Phase 2
Completed N=398
Evaluation of Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa (AURORA)
Hidradenitis suppurativa · Acne Inversa
Source: ClinicalTrials.gov NCT03852472 ↗
Enrolled (actual)
398
Serious AEs
1.9%
Results posted
Mar 2024
Primary outcomePrimary: Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12. — 30.8; 22.4; 35.1 percentage of participants — p=0.1321
Summary
Phase 2 study of Avacopan in Subjects with Moderate to Severe Hidradenitis Suppurativa
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12. |
30.8; 22.4; 35.1 | 0.1321 |
| SECONDARY Change From Baseline in Total AN Count at Week 12 |
-3.1; -3.4; -5.1 | 0.5784 |
| 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 |
26; 23; 17 | — |
| SECONDARY Area Under the Curve From Time 0-3hrs (AUC 0-3hrs) of Metabolite M1 Plasma Concentration on Day 1 |
18.0; 50.3 | — |
| SECONDARY Number of Responders With Baseline Hurley Stage II Who Achieved an AN Count of 0, 1, or 2 at Week 12 |
29; 15; 20 | — |
| SECONDARY Change of IHS4 Score Relative to Baseline at Week 12. |
-6.4; -7.9; -9.8 | — |
| SECONDARY Change From Baseline in Inflammatory Nodule Count at Week 12 |
-2.4; -2.5; -3.9 | — |
| SECONDARY Change From Baseline in Abscess Count at Week 12 |
-0.8; -0.8; -1.2 | — |
| SECONDARY Change From Baseline in Draining Fistula Count at Week 12 |
-0.3; -0.5; -0.4; -0.5; -0.8; -0.4 | — |
| SECONDARY Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS |
-3.0; -3.5; -6.3; -5.7; -7.2; -6.5 | — |
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age
- Clinical diagnosis of HS (Hurley Stage II or III), confirmed by a dermatologist, for at least 6 months prior to Screening
- HS lesions are present in at least 2 distinct anatomic areas
- Inadequate or loss of response to a systemic course of antibiotics typically of at least 90 days
- Must have at least 5 inflammatory nodules or abscesses at screening
- Use adequate birth control for subject and partners of child bearing potential
- Willing and able to give written Informed Consent
Exclusion Criteria
- Pregnant or breast-feeding
- Any other skin disease that may interfere with the assessment of HS
- Rapidly progressive, expanding HS within 30 days prior to screening
- More than 20 draining fistulae at screening
- Any anti-TNF-α treatment for HS or for other conditions prior to Day 1 visit will be prohibited. Exception: Subjects who were previously treated with an anti-TNF-α drug and discontinued treatment >12 weeks prior to Day 1 visit are allowed for enrollment
- Systemic antibiotics are generally excluded
- Topical antibiotics use within 14 days prior to Day 1 is excluded
- Have started a topical prescription medicine for HS within 14 days prior to screening
- A systemic medicine for HS, including biologics and other systemic therapies
- Have received within 14 days prior to Day 1 visit or is expected to require oral or transdermal opioid analgesics (except for tramadol) for any reason
Data sourced from ClinicalTrials.gov (NCT03852472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.