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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1 RTA 901 Dose 1 		Participants will receive study drug, once daily (QD), during the 2-week Run-in Period. Following randomization, the participants will receive a dose of RTA 901, QD, for a 12-week treatment duration.
  • Drug: RTA 901
    Administered as specified in the treatment arm.
    Other names:
    • BIIB143
    • Cemdomespib
Experimental
Part 1 RTA 901 Dose 2 		Participants will receive study drug, QD, during the 2-week Run-in Period. Following randomization, the participants will receive a dose of RTA 901, QD, for a 12-week treatment duration.
  • Drug: RTA 901
    Administered as specified in the treatment arm.
    Other names:
    • BIIB143
    • Cemdomespib
Placebo Comparator
Part 1 RTA 901-Matching Placebo 		Participants will receive study drug, QD, during the 2-week Run-in Period. Following randomization, the participants will receive a dose of RTA 901-matching placebo, QD, for a 12-week treatment duration.
  • Drug: RTA 901-Matching Placebo
    Administered as specified in the treatment arm.
Experimental
Part 2 RTA 901 Dose 1 		Participants will receive study drug, QD, during the 2-week Run-in Period. Following randomization, the participants will receive a dose of RTA 901, QD, for a 12-week treatment duration.
  • Drug: RTA 901
    Administered as specified in the treatment arm.
    Other names:
    • BIIB143
    • Cemdomespib
Experimental
Part 2 RTA 901 Dose 2 		Participants will receive study drug, QD, during the 2-week Run-in Period. Following randomization, the participants will receive a dose of RTA 901, QD, for a 12-week treatment duration.
  • Drug: RTA 901
    Administered as specified in the treatment arm.
    Other names:
    • BIIB143
    • Cemdomespib
Placebo Comparator
Part 2 RTA 901-Matching Placebo 		Participants will receive study drug, QD, during the 2-week Run-in Period. Following randomization, the participants will receive a dose of RTA 901-matching placebo, QD, for a 12-week treatment duration.
  • Drug: RTA 901-Matching Placebo
    Administered as specified in the treatment arm.

More Details

Status
Terminated
Sponsor
Biogen

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.