A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ORKA-002 in Adult Participants With Moderate-to-Severe Hidradenitis Suppurativa
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 15
- 主要终点
- Proportion of participants achieving HiSCR75 at Week 16
研究概览
简要总结
This is a multicenter, randomized, double-blinded, placebo-controlled clinical study of ORKA-002 in adult participants with moderate-to-severe HS.
详细描述
The study will evaluate an induction dosing regimen of ORKA-002 administered every 4 weeks for 12 weeks compared with placebo during a double-blind induction period through Week 16. This will be followed by an open-label maintenance period, during which ORKA-002 will be administered every 12 weeks. The study will consist of four periods:
- Screening Period
- Induction Period (double-blind)
- Maintenance Period (open-label)
- Post-Treatment Follow-Up Period
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has signs and symptoms of HS for at least 6 months;
- •Has HS lesions present in ≥ 2 distinct anatomic areas, one of which must be at least Hurley Stage II or III;
- •Has a history of inadequate response to systemic antibiotic treatment for HS, exhibited recurrence of HS symptoms after discontinuation of systemic antibiotics for HS, demonstrated intolerance to systemic antibiotics for HS, or has a contraindication to systemic antibiotics for HS
排除标准
- •Presence of any other active skin disease or condition that may interfere with the assessment of HS;
- •Diagnosis or suspected diagnosis of autoimmune diseases or inflammatory conditions other than HS
研究组 & 干预措施
Induction Period - Arm 2 (Placebo)
Participants will receive Placebo per protocol Induction regimen.
干预措施: Placebo (Other)
Induction Period - Arm 1 (ORKA-002)
Participants will receive ORKA-002 per protocol Induction regimen.
干预措施: ORKA-002 (Drug)
结局指标
主要结局
Proportion of participants achieving HiSCR75 at Week 16
时间窗: Week 16
At least a 75% reduction from Baseline in the total abscess and inflammatory nodule count, with no increase from Baseline in abscess or draining tunnel count.
次要结局
- Proportion of participants achieving HiSCR50 at Week 16(Week 16)
- Change from Baseline in the weekly mean of the Hidradenitis Suppurativa Symptom Daily Diary (HSSDD) worst skin pain score at Week 16(Week 16)
- Proportion of participants with a ≥ 3-point decrease from Baseline in the weekly mean of the HSSDD worst skin pain score at Week 16 among those with a Baseline score ≥ 3(Week 16)
- Incidence of TEAEs, TESAEs, and TEAESIs and Observed values, potentially clinically important values, and change from baseline in vital signs, laboratory tests, and electrocardiograms(Day 1 through Week 92)