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

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ClinicalTrials.gov Identifier: NCT03852472
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
ChemoCentryx

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

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Acne Inversa Drug: Avacopan Other: Placebo Phase 2

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.

Primary efficacy analysis will be at 12 weeks.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Primary Completion Date : May 21, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Group A
Placebo b.i.d
Other: Placebo
Placebo

Active Comparator: Group B
Avacopan 10 mg b.i.d
Drug: Avacopan
Active treatment
Other Name: CCX168

Active Comparator: Group C
Avacopan 30 mg b.i.d
Drug: Avacopan
Active treatment
Other Name: CCX168




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 of at least 90 days
  • Must have at least 3 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-α 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-α 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
  • With the exception of permissible antibiotic treatment regimen, have received 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

Information from the National Library of Medicine

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


Contacts
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Contact: Jin Li 650-210-2986 jli@chemocentryx.com

  Show 47 Study Locations
Sponsors and Collaborators
ChemoCentryx
Investigators
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Study Director: Peter Staehr, MD ChemoCentryx Inc

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Responsible Party: ChemoCentryx
ClinicalTrials.gov Identifier: NCT03852472     History of Changes
Other Study ID Numbers: CL016_168
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ChemoCentryx:
Avacopan
ChemoCentryx
Skin Disease
Inflammatory nodule
Abscess
Sinus formation
Fistula formation

Additional relevant MeSH terms:
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Hidradenitis
Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration