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

Last updated: November 10, 2025
Sponsor: Insmed Incorporated
Overall Status: Active - Not Recruiting

Phase

2

Condition

Rosacea

Scalp Disorders

Acne Inversa

Treatment

Brensocatib

Placebo

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 signs and symptomsconsistent with HS for at least 6 months 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 up to 100 mg twice daily is permitted provided thedosing regimen being stable for at least 8 weeks before the Baseline Visit and isexpected 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: 214
Treatment Group(s): 2
Primary Treatment: Brensocatib
Phase: 2
Study Start date:
December 16, 2024
Estimated Completion Date:
January 28, 2027

Connect with a study center

  • AUS003

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • AUS004

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • AUS003

    Darlinghurst 2169378, New South Wales 2155400 2010
    Australia

    Site Not Available

  • AUS004

    Kogarah 2161185, New South Wales 2155400 2217
    Australia

    Site Not Available

  • AUS001

    Brisbane, Queensland 4151
    Australia

    Site Not Available

  • AUS001

    Brisbane 2174003, Queensland 2152274 4151
    Australia

    Site Not Available

  • AUS006

    Woolloongabba 6943568, Queensland 2152274 4102
    Australia

    Site Not Available

  • AUS002

    Fremantle, Western Australia 6160
    Australia

    Site Not Available

  • AUS002

    Fremantle 2071223, Western Australia 2058645 6160
    Australia

    Site Not Available

  • BGR001

    Lovech, 5500
    Bulgaria

    Site Not Available

  • BGR001

    Lovech 729559, 5500
    Bulgaria

    Site Not Available

  • BGR003

    Pleven, 5800
    Bulgaria

    Site Not Available

  • BGR003

    Pleven 728203, 5800
    Bulgaria

    Site Not Available

  • BGR004

    Sofia, 1592
    Bulgaria

    Site Not Available

  • BGR004

    Sofia 727011, 1592
    Bulgaria

    Site Not Available

  • BGR002

    Stara Zagora, 6003
    Bulgaria

    Site Not Available

  • BGR002

    Stara Zagora 726848, 6003
    Bulgaria

    Site Not Available

  • CAN003

    Barrie, Ontario L4M 7G1
    Canada

    Site Not Available

  • CAN006

    Guelph, Ontario N1L 0B7
    Canada

    Site Not Available

  • CAN007

    Peterborough, Ontario K9J 5K2
    Canada

    Site Not Available

  • CAN009

    Richmond Hill, Ontario L4C 9M7
    Canada

    Active - Recruiting

  • CAN011

    Richmond Hill, Ontario L4B 1A5
    Canada

    Site Not Available

  • CAN010

    Toronto, Ontario M2N 3A6
    Canada

    Site Not Available

  • CAN003

    Barrie 5894171, Ontario 6093943 L4M 7G1
    Canada

    Site Not Available

  • CAN006

    Guelph 5967629, Ontario 6093943 N1L 0B7
    Canada

    Site Not Available

  • CAN007

    Peterborough 6101645, Ontario 6093943 K9J 5K2
    Canada

    Site Not Available

  • CAN009

    Richmond Hill 6122091, Ontario 6093943 L4C 9M7
    Canada

    Site Not Available

  • CAN011

    Richmond Hill 6122091, Ontario 6093943 L4B 1A5
    Canada

    Site Not Available

  • CAN010

    Toronto 6167865, Ontario 6093943 M2N 3A6
    Canada

    Site Not Available

  • CAN004

    Quebec, G1W 4R4
    Canada

    Site Not Available

  • CAN004

    Québec 6325494, G1W 4R4
    Canada

    Site Not Available

  • FRA001

    Lyon, Auvergne-Rhône-Alpes 69003
    France

    Site Not Available

  • FRA001

    Lyon 2996944, Auvergne-Rhône-Alpes 11071625 69003
    France

    Site Not Available

  • FRA004

    Toulouse, Haute-Garonne 31000
    France

    Site Not Available

  • FRA004

    Toulouse 2972315, Haute-Garonne 31000
    France

    Site Not Available

  • FRA002

    Antony, 92160
    France

    Site Not Available

  • FRA002

    Antony 3037423, 92160
    France

    Site Not Available

  • FRA003

    Paris, 75010
    France

    Site Not Available

  • FRA003

    Paris 2988507, 75010
    France

    Site Not Available

  • FRA005

    Rouen, 76031
    France

    Site Not Available

  • FRA005

    Rouen 2982652, 76031
    France

    Site Not Available

  • DEU007

    Langenau 2881259, Baden-Wurttemberg 2953481 89129
    Germany

    Site Not Available

  • DEU007

    Langenau, Baden-Württemberg 89129
    Germany

    Site Not Available

  • DEU002

    Darmstadt 2938913, Hesse 2905330 64283
    Germany

    Site Not Available

  • DEU002

    Darmstadt, Hessen 64283
    Germany

    Site Not Available

  • DEU001

    Bochum, North Rhine-Westphalia 44791
    Germany

    Site Not Available

  • DEU001

    Bochum 2947416, North Rhine-Westphalia 2861876 44791
    Germany

    Site Not Available

  • DEU003

    Dresden, Sachsen 1307
    Germany

    Site Not Available

  • DEU003

    Dresden 2935022, Saxony 2842566 1307
    Germany

    Site Not Available

  • DEU006

    Dessau-Roßlau, 6847
    Germany

    Site Not Available

  • DEU005

    Lubeck, 23538
    Germany

    Site Not Available

  • DEU005

    Lübeck, 23538
    Germany

    Site Not Available

  • DEU005

    Lübeck, 23538
    Germany

    Site Not Available

  • DEU005

    Lübeck 2875601, 23538
    Germany

    Site Not Available

  • GRC002

    Athens 264371, Attica 6692632 106 79
    Greece

    Site Not Available

  • GRC004

    Chaïdári 260183, Attica 6692632 124 62
    Greece

    Site Not Available

  • GRC002

    Athina, Attiki 106 79
    Greece

    Site Not Available

  • GRC004

    Chaidari, Attiki 124 62
    Greece

    Site Not Available

  • GRC001

    N. Efkapria-Pavlos Melas, Thessaloniki 56403
    Greece

    Site Not Available

  • GRC003

    Thessaloniki, 54643
    Greece

    Site Not Available

  • GRC003

    Thessaloniki 734077, 54643
    Greece

    Site Not Available

  • NLD001

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • NLD001

    Rotterdam 2747891, 3015 GD
    Netherlands

    Site Not Available

  • POL006

    Wroclaw, Lower Silesia 51-685
    Poland

    Active - Recruiting

  • POL006

    Wroclaw 3081368, Lower Silesian Voivodeship 3337492 51-685
    Poland

    Site Not Available

  • POL008

    Warsaw 756135, Masovian Voivodeship 858787 02-507
    Poland

    Site Not Available

  • POL008

    Warsaw, Mazowieckie 02-507
    Poland

    Site Not Available

  • POL002

    Rzeszow, Podkarpackie 35-055
    Poland

    Site Not Available

  • POL002

    Rzeszów, Podkarpackie 35-055
    Poland

    Site Not Available

  • POL002

    Rzeszów 759734, Podkarpackie Voivodeship 858788 35-055
    Poland

    Site Not Available

  • POL004

    Krakow 3094802, 30-727
    Poland

    Site Not Available

  • POL004

    Kraków, 30-727
    Poland

    Site Not Available

  • POL004

    Kraków, 30-727
    Poland

    Site Not Available

  • POL001

    Warsaw 756135, 02-962
    Poland

    Site Not Available

  • POL007

    Warsaw 756135, 02-793
    Poland

    Site Not Available

  • POL001

    Warszawa, 02-962
    Poland

    Site Not Available

  • POL007

    Warszawa, 02-793
    Poland

    Active - Recruiting

  • POL005

    Wroclaw, 50-450
    Poland

    Site Not Available

  • POL003

    Wroclaw 3081368, 50-566
    Poland

    Site Not Available

  • POL005

    Wroclaw 3081368, 50-450
    Poland

    Site Not Available

  • POL003

    WrocÅ'aw, 50-566
    Poland

    Site Not Available

  • POL003

    Wrocław, 50-566
    Poland

    Site Not Available

  • ESP006

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • ESP006

    Badalona 3129028, Barcelona 08916
    Spain

    Site Not Available

  • ESP004

    Las Palmas De Gran Canaria, Las Palmas Provincia 35010
    Spain

    Site Not Available

  • ESP004

    Las Palmas de Gran Canaria 2515270, Las Palmas Provincia 35010
    Spain

    Site Not Available

  • ESP001

    Manises, Valencia 46940
    Spain

    Site Not Available

  • ESP001

    Manises 2514197, Valencia 2593113 46940
    Spain

    Site Not Available

  • ESP002

    Madrid, 28007
    Spain

    Active - Recruiting

  • ESP003

    Madrid, 28034
    Spain

    Site Not Available

  • ESP005

    Madrid, 28026
    Spain

    Active - Recruiting

  • ESP002

    Madrid 3117735, 28007
    Spain

    Site Not Available

  • ESP003

    Madrid 3117735, 28034
    Spain

    Site Not Available

  • ESP005

    Madrid 3117735, 28026
    Spain

    Site Not Available

  • USA001

    Phoenix, Arizona 85054-4502
    United States

    Site Not Available

  • USA001

    Phoenix 5308655, Arizona 5551752 85054-4502
    United States

    Site Not Available

  • USA007

    Sacramento, California 95815
    United States

    Site Not Available

  • USA007

    Sacramento 5389489, California 5332921 95815
    United States

    Site Not Available

  • USA026

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • USA021

    Margate, Florida 33063
    United States

    Site Not Available

  • USA018

    Miami, Florida 33125
    United States

    Site Not Available

  • USA025

    Ocala, Florida 34470
    United States

    Site Not Available

  • USA004

    Tampa, Florida 33613
    United States

    Site Not Available

  • USA010

    Weston, Florida 33331
    United States

    Site Not Available

  • USA026

    Coral Gables 4151871, Florida 4155751 33134
    United States

    Site Not Available

  • USA027

    Hollywood 4158928, Florida 4155751 33024
    United States

    Site Not Available

  • USA021

    Margate 4163407, Florida 4155751 33063
    United States

    Site Not Available

  • USA018

    Miami 4164138, Florida 4155751 33125
    United States

    Site Not Available

  • USA025

    Ocala 4166673, Florida 4155751 34470
    United States

    Site Not Available

  • USA004

    Tampa 4174757, Florida 4155751 33613
    United States

    Site Not Available

  • USA010

    Weston 4178003, Florida 4155751 33331
    United States

    Site Not Available

  • USA011

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • USA028

    Atlanta 4180439, Georgia 4197000 30329
    United States

    Site Not Available

  • USA011

    Sandy Springs 4221333, Georgia 4197000 30328
    United States

    Site Not Available

  • USA003

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • USA003

    Plainfield 4263108, Indiana 4921868 46168
    United States

    Site Not Available

  • USA002

    Baton Rouge, Louisiana 70809-2725
    United States

    Site Not Available

  • USA002

    Baton Rouge 4315588, Louisiana 4331987 70809-2725
    United States

    Site Not Available

  • USA017

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • USA017

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • USA012

    Detroit, Michigan 48201
    United States

    Site Not Available

  • USA012

    Detroit 4990729, Michigan 5001836 48201
    United States

    Site Not Available

  • USA024

    Fort Gratiot, Michigan 5001836 48059
    United States

    Site Not Available

  • USA020

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • USA020

    Minneapolis 5037649, Minnesota 5037779 55455
    United States

    Site Not Available

  • USA015

    Saint Louis, Missouri 63104
    United States

    Site Not Available

  • USA015

    St Louis 4407066, Missouri 4398678 63104
    United States

    Site Not Available

  • USA013

    Lebanon, New Hampshire 03766
    United States

    Site Not Available

  • USA013

    Lebanon 5088597, New Hampshire 5090174 03766
    United States

    Site Not Available

  • USA009

    Cleveland, Ohio 44106-1716
    United States

    Site Not Available

  • USA016

    Springfield, Ohio 45505
    United States

    Site Not Available

  • USA009

    Cleveland 5150529, Ohio 5165418 44106-1716
    United States

    Site Not Available

  • USA016

    Springfield 4525353, Ohio 5165418 45505
    United States

    Site Not Available

  • USA019

    Hershey, Pennsylvania 17033-2360
    United States

    Site Not Available

  • USA019

    Hershey 5193342, Pennsylvania 6254927 17033-2360
    United States

    Site Not Available

  • USA022

    Philadelphia 4560349, Pennsylvania 6254927 19104-5127
    United States

    Site Not Available

  • USA005

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • USA023

    Dallas, Texas 75231-6077
    United States

    Site Not Available

  • USA005

    Dallas 4684888, Texas 4736286 75230
    United States

    Site Not Available

  • USA023

    Dallas 4684888, Texas 4736286 75231-6077
    United States

    Site Not Available

  • USA008

    Spokane, Washington 99202
    United States

    Site Not Available

  • USA008

    Spokane 5811696, Washington 5815135 99202
    United States

    Site Not Available

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