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New hope for painful skin condition: experimental drug shows promise

NCT ID NCT06118099

Disease control Sponsor: Sanofi 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026

Summary

This study tested a new drug called amlitelimab for adults with moderate to severe hidradenitis suppurativa, a painful skin condition that causes boils and tunnels. About 90 people received either the drug or a placebo for 16 weeks, with an optional long-term extension. The goal was to see if the drug reduces skin abscesses and inflammation better than placebo.

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

90 people

The number who actually took part.

Started

Nov 2023

Finished

Oct 2025

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 70 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: * Participant must be 18 (or country's age of majority if \>18) years to 70 years of age inclusive, at the time of signing the informed consent. * Participants with a history of signs and symptoms consistent with HS for at least 1 year prior to baseline. * Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left, and right axilla; or left axilla and left inguino-crural fold), 1 of which must be Hurley Stage II or Hurley Stage III. * Participant must have had an inadequate response to at least a 12-week trial of an oral antibiotic for treatment of HS Exclusion Criteria: * Participants with a diagnosis of inflammatory conditions other than HS (including but not limited to systemic lupus erythematosus, systemic sclerosis, myositis, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, multiple sclerosis, Behcet's disease, sarcoidosis, etc) * Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

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Conditions

The condition(s) this trial relates to.

hidradenitis hidradenitis suppurativa

As listed by the trial registrant

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

Hidradenitis

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center Site Number : 8400006

    Boston, Massachusetts, 02215, United States

  • Center for Clinical Studies, LTD. LLP Site Number : 8400001

    Houston, Texas, 77004, United States

  • Center for Dermatology Clinical Research Site Number : 8400010

    Fremont, California, 94538-1614, United States

  • Centricity Research Site Number : 8400009

    Dublin, Ohio, 43016, United States

  • Clinical Partners, LLC Site Number : 8400003

    Johnston, Rhode Island, 02919, United States

  • Corazon USA, LLC (DBA Life Clinical Trials) Site Number : 8400011

    Margate, Florida, 33063, United States

  • Florida International Research Center Site Number : 8400016

    Miami, Florida, 33173, United States

  • Investigational Site Number : 0360001

    Darlinghurst, New South Wales, 2010, Australia

  • Investigational Site Number : 0360002

    Melbourne, Victoria, 3004, Australia

  • Investigational Site Number : 0360003

    Phillip, Australian Capital Territory, 2606, Australia

  • Investigational Site Number : 1240001

    Québec, G1W 4R4, Canada

  • Investigational Site Number : 1240002

    Hamilton, Ontario, L8L 3C3, Canada

  • Investigational Site Number : 1240007

    Barrie, Ontario, L4M 7G1, Canada

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 7640881, Chile

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 8380465, Chile

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7580206, Chile

  • Investigational Site Number : 2500001

    Reims, 51100, France

  • Investigational Site Number : 2500002

    Saint-Mandé, 94163, France

  • Investigational Site Number : 2500003

    Lyon, 69003, France

  • Investigational Site Number : 2500004

    Rouen, 76031, France

  • Investigational Site Number : 2500005

    La Rochelle, 17019, France

  • Investigational Site Number : 2760001

    Münster, 48149, Germany

  • Investigational Site Number : 2760002

    Bochum, 44791, Germany

  • Investigational Site Number : 3480001

    Debrecen, 4032, Hungary

  • Investigational Site Number : 3480002

    Szeged, 6720, Hungary

  • Investigational Site Number : 3480004

    Budapest, 1083, Hungary

  • Investigational Site Number : 3800001

    Catania, 95123, Italy

  • Investigational Site Number : 3800002

    Cona (Ferrara), 44124, Italy

  • Investigational Site Number : 6160001

    Warsaw, Masovian Voivodeship, 02-507, Poland

  • Investigational Site Number : 6160003

    Wroclaw, 50-566, Poland

  • Investigational Site Number : 6160004

    Warsaw, 02-962, Poland

  • Investigational Site Number : 6200001

    Lisbon, 1998-018, Portugal

  • Investigational Site Number : 6200002

    Lisbon, 1649-035, Portugal

  • Investigational Site Number : 7240001

    Barcelona, Barcelona [Barcelona], 08041, Spain

  • Investigational Site Number : 7240002

    Madrid, Madrid, Comunidad de, 28046, Spain

  • Investigational Site Number : 7240003

    Badalona, Catalunya [Cataluña], 08916, Spain

  • Investigational Site Number : 7240006

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

  • Medical Dermatology Specialists Site Number : 8400002

    Phoenix, Arizona, 85006-2754, United States

  • Stryde Research Epiphany Dermatology Site Number : 8400014

    Southlake, Texas, 76092, United States

  • University of South Florida Site Number : 8400012

    Tampa, Florida, 33612, United States

  • Vast Skin Specialists Site Number : 8400015

    Addison, Texas, 75001, United States

  • Washington University School of Medicine Site Number : 8400007

    St Louis, Missouri, 63110, United States

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Other studies related to the condition(s) this trial covers.