Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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)
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
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