Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug shows promise for painful skin condition in large trial

NCT ID NCT04242446

Disease control Sponsor: UCB Biopharma SRL 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 drug called bimekizumab in 505 adults with moderate to severe hidradenitis suppurativa, a chronic skin condition that causes painful lumps. The main goal was to see if the drug reduces the number of inflamed lumps by at least half after 16 weeks, compared to a placebo. The trial is complete and aims to find a better treatment option for this hard-to-manage disease.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

505 people

The number who actually took part.

Started

Feb 2020

Finished

Feb 2023

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 years and older

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 at least 18 years of age, at the time of signing the informed consent. If a study participant is under the local age of consent and is at least 18 years of age, written informed consent will be obtained from both the study participant and the legal representative * Study participants must have a diagnosis of Hidradenitis Suppurativa (HS) based on clinical history and physical examination for at least 6 months prior to the Baseline visit * Study participant must have HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla), 1 of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline visits * Study participant must have moderate to severe HS defined as a total of ≥5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline visits * Study participant must have had an inadequate response to a course of a systemic antibiotic for treatment of HS as assessed by the Investigator through study participant interview and review of medical history * A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: 1. Not a woman of childbearing potential (WOCBP) OR 2. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 20 weeks after the last dose of investigational medicinal product (IMP) Exclusion Criteria: * Draining tunnel count of \>20 at the Baseline Visit * Any other active skin disease or condition (eg, bacterial cellulitis, candida intertrigo, extensive condyloma) that may, in the opinion of the Investigator, interfere with the assessment of hidradenitis suppurativa (HS) * Study participant has a diagnosis of sarcoidosis, systemic lupus erythematosus, or active inflammatory bowel disease (IBD) * Primary immunosuppressive condition, including taking immunosuppressive therapy following an organ transplant, or has had a splenectomy * Female who is breastfeeding, pregnant, or plans to become pregnant during the study or within 20 weeks following the final dose of investigational medicinal product (IMP) * Active infection or history of certain infection(s) * Active tuberculosis (TB) infection, latent TB infection, high risk of exposure to TB infection, current or history of nontuberculous mycobacterium (NTM) infection * Concurrent malignancy. Study participants with a history of malignancy within the past 5 years prior to the Screening Visit are excluded, EXCEPT if the malignancy was a cutaneous squamous or basal cell carcinoma, or in situ cervical cancer that has been treated and is considered cured * History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease * Known hypersensitivity to any components of bimekizumab or comparative drugs as stated in this protocol * Concomitant and prior medication restrictions * Myocardial infarction or stroke within the 6 months prior to the Screening Visit * Study participant has the presence of active suicidal ideation, or positive suicide behavior using the "Screening" version of the electronic Columbia Suicide Severity Rating Scale (eC-SSRS) * Presence of moderately severe major depression or severe major depression * Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Hidradenitis suppurativa are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Hs0003 20088

    Tel Aviv, Israel

  • Hs0003 20089

    Haifa, Israel

  • Hs0003 30011

    East Melbourne, Australia

  • Hs0003 30012

    Woolloongabba, Australia

  • Hs0003 30015

    Campbelltown, Australia

  • Hs0003 30016

    Carlton, Australia

  • Hs0003 30017

    Kogarah, Australia

  • Hs0003 40002

    Leuven, Belgium

  • Hs0003 40004

    Brussels, Belgium

  • Hs0003 40049

    Seville, Spain

  • Hs0003 40050

    Istanbul, Turkey (Türkiye)

  • Hs0003 40053

    Ankara, Turkey (Türkiye)

  • Hs0003 40060

    Liège, Belgium

  • Hs0003 40121

    Brussels, Belgium

  • Hs0003 40127

    Aarhus N, Denmark

  • Hs0003 40132

    Nice, France

  • Hs0003 40174

    Mainz, Germany

  • Hs0003 40177

    Münster, Germany

  • Hs0003 40197

    Amiens, France

  • Hs0003 40230

    Valencia, Spain

  • Hs0003 40246

    Saint-Mandé, France

  • Hs0003 40248

    Bochum, Germany

  • Hs0003 40249

    Kiel, Germany

  • Hs0003 40251

    Athens, Greece

  • Hs0003 40252

    Thessaloniki, Greece

  • Hs0003 40253

    Athens, Greece

  • Hs0003 40257

    Roma, Italy

  • Hs0003 40258

    Rozzano, Italy

  • Hs0003 40261

    Catania, Italy

  • Hs0003 40263

    Roma, Italy

  • Hs0003 40264

    Rotterdam, Netherlands

  • Hs0003 40266

    Badalona, Spain

  • Hs0003 40270

    Antalya, Turkey (Türkiye)

  • Hs0003 40271

    Izmir, Turkey (Türkiye)

  • Hs0003 40272

    Istanbul, Turkey (Türkiye)

  • Hs0003 40273

    Gaziantep, Turkey (Türkiye)

  • Hs0003 40285

    Toulon, France

  • Hs0003 40288

    Darmstadt, Germany

  • Hs0003 40292

    Groningen, Netherlands

  • Hs0003 40294

    Las Palmas de Gran Canaria, Spain

  • Hs0003 40295

    Pontevedra, Spain

  • Hs0003 40318

    Rouen, France

  • Hs0003 40323

    München, Germany

  • Hs0003 40324

    Dresden, Germany

  • Hs0003 40325

    Berlin, Germany

  • Hs0003 40327

    Bonn, Germany

  • Hs0003 40330

    Torino, Italy

  • Hs0003 40331

    Terracina, Italy

  • Hs0003 40332

    Trondheim, Norway

  • Hs0003 40337

    Bern, Switzerland

  • Hs0003 40342

    Angers, France

  • Hs0003 40351

    Breda, Netherlands

  • Hs0003 40355

    Le Mans, France

  • Hs0003 40357

    Magdeburg, Germany

  • Hs0003 40406

    Geneva, Switzerland

  • Hs0003 50008

    Johnston, Rhode Island, 02919, United States

  • Hs0003 50133

    Surrey, Canada

  • Hs0003 50137

    East Windsor, New Jersey, 08520, United States

  • Hs0003 50138

    Columbus, Ohio, 43213, United States

  • Hs0003 50140

    Birmingham, Alabama, 35233, United States

  • Hs0003 50141

    Tampa, Florida, 33613, United States

  • Hs0003 50142

    Nashville, Tennessee, 37215, United States

  • Hs0003 50146

    Boston, Massachusetts, 02215, United States

  • Hs0003 50147

    Hershey, Pennsylvania, 17033, United States

  • Hs0003 50149

    San Antonio, Texas, 78213, United States

  • Hs0003 50151

    Chapel Hill, North Carolina, 27516, United States

  • Hs0003 50153

    Ormond Beach, Florida, 32174, United States

  • Hs0003 50161

    Los Angeles, California, 90045, United States

  • Hs0003 50166

    Dallas, Texas, 75246, United States

  • Hs0003 50173

    St. John's, Canada

  • Hs0003 50175

    Phoenix, Arizona, 85006, United States

  • Hs0003 50177

    Cincinnati, Ohio, 45219, United States

  • Hs0003 50180

    Providence, Rhode Island, 02903, United States

  • Hs0003 50190

    Richmond Hill, Canada

  • Hs0003 50192

    Saskatoon, Canada

  • Hs0003 50194

    Omaha, Nebraska, 68144, United States

  • Hs0003 50198

    Beverly, Massachusetts, 01915, United States

  • Hs0003 50201

    Arlington, Texas, 76011, United States

  • Hs0003 50204

    Tulsa, Oklahoma, 74135, United States

  • Hs0003 50205

    North Miami Beach, Florida, 33162-4708, United States

  • Hs0003 50208

    Las Vegas, Nevada, 89148, United States

  • Hs0003 50210

    Atlanta, Georgia, 30309, United States

  • Hs0003 50220

    San Diego, California, 92123, United States

  • Hs0003 50233

    Barrie, Canada

  • Hs0003 50235

    New York, New York, 10003, United States

  • Hs0003 50270

    Seattle, Washington, 98101, United States

  • Hs0003 50280

    Watkinsville, Georgia, 30677, United States

  • Hs0003 50425

    Murray, Kentucky, 42071, United States

More trials for these conditions

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