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

Last updated: May 9, 2025
Sponsor: Insmed Incorporated
Overall Status: Active - Recruiting

Phase

2

Condition

Hidradenitis Suppurativa

Acne Inversa

Rosacea

Treatment

Placebo

Brensocatib

Clinical Study ID

NCT06685835
INS1007-231
2024-515959-38-00
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of HS (confirmed by a dermatologist), with a history of HS for at least 6months before the Screening Visit.

  • Moderate or severe HS defined as a total of ≥6 inflammatory lesions (inflammatorynodules 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 HurleyStage II or Hurley Stage III at both the Screening and Baseline Visits.

Exclusion

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 expectedto have periodontal disease-related procedures within the study period.

  • Received systemic (intravenous or orally [PO]) antibiotic therapy within 8 weeksbefore the Baseline Visit a. Doxycycline or minocycline 100 mg twice daily provided the dosing regimen beingstable 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 forat least 4 weeks before the Baseline Visit.

  • Received prescription topical therapies for the treatment of HS within 2 weeksbefore the Baseline Visit.

  • Received any anti-tumor necrosis factor (TNF)-α/other biologics treatment within 12weeks or 5 elimination half-lives, whichever is longer, before the Baseline Visit.

  • Received systemic nonbiologic therapies (eg, corticosteroids and retinoids) for HSwithin 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

Total Participants: 204
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
December 16, 2024
Estimated Completion Date:
January 28, 2027

Connect with a study center

  • AUS001

    Brisbane, Queensland 4151
    Australia

    Active - Recruiting

  • BGR001

    Lovech, 5500
    Bulgaria

    Active - Recruiting

  • BGR003

    Pleven, 5800
    Bulgaria

    Active - Recruiting

  • BGR004

    Sofia, 1592
    Bulgaria

    Active - Recruiting

  • BGR002

    Stara Zagora, 6003
    Bulgaria

    Active - Recruiting

  • CAN006

    Guelph, Ontario N1L 0B7
    Canada

    Active - Recruiting

  • CAN007

    Peterborough, Ontario K9J 5K2
    Canada

    Active - Recruiting

  • CAN009

    Richmond Hill, Ontario L4C 9M7
    Canada

    Active - Recruiting

  • FRA001

    Lyon, Auvergne-Rhône-Alpes 69003
    France

    Active - Recruiting

  • FRA004

    Toulouse, Haute-Garonne 31000
    France

    Active - Recruiting

  • FRA002

    Antony, 92160
    France

    Active - Recruiting

  • FRA003

    Paris, 75010
    France

    Active - Recruiting

  • FRA005

    Rouen, 76031
    France

    Active - Recruiting

  • DEU007

    Langenau, Baden-Wurttemberg 89129
    Germany

    Active - Recruiting

  • DEU002

    Darmstadt, Hessen 64283
    Germany

    Active - Recruiting

  • DEU001

    Bochum, North Rhine-Westphalia 44791
    Germany

    Active - Recruiting

  • DEU003

    Dresden, Sachsen 1307
    Germany

    Site Not Available

  • DEU006

    Dessau-Roßlau, 6847
    Germany

    Site Not Available

  • DEU005

    Lübeck, 23538
    Germany

    Site Not Available

  • GRC002

    Athina, Attiki 106 79
    Greece

    Active - Recruiting

  • GRC004

    Chaidari, Attiki 124 62
    Greece

    Active - Recruiting

  • GRC001

    N. Efkapria-Pavlos Melas, Thessaloniki 56403
    Greece

    Active - Recruiting

  • GRC003

    Thessaloniki, 54643
    Greece

    Active - Recruiting

  • NLD001

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • POL006

    Wroclaw, Lower Silesia 51-685
    Poland

    Active - Recruiting

  • POL008

    Warsaw, Mazowieckie 02-507
    Poland

    Active - Recruiting

  • POL002

    Rzeszow, Podkarpackie 35-055
    Poland

    Active - Recruiting

  • POL004

    Kraków, 30-727
    Poland

    Active - Recruiting

  • POL001

    Warszawa, 02-962
    Poland

    Active - Recruiting

  • POL007

    Warszawa, 02-793
    Poland

    Active - Recruiting

  • POL005

    Wroclaw, 50-450
    Poland

    Active - Recruiting

  • POL003

    WrocÅ'aw, 50-566
    Poland

    Site Not Available

  • ESP006

    Badalona, Barcelona 8916
    Spain

    Site Not Available

  • ESP004

    Las Palmas De Gran Canaria, Las Palmas Provincia 35010
    Spain

    Active - Recruiting

  • ESP001

    Manises, Valencia 46940
    Spain

    Site Not Available

  • ESP002

    Madrid, 28007
    Spain

    Active - Recruiting

  • ESP003

    Madrid, 28034
    Spain

    Active - Recruiting

  • ESP005

    Madrid, 28026
    Spain

    Active - Recruiting

  • USA007

    Sacramento, California 95815
    United States

    Active - Recruiting

  • USA026

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • USA021

    Margate, Florida 33063
    United States

    Active - Recruiting

  • USA025

    Ocala, Florida 34470
    United States

    Active - Recruiting

  • USA004

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • USA010

    Weston, Florida 33331
    United States

    Active - Recruiting

  • USA011

    Sandy Springs, Georgia 30328
    United States

    Active - Recruiting

  • USA003

    Plainfield, Indiana 46168
    United States

    Active - Recruiting

  • USA002

    Baton Rouge, Louisiana 70809-2725
    United States

    Active - Recruiting

  • USA024

    Fort Gratiot, Michigan 48059
    United States

    Active - Recruiting

  • USA013

    Lebanon, New Hampshire 03766
    United States

    Site Not Available

  • USA016

    Springfield, Ohio 45505
    United States

    Active - Recruiting

  • USA005

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • USA023

    Dallas, Texas 75231-6077
    United States

    Active - Recruiting

  • USA008

    Spokane, Washington 99202
    United States

    Active - Recruiting

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