.
UAS7 score change (LS mean Change) from baseline at Week 12 estimated with a mixed-effect repeated measurement analysis of UAS7 score change from baseline (FAS)
Outcome measures
| Measure |
LOU064 Arm 1
n=41 Participants
10 mg LOU064 q.d. capsule once daily
|
LOU064 Arm 2
n=41 Participants
35 mg capsule q.d. LOU064 once daily
|
LOU064 Arm 3
n=45 Participants
100 mg capsule q.d. LOU064 once daily
|
LOU064 Arm 4
n=40 Participants
10 mg capsule LOU064 bid
|
LOU064 Arm 5
n=39 Participants
25 mg capsule LOU064 bid
|
LOU064 Arm 6
n=35 Participants
100 mg capsule LOU064 bid
|
Placebo Arm
n=39 Participants
Participants took matching placebo twice daily
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12
|
-18.11 Score
Standard Error 1.934
|
-17.97 Score
Standard Error 1.934
|
-15.27 Score
Standard Error 1.850
|
-17.67 Score
Standard Error 1.939
|
-20.21 Score
Standard Error 1.964
|
-17.38 Score
Standard Error 1.985
|
-7.87 Score
Standard Error 2.001
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set (FAS) included all randomized subjects. Following intent-to-treat principle, subjects were analyzed according to the treatment and strata assigned to at randomization.
UAS7=0 and UAS7\<=6 response rate over time by treatment group (non-responder imputation) The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. The maximum UAS7 value is 42. A higher score indicates more severe disease. A negative change score (week 4 score minus Baseline score) indicates improvement.
Outcome measures
| Measure |
LOU064 Arm 1
n=44 Participants
10 mg LOU064 q.d. capsule once daily
|
LOU064 Arm 2
n=44 Participants
35 mg capsule q.d. LOU064 once daily
|
LOU064 Arm 3
n=47 Participants
100 mg capsule q.d. LOU064 once daily
|
LOU064 Arm 4
n=44 Participants
10 mg capsule LOU064 bid
|
LOU064 Arm 5
n=43 Participants
25 mg capsule LOU064 bid
|
LOU064 Arm 6
n=45 Participants
100 mg capsule LOU064 bid
|
Placebo Arm
n=42 Participants
Participants took matching placebo twice daily
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Either Complete Absence of Hives and Itch (UAS7=0) or Well-controlled Disease (UAS7<=6)
UAS<=6
|
47.7 Percent of participants
Interval 34.8 to 61.0
|
52.3 Percent of participants
Interval 39.0 to 65.2
|
38.3 Percent of participants
Interval 34.8 to 61.0
|
47.7 Percent of participants
Interval 26.6 to 61.0
|
55.8 Percent of participants
Interval 42.3 to 68.6
|
42.2 Percent of participants
Interval 29.9 to 55.5
|
28.6 Percent of participants
Interval 17.7 to 42.3
|
|
Percentage of Participants With Either Complete Absence of Hives and Itch (UAS7=0) or Well-controlled Disease (UAS7<=6)
UAS7=0
|
29.5 Percent of participants
Interval 18.7 to 43.0
|
29.5 Percent of participants
Interval 18.7 to 43.0
|
29.8 Percent of participants
Interval 19.3 to 42.7
|
31.8 Percent of participants
Interval 20.6 to 45.3
|
41.9 Percent of participants
Interval 29.3 to 55.5
|
26.7 Percent of participants
Interval 16.5 to 39.8
|
14.3 Percent of participants
Interval 6.7 to 26.7
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Full Analysis Set (FAS) included all randomized subjects. Following intent-to-treat principle, subjects were analyzed according to the treatment and strata assigned to at randomization.
The Weekly angioedema activity score (AAS) is a validated tool to assess occurrence of episodes of angioedema. If the subject reports the occurrence of angioedema ("opening question") with "no", AAS score for this day is 0. If "yes" is the answer to the opening question, the subject will continue to answer questions about the duration, severity and impact on daily functioning and appearance of the angioedema. The AAS7 is a weekly AAS score (AAS7). Minimum and maximum possible AAS7 scores are 0-105. Higher score means more severe disease.
Outcome measures
| Measure |
LOU064 Arm 1
n=44 Participants
10 mg LOU064 q.d. capsule once daily
|
LOU064 Arm 2
n=44 Participants
35 mg capsule q.d. LOU064 once daily
|
LOU064 Arm 3
n=47 Participants
100 mg capsule q.d. LOU064 once daily
|
LOU064 Arm 4
n=44 Participants
10 mg capsule LOU064 bid
|
LOU064 Arm 5
n=43 Participants
25 mg capsule LOU064 bid
|
LOU064 Arm 6
n=45 Participants
100 mg capsule LOU064 bid
|
Placebo Arm
n=42 Participants
Participants took matching placebo twice daily
|
|---|---|---|---|---|---|---|---|
|
Cumulative Number of Weeks With an AAS7=0 Response
|
10.2 Weeks
Standard Deviation 2.33
|
10.5 Weeks
Standard Deviation 2.59
|
10.0 Weeks
Standard Deviation 3.06
|
9.8 Weeks
Standard Deviation 3.05
|
10.3 Weeks
Standard Deviation 2.45
|
9.2 Weeks
Standard Deviation 3.38
|
8.2 Weeks
Standard Deviation 3.50
|
SECONDARY outcome
Timeframe: Week 4 and Week 12Population: Full Analysis Set (FAS) included all randomized subjects. Following intent-to-treat principle, subjects were analyzed according to the treatment and strata assigned to at randomization.
Percentage of subjects with DLQI 0/1 response by treatment group and visit (non-responder imputation) The Dermatology Life Quality Index (DLQI) is a 10-item dermatology-specific quality of life (QoL) measure. Subjects rate their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives thinking about the previous 7 days. An overall score is calculated and ranges from 0 to 30 (higher score meaning worse disease-related QoL). A DLQI score of 0 or 1 means that there is no impact of a skin disease on the patient's life.
Outcome measures
| Measure |
LOU064 Arm 1
n=44 Participants
10 mg LOU064 q.d. capsule once daily
|
LOU064 Arm 2
n=44 Participants
35 mg capsule q.d. LOU064 once daily
|
LOU064 Arm 3
n=47 Participants
100 mg capsule q.d. LOU064 once daily
|
LOU064 Arm 4
n=44 Participants
10 mg capsule LOU064 bid
|
LOU064 Arm 5
n=43 Participants
25 mg capsule LOU064 bid
|
LOU064 Arm 6
n=45 Participants
100 mg capsule LOU064 bid
|
Placebo Arm
n=42 Participants
Participants took matching placebo twice daily
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With DLQI Score of 0 or 1
Week 4
|
38.6 Percentage of participants
Interval 26.5 to 52.2
|
29.5 Percentage of participants
Interval 18.7 to 43.0
|
29.8 Percentage of participants
Interval 19.3 to 42.7
|
29.5 Percentage of participants
Interval 18.7 to 43.0
|
51.2 Percentage of participants
Interval 37.8 to 64.3
|
33.3 Percentage of participants
Interval 22.1 to 46.7
|
16.7 Percentage of participants
Interval 8.4 to 29.4
|
|
Percentage of Participants With DLQI Score of 0 or 1
Week 12
|
34.1 Percentage of participants
Interval 22.6 to 47.6
|
40.9 Percentage of participants
Interval 28.6 to 54.4
|
38.3 Percentage of participants
Interval 26.6 to 51.4
|
40.9 Percentage of participants
Interval 28.6 to 54.4
|
53.5 Percentage of participants
Interval 40.0 to 66.5
|
35.6 Percentage of participants
Interval 24.0 to 48.9
|
28.6 Percentage of participants
Interval 17.7 to 42.3
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: FAS
Summary of DLQI score and change from baseline The Dermatology Life Quality Index (DLQI) is a 10-item dermatology-specific quality of life (QoL) measure. Subjects rate their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives thinking about the previous 7 days. An overall score is calculated and ranges from 0 to 30 (higher score meaning worse disease-related QoL).
Outcome measures
| Measure |
LOU064 Arm 1
n=44 Participants
10 mg LOU064 q.d. capsule once daily
|
LOU064 Arm 2
n=44 Participants
35 mg capsule q.d. LOU064 once daily
|
LOU064 Arm 3
n=47 Participants
100 mg capsule q.d. LOU064 once daily
|
LOU064 Arm 4
n=44 Participants
10 mg capsule LOU064 bid
|
LOU064 Arm 5
n=43 Participants
25 mg capsule LOU064 bid
|
LOU064 Arm 6
n=45 Participants
100 mg capsule LOU064 bid
|
Placebo Arm
n=42 Participants
Participants took matching placebo twice daily
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in DLQI Score
Week 4
|
-9.60 Scores on a scale
Standard Deviation 7.214
|
-8.38 Scores on a scale
Standard Deviation 7.241
|
-7.18 Scores on a scale
Standard Deviation 7.534
|
-6.20 Scores on a scale
Standard Deviation 6.416
|
-9.21 Scores on a scale
Standard Deviation 7.994
|
-6.15 Scores on a scale
Standard Deviation 5.149
|
-3.33 Scores on a scale
Standard Deviation 8.090
|
|
Mean Change From Baseline in DLQI Score
Week 12
|
-9.03 Scores on a scale
Standard Deviation 6.216
|
-7.31 Scores on a scale
Standard Deviation 9.392
|
-6.60 Scores on a scale
Standard Deviation 7.798
|
-8.25 Scores on a scale
Standard Deviation 6.551
|
-8.97 Scores on a scale
Standard Deviation 8.891
|
-6.27 Scores on a scale
Standard Deviation 5.513
|
-4.38 Scores on a scale
Standard Deviation 6.780
|
SECONDARY outcome
Timeframe: Week 4 and Week 12Population: Full Analysis Set (FAS) included all randomized subjects. Following intent-to-treat principle, subjects were analyzed according to the treatment and strata assigned to at randomization.
Assessment of the area under the blood concentration-time curve (AUC) up to four hours following oral administration at Week 4 and Week 12 .
Outcome measures
| Measure |
LOU064 Arm 1
n=44 Participants
10 mg LOU064 q.d. capsule once daily
|
LOU064 Arm 2
n=44 Participants
35 mg capsule q.d. LOU064 once daily
|
LOU064 Arm 3
n=47 Participants
100 mg capsule q.d. LOU064 once daily
|
LOU064 Arm 4
n=44 Participants
10 mg capsule LOU064 bid
|
LOU064 Arm 5
n=43 Participants
25 mg capsule LOU064 bid
|
LOU064 Arm 6
n=45 Participants
100 mg capsule LOU064 bid
|
Placebo Arm
Participants took matching placebo twice daily
|
|---|---|---|---|---|---|---|---|
|
Area Under the Blood Concentration-time Curve (AUC) of LOU064
Week 4
|
45.2 hr*ng/mL
Standard Deviation 18.4
|
131 hr*ng/mL
Standard Deviation 65.4
|
427 hr*ng/mL
Standard Deviation 314
|
55.9 hr*ng/mL
Standard Deviation 32.3
|
107 hr*ng/mL
Standard Deviation 56.8
|
418 hr*ng/mL
Standard Deviation 246
|
—
|
|
Area Under the Blood Concentration-time Curve (AUC) of LOU064
Week 12
|
41.8 hr*ng/mL
Standard Deviation 19.5
|
159 hr*ng/mL
Standard Deviation 151
|
441 hr*ng/mL
Standard Deviation 313
|
54.4 hr*ng/mL
Standard Deviation 29.4
|
118 hr*ng/mL
Standard Deviation 66.6
|
469 hr*ng/mL
Standard Deviation 240
|
—
|
SECONDARY outcome
Timeframe: Week 4 and Week 12Population: FAS
Assessment of the observed maximum blood concentration (Cmax) of LOU064 following drug administration at Week 4 and Week 12 .
Outcome measures
| Measure |
LOU064 Arm 1
n=44 Participants
10 mg LOU064 q.d. capsule once daily
|
LOU064 Arm 2
n=44 Participants
35 mg capsule q.d. LOU064 once daily
|
LOU064 Arm 3
n=47 Participants
100 mg capsule q.d. LOU064 once daily
|
LOU064 Arm 4
n=44 Participants
10 mg capsule LOU064 bid
|
LOU064 Arm 5
n=43 Participants
25 mg capsule LOU064 bid
|
LOU064 Arm 6
n=45 Participants
100 mg capsule LOU064 bid
|
Placebo Arm
Participants took matching placebo twice daily
|
|---|---|---|---|---|---|---|---|
|
Observed Maximum Blood Concentration (Cmax) of LOU064
Week 4
|
27.6 ng/mL
Standard Deviation 13.7
|
67.2 ng/mL
Standard Deviation 32.7
|
194 ng/mL
Standard Deviation 142
|
32.2 ng/mL
Standard Deviation 18.7
|
55.5 ng/mL
Standard Deviation 34.7
|
196 ng/mL
Standard Deviation 144
|
—
|
|
Observed Maximum Blood Concentration (Cmax) of LOU064
Week 12
|
26.1 ng/mL
Standard Deviation 14.5
|
80.3 ng/mL
Standard Deviation 53.9
|
199 ng/mL
Standard Deviation 137
|
31.2 ng/mL
Standard Deviation 16.0
|
64.9 ng/mL
Standard Deviation 42.3
|
219 ng/mL
Standard Deviation 125
|
—
|
SECONDARY outcome
Timeframe: Week 4 and Week 12Population: Full Analysis Set (FAS) included all randomized subjects. Following intent-to-treat principle, subjects were analyzed according to the treatment and strata assigned to at randomization.
Assessment of the time to reach the maximum concentration (Tmax) of LOU064 following drug administration at Weeks 4 and 12
Outcome measures
| Measure |
LOU064 Arm 1
n=44 Participants
10 mg LOU064 q.d. capsule once daily
|
LOU064 Arm 2
n=44 Participants
35 mg capsule q.d. LOU064 once daily
|
LOU064 Arm 3
n=47 Participants
100 mg capsule q.d. LOU064 once daily
|
LOU064 Arm 4
n=44 Participants
10 mg capsule LOU064 bid
|
LOU064 Arm 5
n=43 Participants
25 mg capsule LOU064 bid
|
LOU064 Arm 6
n=45 Participants
100 mg capsule LOU064 bid
|
Placebo Arm
Participants took matching placebo twice daily
|
|---|---|---|---|---|---|---|---|
|
Time to Reach the Maximum Concentration (Tmax) of LOU064
Week 12
|
1.17 hours
Interval 0.0 to 4.08
|
1.48 hours
Interval 0.5 to 4.0
|
1.61 hours
Interval 0.0 to 4.0
|
1.17 hours
Interval 0.5 to 4.0
|
1.32 hours
Interval 0.0 to 4.0
|
1.39 hours
Interval 0.5 to 4.0
|
—
|
|
Time to Reach the Maximum Concentration (Tmax) of LOU064
Week 4
|
1.33 hours
Interval 0.0 to 4.0
|
1.54 hours
Interval 0.0 to 4.0
|
1.52 hours
Interval 0.5 to 3.0
|
0.900 hours
Interval 0.0 to 2.0
|
1.15 hours
Interval 0.0 to 3.02
|
1.52 hours
Interval 0.0 to 3.08
|
—
|
Adverse Events
LOU064 10mg q.d.
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
LOU064 35mg q.d.
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
LOU064 100mg q.d.
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
LOU064 10mg b.i.d.
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
LOU064 25mg b.i.d.
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
LOU064 100mg b.i.d.
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Any LOU064
Serious events: 5 serious events
Other events: 74 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LOU064 10mg q.d.
n=44 participants at risk
10 mg LOU064 qd capsule once daily
|
LOU064 35mg q.d.
n=44 participants at risk
35 mg capsule qd LOU064 once daily
|
LOU064 100mg q.d.
n=47 participants at risk
100 mg capsule qd LOU064 once daily
|
LOU064 10mg b.i.d.
n=44 participants at risk
10 mg capsule LOU064 bid
|
LOU064 25mg b.i.d.
n=43 participants at risk
25 mg capsule LOU064 bid
|
LOU064 100mg b.i.d.
n=45 participants at risk
100 mg capsule LOU064 bid
|
Any LOU064
n=267 participants at risk
Any LOU064
|
Placebo
n=42 participants at risk
Participants took matching placebo twice daily
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.3%
1/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/47 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/43 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/45 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.37%
1/267 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/42 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
|
Infections and infestations
Renal abscess
|
0.00%
0/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/47 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
2.3%
1/43 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/45 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.37%
1/267 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/42 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/47 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
2.3%
1/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/43 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/45 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.37%
1/267 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/42 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
|
Skin and subcutaneous tissue disorders
Chronic spontaneous urticaria
|
0.00%
0/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/47 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
2.3%
1/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
2.3%
1/43 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/45 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.75%
2/267 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/42 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
Other adverse events
| Measure |
LOU064 10mg q.d.
n=44 participants at risk
10 mg LOU064 qd capsule once daily
|
LOU064 35mg q.d.
n=44 participants at risk
35 mg capsule qd LOU064 once daily
|
LOU064 100mg q.d.
n=47 participants at risk
100 mg capsule qd LOU064 once daily
|
LOU064 10mg b.i.d.
n=44 participants at risk
10 mg capsule LOU064 bid
|
LOU064 25mg b.i.d.
n=43 participants at risk
25 mg capsule LOU064 bid
|
LOU064 100mg b.i.d.
n=45 participants at risk
100 mg capsule LOU064 bid
|
Any LOU064
n=267 participants at risk
Any LOU064
|
Placebo
n=42 participants at risk
Participants took matching placebo twice daily
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
2/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/47 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
9.1%
4/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/43 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
2.2%
1/45 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
2.6%
7/267 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
4.8%
2/42 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
|
Gastrointestinal disorders
Nausea
|
4.5%
2/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
6.8%
3/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
2.1%
1/47 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
2.3%
1/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
2.3%
1/43 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
4.4%
2/45 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
3.7%
10/267 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/42 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
|
General disorders
Pyrexia
|
6.8%
3/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/47 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
4.5%
2/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
2.3%
1/43 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/45 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
2.2%
6/267 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/42 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
|
Infections and infestations
Nasopharyngitis
|
15.9%
7/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
4.5%
2/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
4.3%
2/47 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
9.1%
4/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
9.3%
4/43 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
8.9%
4/45 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
8.6%
23/267 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
7.1%
3/42 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
1/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
4.5%
2/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
4.3%
2/47 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
7.0%
3/43 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
0.00%
0/45 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
3.0%
8/267 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
2.4%
1/42 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
|
Nervous system disorders
Headache
|
2.3%
1/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
15.9%
7/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
8.5%
4/47 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
6.8%
3/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
14.0%
6/43 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
11.1%
5/45 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
9.7%
26/267 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
14.3%
6/42 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
|
Skin and subcutaneous tissue disorders
Chronic spontaneous urticaria
|
6.8%
3/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
4.5%
2/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
6.4%
3/47 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
9.1%
4/44 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
4.7%
2/43 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
4.4%
2/45 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
6.0%
16/267 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
2.4%
1/42 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until 30 days after last dose of study treatment, and up to 16 weeks
AEs and SAEs are any untoward sign or symptom that occurs during the study treatment and up to 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER