RECRUITING

A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary purpose of the study is evaluate the effect of brensocatib compared with placebo.

Official Title

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa - The CEDAR Study

Quick Facts

Study Start:2024-12-30

Study Completion:2027-01-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06685835

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Diagnosis of HS (confirmed by a dermatologist), with a history of HS for at least 6 months before the Screening Visit. * Moderate or severe HS defined as a total of ≥6 inflammatory lesions (inflammatory nodules and/or abscesses) for at least 8 weeks before the Baseline Visit. * HS lesions in at least 2 distinct anatomic areas, 1 of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline Visits.	* Draining tunnel count of ≥20 at the Baseline Visit. * Surgical or laser intervention for an HS lesion during the Screening Period. * Clinical diagnosis of Papillon-Lefèvre Syndrome. * Participants with an absolute neutrophil count \<1,000/mm3 at the Screening Visit. * Participants having active liver disease or hepatic dysfunction. * Have diagnosed periodontal disease under active management by a dentist or expected to have periodontal disease-related procedures within the study period. * Received systemic (intravenous or orally \[PO\]) antibiotic therapy within 8 weeks before the Baseline Visit * Received PO or transdermal opioid analgesics (except tramadol) for any reason within 4 weeks before the Baseline Visit. * Permitted analgesics for HS-related pain have not been at a stable dose regimen for at least 4 weeks before the Baseline Visit. * Received prescription topical therapies for the treatment of HS within 2 weeks before the Baseline Visit. * Received any anti-tumor necrosis factor (TNF)-α/other biologics treatment within 12 weeks or 5 elimination half-lives, whichever is longer, before the Baseline Visit. * Received systemic nonbiologic therapies (eg, corticosteroids and retinoids) for HS within 4 weeks before the Baseline Visit. * Received any immunomodulatory agents within 4 weeks before the Baseline Visit.

Inclusion Criteria

Exclusion Criteria

* Diagnosis of HS (confirmed by a dermatologist), with a history of HS for at least 6 months before the Screening Visit.
* Moderate or severe HS defined as a total of ≥6 inflammatory lesions (inflammatory nodules and/or abscesses) for at least 8 weeks before the Baseline Visit.
* HS lesions in at least 2 distinct anatomic areas, 1 of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline Visits.

* Draining tunnel count of ≥20 at the Baseline Visit.
* Surgical or laser intervention for an HS lesion during the Screening Period.
* Clinical diagnosis of Papillon-Lefèvre Syndrome.
* Participants with an absolute neutrophil count \<1,000/mm3 at the Screening Visit.
* Participants having active liver disease or hepatic dysfunction.
* Have diagnosed periodontal disease under active management by a dentist or expected to have periodontal disease-related procedures within the study period.
* Received systemic (intravenous or orally \[PO\]) antibiotic therapy within 8 weeks before the Baseline Visit
* Received PO or transdermal opioid analgesics (except tramadol) for any reason within 4 weeks before the Baseline Visit.
* Permitted analgesics for HS-related pain have not been at a stable dose regimen for at least 4 weeks before the Baseline Visit.
* Received prescription topical therapies for the treatment of HS within 2 weeks before the Baseline Visit.
* Received any anti-tumor necrosis factor (TNF)-α/other biologics treatment within 12 weeks or 5 elimination half-lives, whichever is longer, before the Baseline Visit.
* Received systemic nonbiologic therapies (eg, corticosteroids and retinoids) for HS within 4 weeks before the Baseline Visit.
* Received any immunomodulatory agents within 4 weeks before the Baseline Visit.

Contacts and Locations

Study Contact

Insmed Medical Information

CONTACT

1-844-446-7633

medicalinformation@insmed.com

Study Locations (Sites)

USA002

Baton Rouge, Louisiana, 70809-2725

United States

Collaborators and Investigators

Sponsor: Insmed Incorporated

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-30

Study Completion Date2027-01-28

Study Record Updates

Study Start Date2024-12-30

Study Completion Date2027-01-28

Terms related to this study

Keywords Provided by Researchers

Additional Relevant MeSH Terms

Hidradenitis Suppurativa