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New drug shows promise for Long-Term control of painful skin condition

NCT ID NCT04901195

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 3 times

Summary

This phase 3 trial is testing the long-term safety of bimekizumab, a drug that targets inflammation, in 658 people with moderate to severe hidradenitis suppurativa (HS), a chronic skin condition causing painful boils. Participants who completed a previous study will receive bimekizumab for up to 48 weeks. The main goal is to track side effects, with secondary focus on serious adverse events. This study aims to see if bimekizumab can be a safe long-term 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, this could confirm bimekizumab as a safe long-term treatment option for managing moderate to severe hidradenitis suppurativa.
What could go wrong
This is an extension study focused on safety, not new efficacy data. Long-term use may still carry risks like infections or allergic reactions, and results may not apply to all patients.

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

658 people

The number who actually took part.

Started

May 2021

Finished

Jul 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 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: * Study participant has completed the Maintenance Treatment Period through Week 48 in HS0003 (NCT04242446) or HS0004 (NCT04242498), was eligible to receive bimekizumab at the time of completing the feeder study, and did not meet any withdrawal criteria of the feeder study * Study participant is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgement of the Investigator * 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 open-label extension period and for at least 20 weeks after the final dose of investigational medicinal product (IMP) Exclusion Criteria: * Female study participant 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) * Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study as determined by the Investigator based on protocol required assessments Note: For any study participant with an ongoing serious adverse event (SAE) from HS0003 (NCT04242446) or HS0004 (NCT04242498), or any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry or a history of serious infections in HS0003 or HS0004, the Medical Monitor must be consulted prior to the study participant's entry into HS0005, although the decision on whether to enroll the participant remains with the Investigator. * Study participant has a positive or indeterminate interferon-gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated * Study participant has ongoing or planned use of prohibited hidradenitis suppurativa (HS) or non-HS treatment * Study participant plans to participate in another study of a medicinal product or device under investigation during this study

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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

  • Hs0005 20033

    Nagoya, Japan

  • Hs0005 20037

    Osaka, Japan

  • Hs0005 20043

    Itabashi-ku, Japan

  • Hs0005 20144

    Fukuoka, Japan

  • Hs0005 20152

    Nakagami-gun, Japan

  • Hs0005 20153

    Obihiro, Japan

  • Hs0005 20154

    Sapporo, Japan

  • Hs0005 20170

    Kurume, Japan

  • Hs0005 20171

    Sendai, Japan

  • Hs0005 20178

    Nishinomiya, Japan

  • Hs0005 20190

    Kyoto, Japan

  • Hs0005 20195

    Kagoshima, Japan

  • Hs0005 20196

    Bunkyō City, Japan

  • Hs0005 30009

    Westmead, Australia

  • Hs0005 30011

    East Melbourne, Australia

  • Hs0005 30012

    Woolloongabba, Australia

  • Hs0005 30014

    St Leonards, Australia

  • Hs0005 30015

    Campbelltown, Australia

  • Hs0005 30016

    Carlton, Australia

  • Hs0005 30017

    Kogarah, Australia

  • Hs0005 30018

    Parkville, Australia

  • Hs0005 40002

    Leuven, Belgium

  • Hs0005 40049

    Seville, Spain

  • Hs0005 40063

    Prague, Czechia

  • Hs0005 40095

    Wroclaw, Poland

  • Hs0005 40121

    Woluwe-Saint-Lambert, Belgium

  • Hs0005 40130

    Marseille, France

  • Hs0005 40132

    Nice, France

  • Hs0005 40142

    Hamburg, Germany

  • Hs0005 40159

    Barcelona, Spain

  • Hs0005 40174

    Mainz, Germany

  • Hs0005 40177

    Münster, Germany

  • Hs0005 40194

    Prague, Czechia

  • Hs0005 40197

    Amiens, France

  • Hs0005 40230

    Valencia, Spain

  • Hs0005 40245

    Antony, France

  • Hs0005 40246

    Saint-Mandé, France

  • Hs0005 40247

    Lyon, France

  • Hs0005 40248

    Bochum, Germany

  • Hs0005 40249

    Kiel, Germany

  • Hs0005 40250

    Lübeck, Germany

  • Hs0005 40251

    Athens, Greece

  • Hs0005 40252

    Efkarpia, Greece

  • Hs0005 40254

    Debrecen, Hungary

  • Hs0005 40258

    Rozzano, Italy

  • Hs0005 40261

    Catania, Italy

  • Hs0005 40263

    Roma, Italy

  • Hs0005 40264

    Rotterdam, Netherlands

  • Hs0005 40266

    Badalona, Spain

  • Hs0005 40267

    Barcelona, Spain

  • Hs0005 40268

    Madrid, Spain

  • Hs0005 40270

    Antalya, Turkey (Türkiye)

  • Hs0005 40271

    Izmir, Turkey (Türkiye)

  • Hs0005 40272

    Istanbul, Turkey (Türkiye)

  • Hs0005 40273

    Gaziantep, Turkey (Türkiye)

  • Hs0005 40284

    Sofia, Bulgaria

  • Hs0005 40285

    Toulon, France

  • Hs0005 40286

    Toulouse, France

  • Hs0005 40287

    Frankfurt am Main, Germany

  • Hs0005 40288

    Darmstadt, Germany

  • Hs0005 40292

    Groningen, Netherlands

  • Hs0005 40293

    Rzeszów, Poland

  • Hs0005 40294

    Las Palmas de Gran Canaria, Spain

  • Hs0005 40295

    Pontevedra, Spain

  • Hs0005 40297

    Manises, Spain

  • Hs0005 40298

    Granada, Spain

  • Hs0005 40311

    Sofia, Bulgaria

  • Hs0005 40313

    Pleven, Bulgaria

  • Hs0005 40314

    Sofia, Bulgaria

  • Hs0005 40315

    Sofia, Bulgaria

  • Hs0005 40318

    Rouen, France

  • Hs0005 40320

    La Rochelle, France

  • Hs0005 40321

    Auxerre, France

  • Hs0005 40323

    München, Germany

  • Hs0005 40324

    Dresden, Germany

  • Hs0005 40325

    Berlin, Germany

  • Hs0005 40326

    Berlin, Germany

  • Hs0005 40327

    Bonn, Germany

  • Hs0005 40328

    Hanover, Germany

  • Hs0005 40330

    Torino, Italy

  • Hs0005 40333

    Wroclaw, Poland

  • Hs0005 40334

    Wroclaw, Poland

  • Hs0005 40335

    Warsaw, Poland

  • Hs0005 40339

    Leeds, United Kingdom

  • Hs0005 40344

    Dublin, Ireland

  • Hs0005 40347

    Lodz, Poland

  • Hs0005 40351

    Breda, Netherlands

  • Hs0005 40353

    Stara Zagora, Bulgaria

  • Hs0005 40355

    Le Mans, France

  • Hs0005 40356

    Dresden, Germany

  • Hs0005 40403

    Saint-Etienne, France

  • Hs0005 40404

    Reims, France

  • Hs0005 40406

    Geneva, Switzerland

  • Hs0005 50008

    Johnston, Rhode Island, 02919, United States

  • Hs0005 50084

    Charleston, South Carolina, 29425, United States

  • Hs0005 50105

    St Louis, Missouri, 63110, United States

  • Hs0005 50133

    Surrey, Canada

  • Hs0005 50134

    Waterloo, Canada

  • Hs0005 50135

    Edmonton, Canada

  • Hs0005 50136

    Winnipeg, Canada

  • Hs0005 50137

    East Windsor, New Jersey, 08520, United States

  • Hs0005 50138

    Columbus, Ohio, 43213, United States

  • Hs0005 50140

    Birmingham, Alabama, 35249, United States

  • Hs0005 50141

    Salt Lake City, Utah, 84107, United States

  • Hs0005 50142

    Nashville, Tennessee, 37215, United States

  • Hs0005 50145

    Columbus, Ohio, 43230, United States

  • Hs0005 50146

    Boston, Massachusetts, 02215, United States

  • Hs0005 50147

    Hershey, Pennsylvania, 17033, United States

  • Hs0005 50148

    Pflugerville, Texas, 78660, United States

  • Hs0005 50151

    Chapel Hill, North Carolina, 27516, United States

  • Hs0005 50152

    Orange Park, Florida, 32073, United States

  • Hs0005 50159

    Newington, New Hampshire, 03801, United States

  • Hs0005 50161

    Los Angeles, California, 90045, United States

  • Hs0005 50162

    Fountain Valley, California, 92708, United States

  • Hs0005 50172

    Cobourg, Canada

  • Hs0005 50174

    London, Canada

  • Hs0005 50175

    Phoenix, Arizona, 85006, United States

  • Hs0005 50177

    Cincinnati, Ohio, 45219, United States

  • Hs0005 50178

    Clarkston, Michigan, 48346, United States

  • Hs0005 50179

    Winston-Salem, North Carolina, 27157, United States

  • Hs0005 50180

    Providence, Rhode Island, 02903, United States

  • Hs0005 50184

    Pembroke Pines, Florida, 33028, United States

  • Hs0005 50190

    Richmond Hill, Canada

  • Hs0005 50192

    Saskatoon, Canada

  • Hs0005 50193

    Sandy Springs, Georgia, 30329, United States

  • Hs0005 50194

    Omaha, Nebraska, 68144, United States

  • Hs0005 50196

    Thousand Oaks, California, 91320, United States

  • Hs0005 50198

    Beverly, Massachusetts, 01915, United States

  • Hs0005 50199

    Miami, Florida, 33136, United States

  • Hs0005 50200

    Verona, New Jersey, 07044, United States

  • Hs0005 50201

    Arlington, Texas, 76011, United States

  • Hs0005 50202

    Fairborn, Ohio, 45324, United States

  • Hs0005 50204

    Tulsa, Oklahoma, 74137, United States

  • Hs0005 50205

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

  • Hs0005 50208

    Las Vegas, Nevada, 89148, United States

  • Hs0005 50211

    Durham, North Carolina, 27710, United States

  • Hs0005 50220

    San Diego, California, 92123, United States

  • Hs0005 50233

    Barrie, Canada

  • Hs0005 50234

    Plainfield, Indiana, 46168, United States

  • Hs0005 50235

    New York, New York, 10003, United States

  • Hs0005 50236

    Greenville, South Carolina, 29615, United States

  • Hs0005 50237

    Albuquerque, New Mexico, 87102, United States

  • Hs0005 50270

    Seattle, Washington, 98101, United States

  • Hs0005 50280

    Watkinsville, Georgia, 30677, United States

  • Hs0005 50425

    Murray, Kentucky, 42071, United States

More trials for these conditions

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