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

Running, not enrolling · Phase 3

Conditions studied: Hidradenitis Suppurativa

In brief

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)

Key facts

Study ID

NCT04901195

Run by

UCB Biopharma SRL

People needed

658

Starts

2021-05-27

Expected to finish

2026-07-28

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Not a woman of childbearing potential (WOCBP) OR
• 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)

You may not qualify if…

• 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

Where it is running

• 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 50140 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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