2024-511035-10-00招募中3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 347
- 试验地点
- 44
- 主要终点
- Percentage of participants with treatment- emergent adverse events (TEAEs) during the study
研究概览
简要总结
Evaluate the safety of long-term therapy of bimekizumab in study participants with moderate to severe Hidradenitis Suppurativa (HS)
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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).
- •In France and in Germany, at the time of implementation of Protocol Amendments 2.3/France and 2.4/Germany, respectively, and after the participant provides informed consent, eligible participants will continue for an additional 48‑week open‑label treatment period if the criteria specified in the Protocol are met. In France, Protocol Amendment 2.6/France has further extended the open-label treatment period for up to 40 additional weeks.
排除标准
- •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.
- •In France and in Germany, at the time of implementation of Protocol Amendments 2.3/France and 2.4/Germany, respectively, and after the participant provides informed consent, eligible participants will continue for an additional 48‑week open‑label treatment period if the criteria specified in the Protocol are met. In France, Protocol Amendment 2.6/France has further extended the open-label treatment period for up to 40 additional weeks.
研究组 & 干预措施
bimekizumab
Experimental
Participants receiving bimekizumab
干预措施: bimekizumab (Drug)
结局指标
主要结局
Percentage of participants with treatment- emergent adverse events (TEAEs) during the study
Percentage of participants with treatment- emergent adverse events (TEAEs) during the study
次要结局
- Percentage of participants with treatment- emergent serious adverse events (SAEs) during the study
- Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the study
- Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
- Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
- Percentage of participants with Flare
- Hidradenitis Suppurativa Symptom Questionnaire (HSSQ) Response for Skin Pain
- Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score
研究者
UCB Cares
Scientific
UCB Biopharma
研究点 (44)
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