Trial · NCT03852472
Evaluation of Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa (AURORA)
NCT03852472, Phase 2, Completed, Amgen; results first posted 2024-03-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa (AURORA). Trials, record NCT03852472. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03852472
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa (AURORA)
- NCT number
- NCT03852472
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 435 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Hidradenitis Suppurativa, Acne Inversa
- Interventions
- Avacopan, Placebo
- First posted
- 2019-02-25
- Last updated
- 2025-03-17
- Results first posted
- 2024-03-15
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12. | 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. |
| Secondary | Change From Baseline in Total AN Count at Week 12 | 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 |
| Secondary | 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 | 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 |
| Secondary | Area Under the Curve From Time 0-3hrs (AUC 0-3hrs) of Metabolite M1 Plasma Concentration on Day 1 | 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 |
| Secondary | Number of Responders With Baseline Hurley Stage II Who Achieved an AN Count of 0, 1, or 2 at Week 12 | 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. |
| Secondary | Change of IHS4 Score Relative to Baseline at Week 12. | 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 |
| Secondary | Change From Baseline in Inflammatory Nodule Count at Week 12 | 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. |
| Secondary | Change From Baseline in Abscess Count at Week 12 | 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. |
| Secondary | Change From Baseline in Draining Fistula Count at Week 12 | 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. |
| Secondary | Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12. | Baseline to Week 12 | percentage of participants | NUMBER | |
| SECONDARY | Change From Baseline in Total AN Count at Week 12 | Baseline to Week 12 | percentage of ANs | MEAN | |
| SECONDARY | 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 | Baseline to Week 12 | number of responders | NUMBER | |
| SECONDARY | Area Under the Curve From Time 0-3hrs (AUC 0-3hrs) of Metabolite M1 Plasma Concentration on Day 1 | Day 1 | h*ng/mL | MEAN | |
| SECONDARY | Number of Responders With Baseline Hurley Stage II Who Achieved an AN Count of 0, 1, or 2 at Week 12 | Baseline and Week 12 | number of responders | NUMBER | |
| SECONDARY | Change of IHS4 Score Relative to Baseline at Week 12. | Baseline and Week 12 | score on a scale | MEAN | |
| SECONDARY | Change From Baseline in Inflammatory Nodule Count at Week 12 | Baseline and Week 12 | count of inflammatory nodules | MEAN | |
| SECONDARY | Change From Baseline in Abscess Count at Week 12 | Baseline and Week 12 | count of abscesses | MEAN | |
| SECONDARY | Change From Baseline in Draining Fistula Count at Week 12 | Baseline and Week 2, Week 4, Week 8 and Week 12 | Draining Fistulae | MEAN | |
| SECONDARY | Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS | Baseline and Week 2, Week 4, Week 8 and Week 12 | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group47
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12. | Placebo | 30.8 | percentage of participants | ||
| Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12. | Avacopan 10 mg | 22.4 | percentage of participants | ||
| Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12. | Avacopan 30 mg | 35.1 | percentage of participants | ||
| Change From Baseline in Total AN Count at Week 12 | Placebo | -3.1 | Standard Deviation 8.57 | percentage of ANs | |
| Change From Baseline in Total AN Count at Week 12 | Avacopan 10 mg | -3.4 | Standard Deviation 10.58 | percentage of ANs | |
| Change From Baseline in Total AN Count at Week 12 | Avacopan 30 mg | -5.1 | Standard Deviation 8.41 | percentage of ANs | |
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 | Placebo | 26 | number of responders | ||
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 | Avacopan 10 mg | 23 | number of responders | ||
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 | Avacopan 30 mg | 17 | number of responders | ||
| Area Under the Curve From Time 0-3hrs (AUC 0-3hrs) of Metabolite M1 Plasma Concentration on Day 1 | Avacopan 10 mg | 18.0 | Standard Deviation 8.23 | h*ng/mL |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 results by groupParticipant flow50
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 - 12 Weeks | STARTED | Group A | 130 | |
| Period 1 - 12 Weeks | STARTED | Group B | 134 | |
| Period 1 - 12 Weeks | STARTED | Group C | 134 | |
| Period 1 - 12 Weeks | STARTED | Placebo to Avacopan 10 mg | 0 | |
| Period 1 - 12 Weeks | STARTED | Placebo to Avacopan 30 mg | 0 | |
| Period 1 - 12 Weeks | Excluded Site 138 Subjects From ITT1 | Group A | 13 | |
| Period 1 - 12 Weeks | Excluded Site 138 Subjects From ITT1 | Group B | 11 | |
| Period 1 - 12 Weeks | Excluded Site 138 Subjects From ITT1 | Group C | 13 | |
| Period 1 - 12 Weeks | Excluded Site 138 Subjects From ITT1 | Placebo to Avacopan 10 mg | 0 | |
| Period 1 - 12 Weeks | Excluded Site 138 Subjects From ITT1 | Placebo to Avacopan 30 mg | 0 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 participant flowAdverse events161
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hidradenitis | Skin and subcutaneous tissue disorders | Placebo Period 1 | 17 | 129 | 35 |
| other | Hidradenitis | Skin and subcutaneous tissue disorders | Avacopan 10 mg Period 1 | 14 | 134 | 15 |
| other | Hidradenitis | Skin and subcutaneous tissue disorders | Avacopan 30 mg Period 1 | 12 | 135 | 23 |
| other | Hidradenitis | Skin and subcutaneous tissue disorders | Placebo to Avacopan 10 mg Period 2 | 5 | 56 | 6 |
| other | Hidradenitis | Skin and subcutaneous tissue disorders | Placebo to Avacopan 30 mg Period 2 | 8 | 52 | 12 |
| other | Hidradenitis | Skin and subcutaneous tissue disorders | Avacopan 10 mg Period 2 | 19 | 108 | 30 |
| other | Hidradenitis | Skin and subcutaneous tissue disorders | Avacopan 30 mg Period 2 | 19 | 109 | 31 |
| other | Headache | Nervous system disorders | Placebo Period 1 | 4 | 129 | 10 |
| other | Headache | Nervous system disorders | Avacopan 10 mg Period 1 | 8 | 134 | 8 |
| other | Headache | Nervous system disorders | Avacopan 30 mg Period 1 | 4 | 135 | 4 |
1 to 10 of 161Source ClinicalTrials.gov
See all 161 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Period 1 | 0 | 129 |
| Total, all-cause mortality | Avacopan 10 mg Period 1 | 0 | 134 |
| Total, all-cause mortality | Avacopan 30 mg Period 1 | 0 | 135 |
| Total, all-cause mortality | Placebo to Avacopan 10 mg Period 2 | 0 | 56 |
| Total, all-cause mortality | Placebo to Avacopan 30 mg Period 2 | 0 | 52 |
| Total, all-cause mortality | Avacopan 10 mg Period 2 | 0 | 108 |
| Total, all-cause mortality | Avacopan 30 mg Period 2 | 0 | 109 |
| Total, other adverse events | Placebo Period 1 | 22 | 129 |
| Total, other adverse events | Avacopan 10 mg Period 1 | 18 | 134 |
| Total, other adverse events | Avacopan 30 mg Period 1 | 15 | 135 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03852472
GET https://conductscience.org/api/trials/v1/NCT03852472/results?page=2