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
- Conditions
- Acne inversa / acne ectopica10040790
- Registration Number
- NL-OMON54446
- Lead Sponsor
- CB Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 16
- 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:
a) Not a woman of childbearing potential (WOCBP)
OR
b) 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)
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Evaluate the safety of long term therapy of bimekizumab in study participants<br /><br>with moderate to severe HS<br /><br>• Treatment-emergent adverse events (TEAEs)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Evaluate the safety of long term therapy of bimekizumab using other safety<br /><br>measures in study participants with moderate to severe HS<br /><br>• Treatment-emergent serious adverse events (SAEs)<br /><br>• TEAEs leading to study withdrawal</p><br>