An Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 32
- 主要终点
- Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs of Special Interest (TEAESIs)
研究概览
简要总结
An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis, who previously participated in an Oruka Therapeutics sponsored study.
详细描述
This open-label extension study evaluates the long-term safety and efficacy of ORKA-001 in adults with moderate-to-severe plaque psoriasis. The study includes an open-label treatment period of up to approximately 96 weeks and a post-treatment follow-up period of approximately 48 weeks following the last study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Signed informed consent by participants from previous trial choosing to transition into the OLE.
- •Participants who have successfully completed the preceding trial.
- •For women of childbearing potential, must have a negative urine pregnancy test at Baseline visit.
- •For women of childbearing potential and fertile male participants with a partner of childbearing potential must be willing to continue to use highly effective contraception
排除标准
- •Participants who experienced any adverse events with ORKA-001 in the preceding trial that led to permanent investigational medicinal product discontinuation or, in the opinion of the Investigator, would preclude continued treatment with ORKA-001
- •Participants who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the Investigator), during the preceding trial.
- •Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding during the medical examination that, in the opinion of the Investigator would compromise the safety of the participant or the quality of the data.
- •Any clinically significant laboratory abnormality based on the last available lab results received during the preceding trial, that, according to the Investigator's medical assessment, precludes them from continued treatment with ORKA-
- •Participant is pregnant or breastfeeding.
研究组 & 干预措施
No Drug
Participants will receive no drug until protocol defined PASI response criterion is met.
ORKA-001 Twice Yearly
Participants will receive ORKA-001 every 6 months per OLE protocol.
干预措施: ORKA-001 (Drug)
ORKA-001 Once Yearly (High Dose)
Participants will receive ORKA-001 once a year per OLE protocol.
干预措施: ORKA-001 (Drug)
ORKA-001 Once Yearly (Low Dose)
Participants will receive ORKA-001 once a year per OLE protocol.
干预措施: ORKA-001 (Drug)
结局指标
主要结局
Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs of Special Interest (TEAESIs)
时间窗: Day 1 through Week 144
Incidence of treatment adverse events, treatment-emergent serious adverse events, treatment adverse events of special interest, and potential clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms.
Incidence of Treatment-emergent Adverse Events (TEAEs) and TEAEs of Special Interest (TEAESIs)
时间窗: Day 1 through Week 144
Incidence of treatment adverse events, treatment adverse events of special interest, and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms.
次要结局
- Proportion of Participants with an Improvement of their OLE Baseline PASI Score in the Subset of Participants who did not Achieve PASI75 at OLE Baseline(Day 1 through Week 96)
- Time-to-loss of PASI100 in the Subset of Participants who achieved PASI100 at Baseline of OLE(Day 1 through Week 96)
- Time-to-loss of PASI90 in the Subset of Participants who achieved PASI90 at Baseline of the OLE(Day 1 through Week 96)
- Proportion of Participants Maintaining or with Improvement of OLE Baseline PASI Score(Day 1 through Week 96)
- Proportion of Participants Maintaining PASI100 in the Subset of Participants Meeting the Criterion at Baseline of OLE(Day 1 through Week 96)
- Proportion of Participants Maintaining PASI90 in the Subset of Participants Meeting the Criterion at Baseline of OLE(Day 1 through Week 96)
- Proportion of Participants Maintaining Investigator's Global Assessment (IGA) 0 in the Subset of Participants Meeting the Criterion at Baseline of OLE(Day 1 through Week 96)
- Proportion of Participants Maintaining Investigator's Global Assessment (IGA) 0/1 in the Subset of Participants Meeting the Criterion at Baseline of OLE(Time Frame: Day 1 through Week 96)
- Time-to-loss of PASI100 in Subset of Participants with PASI100 at Baseline of OLE(Day 1 through Week 96)
- PASI Score Over Time(Day 1 through Week 96)
- IGA Score Over Time(Day 1 through Week 96)