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

Amgen

Status and phase: Completed; Phase 2

Conditions: Acne Inversa; Hidradenitis Suppurativa

Treatments: Other: Placebo; Drug: Avacopan

Study type: Interventional

Funder types: Industry

Identifiers

NCT03852472

CL016_168

Details and patient eligibility

About

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

Full 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.

Enrollment: 435 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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435 participants in 5 patient groups, including a placebo group

Group A

Placebo Comparator group

Description:

Placebo twice daily (BID) for Period 1 of the study

Treatment:

Other: Placebo

Group B

Experimental group

Description:

Avacopan 10 mg twice daily (BID) for Period 1+2 of the study

Treatment:

Drug: Avacopan

Group C

Experimental group

Description:

Avacopan 30 mg twice daily (BID) for Period 1+2 of the study

Treatment:

Drug: Avacopan

Placebo to Avacopan 10 mg

Experimental group

Description:

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.

Treatment:

Drug: Avacopan

Placebo to Avacopan 30 mg

Experimental group

Description:

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.

Treatment:

Drug: Avacopan