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 Details — Status: Completed

Administrative data

• NCT number: NCT03852472
• Other study ID #: CL016_168
• Status: Completed
• Phase: Phase 2
• Start date: December 21, 2018
• Est. completion date: March 9, 2021

Study information

• Verified date: February 2024
• Source: ChemoCentryx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 435
• Est. completion date: March 9, 2021
• Est. primary completion date: January 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-a 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-a 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

Related Conditions & MeSH terms

• Acne Inversa
• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• Avacopan
Active treatment

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Clinical Site	Athens	Ohio
United States	Clinical Site	Atlanta	Georgia
United States	Clinical Site	Austin	Texas
United States	Clinical Site	Austin	Texas
United States	Clinical Site	Beverly	Massachusetts
United States	Clinical Site	Bexley	Ohio
United States	Clinical Site	Birmingham	Alabama
United States	Clinical Site	Birmingham	Alabama
United States	Clinical Site	Boca Raton	Florida
United States	Clinical Site	Boise	Idaho
United States	Clinical Site	Boston	Massachusetts
United States	Clinical Site	Chapel Hill	North Carolina
United States	Clinical Site	Charleston	South Carolina
United States	Clinical Site	Charlotte	North Carolina
United States	Clinical Site	Charlotte	North Carolina
United States	Clinical Site	Charlotte	North Carolina
United States	Clinical Site	Clarkston	Michigan
United States	Clinical Site	Clearwater	Florida
United States	Clinical Site	Cleveland	Ohio
United States	Clinical Site	Crown Point	Indiana
United States	Clinical Site	Dallas	Texas
United States	Clinical Site	Drexel Hill	Pennsylvania
United States	Clinical Site	Evansville	Indiana
United States	Clinical Site	Fort Gratiot	Michigan
United States	Clinical Site	Fort Smith	Arkansas
United States	Clinical Site	Fountain Valley	California
United States	Clinical Site	Fremont	California
United States	Clinical Site	Fullerton	California
United States	Clinical Site	Hershey	Pennsylvania
United States	Clinical Site	Hialeah	Florida
United States	Clinical Site	Hollywood	Florida
United States	Clinical Site	Homestead	Florida
United States	Clinical Site	Houston	Texas
United States	Clinical Site	Houston	Texas
United States	Clinical Site	Houston	Texas
United States	Clinical Site	Huntington Beach	California
United States	Clinical Site	Indianapolis	Indiana
United States	Clinical Site	Inglewood	California
United States	Clinical Site	Largo	Maryland
United States	Clinical Site	Los Angeles	California
United States	Clinical Site	Los Angeles	California
United States	Clinical Site	Los Angeles	California
United States	Clinical Site	Louisville	Kentucky
United States	Clinical Site	Manhattan Beach	California
United States	Clinical Site	Marietta	Georgia
United States	Clinical Site	Marion	Ohio
United States	Clinical Site	Mason	Ohio
United States	Clinical Site	Metairie	Louisiana
United States	Clinical Site	Miami	Florida
United States	Clinical Site	Miami	Florida
United States	Clinical Site	Miami	Florida
United States	Clinical Site	Minneapolis	Minnesota
United States	Clinical Site	Mobile	Alabama
United States	Clinical Site	Morgantown	West Virginia
United States	Clinical Site	Nashville	Tennessee
United States	Clinical Site	New Orleans	Louisiana
United States	Clinical Site	New York	New York
United States	Clinical Site	Newnan	Georgia
United States	Clinical Site	Newport Beach	California
United States	Clinical Site	Norman	Oklahoma
United States	Clinical Site	Northridge	California
United States	Clinical Site	Ocala	Florida
United States	Clinical Site	Omaha	Nebraska
United States	Clinical Site	Orlando	Florida
United States	Clinical Site	Pembroke Pines	Florida
United States	Clinical Site	Philadelphia	Pennsylvania
United States	Clinical Site	Phoenix	Arizona
United States	Clinical Site	Portland	Oregon
United States	Clinical Site	Quincy	Massachusetts
United States	Clinical Site	Redwood City	California
United States	Clinical Site	Rochester	New York
United States	Clinical Site	Rogers	Arkansas
United States	Clinical Site	Saint Joseph	Michigan
United States	Clinical Site	Saint Louis	Missouri
United States	Clinical Site	San Antonio	Texas
United States	Clinical Site	Sandy Springs	Georgia
United States	Clinical Site	Scottsdale	Arizona
United States	Clinical Site	Skokie	Illinois
United States	Clinical Site	Skokie	Illinois
United States	Clinical Site	Spokane	Washington
United States	Clinical Site	Sugar Land	Texas
United States	Clinical Site	Tampa	Florida
United States	Clinical Site	Tampa	Florida
United States	Clinical Site	Tampa	Florida
United States	Clinical Site	Thousand Oaks	California
United States	Clinical Site	Troy	Michigan
United States	Clinical Site	Verona	New Jersey
United States	Clinical Site	Walnut Creek	California
United States	Clinical Site	Warwick	Rhode Island
United States	Clinical Site	Weston	Florida
United States	Clinical Site	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
ChemoCentryx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12.	The percentage of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 in the ITT1 population using the NRI-CMH Test. A response was defined as a reduction of at least 50 in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count compared with baseline.; The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.; NRI- non-responder imputation; CMH- Cochran-Mantel-Haenszel. Percentage values have been reported as opposed to proportion values to allow for statistical analyses.	Baseline to Week 12
Secondary	Change From Baseline in Total AN Count at Week 12	The Change from Baseline in total AN (abscess and inflammatory nodule) count at Week 12 using MMRM and OC in the ITT1 population.; The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.; MMRM - mixed effects model for repeated measures; OC- observed case	Baseline to Week 12
Secondary	Number of Responders Achieving at Least 30% Reduction and at Least 1 Unit Reduction From Baseline in the Subject's Global Assessment of Skin Pain (NRS30) in Subjects With a Baseline NRS of at Least 3, Evaluated at Week 12	NRS30 = The number of responders achieving at least 30% reduction and at least 1 unit reduction from baseline in the subject's global assessment of skin pain score. Percentage is based on the number of subjects with a baseline pain score of at least 3 in each treatment group.; Weekly averages of daily pain will be calculated based on subjects' daily diary recording of the worst pain experienced in the previous 24 hours.; The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.; NRI- non-responder imputation	Baseline to Week 12
Secondary	Area Under the Curve From Time 0-3hrs (AUC 0-3hrs) of Metabolite M1 Plasma Concentration on Day 1	The Area under the curve from Time 0-3hrs (AUC 0-3hrs) of Metabolite M1 plasma concentration on Day 1 in the PK population.; PK- pharmacokinetics	Day 1
Secondary	Number of Responders With Baseline Hurley Stage II Who Achieved an AN Count of 0, 1, or 2 at Week 12	The number of responders With Baseline Hurley Stage II Who Achieved an Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12 using the NRI-CMH Test in the ITT1 population. Hurley Stage II disease is defined as having 1 or more widely separated recurrent abscesses with tract formation and scars.; The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.	Baseline and Week 12
Secondary	Change of IHS4 Score Relative to Baseline at Week 12.	The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.; IHS4 score (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + [number of draining tunnels (fistulae/sinuses) multiplied by 4]. A score of 3 or less signifies mild HS, a score of 4-10 signifies moderate HS and a score of 11 or higher signifies severe HS.; IHS4- International HS Severity Scoring System	Baseline and Week 12
Secondary	Change From Baseline in Inflammatory Nodule Count at Week 12	A reduction in AN signifies improvement. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.	Baseline and Week 12
Secondary	Change From Baseline in Abscess Count at Week 12	A reduction in abscess count signifies improvement. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.	Baseline and Week 12
Secondary	Change From Baseline in Draining Fistula Count at Week 12	The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.	Baseline and Week 2, Week 4, Week 8 and Week 12
Secondary	Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS	Twelve body areas will be evaluated to calculate the Sartorius and modified Sartorius scores: left and right axillae, left and right inframammary areas, intermammary area, left and right buttocks, left and right inguinocrural folds, perianal area, perineal area, and other. The presence of nodules, abscesses, fistulae, scars, and other findings will be recorded. The longest distance between two lesions and whether lesions are separated by normal skin is recorded. A score of 4 indicates the least severe disease, and higher scores indicate increasingly severe disease. There is no upper limit in the score. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.	Baseline and Week 2, Week 4, Week 8 and Week 12