ACTIVE_NOT_RECRUITING

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

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Conditions

Hidradenitis SuppurativaHS

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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:2024-12-16
Study Completion:2027-01-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_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 CriteriaExclusion Criteria
  1. * Diagnosis of HS (confirmed by a dermatologist), with a history of signs and symptoms consistent with HS for at least 6 months before the Screening Visit.
  2. * 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.
  3. * 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.
  1. * Draining tunnel count of ≥20 at the Baseline Visit.
  2. * Surgical or laser intervention for an HS lesion during the Screening Period.
  3. * Clinical diagnosis of Papillon-Lefèvre Syndrome.
  4. * Participants with an absolute neutrophil count \<1,000/mm3 at the Screening Visit.
  5. * Participants having active liver disease or hepatic dysfunction.
  6. * Have diagnosed periodontal disease under active management by a dentist or expected to have periodontal disease-related procedures within the study period.
  7. * Received systemic (intravenous or orally \[PO\]) antibiotic therapy within 8 weeks before the Baseline Visit
  8. * Received PO or transdermal opioid analgesics (except tramadol) for any reason within 4 weeks before the Baseline Visit.
  9. * Permitted analgesics for HS-related pain have not been at a stable dose regimen for at least 4 weeks before the Baseline Visit.
  10. * Received prescription topical therapies for the treatment of HS within 2 weeks before the Baseline Visit.
  11. * 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.
  12. * Received systemic nonbiologic therapies (eg, corticosteroids and retinoids) for HS within 4 weeks before the Baseline Visit.
  13. * Received any immunomodulatory agents within 4 weeks before the Baseline Visit.

Contacts and Locations

Study Locations (Sites)

USA001
Phoenix, Arizona, 85054-4502
United States
USA007
Sacramento, California, 95815
United States
USA026
Coral Gables, Florida, 33134
United States
USA027
Hollywood, Florida, 33024
United States
USA021
Margate, Florida, 33063
United States
USA018
Miami, Florida, 33125
United States
USA025
Ocala, Florida, 34470
United States
USA004
Tampa, Florida, 33613
United States
USA010
Weston, Florida, 33331
United States
USA028
Atlanta, Georgia, 30329
United States
USA011
Sandy Springs, Georgia, 30328
United States
USA003
Plainfield, Indiana, 46168
United States
USA002
Baton Rouge, Louisiana, 70809-2725
United States
USA017
Boston, Massachusetts, 02115
United States
USA012
Detroit, Michigan, 48201
United States
USA024
Fort Gratiot, Michigan, 48059
United States
USA020
Minneapolis, Minnesota, 55455
United States
USA015
St Louis, Missouri, 63104
United States
USA013
Lebanon, New Hampshire, 03766
United States
USA009
Cleveland, Ohio, 44106-1716
United States
USA016
Springfield, Ohio, 45505
United States
USA019
Hershey, Pennsylvania, 17033-2360
United States
USA022
Philadelphia, Pennsylvania, 19104-5127
United States
USA005
Dallas, Texas, 75230
United States
USA023
Dallas, Texas, 75231-6077
United States
USA008
Spokane, Washington, 99202
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 Date2024-12-16
Study Completion Date2027-01-28

Study Record Updates

Study Start Date2024-12-16
Study Completion Date2027-01-28

Terms related to this study

Keywords Provided by Researchers

  • HS

Additional Relevant MeSH Terms

  • Hidradenitis Suppurativa