A Multicenter, Randomized, Double-blinded, Placebo-controlled, Dose-range Finding Study of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 72
- 主要终点
- Proportion of Participants Achieving 100% Reduction in PASI Score at Week 16
研究概览
简要总结
This is a multicenter, randomized, double-blinded, placebo-controlled, dose-range finding study to evaluate the efficacy and safety of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis.
详细描述
This is a multicenter, randomized, double-blinded, placebo-controlled, dose ranging study designed to identify the optimal induction dosing regimen of ORKA-001 in approximately 160 adult participants with moderate-to-severe plaque psoriasis.
The study will evaluate the efficacy and safety of 3 induction dosing regimens of ORKA-001 compared to placebo and will include 3 maintenance regimens.
The study will consist of 4 periods:
- Screening Period of up to 6 weeks
- Induction Period of up to 28 weeks (Day 1 [Baseline] to Week 28)
- Maintenance Period of up to approximately 72 weeks (Week 28 to Week 100)
- Post-treatment Follow-up Period: Participants will have the option to enter the open-label extension (OLE) study. Participants who opt out of the OLE study and/or withdraw from the study must be followed for 48 weeks after the End of Treatment (EOT)/Early Termination (ET) visit.
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
- •Participants ≥ 18 years of age
- •Have a diagnosis of plaque psoriasis for > 6 months
- •Have moderate-to-severe chronic plaque psoriasis defined as:
- •BSA ≥ 10%, and
- •PASI ≥ 12, and
- •IGA score of ≥ 3 on a 5-point scale
- •Candidate for systemic therapy or phototherapy
- •Women of childbearing potential must have a negative pregnancy test.
排除标准
- •Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis
- •Significant history or clinical manifestation of any metabolic, other dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, respiratory, endocrine, or psychiatric disorder, or any infectious disease
- •History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence
- •A known hypersensitivity to any components of the ORKA-001 drug product
- •Women who are breastfeeding or plan to breastfeed during the study
研究组 & 干预措施
(Maintenance Period - Arm 2) ORKA-001
Participants will receive 600 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response.
干预措施: ORKA-001 (Drug)
(Maintenance Period - Arm 3) Placebo
Participants will receive Placebo per protocol Maintenance regimen, based on protocol defined response.
干预措施: Placebo (Other)
(Induction Period - Arm 3) ORKA-001
Participants will receive 600 mg ORKA-001 per protocol Induction regimen.
干预措施: ORKA-001 (Drug)
(Induction Period - Arm 1) ORKA-001
Participants will receive 37.5 mg ORKA-001 per protocol Induction regimen.
干预措施: ORKA-001 (Drug)
(Maintenance Period - Arm 1) ORKA-001
Participants will receive 300 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response.
干预措施: ORKA-001 (Drug)
(Induction Period - Arm 2) ORKA-001
Participants will receive 300 mg ORKA-001 per protocol Induction regimen.
干预措施: ORKA-001 (Drug)
(Induction Period - Arm 4) Placebo
Participants will receive Placebo per protocol Induction regimen.
干预措施: Placebo (Other)
结局指标
主要结局
Proportion of Participants Achieving 100% Reduction in PASI Score at Week 16
时间窗: Week 16
The Psoriasis Area and Severity Index Score (PASI) is an evaluation tool that combines the assessment of the severity and the area affected by psoriasis into a single score ranging from 0 (no disease) to 72 (maximum disease).
次要结局
- Proportion of Participants Who Achieve an IGA = 0 (Clear) at Week 16(Week 16)
- Proportion of Participants Achieving 90% Reduction in PASI Score at Week 16(Week 16)
- Proportion of Participants Who Achieve an IGA = 0 (Clear) or 1 (Almost Clear) at Week 16(Week 16)
- Proportion of Participants Maintaining 100% Reduction in PASI Score at Week 100(Week 100)
- Proportion of Participants Maintaining an IGA = 0 (Clear) at Week 100(Week 100)
- Proportion of Participants Maintaining 90% Reduction in PASI Score at Week 100(Week 100)
- Proportion of Participants Maintaining an IGA = 0 (Clear) or 1 (Almost Clear) at Week 100(Week 100)
- Proportion of Participants Maintaining 75% Reduction in PASI Score at Week 100(Week 100)
- Incidence of Treatment-emergent Adverse Events (TEAEs) and TEAEs of Special Interest (TEAESIs)(Day 1 through Week 100)