Evaluation of Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa (AURORA)

Study Overview
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Brief Summary
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Phase 2 study of Avacopan in Subjects with Moderate to Severe Hidradenitis Suppurativa

Detailed Description
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A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 study in subjects with moderate to severe Hidradenitis Suppurativa. The study is multicenter and will consist of three subject groups. Subjects will be randomized 1:1:1 to a treatment of 10mg avacopan twice daily, 30 mg avacopan twice daily or placebo twice daily for 12 weeks. Following the 12 weeks double-blind treatment period, subjects on placebo will be re-randomized 1:1 to receive 10 mg or 30 mg avacopan twice daily for additional 24 weeks. Subjects treated with avacopan will continue to receive the same dose (either 10 mg or 30 mg twice daily) for additional 24 weeks. Subjects will be on study treatment for 36 weeks and will be followed for 44 weeks for assessment of safety and efficacy. Primary efficacy analysis will be at 12 weeks.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa

Conditions
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Hidradenitis Suppurativa, Acne Inversa

Intervention / Treatment
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* Drug: Avacopan
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group A<br>Placebo b.i.d | Other: Placebo<br>* Placebo<br>|
| Active Comparator: Group B<br>Avacopan 10 mg b.i.d | Drug: Avacopan<br>* Active treatment<br>* Other names: CCX168;|
| Active Comparator: Group C<br>Avacopan 30 mg b.i.d | Drug: Avacopan<br>* Active treatment<br>* Other names: CCX168;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary efficacy endpoint assessed by the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12. | The proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Avacopan, ChemoCentryx, Skin Disease, Inflammatory nodule, Abscess, Sinus formation, Fistula formation