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

Last updated: November 27, 2025
Sponsor: Reata, a wholly owned subsidiary of Biogen
Overall Status: Terminated

Phase

2

Condition

Pain (Pediatric)

Pain

Treatment

Placebo

RTA 901

RTA 901-Matching Placebo

Clinical Study ID

NCT05895552
297DP201
901-C-2102
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Run-in Inclusion Criteria:

  • Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) atleast 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 painthat is burning, lancinating, tingling, or shooting (electric shock-like). Pain inthe lower extremities may occur with paresthesia or dysesthesia (unpleasantsensations of burning). Neuropathic pain may be accompanied by an exaggeratedresponse to painful stimuli (hyperalgesia) and pain evoked by light touch orcontact, 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

Exclusion

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

Total Participants: 209
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 2
Study Start date:
July 28, 2023
Estimated Completion Date:
November 15, 2024

Study Description

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

Connect with a study center

  • Centricity Research Phoenix Multispecialty

    Mesa 5304391, Arizona 5551752 85206
    United States

    Site Not Available

  • Arizona Research Center

    Phoenix 5308655, Arizona 5551752 85053
    United States

    Site Not Available

  • Clinical Research Institute LLC

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Hope Clinical Research, Inc.

    Canoga Park 5333913, California 5332921 91303
    United States

    Site Not Available

  • Valley Research - Trials

    Fresno 5350937, California 5332921 93720
    United States

    Site Not Available

  • Clinical Research Institute

    Los Angeles 5368361, California 5332921 90048
    United States

    Site Not Available

  • Acclaim Clinical Research

    San Diego 5391811, California 5332921 92120
    United States

    Site Not Available

  • Optimus Medical Group

    San Francisco 5391959, California 5332921 94102
    United States

    Site Not Available

  • PIH Health Whittier Hospital

    Whittier 5409059, California 5332921 90606
    United States

    Site Not Available

  • Denver Endocrinology Diabetes and Thyroid Center PC

    Englewood 5421250, Colorado 5417618 80113
    United States

    Site Not Available

  • Paradigm Clinical Research

    Wheat Ridge 5443948, Colorado 5417618 80033
    United States

    Site Not Available

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Finlay Medical Research

    Miami, Florida 33126
    United States

    Site Not Available

  • Baycare Clinical Research

    Tampa, Florida 33607
    United States

    Site Not Available

  • Clinical Research of West Florida, Inc.

    Tampa, Florida 33606
    United States

    Site Not Available

  • VICIS Clinical Research

    Tampa, Florida 33615
    United States

    Site Not Available

  • Clinical Site Partners, Orlando

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Clinical Research of West Florida Inc

    Clearwater 4151316, Florida 4155751 33765
    United States

    Site Not Available

  • Innovative Research of West Florida, Inc.

    Clearwater 4151316, Florida 4155751 33756
    United States

    Site Not Available

  • East Coast Institute for Research, LLC

    Jacksonville 4160021, Florida 4155751 32204
    United States

    Site Not Available

  • Multi Specialty Research Associates, LLC

    Lake City 4161187, Florida 4155751 32055
    United States

    Site Not Available

  • 3 Sync LLC

    Lake Worth 4161422, Florida 4155751 33460
    United States

    Site Not Available

  • Finlay Medical Research

    Miami 4164138, Florida 4155751 33126
    United States

    Site Not Available

  • New Horizon Research Center

    Miami 4164138, Florida 4155751 33165
    United States

    Site Not Available

  • Floridian Clinical Research

    Miami Lakes 4164186, Florida 4155751 33016
    United States

    Site Not Available

  • IMA Clinical Research, PC

    St. Petersburg 4171563, Florida 4155751 33709
    United States

    Site Not Available

  • 3 Sync LLC

    Sunrise 4174402, Florida 4155751 33013
    United States

    Site Not Available

  • Baycare Clinical Research

    Tampa 4174757, Florida 4155751 33607
    United States

    Site Not Available

  • Clinical Research of West Florida, Inc.

    Tampa 4174757, Florida 4155751 33606
    United States

    Site Not Available

  • Genesis Clinical Research

    Tampa 4174757, Florida 4155751 33603
    United States

    Site Not Available

  • VICIS Clinical Research

    Tampa 4174757, Florida 4155751 33615
    United States

    Site Not Available

  • Clinical Site Partners, Orlando

    Winter Park 4178560, Florida 4155751 32789
    United States

    Site Not Available

  • Conquest Research, LLC

    Winter Park 4178560, Florida 4155751 32789
    United States

    Site Not Available

  • Centricity Research Columbus Endocrinology

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Agile Clinical Research Trials, LLC

    Atlanta 4180439, Georgia 4197000 30328
    United States

    Site Not Available

  • East Coast Institute for Research, LLC

    Canton 4186213, Georgia 4197000 30114
    United States

    Site Not Available

  • Centricity Research Columbus Endocrinology

    Columbus 4188985, Georgia 4197000 31904
    United States

    Site Not Available

  • East Coast Institute for Research, LLC

    Macon 4207400, Georgia 4197000 31210
    United States

    Site Not Available

  • Methodist Medical Center of Illinois

    Peoria 4905687, Illinois 4896861 61606
    United States

    Site Not Available

  • MediSphere Medical Research Center, LLC

    Evansville 4257227, Indiana 4921868 47714
    United States

    Site Not Available

  • Integrated Clinical Trial Services, Inc.

    West Des Moines 4881346, Iowa 4862182 50265
    United States

    Site Not Available

  • Tandem Clinical Research

    Marrero 4332628, Louisiana 4331987 70072
    United States

    Site Not Available

  • Tandem Clinical Research

    Metairie 4333177, Louisiana 4331987 70006
    United States

    Site Not Available

  • Boston Clinical Trials, LLC

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • Boston Clinical Trials, LLC

    Boston 4930956, Massachusetts 6254926 02131
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • ActivMed Practices & Research, LLC

    Methuen 4943828, Massachusetts 6254926 01844
    United States

    Site Not Available

  • Revival Research Institute, LLC.

    Sterling Heights 5011148, Michigan 5001836 48126
    United States

    Site Not Available

  • StudyMetrix Research

    City of Saint Peters 4407237, Missouri 4398678 63303
    United States

    Site Not Available

  • Clinical Research Consultants, LLC

    Kansas City 4393217, Missouri 4398678 64111
    United States

    Site Not Available

  • Velocity Clinical Research, Inc.

    Lincoln 5072006, Nebraska 5073708 68510
    United States

    Site Not Available

  • Velocity Clinical Research, Inc.

    Norfolk 5073965, Nebraska 5073708 68510
    United States

    Site Not Available

  • Excel Clinical Research

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Las Vegas Endocrinology

    Henderson 5505411, Nevada 5509151 89074
    United States

    Site Not Available

  • Excel Clinical Research

    Las Vegas 5506956, Nevada 5509151 89109
    United States

    Site Not Available

  • Jubilee Clinical Research Inc

    Las Vegas 5506956, Nevada 5509151 89106
    United States

    Site Not Available

  • ActivMed Practices & Research, LLC

    Portsmouth 5091383, New Hampshire 5090174 03801
    United States

    Site Not Available

  • Columbia University

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Richmond Behavioral Associates

    Staten Island 5139568, New York 5128638 10314
    United States

    Site Not Available

  • Carolina Institute for Clinical Research

    Fayetteville, North Carolina 28303
    United States

    Active - Recruiting

  • Carolina Institute for Clinical Research, LLC

    Fayetteville 4466033, North Carolina 4482348 28303
    United States

    Site Not Available

  • Diabetes & Endocrinology Associates of Stark County, Inc.

    Canton, Ohio 44718
    United States

    Site Not Available

  • Remington Davis

    Columbus, Ohio 43215
    United States

    Active - Recruiting

  • Diabetes & Endocrinology Associates of Stark County, Inc.

    Canton 5149222, Ohio 5165418 44718
    United States

    Site Not Available

  • Velocity Clinical Research, Cincinnati

    Cincinnati 4508722, Ohio 5165418 45242
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

  • Remington-Davis, Inc.

    Columbus 4509177, Ohio 5165418 43215
    United States

    Site Not Available

  • Meta Medical Research Institute

    Dayton 4509884, Ohio 5165418 45432
    United States

    Site Not Available

  • Velocity Clinical Research, Providence

    East Greenwich 5221875, Rhode Island 5224323 68510
    United States

    Site Not Available

  • WR-Notus Clinical Research

    Charleston, South Carolina 29414
    United States

    Active - Recruiting

  • Notus Clinical Research

    Charleston 4574324, South Carolina 4597040 29414
    United States

    Site Not Available

  • WR-ClinSearch

    Chattanooga, Tennessee 37421
    United States

    Active - Recruiting

  • WR-ClinSearch, LLC

    Chattanooga 4612862, Tennessee 4662168 37421
    United States

    Site Not Available

  • Trinity Clinical Research LLC

    Tullahoma 4663494, Tennessee 4662168 37388
    United States

    Site Not Available

  • Amir A Hassan, MD, PA

    Houston, Texas 77089
    United States

    Site Not Available

  • Biopharma Informatic, LLC

    Houston, Texas 77084
    United States

    Active - Recruiting

  • Endocrine IPS, PLLC

    Houston, Texas 77079
    United States

    Site Not Available

  • Nerve and Muscle Center of Texas

    Houston, Texas 77030
    United States

    Site Not Available

  • VIP Trials

    San Antonio, Texas 78230
    United States

    Site Not Available

  • FutureSearch Trials of Neurology

    Austin 4671654, Texas 4736286 78731
    United States

    Site Not Available

  • REX Clinical Trials, LLC

    Beaumont 4672989, Texas 4736286 77701
    United States

    Site Not Available

  • Zenos Clinical Research

    Dallas 4684888, Texas 4736286 75230
    United States

    Site Not Available

  • Care United Research, LLC

    Forney 4691833, Texas 4736286 75126
    United States

    Site Not Available

  • Diabetes and Thyroid Center of Fort Worth

    Fort Worth 4691930, Texas 4736286 76053
    United States

    Site Not Available

  • Amir A Hassan, MD, PA

    Houston 4699066, Texas 4736286 77089
    United States

    Site Not Available

  • Biopharma Informatic, LLC

    Houston 4699066, Texas 4736286 77043
    United States

    Site Not Available

  • Endocrine IPS, PLLC

    Houston 4699066, Texas 4736286 77079
    United States

    Site Not Available

  • Nerve and Muscle Center of Texas

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • 3 Sync LLC

    Kingwood 7534469, Texas 4736286 77339
    United States

    Site Not Available

  • Epic Clinical Research

    Lewisville 4706057, Texas 4736286 75057
    United States

    Site Not Available

  • Shadow Creek Medical Clinic

    Pearland 4718097, Texas 4736286 77584
    United States

    Site Not Available

  • Diabetes & Glandular Disease Clinic, P.A.

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • VIP Trials

    San Antonio 4726206, Texas 4736286 78230
    United States

    Site Not Available

  • Velocity Clinical Research, Salt Lake City

    West Jordan 5784549, Utah 5549030 84088
    United States

    Site Not Available

  • Rainier Clinical Research Center

    Renton 5808189, Washington 5815135 98057
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.