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

Purpose

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

Condition

Hidradenitis Suppurativa

Eligibility

Eligible Ages: Between 18 Years and 80 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion 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.

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 100 mg twice daily 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.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Brensocatib 10 mg	Participants will receive brensocatib 10 mg tablet, once daily (QD), orally for 52 weeks.	Drug: Brensocatib Film-coated Oral tablet Other names: INS1007
Experimental Brensocatib 40 mg	Participants will receive brensocatib 40 mg tablet, QD, orally for 52 weeks.	Drug: Brensocatib Film-coated Oral tablet Other names: INS1007
Placebo Comparator Placebo Followed by Brensocatib 10 mg	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 Film-coated Oral tablet Other names: INS1007 Drug: Placebo Film-coated Oral tablet
Placebo Comparator Placebo Followed by Brensocatib 40 mg	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 Film-coated Oral tablet Other names: INS1007 Drug: Placebo Film-coated Oral tablet

Recruiting Locations

USA007
Sacramento, California 95815

USA026
Coral Gables, Florida 33134

USA021
Margate, Florida 33063

USA025
Ocala, Florida 34470

USA004
Tampa, Florida 33613

USA010
Weston, Florida 33331

USA011
Sandy Springs, Georgia 30328

USA003
Plainfield, Indiana 46168

USA002
Baton Rouge, Louisiana 70809-2725

USA024
Fort Gratiot, Michigan 48059

USA016
Springfield, Ohio 45505

USA005
Dallas, Texas 75230

USA023
Dallas, Texas 75231-6077

USA008
Spokane, Washington 99202

More Details

NCT ID: NCT06685835
Status: Recruiting
Sponsor: Insmed Incorporated

Study Contact

Insmed Medical Information
1-844-446-7633
medicalinformation@insmed.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.