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NCT04901195

PHASE3

A Study to Test the Long-term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

Sponsor: UCB Biopharma SRL

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the safety of long-term therapy of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)

Official title: A Phase 3, Open-Label, Parallel Group, Multicenter, Extension Study Evaluating the Long-Term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

658

Start Date

2021-05-27

Completion Date

2026-07-22

Last Updated

2026-10-06

Healthy Volunteers

Conditions

Hidradenitis Suppurativa

Interventions

DRUG

Bimekizumab

Subjects will receive bimekizumab at pre-specified time-points.

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

Locations (145)

Hs0005 50140

Birmingham, Alabama, United States

Hs0005 50175

Phoenix, Arizona, United States

Hs0005 50162

Fountain Valley, California, United States

Hs0005 50161

Los Angeles, California, United States

Hs0005 50220

San Diego, California, United States

Hs0005 50196

Thousand Oaks, California, United States

Hs0005 50199

Miami, Florida, United States

Hs0005 50205

North Miami Beach, Florida, United States

Hs0005 50152

Orange Park, Florida, United States

Hs0005 50184

Pembroke Pines, Florida, United States

Hs0005 50193

Sandy Springs, Georgia, United States

Hs0005 50280

Watkinsville, Georgia, United States

Hs0005 50234

Plainfield, Indiana, United States

Hs0005 50425

Murray, Kentucky, United States

Hs0005 50198

Beverly, Massachusetts, United States

Hs0005 50146

Boston, Massachusetts, United States

Hs0005 50178

Clarkston, Michigan, United States

Hs0005 50105

St Louis, Missouri, United States

Hs0005 50194

Omaha, Nebraska, United States

Hs0005 50208

Las Vegas, Nevada, United States

Hs0005 50159

Newington, New Hampshire, United States

Hs0005 50137

East Windsor, New Jersey, United States

Hs0005 50200

Verona, New Jersey, United States

Hs0005 50237

Albuquerque, New Mexico, United States

Hs0005 50235

New York, New York, United States

Hs0005 50151

Chapel Hill, North Carolina, United States

Hs0005 50211

Durham, North Carolina, United States

Hs0005 50179

Winston-Salem, North Carolina, United States

Hs0005 50177

Cincinnati, Ohio, United States

Hs0005 50138

Columbus, Ohio, United States

Hs0005 50145

Columbus, Ohio, United States

Hs0005 50202

Fairborn, Ohio, United States

Hs0005 50204

Tulsa, Oklahoma, United States

Hs0005 50147

Hershey, Pennsylvania, United States

Hs0005 50008

Johnston, Rhode Island, United States

Hs0005 50180

Providence, Rhode Island, United States

Hs0005 50084

Charleston, South Carolina, United States

Hs0005 50236

Greenville, South Carolina, United States

Hs0005 50142

Nashville, Tennessee, United States

Hs0005 50201

Arlington, Texas, United States

Hs0005 50148

Pflugerville, Texas, United States

Hs0005 50141

Salt Lake City, Utah, United States

Hs0005 50270

Seattle, Washington, United States

Hs0005 30015

Campbelltown, Australia

Hs0005 30016

Carlton, Australia

Hs0005 30011

East Melbourne, Australia

Hs0005 30017

Kogarah, Australia

Hs0005 30018

Parkville, Australia

Hs0005 30014

St Leonards, Australia

Hs0005 30009

Westmead, Australia

Hs0005 30012

Woolloongabba, Australia

Hs0005 40002

Leuven, Belgium

Hs0005 40121

Woluwe-Saint-Lambert, Belgium

Hs0005 40313

Pleven, Bulgaria

Hs0005 40284

Sofia, Bulgaria

Hs0005 40311

Sofia, Bulgaria

Hs0005 40314

Sofia, Bulgaria

Hs0005 40315

Sofia, Bulgaria

Hs0005 40353

Stara Zagora, Bulgaria

Hs0005 50233

Barrie, Canada

Hs0005 50172

Cobourg, Canada

Hs0005 50135

Edmonton, Canada

Hs0005 50174

London, Canada

Hs0005 50190

Richmond Hill, Canada

Hs0005 50192

Saskatoon, Canada

Hs0005 50133

Surrey, Canada

Hs0005 50134

Waterloo, Canada

Hs0005 50136

Winnipeg, Canada

Hs0005 40063

Prague, Czechia

Hs0005 40194

Prague, Czechia

Hs0005 40197

Amiens, France

Hs0005 40245

Antony, France

Hs0005 40321

Auxerre, France

Hs0005 40320

La Rochelle, France

Hs0005 40355

Le Mans, France

Hs0005 40247

Lyon, France

Hs0005 40130

Marseille, France

Hs0005 40132

Nice, France

Hs0005 40404

Reims, France

Hs0005 40318

Rouen, France

Hs0005 40403

Saint-Etienne, France

Hs0005 40246

Saint-Mandé, France

Hs0005 40285

Toulon, France

Hs0005 40286

Toulouse, France

Hs0005 40325

Berlin, Germany

Hs0005 40326

Berlin, Germany

Hs0005 40248

Bochum, Germany

Hs0005 40327

Bonn, Germany

Hs0005 40288

Darmstadt, Germany

Hs0005 40324

Dresden, Germany

Hs0005 40356

Dresden, Germany

Hs0005 40287

Frankfurt am Main, Germany

Hs0005 40142

Hamburg, Germany

Hs0005 40328

Hanover, Germany

Hs0005 40249

Kiel, Germany

Hs0005 40250

Lübeck, Germany

Hs0005 40174

Mainz, Germany

Hs0005 40323

München, Germany

Hs0005 40177

Münster, Germany

Hs0005 40251

Athens, Greece

And 45 more locations on ClinicalTrials.gov

Clinical Research Directory

A Study to Test the Long-term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (145)