TerminatedPhase 2

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

Stopped: Sponsor decision to close study early; not due to safety concerns.

United States209 participantsStarted 2023-07-28

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Run-in Inclusion Criteria: * Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) at least 1 year prior to Screening * Clinical diagnosis of DPNP defined as symptomatic distal symmetric polyneuropathy (secondary to diabetes) in the lower extremities, which may include symptoms of pain that is burning, lancinating, tingling, or shooting (electric shock-like). Pain in the lower extremities may occur with paresthesia or dysesthesia (unpleasant sensations of burning). Neuropathic pain may be accompanied by an exaggerated response to painful stimuli (hyperalgesia) and pain evoked by light touch or contact, eg, with socks, shoes, and bedclothes (allodynia); * NPRS pain intensity score ≥ 4 on an 11-point scale at Screening * A score ≥ 2.5 on the Michigan Neuropathy Screening Instrument (MNSI) Part B Run-in Exclusion Criteria: * Has neuropathy from a cause other than T1DM or T2DM * Has a condition other than DPNP that could confound the assessment of pain (eg, fibromyalgia or regional pain caused by lumbar or cervical compression); * Diabetic foot ulceration or infection within 90 days prior to Screening * Prior participation in a study with RTA 901; NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

What they're measuring

Change From Baseline in Weekly Average Pain Intensity Assessed by the Numeric Pain Rating Scale (NPRS) at Week 12

Timeframe: Baseline, Week 12

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) During and Following the Treatment Period

Timeframe: From the first dose of study drug up to end of follow-up period (up to 16 weeks)

Number of Participants With Clinically Significant Abnormalities in Physical Examinations

Timeframe: From the first dose of study drug up to end of follow-up period (up to 16 weeks)

Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters

Timeframe: From the first dose of study drug up to end of follow-up period (up to 16 weeks)

Number of Participants With Shift From Baseline in Clinically Significant Abnormalities in Electrocardiogram (ECG)

Timeframe: From the first dose of study drug up to end of follow-up period (up to 16 weeks)

Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters)

Timeframe: From the first dose of study drug up to end of follow-up period (up to 16 weeks)

Trial details

NCT IDNCT05895552

SponsorReata, a wholly owned subsidiary of Biogen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-15

Results submitted2025-10-28

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