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ACTIVE NOT RECRUITING

NCT06685835

PHASE2

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

Sponsor: Insmed Incorporated

View on ClinicalTrials.gov

Summary

The primary purpose of the study is to 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

214

Start Date

2024-12-16

Completion Date

2026-11-17

Last Updated

2026-03-06

Healthy Volunteers

Conditions

Hidradenitis Suppurativa

Interventions

DRUG

Brensocatib

Film-coated Oral tablet

DRUG

Placebo

Film-coated Oral tablet

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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 a. Doxycycline or minocycline up to 100 mg twice daily is permitted provided the dosing regimen being stable for at least 8 weeks before the Baseline Visit and is expected to continue. * 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. Note: Other Inclusion/Exclusion criteria may apply.

Locations (72)

USA001

Phoenix, Arizona, United States

USA007

Sacramento, California, United States

USA026

Coral Gables, Florida, United States

USA027

Hollywood, Florida, United States

USA021

Margate, Florida, United States

USA018

Miami, Florida, United States

USA025

Ocala, Florida, United States

USA004

Tampa, Florida, United States

USA010

Weston, Florida, United States

USA028

Atlanta, Georgia, United States

USA011

Sandy Springs, Georgia, United States

USA003

Plainfield, Indiana, United States

USA002

Baton Rouge, Louisiana, United States

USA017

Boston, Massachusetts, United States

USA012

Detroit, Michigan, United States

USA024

Fort Gratiot, Michigan, United States

USA020

Minneapolis, Minnesota, United States

USA015

St Louis, Missouri, United States

USA013

Lebanon, New Hampshire, United States

USA009

Cleveland, Ohio, United States

USA016

Springfield, Ohio, United States

USA019

Hershey, Pennsylvania, United States

USA022

Philadelphia, Pennsylvania, United States

USA005

Dallas, Texas, United States

USA023

Dallas, Texas, United States

USA008

Spokane, Washington, United States

AUS003

Darlinghurst, New South Wales, Australia

AUS004

Kogarah, New South Wales, Australia

AUS001

Brisbane, Queensland, Australia

AUS006

Woolloongabba, Queensland, Australia

AUS002

Fremantle, Western Australia, Australia

BGR001

Lovech, Bulgaria

BGR003

Pleven, Bulgaria

BGR004

Sofia, Bulgaria

BGR002

Stara Zagora, Bulgaria

CAN003

Barrie, Ontario, Canada

CAN006

Guelph, Ontario, Canada

CAN007

Peterborough, Ontario, Canada

CAN011

Richmond Hill, Ontario, Canada

CAN009

Richmond Hill, Ontario, Canada

CAN010

Toronto, Ontario, Canada

CAN004

Québec, Canada

FRA001

Lyon, Auvergne-Rhône-Alpes, France

FRA004

Toulouse, Haute-Garonne, France

FRA002

Antony, France

FRA003

Paris, France

FRA005

Rouen, France

DEU007

Langenau, Baden-Wurttemberg, Germany

DEU002

Darmstadt, Hesse, Germany

DEU001

Bochum, North Rhine-Westphalia, Germany

DEU003

Dresden, Saxony, Germany

DEU006

Dessau-RoÃŸlau, Germany

DEU005

Lübeck, Germany

GRC002

Athens, Attica, Greece

GRC004

Chaïdári, Attica, Greece

GRC001

N. Efkapria-Pavlos Melas, Thessaloniki, Greece

GRC003

Thessaloniki, Greece

NLD001

Rotterdam, Netherlands

POL006

Wroclaw, Lower Silesian Voivodeship, Poland

POL008

Warsaw, Masovian Voivodeship, Poland

POL002

Rzeszów, Podkarpackie Voivodeship, Poland

POL004

Krakow, Poland

POL007

Warsaw, Poland

POL001

Warsaw, Poland

POL005

Wroclaw, Poland

POL003

Wroclaw, Poland

ESP006

Badalona, Barcelona, Spain

ESP004

Las Palmas de Gran Canaria, Las Palmas Provincia, Spain

ESP001

Manises, Valencia, Spain

ESP002

Madrid, Spain

ESP005

Madrid, Spain

ESP003

Madrid, Spain

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (72)