2025-522987-34-00招募中2 期
A Phase 2, Long-term Extension Study of the Safety and Efficacy of ORX750 in Participants with Narcolepsy and Idiopathic Hypersomnia Who Completed a Sponsored ORX750 Clinical Trial
Centessa Pharmaceuticals UK Limited4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年2月12日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Incidence, severity, and causal relationship of treatment emergent adverse events (TEAEs), including serious TEAEs
研究概览
简要总结
To evaluate the long-term safety and tolerability of ORX750
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •All Participants: • Participants with narcolepsy (NT1 or NT2) or IH who have completed the full treatment period in Study ORX750-
- •Participants must be able and willing to participate in all scheduled evaluations and procedures per protocol and must agree to be available to complete all study measurements and comply with study restrictions. • Male and female participants must comply with contraception requirements described in the protocol.
- •Returning Participants Only: o 18-65 years of age o BMI ≥17.0 and ≤37 kg/m2 o Estimated glomerular filtration rate ≥60 mL/min/1.73 m2 o Is willing and able to discontinue all medications used for the treatment of narcolepsy or idiopathic hypersomnia o Is willing and able to adhere to additional protocol requirements
- •Rollover Participants Only: o Each participant must provide written informed consent by the final treatment visit (Day 42) in Study ORX750-0201, before the performance of any study-related procedures in the LTE study
排除标准
- •Returning Participants Only: • Participant has a medical condition(s) other than NT1, NT2, or IH for which excluded medications should not be discontinued. • Participant has participated in a study with an investigational drug other than ORX750 within the previous 30 days or within 5 half-lives of the investigational drug administration, whichever is longer, calculated from the last dose of the investigational drug or any AE related to the prior study to the screening day. • Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological or psychiatric disease.
- •Rollover Participants Only: o Development of any new disease/disorder that in the opinion of the investigator would make the participant unable to continue the study.
结局指标
主要结局
Incidence, severity, and causal relationship of treatment emergent adverse events (TEAEs), including serious TEAEs
Incidence, severity, and causal relationship of treatment emergent adverse events (TEAEs), including serious TEAEs
Changes from baseline in laboratory tests, including biochemistry, hematology, and urinalysis
Changes from baseline in laboratory tests, including biochemistry, hematology, and urinalysis
Changes from baselinea in vital signs and weight
Changes from baselinea in vital signs and weight
Changes from baseline in 12-lead electrocardiograms (ECGs)
Changes from baseline in 12-lead electrocardiograms (ECGs)
Columbia-Suicide Severity Rating Scale (C-SSRS) scores
Columbia-Suicide Severity Rating Scale (C-SSRS) scores
次要结局
- PK: - Predose and post dose PK concentrations of ORX750 - Other PK parameters as appropriate
- Efficacy: o Mean sleep latency (changes from baseline to Day 63) in the MWT (average of the first 4 trials) o Subjective daytime sleepiness (changes from baseline to specified post dose timepoints) using the ESS
研究者
Senior Vice President, Clinical Development
Scientific
Centessa Pharmaceuticals UK Limited
研究点 (4)
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