New drug shows promise for painful skin condition

NCT ID NCT04242498

Disease control Sponsor: UCB Biopharma SRL Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested bimekizumab, a drug that targets inflammation, in 509 adults with moderate to severe hidradenitis suppurativa (HS), a chronic skin condition causing painful abscesses and tunnels. Participants received either bimekizumab or a placebo over 16 weeks. The main goal was to see if the drug could reduce abscess and inflammatory nodule counts by at least 50%. The study is complete, and results will show if bimekizumab offers a new treatment option for HS.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: bimekizumab
What this could lead to: If successful, bimekizumab could become a new treatment option to control moderate to severe hidradenitis suppurativa, reducing painful flare-ups and improving quality of life.
What could go wrong: This is a completed Phase 3 trial, but results are not yet fully published. The drug may not work for everyone, and side effects are possible. It is not a cure, and ongoing treatment may be needed.

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

509 people

The number who actually took part.

Started

Mar 2020

Finished

Sep 2022

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 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

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

Hs0004 20033

Nagoya, Japan
Hs0004 20037

Osaka, Japan
Hs0004 20043

Itabashi-ku, Japan
Hs0004 20090

Afula, Israel
Hs0004 20144

Fukuoka, Japan
Hs0004 20152

Nakagami-gun, Japan
Hs0004 20153

Obihiro, Japan
Hs0004 20154

Sapporo, Japan
Hs0004 20170

Kurume, Japan
Hs0004 20171

Sendai, Japan
Hs0004 20178

Nishinomiya, Japan
Hs0004 20190

Kyoto, Japan
Hs0004 20195

Kagoshima, Japan
Hs0004 20196

Bunkyō City, Japan
Hs0004 30009

Westmead, Australia
Hs0004 30014

St Leonards, Australia
Hs0004 30018

Parkville, Australia
Hs0004 40063

Prague, Czechia
Hs0004 40095

Wroclaw, Poland
Hs0004 40101

Sabadell, Spain
Hs0004 40113

London, United Kingdom
Hs0004 40129

Bordeaux, France
Hs0004 40130

Marseille, France
Hs0004 40142

Hamburg, Germany
Hs0004 40159

Barcelona, Spain
Hs0004 40194

Prague, Czechia
Hs0004 40240

Newcastle upon Tyne, United Kingdom
Hs0004 40245

Antony, France
Hs0004 40247

Lyon, France
Hs0004 40250

Lübeck, Germany
Hs0004 40254

Debrecen, Hungary
Hs0004 40267

Barcelona, Spain
Hs0004 40268

Madrid, Spain
Hs0004 40284

Sofia, Bulgaria
Hs0004 40286

Toulouse, France
Hs0004 40287

Frankfurt am Main, Germany
Hs0004 40289

Berlin, Germany
Hs0004 40293

Rzeszów, Poland
Hs0004 40297

Manises, Spain
Hs0004 40298

Granada, Spain
Hs0004 40300

Cardiff, United Kingdom
Hs0004 40311

Sofia, Bulgaria
Hs0004 40313

Pleven, Bulgaria
Hs0004 40314

Sofia, Bulgaria
Hs0004 40315

Sofia, Bulgaria
Hs0004 40320

La Rochelle, France
Hs0004 40321

Auxerre, France
Hs0004 40322

Dessau, Germany
Hs0004 40326

Berlin, Germany
Hs0004 40328

Hanover, Germany
Hs0004 40333

Wroclaw, Poland
Hs0004 40334

Wroclaw, Poland
Hs0004 40335

Warsaw, Poland
Hs0004 40338

Northampton, United Kingdom
Hs0004 40339

Leeds, United Kingdom
Hs0004 40344

Dublin, Ireland
Hs0004 40347

Lodz, Poland
Hs0004 40353

Stara Zagora, Bulgaria
Hs0004 40356

Dresden, Germany
Hs0004 40403

Saint-Etienne, France
Hs0004 40404

Reims, France
Hs0004 50084

Johns Island, South Carolina, 29425, United States
Hs0004 50105

St Louis, Missouri, 63110, United States
Hs0004 50134

Waterloo, Canada
Hs0004 50135

Edmonton, Canada
Hs0004 50136

Winnipeg, Canada
Hs0004 50144

Orlando, Florida, 38219, United States
Hs0004 50145

Columbus, Ohio, 43230, United States
Hs0004 50148

Pflugerville, Texas, 78660, United States
Hs0004 50150

Philadelphia, Pennsylvania, 19103, United States
Hs0004 50152

Orange Park, Florida, 32073, United States
Hs0004 50159

Portsmouth, New Hampshire, 03801, United States
Hs0004 50162

Fountain Valley, California, 92708, United States
Hs0004 50164

Skokie, Illinois, 60077, United States
Hs0004 50172

Cobourg, Canada
Hs0004 50174

London, Canada
Hs0004 50178

Clarkston, Michigan, 48346, United States
Hs0004 50179

Winston-Salem, North Carolina, 27104, United States
Hs0004 50184

Pembroke Pines, Florida, 33028, United States
Hs0004 50189

St. John's, Canada
Hs0004 50193

Sandy Springs, Georgia, 30328, United States
Hs0004 50196

Thousand Oaks, California, 91320, United States
Hs0004 50197

Henderson, Nevada, 89052, United States
Hs0004 50199

Miami, Florida, 33125, United States
Hs0004 50200

Verona, New Jersey, 07044, United States
Hs0004 50202

Fairborn, Ohio, 45324, United States
Hs0004 50211

Durham, North Carolina, 27710, United States
Hs0004 50223

Savannah, Georgia, 31419, United States
Hs0004 50234

Plainfield, Indiana, 46168, United States
Hs0004 50236

Greenville, South Carolina, 29615, United States
Hs0004 50237

Albuquerque, New Mexico, 87106, United States

More trials for these conditions

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