A Phase 2b Pivotal Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Moderate to Severe Hidradenitis Suppurativa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Part A: Number of Participants Who Achieved Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 12
研究概览
简要总结
Izokibep is a potent and selective inhibitor of interleukin 17A (IL-17A) that is being developed for treatment of hidradenitis suppurativa (HS).
This study will evaluate the efficacy, safety, and immunogenicity of izokibep administered subcutaneously (SC) in adult subjects with moderate to severe 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has provided signed informed consent including consenting to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •18 years to 75 years of age
- •Type of Subject and Disease Characteristics
- •Diagnosis of hidradenitis suppurativa (HS) for ≥ 1 year prior to first dose of study drug.
- •Hidradenitis suppurativa lesions present in ≥ 2 distinct anatomic areas , one of which is Hurley Stage II or III.
- •A total abscess and inflammatory nodule (AN) count of ≥ 5 at screening and Day 1 prior to enrollment/randomization.
- •Subject 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 over-the-counter topical antiseptics.
- •Subject must be willing to complete a daily skin pain diary.
排除标准
- •Medical Conditions
- •Draining fistula count of >
- •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.
- •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 subject 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 ≤ 3 months of screening 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
Part A (Open-label) izokibep every week
Participants will receive izokibep every week from Day 1 through Week 31
干预措施: Izokibep (Drug)
Part B (Double-blind) izokibep every week
Participants will receive izokibep every week for 31 weeks.
干预措施: Izokibep (Drug)
Part B (Double-blind) izokibep every other week
Participants will receive izokibep every other week for 30 weeks.
干预措施: Izokibep (Drug)
Part B (Double-blind) placebo every week
Participants will receive placebo every week up to Week 15, then izokibep from Week 16 to Week 31.
干预措施: Placebo to izokibep (Drug)
Part B (Double-blind) placebo every other week
Participants will receive placebo every other week up to Week 14, then izokibep from Week 16 to Week 30.
干预措施: Placebo to izokibep (Drug)
结局指标
主要结局
Part A: Number of Participants Who Achieved Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 12
时间窗: Part A: Baseline to Week 12
HiSCR75 was defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count.
Part B: Number of Participants Who Achieved HiSCR75 at Week 16
时间窗: Part B: Baseline to Week 16
HiSCR75 was defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count.
次要结局
- Part A: Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks)
- Part A: Number of Participants Testing Positive for Anti-drug Antibodies (ADAs)(Baseline, Week 16, Week 32, Week 39)
- Part B: Number of Participants Who Achieved HiSCR90 at Week 16(Part B: Baseline to Week 16)
- Part B: Number of Participants Who Achieved HiSCR100 at Week 16(Part B: Baseline to Week 16)
- Part B: Number of Participants Who Achieved HiSCR50 at Week 16(Part B: Baseline to Week 16)
- Part B: Percentage of Participants Who Experienced ≥ 1 Disease Flare Through 16 Weeks of Treatment(Part B: Day 1 through to Week 16)
- Part B: Number of Participants With Hurley Stage II at Baseline Who Achieved AN Count of 0, 1, or 2(Part B: Week 16)
- Part B: Number of Participants Who Achieved at Least a 3-Point Reduction From Baseline in Numeric Rating Scale (NRS) in Patient Global Assessment of Skin Pain at Its Worst at Week 16 Among Participants With Baseline NRS ≥ 4(Part B: Baseline to Week 16)
- Part B: Number of Participants With TEAEs of Special Interest(Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks)
- Part B: Number of Participants With TEAEs(Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks)
- Part B: Number of Participants Testing Positive for ADAs(Up to 39 weeks)