NCT05895552

A Study of RTA 901 (BIIB143) in Participants With Diabetic Peripheral Neuropathic Pain

A Phase 2 Study to Evaluate the Safety and Efficacy of RTA 901 in Patients With Diabetic Peripheral Neuropathic Pain

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 209 (actual)
• Sponsor: Reata, a wholly owned subsidiary of Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

Conditions

• Diabetic Peripheral Neuropathic Pain

Interventions

Type	Name	Description
DRUG	RTA 901	Administered as specified in the treatment arm.
DRUG	RTA 901-Matching Placebo	Administered as specified in the treatment arm.

Timeline

• Start date: 2023-07-28
• Primary completion: 2024-11-15
• Completion: 2024-11-15
• First posted: 2023-06-08
• Last updated: 2025-12-15
• Results posted: 2025-12-15

Locations

75 sites across 1 country: United States

Regulatory

• FDA-regulated drug study