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

Hidradenitis Suppurativa Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. Primary efficacy analysis will be at 12 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03852472
Study type Interventional
Source ChemoCentryx
Contact
Status Completed
Phase Phase 2
Start date December 21, 2018
Completion date March 9, 2021
View Details
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