Evaluation of Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa (AURORA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03852472|
Recruitment Status : Active, not recruiting
First Posted : February 25, 2019
Last Update Posted : September 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hidradenitis Suppurativa Acne Inversa||Drug: Avacopan Other: Placebo||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||390 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||December 28, 2018|
|Actual Primary Completion Date :||July 30, 2020|
|Estimated Study Completion Date :||June 30, 2021|
Placebo Comparator: Group A
Active Comparator: Group B
Avacopan 10 mg b.i.d
Other Name: CCX168
Active Comparator: Group C
Avacopan 30 mg b.i.d
Other Name: CCX168
- Primary efficacy endpoint assessed by the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12. [ Time Frame: 12 weeks ]The proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03852472
|Study Director:||Peter Staehr, MD||ChemoCentryx Inc|