Trial Outcomes & Findings for Evaluation of Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa (AURORA) (NCT NCT03852472)
NCT ID: NCT03852472
Last Updated: 2025-03-17
Results Overview
The percentage of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 in the ITT1 population using the NRI-CMH Test. A response was defined as a reduction of at least 50 in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count compared with baseline. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1. NRI- non-responder imputation; CMH- Cochran-Mantel-Haenszel. Percentage values have been reported as opposed to proportion values to allow for statistical analyses.
COMPLETED
PHASE2
435 participants
Baseline to Week 12
2025-03-17
Participant Flow
Participant milestones
| Measure |
Group A
Period 1- Placebo BID for 12 Weeks
|
Group B
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
|
Group C
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
|
Placebo to Avacopan 10 mg
Treatment period 2, subjects randomized to placebo during period 1 were rerandomized 1:1 to receive 10 mg or 30 mg avacopan BID in period 2.
|
Placebo to Avacopan 30 mg
Treatment period 2, subjects randomized to placebo during period 1 were rerandomized 1:1 to receive 10 mg or 30 mg avacopan BID in period 2.
|
|---|---|---|---|---|---|
|
Period 1 - 12 Weeks
STARTED
|
130
|
134
|
134
|
0
|
0
|
|
Period 1 - 12 Weeks
Excluded Site 138 Subjects From ITT1
|
13
|
11
|
13
|
0
|
0
|
|
Period 1 - 12 Weeks
COMPLETED
|
109
|
108
|
109
|
0
|
0
|
|
Period 1 - 12 Weeks
NOT COMPLETED
|
21
|
26
|
25
|
0
|
0
|
|
Period 2 - Week 44
STARTED
|
0
|
108
|
108
|
56
|
53
|
|
Period 2 - Week 44
Excluded Site 138 Subjects From ITT2
|
0
|
7
|
9
|
3
|
6
|
|
Period 2 - Week 44
Completed Week 36
|
0
|
71
|
79
|
41
|
36
|
|
Period 2 - Week 44
Completed Week 44
|
0
|
70
|
75
|
39
|
35
|
|
Period 2 - Week 44
COMPLETED
|
0
|
70
|
75
|
39
|
35
|
|
Period 2 - Week 44
NOT COMPLETED
|
0
|
38
|
33
|
17
|
18
|
Reasons for withdrawal
| Measure |
Group A
Period 1- Placebo BID for 12 Weeks
|
Group B
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
|
Group C
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
|
Placebo to Avacopan 10 mg
Treatment period 2, subjects randomized to placebo during period 1 were rerandomized 1:1 to receive 10 mg or 30 mg avacopan BID in period 2.
|
Placebo to Avacopan 30 mg
Treatment period 2, subjects randomized to placebo during period 1 were rerandomized 1:1 to receive 10 mg or 30 mg avacopan BID in period 2.
|
|---|---|---|---|---|---|
|
Period 1 - 12 Weeks
Withdrawal by Subject
|
8
|
10
|
7
|
0
|
0
|
|
Period 1 - 12 Weeks
Subject noncompliance with dosing or diary completion
|
0
|
1
|
3
|
0
|
0
|
|
Period 1 - 12 Weeks
Lost to Follow-up
|
5
|
5
|
7
|
0
|
0
|
|
Period 1 - 12 Weeks
Noncompliance with the protocol
|
2
|
0
|
4
|
0
|
0
|
|
Period 1 - 12 Weeks
At the discretion of the investigator or sponsor for any reason
|
0
|
3
|
0
|
0
|
0
|
|
Period 1 - 12 Weeks
Adverse Event
|
4
|
6
|
4
|
0
|
0
|
|
Period 1 - 12 Weeks
Reason not stated
|
2
|
1
|
0
|
0
|
0
|
|
Period 2 - Week 44
Withdrawal by Subject
|
0
|
22
|
15
|
10
|
10
|
|
Period 2 - Week 44
Subject noncompliance with dosing or diary completion
|
0
|
2
|
1
|
1
|
0
|
|
Period 2 - Week 44
Lost to Follow-up
|
0
|
8
|
12
|
1
|
2
|
|
Period 2 - Week 44
Noncompliance with the protocol
|
0
|
2
|
1
|
0
|
0
|
|
Period 2 - Week 44
At the discretion of the investigator or sponsor for any reason
|
0
|
1
|
3
|
2
|
3
|
|
Period 2 - Week 44
Adverse Event
|
0
|
3
|
1
|
2
|
2
|
|
Period 2 - Week 44
COVID-19 Related
|
0
|
0
|
0
|
1
|
0
|
|
Period 2 - Week 44
Reason not stated
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Baseline characteristic value is not available for all patients.
Baseline characteristics by cohort
| Measure |
Group A
n=130 Participants
Period 1- Placebo BID for 12 Weeks
|
Group B
n=134 Participants
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
|
Group C
n=134 Participants
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
|
Total
n=398 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36.9 years
STANDARD_DEVIATION 11.87 • n=130 Participants
|
36.0 years
STANDARD_DEVIATION 12.05 • n=134 Participants
|
36.8 years
STANDARD_DEVIATION 11.57 • n=134 Participants
|
36.6 years
STANDARD_DEVIATION 11.81 • n=398 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=130 Participants
|
30 Participants
n=134 Participants
|
28 Participants
n=134 Participants
|
81 Participants
n=398 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=130 Participants
|
104 Participants
n=134 Participants
|
106 Participants
n=134 Participants
|
317 Participants
n=398 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=130 Participants
|
22 Participants
n=134 Participants
|
39 Participants
n=134 Participants
|
92 Participants
n=398 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
99 Participants
n=130 Participants
|
112 Participants
n=134 Participants
|
95 Participants
n=134 Participants
|
306 Participants
n=398 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=130 Participants
|
0 Participants
n=134 Participants
|
0 Participants
n=134 Participants
|
0 Participants
n=398 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=130 Participants
|
0 Participants
n=134 Participants
|
0 Participants
n=134 Participants
|
0 Participants
n=398 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=130 Participants
|
1 Participants
n=134 Participants
|
0 Participants
n=134 Participants
|
1 Participants
n=398 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=130 Participants
|
2 Participants
n=134 Participants
|
0 Participants
n=134 Participants
|
3 Participants
n=398 Participants
|
|
Race (NIH/OMB)
Black or African American
|
43 Participants
n=130 Participants
|
46 Participants
n=134 Participants
|
34 Participants
n=134 Participants
|
123 Participants
n=398 Participants
|
|
Race (NIH/OMB)
White
|
83 Participants
n=130 Participants
|
82 Participants
n=134 Participants
|
96 Participants
n=134 Participants
|
261 Participants
n=398 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=130 Participants
|
0 Participants
n=134 Participants
|
2 Participants
n=134 Participants
|
2 Participants
n=398 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=130 Participants
|
3 Participants
n=134 Participants
|
2 Participants
n=134 Participants
|
8 Participants
n=398 Participants
|
|
Height
|
166.69 cm
STANDARD_DEVIATION 8.696 • n=129 Participants • Baseline characteristic value is not available for all patients.
|
168.67 cm
STANDARD_DEVIATION 9.852 • n=134 Participants • Baseline characteristic value is not available for all patients.
|
167.66 cm
STANDARD_DEVIATION 9.021 • n=134 Participants • Baseline characteristic value is not available for all patients.
|
167.69 cm
STANDARD_DEVIATION 9.221 • n=397 Participants • Baseline characteristic value is not available for all patients.
|
|
Weight
|
102.48 kg
STANDARD_DEVIATION 23.425 • n=130 Participants
|
103.02 kg
STANDARD_DEVIATION 27.817 • n=134 Participants
|
103.46 kg
STANDARD_DEVIATION 28.601 • n=134 Participants
|
102.99 kg
STANDARD_DEVIATION 26.678 • n=398 Participants
|
|
BMI
|
36.87 kg/m²
STANDARD_DEVIATION 8.824 • n=129 Participants • Baseline characteristic value is not available for all patients.
|
36.14 kg/m²
STANDARD_DEVIATION 8.728 • n=134 Participants • Baseline characteristic value is not available for all patients.
|
36.75 kg/m²
STANDARD_DEVIATION 9.384 • n=134 Participants • Baseline characteristic value is not available for all patients.
|
36.58 kg/m²
STANDARD_DEVIATION 8.969 • n=397 Participants • Baseline characteristic value is not available for all patients.
|
|
Hurley Stage of HS
Stage II
|
85 Participants
n=130 Participants
|
84 Participants
n=134 Participants
|
87 Participants
n=134 Participants
|
256 Participants
n=398 Participants
|
|
Hurley Stage of HS
Stage III
|
45 Participants
n=130 Participants
|
50 Participants
n=134 Participants
|
47 Participants
n=134 Participants
|
142 Participants
n=398 Participants
|
|
HS Disease Duration from Time of Diagnosis
|
11.06 years
STANDARD_DEVIATION 10.275 • n=130 Participants
|
10.64 years
STANDARD_DEVIATION 8.733 • n=134 Participants
|
11.21 years
STANDARD_DEVIATION 9.521 • n=134 Participants
|
10.97 years
STANDARD_DEVIATION 9.502 • n=398 Participants
|
|
Number of AN Count
|
11.6 abscess and inflammatory nodules
STANDARD_DEVIATION 9.83 • n=130 Participants
|
13.5 abscess and inflammatory nodules
STANDARD_DEVIATION 13.41 • n=134 Participants
|
12.3 abscess and inflammatory nodules
STANDARD_DEVIATION 9.62 • n=134 Participants
|
12.5 abscess and inflammatory nodules
STANDARD_DEVIATION 11.10 • n=398 Participants
|
|
Number of Draining Fistulae
|
2.8 Draining Fistulae
STANDARD_DEVIATION 3.83 • n=130 Participants
|
3.2 Draining Fistulae
STANDARD_DEVIATION 4.15 • n=134 Participants
|
2.4 Draining Fistulae
STANDARD_DEVIATION 3.73 • n=134 Participants
|
2.8 Draining Fistulae
STANDARD_DEVIATION 3.91 • n=398 Participants
|
|
IHS4 Score
|
29.6 score on a scale
STANDARD_DEVIATION 29.34 • n=130 Participants
|
33.8 score on a scale
STANDARD_DEVIATION 31.95 • n=134 Participants
|
30.0 score on a scale
STANDARD_DEVIATION 25.02 • n=134 Participants
|
31.2 score on a scale
STANDARD_DEVIATION 28.90 • n=398 Participants
|
|
Subject's Global Assessment of Skin Pain NRS
|
5.6 score on a scale
STANDARD_DEVIATION 2.52 • n=126 Participants • Baseline characteristic value is not available for all patients.
|
5.3 score on a scale
STANDARD_DEVIATION 2.54 • n=129 Participants • Baseline characteristic value is not available for all patients.
|
5.2 score on a scale
STANDARD_DEVIATION 2.47 • n=127 Participants • Baseline characteristic value is not available for all patients.
|
5.4 score on a scale
STANDARD_DEVIATION 2.51 • n=382 Participants • Baseline characteristic value is not available for all patients.
|
|
Previous TNF Inhibitor Use
Yes
|
35 Participants
n=130 Participants
|
38 Participants
n=134 Participants
|
36 Participants
n=134 Participants
|
109 Participants
n=398 Participants
|
|
Previous TNF Inhibitor Use
No
|
95 Participants
n=130 Participants
|
96 Participants
n=134 Participants
|
98 Participants
n=134 Participants
|
289 Participants
n=398 Participants
|
|
Previously Started (allowed) Concomitant Antibiotic
Yes
|
8 Participants
n=130 Participants
|
9 Participants
n=134 Participants
|
7 Participants
n=134 Participants
|
24 Participants
n=398 Participants
|
|
Previously Started (allowed) Concomitant Antibiotic
No
|
122 Participants
n=130 Participants
|
125 Participants
n=134 Participants
|
127 Participants
n=134 Participants
|
374 Participants
n=398 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12The percentage of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 in the ITT1 population using the NRI-CMH Test. A response was defined as a reduction of at least 50 in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count compared with baseline. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1. NRI- non-responder imputation; CMH- Cochran-Mantel-Haenszel. Percentage values have been reported as opposed to proportion values to allow for statistical analyses.
Outcome measures
| Measure |
Placebo
n=130 Participants
Placebo BID for 12 Weeks
|
Avacopan 10 mg
n=134 Participants
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
|
Avacopan 30 mg
n=134 Participants
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
|
|---|---|---|---|
|
Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12.
|
30.8 percentage of participants
|
22.4 percentage of participants
|
35.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12The Change from Baseline in total AN (abscess and inflammatory nodule) count at Week 12 using MMRM and OC in the ITT1 population. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1. MMRM - mixed effects model for repeated measures; OC- observed case
Outcome measures
| Measure |
Placebo
n=110 Participants
Placebo BID for 12 Weeks
|
Avacopan 10 mg
n=110 Participants
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
|
Avacopan 30 mg
n=110 Participants
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
|
|---|---|---|---|
|
Change From Baseline in Total AN Count at Week 12
|
-3.1 percentage of ANs
Standard Deviation 8.57
|
-3.4 percentage of ANs
Standard Deviation 10.58
|
-5.1 percentage of ANs
Standard Deviation 8.41
|
SECONDARY outcome
Timeframe: Baseline to Week 12NRS30 = The number of responders achieving at least 30% reduction and at least 1 unit reduction from baseline in the subject's global assessment of skin pain score. Percentage is based on the number of subjects with a baseline pain score of at least 3 in each treatment group. Weekly averages of daily pain will be calculated based on subjects' daily diary recording of the worst pain experienced in the previous 24 hours. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1. NRI- non-responder imputation
Outcome measures
| Measure |
Placebo
n=105 Participants
Placebo BID for 12 Weeks
|
Avacopan 10 mg
n=104 Participants
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
|
Avacopan 30 mg
n=104 Participants
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
|
|---|---|---|---|
|
Number of Responders Achieving at Least 30% Reduction and at Least 1 Unit Reduction From Baseline in the Subject's Global Assessment of Skin Pain (NRS30) in Subjects With a Baseline NRS of at Least 3, Evaluated at Week 12
|
26 number of responders
|
23 number of responders
|
17 number of responders
|
SECONDARY outcome
Timeframe: Day 1The Area under the curve from Time 0-3hrs (AUC 0-3hrs) of Metabolite M1 plasma concentration on Day 1 in the PK population. PK- pharmacokinetics
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebo BID for 12 Weeks
|
Avacopan 10 mg
n=29 Participants
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
|
Avacopan 30 mg
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
|
|---|---|---|---|
|
Area Under the Curve From Time 0-3hrs (AUC 0-3hrs) of Metabolite M1 Plasma Concentration on Day 1
|
18.0 h*ng/mL
Standard Deviation 8.23
|
50.3 h*ng/mL
Standard Deviation 34.3
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12The number of responders With Baseline Hurley Stage II Who Achieved an Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12 using the NRI-CMH Test in the ITT1 population. Hurley Stage II disease is defined as having 1 or more widely separated recurrent abscesses with tract formation and scars. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.
Outcome measures
| Measure |
Placebo
n=85 Participants
Placebo BID for 12 Weeks
|
Avacopan 10 mg
n=84 Participants
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
|
Avacopan 30 mg
n=87 Participants
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
|
|---|---|---|---|
|
Number of Responders With Baseline Hurley Stage II Who Achieved an AN Count of 0, 1, or 2 at Week 12
|
29 number of responders
|
15 number of responders
|
20 number of responders
|
SECONDARY outcome
Timeframe: Baseline and Week 12The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1. IHS4 score (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + \[number of draining tunnels (fistulae/sinuses) multiplied by 4\]. A score of 3 or less signifies mild HS, a score of 4-10 signifies moderate HS and a score of 11 or higher signifies severe HS. IHS4- International HS Severity Scoring System
Outcome measures
| Measure |
Placebo
n=110 Participants
Placebo BID for 12 Weeks
|
Avacopan 10 mg
n=110 Participants
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
|
Avacopan 30 mg
n=110 Participants
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
|
|---|---|---|---|
|
Change of IHS4 Score Relative to Baseline at Week 12.
|
-6.4 score on a scale
Standard Deviation 16.99
|
-7.9 score on a scale
Standard Deviation 22.14
|
-9.8 score on a scale
Standard Deviation 15.69
|
SECONDARY outcome
Timeframe: Baseline and Week 12A reduction in AN signifies improvement. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.
Outcome measures
| Measure |
Placebo
n=110 Participants
Placebo BID for 12 Weeks
|
Avacopan 10 mg
n=110 Participants
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
|
Avacopan 30 mg
n=110 Participants
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
|
|---|---|---|---|
|
Change From Baseline in Inflammatory Nodule Count at Week 12
|
-2.4 count of inflammatory nodules
Standard Deviation 7.48
|
-2.5 count of inflammatory nodules
Standard Deviation 9.17
|
-3.9 count of inflammatory nodules
Standard Deviation 7.06
|
SECONDARY outcome
Timeframe: Baseline and Week 12A reduction in abscess count signifies improvement. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.
Outcome measures
| Measure |
Placebo
n=110 Participants
Placebo BID for 12 Weeks
|
Avacopan 10 mg
n=110 Participants
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
|
Avacopan 30 mg
n=110 Participants
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
|
|---|---|---|---|
|
Change From Baseline in Abscess Count at Week 12
|
-0.8 count of abscesses
Standard Deviation 3.68
|
-0.8 count of abscesses
Standard Deviation 3.38
|
-1.2 count of abscesses
Standard Deviation 2.73
|
SECONDARY outcome
Timeframe: Baseline and Week 2, Week 4, Week 8 and Week 12The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.
Outcome measures
| Measure |
Placebo
n=130 Participants
Placebo BID for 12 Weeks
|
Avacopan 10 mg
n=134 Participants
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
|
Avacopan 30 mg
n=134 Participants
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
|
|---|---|---|---|
|
Change From Baseline in Draining Fistula Count at Week 12
Week 2
|
-0.3 Draining Fistulae
Standard Deviation 2.23
|
-0.5 Draining Fistulae
Standard Deviation 2.22
|
-0.4 Draining Fistulae
Standard Deviation 1.79
|
|
Change From Baseline in Draining Fistula Count at Week 12
Week 4
|
-0.5 Draining Fistulae
Standard Deviation 2.17
|
-0.8 Draining Fistulae
Standard Deviation 2.88
|
-0.4 Draining Fistulae
Standard Deviation 2.16
|
|
Change From Baseline in Draining Fistula Count at Week 12
Week 8
|
-0.4 Draining Fistulae
Standard Deviation 1.82
|
-0.9 Draining Fistulae
Standard Deviation 2.93
|
-0.6 Draining Fistulae
Standard Deviation 2.03
|
|
Change From Baseline in Draining Fistula Count at Week 12
Week 12
|
-0.6 Draining Fistulae
Standard Deviation 2.11
|
-0.9 Draining Fistulae
Standard Deviation 2.57
|
-0.5 Draining Fistulae
Standard Deviation 1.87
|
SECONDARY outcome
Timeframe: Baseline and Week 2, Week 4, Week 8 and Week 12Twelve body areas will be evaluated to calculate the Sartorius and modified Sartorius scores: left and right axillae, left and right inframammary areas, intermammary area, left and right buttocks, left and right inguinocrural folds, perianal area, perineal area, and other. The presence of nodules, abscesses, fistulae, scars, and other findings will be recorded. The longest distance between two lesions and whether lesions are separated by normal skin is recorded. A score of 4 indicates the least severe disease, and higher scores indicate increasingly severe disease. There is no upper limit in the score. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.
Outcome measures
| Measure |
Placebo
n=130 Participants
Placebo BID for 12 Weeks
|
Avacopan 10 mg
n=134 Participants
Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
|
Avacopan 30 mg
n=134 Participants
Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
|
|---|---|---|---|
|
Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS
Week 4
|
-5.7 score on a scale
Standard Deviation 23.70
|
-7.2 score on a scale
Standard Deviation 22.84
|
-6.5 score on a scale
Standard Deviation 21.37
|
|
Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS
Week 8
|
-9.8 score on a scale
Standard Deviation 32.60
|
-11.5 score on a scale
Standard Deviation 23.64
|
-10.4 score on a scale
Standard Deviation 26.43
|
|
Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS
Week 2
|
-3.0 score on a scale
Standard Deviation 21.02
|
-3.5 score on a scale
Standard Deviation 16.68
|
-6.3 score on a scale
Standard Deviation 17.72
|
|
Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS
Week 12
|
-11.2 score on a scale
Standard Deviation 35.69
|
-12.6 score on a scale
Standard Deviation 25.98
|
-14.4 score on a scale
Standard Deviation 29.96
|
Adverse Events
Placebo Period 1
Avacopan 10 mg Period 1
Avacopan 30 mg Period 1
Placebo to Avacopan 10 mg Period 2
Placebo to Avacopan 30 mg Period 2
Avacopan 10 mg Period 2
Avacopan 30 mg Period 2
Serious adverse events
| Measure |
Placebo Period 1
n=129 participants at risk
Subjects randomized to placebo during period 1
|
Avacopan 10 mg Period 1
n=134 participants at risk
Avacopan 10 mg twice daily (BID) for Period 1 of the study
|
Avacopan 30 mg Period 1
n=135 participants at risk
Avacopan 30 mg twice daily (BID) for Period 1 of the study
|
Placebo to Avacopan 10 mg Period 2
n=56 participants at risk
Placebo population from Period 1 split into Placebo to Avacopan 10 mg twice daily (BID) for Period 2 of the study
|
Placebo to Avacopan 30 mg Period 2
n=52 participants at risk
Placebo population from Period 1 split into Placebo to Avacopan 30 mg twice daily (BID) for Period 2 of the study
|
Avacopan 10 mg Period 2
n=108 participants at risk
Avacopan 10 mg twice daily (BID) for Period 2 of the study
|
Avacopan 30 mg Period 2
n=109 participants at risk
Avacopan 30 mg twice daily (BID) for Period 2 of the study
|
|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/129 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.75%
1/134 • Number of events 1 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/135 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/56 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/52 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/108 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/109 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.78%
1/129 • Number of events 1 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/134 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/135 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/56 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/52 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/108 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/109 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
|
Gastrointestinal disorders
Anal fistula
|
0.78%
1/129 • Number of events 1 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/134 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/135 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/56 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/52 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/108 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/109 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
|
Infections and infestations
Cellulitis
|
0.00%
0/129 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.75%
1/134 • Number of events 1 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/135 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/56 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/52 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/108 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/109 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/129 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/134 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.74%
1/135 • Number of events 1 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/56 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/52 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.93%
1/108 • Number of events 1 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/109 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
|
Gastrointestinal disorders
Gastritis
|
0.78%
1/129 • Number of events 1 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/134 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/135 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/56 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/52 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/108 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/109 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
|
Investigations
Lipase increased
|
0.78%
1/129 • Number of events 1 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/134 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/135 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/56 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/52 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/108 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/109 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/129 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.75%
1/134 • Number of events 1 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/135 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/56 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/52 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/108 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/109 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
|
Psychiatric disorders
Depression
|
0.00%
0/129 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.75%
1/134 • Number of events 1 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/135 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/56 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/52 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/108 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/109 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
|
Psychiatric disorders
Major depression
|
0.78%
1/129 • Number of events 1 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/134 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/135 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/56 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/52 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/108 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/109 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
|
Infections and infestations
Abscess neck
|
0.00%
0/129 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/134 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/135 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/56 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/52 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/108 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.92%
1/109 • Number of events 1 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/129 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/134 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/135 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/56 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/52 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.93%
1/108 • Number of events 1 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/109 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/129 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/134 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/135 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/56 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/52 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.93%
1/108 • Number of events 1 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/109 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/129 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/134 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/135 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/56 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/52 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.93%
1/108 • Number of events 1 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/109 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/129 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/134 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/135 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/56 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/52 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/108 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.92%
1/109 • Number of events 1 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/129 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/134 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/135 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/56 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
1.9%
1/52 • Number of events 1 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/108 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/109 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
|
Investigations
Tuberculin test false positive
|
0.00%
0/129 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/134 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/135 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/56 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/52 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.93%
1/108 • Number of events 1 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/109 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
Other adverse events
| Measure |
Placebo Period 1
n=129 participants at risk
Subjects randomized to placebo during period 1
|
Avacopan 10 mg Period 1
n=134 participants at risk
Avacopan 10 mg twice daily (BID) for Period 1 of the study
|
Avacopan 30 mg Period 1
n=135 participants at risk
Avacopan 30 mg twice daily (BID) for Period 1 of the study
|
Placebo to Avacopan 10 mg Period 2
n=56 participants at risk
Placebo population from Period 1 split into Placebo to Avacopan 10 mg twice daily (BID) for Period 2 of the study
|
Placebo to Avacopan 30 mg Period 2
n=52 participants at risk
Placebo population from Period 1 split into Placebo to Avacopan 30 mg twice daily (BID) for Period 2 of the study
|
Avacopan 10 mg Period 2
n=108 participants at risk
Avacopan 10 mg twice daily (BID) for Period 2 of the study
|
Avacopan 30 mg Period 2
n=109 participants at risk
Avacopan 30 mg twice daily (BID) for Period 2 of the study
|
|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
13.2%
17/129 • Number of events 35 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
10.4%
14/134 • Number of events 15 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
8.9%
12/135 • Number of events 23 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
8.9%
5/56 • Number of events 6 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
15.4%
8/52 • Number of events 12 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
17.6%
19/108 • Number of events 30 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
17.4%
19/109 • Number of events 31 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
|
Nervous system disorders
Headache
|
3.1%
4/129 • Number of events 10 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
6.0%
8/134 • Number of events 8 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
3.0%
4/135 • Number of events 4 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
5.4%
3/56 • Number of events 4 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/52 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
1.9%
2/108 • Number of events 2 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.92%
1/109 • Number of events 1 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
|
Gastrointestinal disorders
Nausea
|
6.2%
8/129 • Number of events 8 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
2.2%
3/134 • Number of events 3 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
3.0%
4/135 • Number of events 4 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/56 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/52 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/108 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/109 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/129 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.75%
1/134 • Number of events 1 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/135 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.00%
0/56 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
3.8%
2/52 • Number of events 2 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
6.5%
7/108 • Number of events 7 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
4.6%
5/109 • Number of events 5 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
|
Infections and infestations
Upper respiratory tract infection
|
3.9%
5/129 • Number of events 5 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
1.5%
2/134 • Number of events 2 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
3.0%
4/135 • Number of events 4 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
5.4%
3/56 • Number of events 3 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
1.9%
1/52 • Number of events 1 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
1.9%
2/108 • Number of events 2 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.92%
1/109 • Number of events 1 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
|
Investigations
Alanine aminotransferase increased
|
1.6%
2/129 • Number of events 2 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
3.0%
4/134 • Number of events 4 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
0.74%
1/135 • Number of events 1 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
5.4%
3/56 • Number of events 3 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
1.9%
1/52 • Number of events 1 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
4.6%
5/108 • Number of events 6 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
2.8%
3/109 • Number of events 4 • All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks
The Safety 1 population was the same as the ITT1 except subjects were assigned to the treatment they received; 1 subject randomized to the placebo group received Avacopan 30 mg during period 1. Thus, this subject is counted in the groups "Avacopan 30 mg Period 1" and "Avacopan 30 mg Period 2" instead of in groups "Placebo Period 1" and "Placebo to Avacopan 30 mg Period 2", respectively
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place