901-C-2102

About this trial

Last updated a year ago

Study ID

901-C-2102

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

Accepting

18+ Years

All

Not accepting

Healthy Volunteers

Trial Timing

Started 2 years ago

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. A total of 384 participants will be randomized in this study. Each part will have 192 participants, with 64 participants randomized 1:1:1 to each treatment arm. 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.

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.