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

Conditions

• Acne Inversa
• Hidradenitis Suppurativa

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Avacopan — DRUG
  Active treatment
• Placebo — OTHER
  Placebo

Study Details

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

Key Dates

Start date

Dec 21, 2018

Status verified

Feb 2025

Primary completion

Jan 14, 2021

Completion

Mar 9, 2021

Study Design

Enrollment

435 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Group A
  Placebo twice daily (BID) for Period 1 of the study
• Experimental: Group B
  Avacopan 10 mg twice daily (BID) for Period 1+2 of the study
• Experimental: Group C
  Avacopan 30 mg twice daily (BID) for Period 1+2 of the study
• Experimental: Placebo to Avacopan 10 mg
  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.
• Experimental: Placebo to Avacopan 30 mg
  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.

Primary Outcome Measure

Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12. [ Time Frame: Baseline to Week 12 ]

Locations (91)

Find similar trials in Birmingham, AL

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