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New hope for painful skin condition: brensocatib enters phase 2b trial

NCT ID NCT06685835

Disease control Sponsor: Insmed Incorporated Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times

Summary

This study tests whether brensocatib can reduce painful lumps and abscesses in people with moderate to severe hidradenitis suppurativa (HS). About 214 adults will receive either brensocatib or a placebo for 16 weeks. The goal is to see if the drug improves skin lesions and overall disease severity.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

214 people

The number who actually took part.

Started

Dec 2024

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hidradenitis suppurativa

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hidradenitis suppurativa

Contacts and locations

Locations

  • AUS001

    Brisbane, Queensland, 4151, Australia

  • AUS002

    Fremantle, Western Australia, 6160, Australia

  • AUS003

    Darlinghurst, New South Wales, 2010, Australia

  • AUS004

    Kogarah, New South Wales, 2217, Australia

  • AUS006

    Woolloongabba, Queensland, 4102, Australia

  • BGR001

    Lovech, 5500, Bulgaria

  • BGR002

    Stara Zagora, 6003, Bulgaria

  • BGR003

    Pleven, 5800, Bulgaria

  • BGR004

    Sofia, 1592, Bulgaria

  • CAN003

    Barrie, Ontario, L4M 7G1, Canada

  • CAN004

    Québec, G1W 4R4, Canada

  • CAN006

    Guelph, Ontario, N1L 0B7, Canada

  • CAN007

    Peterborough, Ontario, K9J 5K2, Canada

  • CAN009

    Richmond Hill, Ontario, L4C 9M7, Canada

  • CAN010

    Toronto, Ontario, M2N 3A6, Canada

  • CAN011

    Richmond Hill, Ontario, L4B 1A5, Canada

  • DEU001

    Bochum, North Rhine-Westphalia, 44791, Germany

  • DEU002

    Darmstadt, Hesse, 64283, Germany

  • DEU003

    Dresden, Saxony, 1307, Germany

  • DEU005

    Lübeck, 23538, Germany

  • DEU006

    Dessau-Roßlau, 6847, Germany

  • DEU007

    Langenau, Baden-Wurttemberg, 89129, Germany

  • ESP001

    Manises, Valencia, 46940, Spain

  • ESP002

    Madrid, 28007, Spain

  • ESP003

    Madrid, 28034, Spain

  • ESP004

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

  • ESP005

    Madrid, 28026, Spain

  • ESP006

    Badalona, Barcelona, 08916, Spain

  • FRA001

    Lyon, Auvergne-Rhône-Alpes, 69003, France

  • FRA002

    Antony, 92160, France

  • FRA003

    Paris, 75010, France

  • FRA004

    Toulouse, Haute-Garonne, 31000, France

  • FRA005

    Rouen, 76031, France

  • GRC001

    N. Efkapria-Pavlos Melas, Thessaloniki, 56403, Greece

  • GRC002

    Athens, Attica, 106 79, Greece

  • GRC003

    Thessaloniki, 54643, Greece

  • GRC004

    Chaïdári, Attica, 124 62, Greece

  • NLD001

    Rotterdam, 3015 GD, Netherlands

  • POL001

    Warsaw, 02-962, Poland

  • POL002

    Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

  • POL003

    Wroclaw, 50-566, Poland

  • POL004

    Krakow, 30-727, Poland

  • POL005

    Wroclaw, 50-450, Poland

  • POL006

    Wroclaw, Lower Silesian Voivodeship, 51-685, Poland

  • POL007

    Warsaw, 02-793, Poland

  • POL008

    Warsaw, Masovian Voivodeship, 02-507, Poland

  • USA001

    Phoenix, Arizona, 85054-4502, United States

  • USA002

    Baton Rouge, Louisiana, 70809-2725, United States

  • USA003

    Plainfield, Indiana, 46168, United States

  • USA004

    Tampa, Florida, 33613, United States

  • USA005

    Dallas, Texas, 75230, United States

  • USA007

    Sacramento, California, 95815, United States

  • USA008

    Spokane, Washington, 99202, United States

  • USA009

    Cleveland, Ohio, 44106-1716, United States

  • USA010

    Weston, Florida, 33331, United States

  • USA011

    Sandy Springs, Georgia, 30328, United States

  • USA012

    Detroit, Michigan, 48201, United States

  • USA013

    Lebanon, New Hampshire, 03766, United States

  • USA015

    St Louis, Missouri, 63104, United States

  • USA016

    Springfield, Ohio, 45505, United States

  • USA017

    Boston, Massachusetts, 02115, United States

  • USA018

    Miami, Florida, 33125, United States

  • USA019

    Hershey, Pennsylvania, 17033-2360, United States

  • USA020

    Minneapolis, Minnesota, 55455, United States

  • USA021

    Margate, Florida, 33063, United States

  • USA022

    Philadelphia, Pennsylvania, 19104-5127, United States

  • USA023

    Dallas, Texas, 75231-6077, United States

  • USA024

    Fort Gratiot, Michigan, 48059, United States

  • USA025

    Ocala, Florida, 34470, United States

  • USA026

    Coral Gables, Florida, 33134, United States

  • USA027

    Hollywood, Florida, 33024, United States

  • USA028

    Atlanta, Georgia, 30329, United States

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