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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

435 participants

Primary outcome timeframe

Baseline to Week 12

Results posted on

2025-03-17

Participant Flow

Participant milestones

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

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

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 12

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.

Outcome measures

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 12

The 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

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 12

NRS30 = 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

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 1

The 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

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 12

The 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

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 12

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. 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

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 12

A 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

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 12

A 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

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 12

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

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 12

Twelve 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

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

Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths

Avacopan 10 mg Period 1

Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths

Avacopan 30 mg Period 1

Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths

Placebo to Avacopan 10 mg Period 2

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Placebo to Avacopan 30 mg Period 2

Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths

Avacopan 10 mg Period 2

Serious events: 4 serious events
Other events: 21 other events
Deaths: 0 deaths

Avacopan 30 mg Period 2

Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths

Serious adverse events

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

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

Study Director

Chemocentryx

Phone: 650-210-2900

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place