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

NCT05895552 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 297DP201901-C-2102
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 75

Brief 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.

Conditions

Diabetic Peripheral Neuropathic Pain

Keywords

RTA 901

Outcome Measures

Primary Outcomes (10)

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

  The NPRS of pain intensity is an 11-point numeric scale, ranging from 0 (representing no pain at all) to 10 (representing the worst pain imaginable). The participants were asked to select a whole number (0 to 10) that best indicates the intensity of his/her neuropathic pain in the past 24 hours. The weekly average score of NPRS was defined as the sum of non-missing daily scores divided by the number of days with non-missing scores for that week. Negative change from baseline indicates decreased pain intensity.

  Baseline, Week 12

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

  An adverse event (AE) was any unfavorable and unintended sign (including any CS abnormal laboratory test result), symptom, or disease temporally associated with use of the study drug, whether or not it is considered to be study drug related. An SAE was any untoward medical occurrence that at any dose resulted in death, in the view of Investigator, placed participant at immediate risk of death, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a birth defect. AEs that presented, or worsened in intensity or frequency, following the initiation of study treatment were categorized as TEAEs.

  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

  Clinically significant abnormalities in physical examinations were based on investigator discretion.

  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

  Vital sign parameters included temperature, pulse rate systolic blood pressure, diastolic blood pressure, and respiratory rate. As pre-specified in protocol, the criteria for determining potentially clinically relevant abnormalities in vital signs included: temperature \< 36.0 and \> 38.0 degrees Celsius (c), pulse rate \< 60 and \> 100 beats per minute (bpm), systolic blood pressure \< 90, \> 140 and \> 160 millimeters of mercury (mmHg), diastolic blood pressure \< 50, \> 90 and \> 100 mmHg, weight (7% or more increase from baseline, 7% or more decrease from baseline) and respiratory rate \< 12 and \> 20 breaths per minute. The categories with at least one participant with clinically significant vital sign abnormalities are reported.

  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)

  Clinical significance of abnormalities in ECG was determined based on the investigator's discretion.

  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)

  Hematology parameters included hematocrit, hemoglobin, erythrocytes, leukocytes, neutrophils, lymphocytes, monocytes, basophils, eosinophils, platelets, mean corpuscular hemoglobin, mean corpuscular volume, and mean corpuscular hemoglobin concentration. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available. Here, shift to low indicated values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high postbaseline values. The categories with at least one participant with shift from baseline in these parameters are reported.

  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 (Blood Chemistry Parameters)

  Parameters included alanine aminotransferase (ALT), aspartate aminotransferase (AST), cholesterol, choriogonadotropin beta, follicle stimulating hormone (FSH), estimated glomerular filtration rate (eGFR), ferritin, creatine kinase, blood urea nitrogen, creatinine, bilirubin(total and direct), alkaline phosphatase, amylase, lipase, sodium, potassium, calcium, phosphorus, uric acid, total protein, glucose, albumin, lactate dehydrogenase, magnesium, chloride, bicarbonate, and gamma-glutamyl transferase. These parameters were flagged as low, normal or high relative to parameter's normal range or as unknown if no result was available, by Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high values postbaseline. Categories with at least one participant with shift from baseline in these parameters are reported.

  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 (Urinalysis)

  Urinalysis included assessments of bacteria, Bilirubin, Calcium Oxalate Crystals, Choriogonadotropin Beta, Color, Erythrocytes, Glucose, Granular Casts, Hyaline Casts, Ketones, Leukocyte Esterase, Leukocytes, Nitrite, Occult Blood, Protein, red blood cells (RBC) Casts, Renal Epithelial Cells, Specific Gravity, Specimen Appearance, Squamous Epithelial Cells, Transitional Epithelial Cells, Triple Phosphate Crystals, Uric Acid Crystals, white blood cells (WBC) Casts and pH. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high postbaseline. The categories with at least one participant with shift from baseline in these parameters are reported.

  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 (Coagulation Parameters)

  Coagulation included assessments of prothrombin. The parameter was flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high postbaseline.

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

• Number of Participants With Clinically Significant Abnormality in Body Weight

  Weight decrease was characterized by a decrease of ≥7% from baseline and weight increase was characterized by an increase of ≥7% from baseline.

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

Secondary Outcomes (6)

• Number of Participants Who Achieved at Least a >=30% Decrease From Baseline in the Average NPRS Score at Week 12

  Baseline, Week 12

• Number of Participants Who Achieved at Least a >=50% Decrease From Baseline in the Average NPRS Score at Week 12

  Baseline, Week 12

• Number of Participants Using Rescue Medications During the Treatment Period

  Up to Week 12

• Amount of Rescue Medications Used During the Treatment Period

  Up to Week 12

• Time to First Occurrence of Rescue Medication Use

  Up to Week 12

Study Arms (6)

Part 1 RTA 901 Dose 1

EXPERIMENTAL

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

Part 1 RTA 901 Dose 2

EXPERIMENTAL

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

Part 1 RTA 901-Matching Placebo

PLACEBO COMPARATOR

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

Part 2 RTA 901 Dose 1

EXPERIMENTAL

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

Part 2 RTA 901 Dose 2

EXPERIMENTAL

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

Part 2 RTA 901-Matching Placebo

PLACEBO COMPARATOR

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

Interventions

RTA 901 DRUG

Administered as specified in the treatment arm.

Also known as: BIIB143, Cemdomespib

Part 1 RTA 901 Dose 1; Part 1 RTA 901 Dose 2; Part 2 RTA 901 Dose 1; Part 2 RTA 901 Dose 2

RTA 901-Matching Placebo DRUG

Administered as specified in the treatment arm.

Part 1 RTA 901-Matching Placebo; Part 2 RTA 901-Matching Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Reata, a wholly owned subsidiary of Biogen: lead

Study Sites (75)

Centricity Research Phoenix Multispecialty

Mesa, Arizona, 85206, United States

Location

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Hope Clinical Research, Inc.

Canoga Park, California, 91303, United States

Location

Valley Research - Trials

Fresno, California, 93720, United States

Location

Clinical Research Institute

Los Angeles, California, 90048, United States

Location

Acclaim Clinical Research

San Diego, California, 92120, United States

Location

Optimus Medical Group

San Francisco, California, 94102, United States

Location

PIH Health Whittier Hospital

Whittier, California, 90606, United States

Location

Denver Endocrinology Diabetes and Thyroid Center PC

Englewood, Colorado, 80113, United States

Location

Paradigm Clinical Research

Wheat Ridge, Colorado, 80033, United States

Location

Innovative Research of West Florida, Inc.

Clearwater, Florida, 33756, United States

Location

Clinical Research of West Florida Inc

Clearwater, Florida, 33765, United States

Location

East Coast Institute for Research, LLC

Jacksonville, Florida, 32204, United States

Location

Multi Specialty Research Associates, LLC

Lake City, Florida, 32055, United States

Location

3 Sync LLC

Lake Worth, Florida, 33460, United States

Location

Finlay Medical Research

Miami, Florida, 33126, United States

Location

New Horizon Research Center

Miami, Florida, 33165, United States

Location

Floridian Clinical Research

Miami Lakes, Florida, 33016, United States

Location

IMA Clinical Research, PC

St. Petersburg, Florida, 33709, United States

Location

3 Sync LLC

Sunrise, Florida, 33013, United States

Location

Genesis Clinical Research

Tampa, Florida, 33603, United States

Location

Clinical Research of West Florida, Inc.

Tampa, Florida, 33606, United States

Location

Baycare Clinical Research

Tampa, Florida, 33607, United States

Location

VICIS Clinical Research

Tampa, Florida, 33615, United States

Location

Clinical Site Partners, Orlando

Winter Park, Florida, 32789, United States

Location

Conquest Research, LLC

Winter Park, Florida, 32789, United States

Location

Agile Clinical Research Trials, LLC

Atlanta, Georgia, 30328, United States

Location

East Coast Institute for Research, LLC

Canton, Georgia, 30114, United States

Location

Centricity Research Columbus Endocrinology

Columbus, Georgia, 31904, United States

Location

East Coast Institute for Research, LLC

Macon, Georgia, 31210, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61606, United States

Location

MediSphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

Integrated Clinical Trial Services, Inc.

West Des Moines, Iowa, 50265, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Tandem Clinical Research

Metairie, Louisiana, 70006, United States

Location

Boston Clinical Trials, LLC

Boston, Massachusetts, 02131, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

ActivMed Practices & Research, LLC

Methuen, Massachusetts, 01844, United States

Location

Revival Research Institute, LLC.

Sterling Heights, Michigan, 48126, United States

Location

StudyMetrix Research

City of Saint Peters, Missouri, 63303, United States

Location

Clinical Research Consultants, LLC

Kansas City, Missouri, 64111, United States

Location

Velocity Clinical Research, Inc.

Lincoln, Nebraska, 68510, United States

Location

Velocity Clinical Research, Inc.

Norfolk, Nebraska, 68510, United States

Location

Las Vegas Endocrinology

Henderson, Nevada, 89074, United States

Location

Jubilee Clinical Research Inc

Las Vegas, Nevada, 89106, United States

Location

Excel Clinical Research

Las Vegas, Nevada, 89109, United States

Location

ActivMed Practices & Research, LLC

Portsmouth, New Hampshire, 03801, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10314, United States

Location

Carolina Institute for Clinical Research, LLC

Fayetteville, North Carolina, 28303, United States

Location

Diabetes & Endocrinology Associates of Stark County, Inc.

Canton, Ohio, 44718, United States

Location

Velocity Clinical Research, Cincinnati

Cincinnati, Ohio, 45242, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Remington-Davis, Inc.

Columbus, Ohio, 43215, United States

Location

Meta Medical Research Institute

Dayton, Ohio, 45432, United States

Location

Velocity Clinical Research, Providence

East Greenwich, Rhode Island, 68510, United States

Location

Notus Clinical Research

Charleston, South Carolina, 29414, United States

Location

WR-ClinSearch, LLC

Chattanooga, Tennessee, 37421, United States

Location

Trinity Clinical Research LLC

Tullahoma, Tennessee, 37388, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

Location

REX Clinical Trials, LLC

Beaumont, Texas, 77701, United States

Location

Zenos Clinical Research

Dallas, Texas, 75230, United States

Location

Care United Research, LLC

Forney, Texas, 75126, United States

Location

Diabetes and Thyroid Center of Fort Worth

Fort Worth, Texas, 76053, United States

Location

Nerve and Muscle Center of Texas

Houston, Texas, 77030, United States

Location

Biopharma Informatic, LLC

Houston, Texas, 77043, United States

Location

Endocrine IPS, PLLC

Houston, Texas, 77079, United States

Location

Amir A Hassan, MD, PA

Houston, Texas, 77089, United States

Location

3 Sync LLC

Kingwood, Texas, 77339, United States

Location

Epic Clinical Research

Lewisville, Texas, 75057, United States

Location

Shadow Creek Medical Clinic

Pearland, Texas, 77584, United States

Location

Diabetes & Glandular Disease Clinic, P.A.

San Antonio, Texas, 78229, United States

Location

VIP Trials

San Antonio, Texas, 78230, United States

Location

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, 84088, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

Limitations and Caveats

The study was terminated prematurely based on the sponsor's decision.

Results Point of Contact

• Title: US Biogen Clinical Trial Center
• Organization: Biogen

clinicaltrials@biogen.com

866-633-4636

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: June 8, 2023
• Study Start: July 28, 2023
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: December 15, 2025
• Results First Posted: December 15, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (75)