Clinical trial NCT03852472: Evaluation of Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa (AURORA)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Acne Inversa
Keywords: Avacopan
ChemoCentryx
Skin Disease
Inflammatory nodule
Abscess
Sinus formation
Fistula formation
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2019-02-25
Enrollment: 435
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 2 study of Avacopan in Subjects with Moderate to Severe Hidradenitis Suppurativa

Detailed description: 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.

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Primary efficacy analysis will be at 12 weeks.

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

Primary outcomes:
measure: Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12.
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Change From Baseline in Total AN Count at Week 12
timeFrame: Baseline to Week 12
measure: 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
timeFrame: Baseline to Week 12
measure: Area Under the Curve From Time 0-3hrs (AUC 0-3hrs) of Metabolite M1 Plasma Concentration on Day 1
timeFrame: Day 1
measure: Number of Responders With Baseline Hurley Stage II Who Achieved an AN Count of 0, 1, or 2 at Week 12
timeFrame: Baseline and Week 12
measure: Change of IHS4 Score Relative to Baseline at Week 12.
timeFrame: Baseline and Week 12
measure: Change From Baseline in Inflammatory Nodule Count at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Abscess Count at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Draining Fistula Count at Week 12
timeFrame: Baseline and Week 2, Week 4, Week 8 and Week 12
measure: Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS
timeFrame: Baseline and Week 2, Week 4, Week 8 and Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Site
state: Alabama
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city: Mobile
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state: Alabama
city: Phoenix
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state: Arizona
city: Scottsdale
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city: Rogers
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city: Rochester
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city: Chapel Hill
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state: North Carolina
city: Charlotte
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city: Charlotte
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city: Bexley
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city: Cleveland
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state: Ohio
city: Marion
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city: Mason
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state: Ohio
city: Norman
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state: Oklahoma
city: Portland
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city: Hershey
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city: Philadelphia
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state: Pennsylvania
city: Warwick
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state: Rhode Island
city: Charleston
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state: South Carolina
city: Nashville
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state: Tennessee
city: Austin
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state: Texas
city: Austin
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state: Texas
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state: Texas
city: Sugar Land
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state: Texas
city: Spokane
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state: Washington
city: Morgantown
country: United States
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state: West Virginia
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: