NCT03852472

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 435 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hidradenitis Suppurativa
• Acne Inversa

Interventions

Type	Name	Description
DRUG	Avacopan	Active treatment
OTHER	Placebo	Placebo

Timeline

• Start date: 2018-12-21
• Primary completion: 2021-01-14
• Completion: 2021-03-09
• First posted: 2019-02-25
• Last updated: 2025-03-17
• Results posted: 2024-03-15

Locations

91 sites across 1 country: United States

Regulatory

• FDA-regulated drug study