A Study of RTA 901 (BIIB143) in Participants With Diabetic Peripheral Neuropathic Pain
Summary
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.
Timeline
- Start
- 2023-07-28
- Primary completion
- 2024-11-15
- Completion
- 2024-11-15
Outcome
Missed primary endpoint
Stopped (Business): “Sponsor decision to close study early; not due to safety concerns.”
registry analysis (superiority test); Part 1: RTA 901 Matching Placebo + SOC vs Part 1: RTA 901 10 mg + SOC; p <0.5224; Least square (LS) mean difference 0.23 (95% CI -0.468 to 0.918); MMRM NCT05895552 ↗
registry analysis (superiority test); Part 1: RTA 901 Matching Placebo + SOC vs Part 1: RTA 901 80 mg + SOC; p <0.8223; LS mean difference -0.08 (95% CI -0.772 to 0.614); MMRM NCT05895552 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RTA 901 | Unknown | — | — |