A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Moderate to Severe Hidradenitis Suppurativa
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 12
研究概览
简要总结
Izokibep is a small protein molecule that acts as a selective, potent inhibitor of interleukin 17A, to which it binds with high affinity. This study investigates izokibep in participants with active Hidradenitis Suppurativa (HS), including tumor necrosis factor-alpha inhibitor (TNFi) naïve participants, and those who had an inadequate response or intolerance to TNFi, or for whom TNFi is contraindicated.
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
- Double (Participant, Investigator)
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 has provided signed informed consent including consenting to comply with the requirements and restrictions listed in the informed consent form (ICF) and in protocol
- •18 years of age or older
- •No known history of active tuberculosis unless adequately treated according to World Health Organization/Center for Disease Control and Prevention therapeutic guidance and determined to be fully recovered by a tuberculosis specialist
- •Type of Participant and Disease Characteristics
- •Diagnosis of HS for ≥ 6 months prior to first dose of study drug
- •Hidradenitis suppurativa lesions present in ≥ 2 distinct anatomic areas, one of which is Hurley Stage II or Hurley Stage III
- •A total AN count of ≥ 5 at screening and Day 1 prior to enrollment/randomization
- •Participant must have had an inadequate response to oral antibiotics OR exhibited recurrence after discontinuation to, OR demonstrated intolerance to, OR have a contraindication to oral antibiotics for treatment of their HS
- •Must agree to use daily or a minimum of 3 days a week over-the-counter topical antiseptics
- •Participant must be willing to complete a daily skin pain diary
排除标准
- •Medical Conditions
- •Draining fistula count of > 20
- •Outpatient surgery ≤ 8 weeks prior or inpatient surgery ≤ 12 weeks prior to enrollment/randomization
- •Other active skin disease or condition that could interfere with study assessments
- •History of active inflammatory bowel disease (IBD) OR symptoms within the last year that may be suggestive of IBD
- •Chronic pain not associated with HS
- •Uncontrolled, clinically significant system disease
- •History of demyelinating disease or neurological symptoms suggestive of demyelinating disease
- •Malignancy within 5 years
- •The participant is at risk of self-harm or harm to others
- •Active infection or history of certain infections
- •Tuberculosis or fungal infection seen on available chest x-ray taken within 3 months prior to first dose of study drug or at screening (Exception: documented evidence of completed treatment and clinically resolved)
- •Known history of human immunodeficiency virus (HIV)
- •Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Group 1
Participants will receive placebo as a subcutaneous (SC) injection every week (QW) from Day 1 to Week 15. Participants will then receive izokibep as a SC injection QW from Week 16 to Week 51.
干预措施: Placebo (Drug)
Group 1
Participants will receive placebo as a subcutaneous (SC) injection every week (QW) from Day 1 to Week 15. Participants will then receive izokibep as a SC injection QW from Week 16 to Week 51.
干预措施: Izokibep (Drug)
Group 2
Participants will receive izokibep QW from Day 1 to Week 51.
干预措施: Izokibep (Drug)
结局指标
主要结局
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 12
时间窗: Week 12
The percentage of participants achieving HiSCR75 was defined as meeting all 3 criteria below: * (\[abscess and inflammatory nodule (AN) count at baseline - AN count at current visit\] / AN count at baseline) × 100% ≥ 75% * Abscess count at baseline ≥ abscess count at the current visit * Draining fistula count at baseline ≥ draining fistula count at the current visit. HiSCR75 was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods.
次要结局
- Percentage of Participants Achieving HiSCR90 at Week 12(Week 12)
- Percentage of Participants Achieving HiSCR50 at Week 12(Week 12)
- Percentage of Participants Achieving HiSCR100 at Week 12(Week 12)
- Percentage of Participants Who Experienced One or More (≥ 1) Disease Flare at Week 12(Up to Week 12)
- Change From Baseline in Dermatology Life Quality Index (DLQI)(Baseline and Week 12)
- Percentage of Participants With Baseline Hurley Stage II Who Achieved AN Count of 0, 1, or 2 at Week 12(Week 12)
- Percentage of Participants With Baseline NRS ≥ 4 Achieving at Least 3-point Reduction at Week 12 in Numeric Rating Scale (NRS) Patient Global Assessment of Skin Pain at Its Worst(Week 12)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and Adverse Event of Special Interest (AESIs) in Period 1(Up to Week 16)
- Number of Participants With TEAEs, SAEs and AESIs in Period 2(From Week 16 to follow-up, Week 59)