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A Study to Test the Long-term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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

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

NCT04901195•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)

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

May 27, 2021

Primary Completion Date

July 28, 2026

Completion Date

July 28, 2026

Last Updated

March 13, 2026

Enrollment

658

ACTUAL participants

Conditions

Hidradenitis Suppurativa

Interventions

Bimekizumab

DRUG

A Study With CIT-013 in HS Patients

NCT06993233

Hidradenitis Suppurativa (HS)

View study

RECRUITINGPHASE1

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

NCT06888193

Moderate to Severe Plaque PsoriasisPsoriatic Arthritis+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study With CIT-013 in HS Patients

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

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