A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS)
NCT ID: NCT06685835
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
214 participants
INTERVENTIONAL
2024-12-16
2027-01-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Brensocatib
Film-coated Oral tablet
Placebo
Film-coated Oral tablet
Brensocatib 10 mg
Participants will receive brensocatib 10 mg tablet, once daily (QD), orally for 52 weeks.
Brensocatib
Film-coated Oral tablet
Brensocatib 40 mg
Participants will receive brensocatib 40 mg tablet, QD, orally for 52 weeks.
Brensocatib
Film-coated Oral tablet
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.
Brensocatib
Film-coated Oral tablet
Placebo
Film-coated Oral tablet
Interventions
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Brensocatib
Film-coated Oral tablet
Placebo
Film-coated Oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Insmed Incorporated
INDUSTRY
Responsible Party
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Locations
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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-Roßlau, , 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
Countries
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Other Identifiers
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2024-515959-38-00
Identifier Type: OTHER
Identifier Source: secondary_id
INS1007-231
Identifier Type: -
Identifier Source: org_study_id