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

NCT06685835 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: INS1007-2312024-515959-38-00
• Study Type: interventional
• Target: 214
• Locations: 10 countries
• Sites: 72

Brief Summary

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

Conditions

Hidradenitis Suppurativa

Keywords

HS

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Total Abscess and Inflammatory Nodule (AN) Count at Week 16

  Baseline and Week 16

Secondary Outcomes (11)

• Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16

  Week 16

• Percentage of Participants Achieving HiSCR75 at Week 16

  Week 16

• Percentage of Participants Achieving ≥2-point Decrease From Baseline in Hidradenitis Suppurativa - Investigator's Global Assessment (HS-IGA) at Week 16

  Week 16

• Change From Baseline in Draining Tunnel Count at Week 16

  Baseline and Week 16

• Percentage of Participants Remaining Free from HS Flare by Week 16

  Week 16

Study Arms (4)

Brensocatib 10 mg

EXPERIMENTAL

Participants will receive brensocatib 10 mg tablet, once daily (QD), orally for 52 weeks.

Drug: Brensocatib

Brensocatib 40 mg

EXPERIMENTAL

Participants will receive brensocatib 40 mg tablet, QD, orally for 52 weeks.

Drug: Brensocatib

Placebo Followed by Brensocatib 10 mg

PLACEBO COMPARATOR

Participants will receive brensocatib-matching placebo tablet, QD, orally for 16 weeks, and then Brensocatib 10 mg tablet, QD, orally for 36 weeks.

Drug: Brensocatib; Drug: Placebo

Placebo Followed by Brensocatib 40 mg

PLACEBO COMPARATOR

Participants will receive brensocatib-matching placebo tablet, QD, orally for 16 weeks, and then Brensocatib 40 mg tablet, QD, orally for 36 weeks.

Drug: Brensocatib; Drug: Placebo

Interventions

Brensocatib DRUG

Film-coated Oral tablet

Also known as: INS1007

Brensocatib 10 mg; Brensocatib 40 mg; Placebo Followed by Brensocatib 10 mg; Placebo Followed by Brensocatib 40 mg

Placebo DRUG

Film-coated Oral tablet

Placebo Followed by Brensocatib 10 mg; Placebo Followed by Brensocatib 40 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insmed Incorporated: lead

Study Sites (72)

USA001

Phoenix, Arizona, 85054-4502, United States

Location

USA007

Sacramento, California, 95815, United States

Location

USA026

Coral Gables, Florida, 33134, United States

Location

USA027

Hollywood, Florida, 33024, United States

Location

USA021

Margate, Florida, 33063, United States

Location

USA018

Miami, Florida, 33125, United States

Location

USA025

Ocala, Florida, 34470, United States

Location

USA004

Tampa, Florida, 33613, United States

Location

USA010

Weston, Florida, 33331, United States

Location

USA028

Atlanta, Georgia, 30329, United States

Location

USA011

Sandy Springs, Georgia, 30328, United States

Location

USA003

Plainfield, Indiana, 46168, United States

Location

USA002

Baton Rouge, Louisiana, 70809-2725, United States

Location

USA017

Boston, Massachusetts, 02115, United States

Location

USA012

Detroit, Michigan, 48201, United States

Location

USA024

Fort Gratiot, Michigan, 48059, United States

Location

USA020

Minneapolis, Minnesota, 55455, United States

Location

USA015

St Louis, Missouri, 63104, United States

Location

USA013

Lebanon, New Hampshire, 03766, United States

Location

USA009

Cleveland, Ohio, 44106-1716, United States

Location

USA016

Springfield, Ohio, 45505, United States

Location

USA019

Hershey, Pennsylvania, 17033-2360, United States

Location

USA022

Philadelphia, Pennsylvania, 19104-5127, United States

Location

USA005

Dallas, Texas, 75230, United States

Location

USA023

Dallas, Texas, 75231-6077, United States

Location

USA008

Spokane, Washington, 99202, United States

Location

AUS003

Darlinghurst, New South Wales, 2010, Australia

Location

AUS004

Kogarah, New South Wales, 2217, Australia

Location

AUS001

Brisbane, Queensland, 4151, Australia

Location

AUS006

Woolloongabba, Queensland, 4102, Australia

Location

AUS002

Fremantle, Western Australia, 6160, Australia

Location

BGR001

Lovech, 5500, Bulgaria

Location

BGR003

Pleven, 5800, Bulgaria

Location

BGR004

Sofia, 1592, Bulgaria

Location

BGR002

Stara Zagora, 6003, Bulgaria

Location

CAN003

Barrie, Ontario, L4M 7G1, Canada

Location

CAN006

Guelph, Ontario, N1L 0B7, Canada

Location

CAN007

Peterborough, Ontario, K9J 5K2, Canada

Location

CAN011

Richmond Hill, Ontario, L4B 1A5, Canada

Location

CAN009

Richmond Hill, Ontario, L4C 9M7, Canada

Location

CAN010

Toronto, Ontario, M2N 3A6, Canada

Location

CAN004

Québec, G1W 4R4, Canada

Location

FRA001

Lyon, Auvergne-Rhône-Alpes, 69003, France

Location

FRA004

Toulouse, Haute-Garonne, 31000, France

Location

FRA002

Antony, 92160, France

Location

FRA003

Paris, 75010, France

Location

FRA005

Rouen, 76031, France

Location

DEU007

Langenau, Baden-Wurttemberg, 89129, Germany

Location

DEU002

Darmstadt, Hesse, 64283, Germany

Location

DEU001

Bochum, North Rhine-Westphalia, 44791, Germany

Location

DEU003

Dresden, Saxony, 1307, Germany

Location

DEU006

Dessau-Roßlau, 6847, Germany

Location

DEU005

Lübeck, 23538, Germany

Location

GRC002

Athens, Attica, 106 79, Greece

Location

GRC004

Chaïdári, Attica, 124 62, Greece

Location

GRC001

N. Efkapria-Pavlos Melas, Thessaloniki, 56403, Greece

Location

GRC003

Thessaloniki, 54643, Greece

Location

NLD001

Rotterdam, 3015 GD, Netherlands

Location

POL006

Wroclaw, Lower Silesian Voivodeship, 51-685, Poland

Location

POL008

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

POL002

Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

Location

POL004

Krakow, 30-727, Poland

Location

POL007

Warsaw, 02-793, Poland

Location

POL001

Warsaw, 02-962, Poland

Location

POL005

Wroclaw, 50-450, Poland

Location

POL003

Wroclaw, 50-566, Poland

Location

ESP006

Badalona, Barcelona, 08916, Spain

Location

ESP004

Las Palmas de Gran Canaria, Las Palmas Provincia, 35010, Spain

Location

ESP001

Manises, Valencia, 46940, Spain

Location

ESP002

Madrid, 28007, Spain

Location

ESP005

Madrid, 28026, Spain

Location

ESP003

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

brensocatib

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 13, 2024
• Study Start: December 16, 2024
• Primary Completion: February 12, 2026
• Study Completion (Estimated): November 17, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6); NL (1); CA (7); ES (6); GR (4); AU (5); FR (5); PL (8); US (26); BU (4)