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

March 5, 2026 updated by: Insmed Incorporated

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa - The CEDAR Study

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study includes 4 periods, i.e. Screening Period (35 days), Treatment Period 1 (up to Week 16), Treatment Period 2 (up to Week 36) and Follow-up Period (4 weeks). Participants who will complete 52 weeks of study treatment may be eligible to enroll in a separate open-label extension (OLE) study. In addition to this, participants who will be enrolled in the OLE study at the Week 52 Visit are not required to complete the Follow-up Period or the Week 56 Visit.

Study Type

Interventional

Enrollment (Actual)

214

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline in Total Abscess and Inflammatory Nodule (AN) Count at Week 16
Time Frame: Baseline and Week 16
Baseline and Week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16
Time Frame: Week 16
Week 16
Percentage of Participants Achieving HiSCR75 at Week 16
Time Frame: Week 16
Week 16
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
Week 16
Change From Baseline in Draining Tunnel Count at Week 16
Time Frame: Baseline and Week 16
Baseline and Week 16
Percentage of Participants Remaining Free from HS Flare by Week 16
Time Frame: Week 16
Week 16
Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16
Time Frame: Baseline and Week 16
Baseline and Week 16
Percentage of Participants Achieving IHS4-55 at Week 16
Time Frame: Week 16
Week 16
Change From Baseline on Dermatology Life Quality Index (DLQI) Global Score at Week 16
Time Frame: Baseline and Week 16
Baseline and Week 16
Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 16 with a Baseline NRS Score ≥3
Time Frame: Week 16
Week 16
Number of Participants who Experienced at Least One Adverse Event (AE)
Time Frame: Up to Week 56
Up to Week 56
Plasma Concentration of Brensocatib
Time Frame: Pre-dose and at multiple timepoints post-dose up to Week 56
Pre-dose and at multiple timepoints post-dose up to Week 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Insmed Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2024

Primary Completion (Actual)

February 12, 2026

Study Completion (Estimated)

November 17, 2026

Study Registration Dates

First Submitted

November 11, 2024

First Submitted That Met QC Criteria

November 11, 2024

First Posted (Actual)

November 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INS1007-231
  • 2024-515959-38-00 (Other Identifier: EU Trial (CTIS) Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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