CClinicalTrials.gg
TerminatedNCT06685835CEDARUpdated Jun 29, 2026

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

A Phase 2 interventional study of Brensocatib and Placebo in Hidradenitis Suppurativa, sponsored by Insmed Incorporated. Terminated at 72 sites in 10 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by Insmed Incorporated · Phase 2, Interventional, and Treatment

Why this study was terminated
Lack of Efficacy
Phase
Phase 2
Study type
Interventional
Enrollment
214
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Hidradenitis Suppurativa

Keywords

  • HS
03

In context

Hidradenitis Suppurativa

277 studies on the registry are indexed under Hidradenitis Suppurativa; 87 are open to participants now.

This study's enrollment of 214 is above the median of 45 across 195 interventional studies indexed under Hidradenitis Suppurativa.

Browse Hidradenitis Suppurativa studies →

Lead sponsor

Insmed Incorporated is the lead sponsor of 50 studies on the registry; 8 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 8 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

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 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.

Note: Other Inclusion/Exclusion criteria may apply.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
214 participants (actual)

Study arms

  • Experimental
    Brensocatib 10 mg

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

    Drug: Brensocatib

  • Experimental
    Brensocatib 40 mg

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

    Drug: Brensocatib

  • 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 · Drug: Placebo

  • 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 · Drug: Placebo

Interventions

  • DrugBrensocatib

    Film-coated Oral tablet

    Also known as: INS1007

  • DrugPlacebo

    Film-coated Oral tablet

06

What researchers measure

Primary outcomes

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

    Time frame: Baseline and Week 16

Secondary outcomes

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

    Time frame: Week 16

  2. Percentage of Participants Achieving HiSCR75 at Week 16

    Time frame: Week 16

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

    Time frame: Week 16

  4. Change From Baseline in Draining Tunnel Count at Week 16

    Time frame: Baseline and Week 16

  5. Percentage of Participants Remaining Free from HS Flare by Week 16

    Time frame: Week 16

  6. Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16

    Time frame: Baseline and Week 16

  7. Percentage of Participants Achieving IHS4-55 at Week 16

    Time frame: Week 16

  8. Change From Baseline on Dermatology Life Quality Index (DLQI) Global Score at Week 16

    Time frame: Baseline and Week 16

  9. Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 16 with a Baseline NRS Score ≥3

    Time frame: Week 16

  10. Number of Participants who Experienced at Least One Adverse Event (AE)

    Time frame: Up to Week 56

  11. Plasma Concentration of Brensocatib

    Time frame: Pre-dose and at multiple timepoints post-dose up to Week 56

07

Study locations

72 sites
  • USA001
    Phoenix, Arizona 85054-4502, United States
  • USA007
    Sacramento, California 95815, United States
  • USA026
    Coral Gables, Florida 33134, United States
  • USA027
    Hollywood, Florida 33024, United States
  • USA021
    Margate, Florida 33063, United States
  • USA018
    Miami, Florida 33125, United States
  • USA025
    Ocala, Florida 34470, United States
  • USA004
    Tampa, Florida 33613, United States
  • USA010
    Weston, Florida 33331, United States
  • USA028
    Atlanta, Georgia 30329, United States
  • USA011
    Sandy Springs, Georgia 30328, United States
  • USA003
    Plainfield, Indiana 46168, United States
  • USA002
    Baton Rouge, Louisiana 70809-2725, United States
  • USA017
    Boston, Massachusetts 02115, United States
  • USA012
    Detroit, Michigan 48201, United States
  • USA024
    Fort Gratiot, Michigan 48059, United States
  • USA020
    Minneapolis, Minnesota 55455, United States
  • USA015
    St Louis, Missouri 63104, United States
  • USA013
    Lebanon, New Hampshire 03766, United States
  • USA009
    Cleveland, Ohio 44106-1716, United States
  • USA016
    Springfield, Ohio 45505, United States
  • USA019
    Hershey, Pennsylvania 17033-2360, United States
  • USA022
    Philadelphia, Pennsylvania 19104-5127, United States
  • USA005
    Dallas, Texas 75230, United States
  • USA023
    Dallas, Texas 75231-6077, United States
  • USA008
    Spokane, Washington 99202, United States
  • AUS003
    Darlinghurst, New South Wales 2010, Australia
  • AUS004
    Kogarah, New South Wales 2217, Australia
  • AUS001
    Brisbane, Queensland 4151, Australia
  • AUS006
    Woolloongabba, Queensland 4102, Australia
  • AUS002
    Fremantle, Western Australia 6160, Australia
  • BGR001
    Lovech, 5500, Bulgaria
  • BGR003
    Pleven, 5800, Bulgaria
  • BGR004
    Sofia, 1592, Bulgaria
  • BGR002
    Stara Zagora, 6003, Bulgaria
  • CAN003
    Barrie, Ontario L4M 7G1, Canada
  • CAN006
    Guelph, Ontario N1L 0B7, Canada
  • CAN007
    Peterborough, Ontario K9J 5K2, Canada
  • CAN011
    Richmond Hill, Ontario L4B 1A5, Canada
  • CAN009
    Richmond Hill, Ontario L4C 9M7, Canada
  • CAN010
    Toronto, Ontario M2N 3A6, Canada
  • CAN004
    Québec, G1W 4R4, Canada
  • FRA001
    Lyon, Auvergne-Rhône-Alpes 69003, France
  • FRA004
    Toulouse, Haute-Garonne 31000, France
  • FRA002
    Antony, 92160, France
  • FRA003
    Paris, 75010, France
  • FRA005
    Rouen, 76031, France
  • DEU007
    Langenau, Baden-Wurttemberg 89129, Germany
  • DEU002
    Darmstadt, Hesse 64283, Germany
  • DEU001
    Bochum, North Rhine-Westphalia 44791, Germany
  • DEU003
    Dresden, Saxony 1307, Germany
  • DEU006
    Dessau-Roßlau, 6847, Germany
  • DEU005
    Lübeck, 23538, Germany
  • GRC002
    Athens, Attica 106 79, Greece
  • GRC004
    Chaïdári, Attica 124 62, Greece
  • GRC001
    N. Efkapria-Pavlos Melas, Thessaloniki 56403, Greece
  • GRC003
    Thessaloniki, 54643, Greece
  • NLD001
    Rotterdam, 3015 GD, Netherlands
  • POL006
    Wroclaw, Lower Silesian Voivodeship 51-685, Poland
  • POL008
    Warsaw, Masovian Voivodeship 02-507, Poland
  • POL002
    Rzeszów, Podkarpackie Voivodeship 35-055, Poland
  • POL004
    Krakow, 30-727, Poland
  • POL007
    Warsaw, 02-793, Poland
  • POL001
    Warsaw, 02-962, Poland
  • POL005
    Wroclaw, 50-450, Poland
  • POL003
    Wroclaw, 50-566, Poland
  • ESP006
    Badalona, Barcelona 08916, Spain
  • ESP004
    Las Palmas de Gran Canaria, Las Palmas Provincia 35010, Spain
  • ESP001
    Manises, Valencia 46940, Spain
  • ESP002
    Madrid, 28007, Spain
  • ESP005
    Madrid, 28026, Spain
  • ESP003
    Madrid, 28034, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06685835
Lead sponsor
Insmed Incorporated
Responsible party
Sponsor
First posted
Nov 13, 2024
Start date
Dec 16, 2024
Primary completion
Feb 12, 2026
Completion
Jun 8, 2026
Last update
Jun 29, 2026

Study contacts

Study Director
study director · Insmed Incorporated

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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