A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 509
- 试验地点
- 182
- 主要终点
- Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be at least 18 years of age, at the time of signing the informed consent. If a study participant is under the local age of consent and is at least 18 years of age, written informed consent will be obtained from both the study participant and the legal representative
- •Study participants must have a diagnosis of Hidradenitis Suppurativa (HS) based on clinical history and physical examination for at least 6 months prior to the Baseline visit
- •Study participant must have HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla), 1 of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline visits
- •Study participant must have moderate to severe HS defined as a total of ≥5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline visits
- •Study participant must have had an inadequate response to a course of a systemic antibiotic for treatment of HS as assessed by the Investigator through study participant interview and review of medical history
- •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 treatment period and for at least 20 weeks after the last dose of investigational medicinal product (IMP)
排除标准
- •Draining tunnel count of >20 at the Baseline Visit
- •Any other active skin disease or condition (eg, bacterial cellulitis, candida intertrigo, extensive condyloma) that may, in the opinion of the Investigator, interfere with the assessment of hidradenitis suppurativa (HS)
- •Study participant has a diagnosis of sarcoidosis, systemic lupus erythematosus, or active inflammatory bowel disease (IBD)
- •Primary immunosuppressive condition, including taking immunosuppressive therapy following an organ transplant, or has had a splenectomy
- •Female 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)
- •Active infection or history of certain infection(s)
- •Active tuberculosis (TB) infection, latent TB infection, high risk of exposure to TB infection, current or history of nontuberculous mycobacterium (NTM) infection
- •Concurrent malignancy. Study participants with a history of malignancy within the past 5 years prior to the Screening Visit are excluded, EXCEPT if the malignancy was a cutaneous squamous or basal cell carcinoma, or in situ cervical cancer that has been treated and is considered cured
- •History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease
- •Known hypersensitivity to any components of bimekizumab or comparative drugs as stated in this protocol this protocol
- •Concomitant and prior medication restrictions
- •Myocardial infarction or stroke within the 6 months prior to the Screening Visit
- •Study participant has the presence of active suicidal ideation, or positive suicide behavior using the "Screening" version of the electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
- •Presence of moderately severe major depression or severe major depression
- •Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening
研究组 & 干预措施
Placebo Group
Subjects randomized to this arm will receive placebo during the Initial Treatment Period and bimekizumab during the Maintenance Treatment Period.
干预措施: Placebo (Other)
Bimekizumab dosing regimen 1
Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the Treatment Period.
干预措施: Bimekizumab (Drug)
Bimekizumab dosing regimen 2
Subjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the Treatment Period.
干预措施: Bimekizumab (Drug)
Placebo Group
Subjects randomized to this arm will receive placebo during the Initial Treatment Period and bimekizumab during the Maintenance Treatment Period.
干预措施: Bimekizumab (Drug)
Bimekizumab dosing regimen 3
Subjects participating in the study will receive assigned bimekizumab dosing regimen 3 during the Treatment Period.
干预措施: Bimekizumab (Drug)
结局指标
主要结局
Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16
时间窗: Week 16
HiSCR50 was defined as at least a 50 percent (%) reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count. Intermittent missing data are imputed using multiple imputation with Markov Chain Monte Carlo (MCMC) method followed by monotone regression for monotone missing data. Lesion counts were imputed and then dichotomized to obtain the response status. Participants who experienced an intercurrent event were treated as nonresponders following the intercurrent event. An intercurrent event was defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to an adverse event (AE) or lack of efficacy. Percentages of participants shown do not account for model effects using the logistic regression model.
次要结局
- Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16(Week 16)
- Percentage of Participants With Flare by Week 16(From Baseline to Week 16)
- Absolute Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16(Baseline, Week 16)
- Absolute Change From Baseline in Worst Skin Pain Score at Week 16(Baseline, Week 16)
- Percentage of Participants Achieving Skin Pain Response at Week 16(Week 16)
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study(From Baseline (Day 1) until Safety Follow-Up (up to Week 71))
- Percentage of Participants With Serious Treatment-emergent Adverse Events During the Study(From Baseline (Day 1) until Safety Follow-Up (up to Week 71))
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From the Study(From Baseline (Day 1) until Safety Follow-Up (up to Week 71))