A Study of RTA 901 (BIIB143) in Participants With Diabetic Peripheral Neuropathic Pain
2期
提前终止
NCT05895552
| 适应症 | Diabetic Peripheral Neuropathic Pain |
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| 分期 | 2期 |
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| 申办方 | Reata, a wholly owned subsidiary of Biogen |
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| 状态 | 提前终止 |
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| 受试者人数 | 209 人 |
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| 干预（药物） | RTA 901, RTA 901-Matching Placebo |
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| 开始日期 | 2023年7月28日 |
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| 完成日期 | 2024年11月15日 |
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| 结果公布日 | 2025年12月15日 |
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摘要
This is a 2-part, randomized, placebo-controlled, double-blind, Phase 2 study to evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of RTA 901 in qualified participants with Diabetic Peripheral Neuropathic Pain (DPNP). Each study part will be randomized into 3 treatment arms; 2 different doses of RTA 901 and RTA 901-maching placebo. The doses of RTA 901 in Part 2 will be selected based on the Exposure-Response (E-R) analyses of data from Part 1. The duration of each part of the study will be approximately 20 weeks, including a Screening period of up to 2 weeks, a Run-in-period of 2 weeks, a Treatment period of 12 weeks, and a Follow-up period of 4 weeks. All participants in Part 1 and Part 2 of the study will follow the same visit and assessment schedule. Eligibility will be assessed during the Screening and Run-in-periods.
Change From Baseline in Weekly Average Pain Intensity Assessed by the Numeric Pain Rating Scale (NPRS) at Week 12
Baseline, Week 12 · score on a scale
| Part 1: RTA 901 Matching Placebo + SOC | -1.71 ± 0.249 score on a scale |
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| Part 1: RTA 901 10 mg + SOC | -1.49 ± 0.248 score on a scale |
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| Part 1: RTA 901 80 mg + SOC | -1.79 ± 0.248 score on a scale |
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| p-value | <0.5224 |
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| Least square (LS) mean difference | 0.23 (95% CI -0.468–0.918) |
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) During and Following the Treatment Period
From the first dose of study drug up to end of follow-up period (up to 16 weeks) · Participants
| Part 1: RTA 901 Matching Placebo + SOC | 39 Participants |
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| Part 1: RTA 901 10 mg + SOC | 43 Participants |
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| Part 1: RTA 901 80 mg + SOC | 35 Participants |
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| Part 1: RTA 901 Matching Placebo + SOC | 4 Participants |
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| Part 1: RTA 901 10 mg + SOC | 5 Participants |
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| Part 1: RTA 901 80 mg + SOC | 1 Participants |
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Number of Participants With Clinically Significant Abnormalities in Physical Examinations
From the first dose of study drug up to end of follow-up period (up to 16 weeks) · Participants
| Part 1: RTA 901 Matching Placebo + SOC | 0 Participants |
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| Part 1: RTA 901 10 mg + SOC | 0 Participants |
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| Part 1: RTA 901 80 mg + SOC | 0 Participants |
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