A Phase 2 Study of RTA 901 (BIIB143) in Participants With Diabetic Peripheral Neuropathic Pain (CYPRESS)
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Interventions
- Drug: RTA 901-Matching Placebo
- Registration Number
- NCT05895552
- Lead Sponsor
- Reata, a wholly owned subsidiary of Biogen
- 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. 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.
- Detailed Description
Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 209
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 RTA 901 Dose 1 RTA 901 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. Part 1 RTA 901 Dose 2 RTA 901 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. Part 1 RTA 901-Matching Placebo 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. Part 2 RTA 901-Matching Placebo 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. Part 2 RTA 901 Dose 1 RTA 901 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. Part 2 RTA 901 Dose 2 RTA 901 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Clinically Significant Abnormality in Physical Examinations Baseline up to Week 16 Number of Participants With Clinically Significant Abnormality in Vital Sign Baseline up to Week 16 Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG) Baseline up to Week 16 Number of Participants With Clinically Significant Abnormality in Clinical Laboratory Measurement Baseline up to Week 16 Number of Participants With Clinically Significant Abnormality in Body Weight Baseline up to Week 16 Change From Baseline in Average Daily Pain Intensity as Assessed by the Numeric Pain Rating Scale (NPRS) at Week 12 Baseline, Week 12 The NPRS of pain intensity is a numeric scale, ranging from 0 (representing no pain at all) to 10 (representing the worst pain imaginable). The participant will select a whole number (0 to 10) that best indicates the intensity of his/her pain in the past 24 hours. Lower scores indicate less pain.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During and Following the Treatment Period From the first day of dosing up to end of follow-up period (Week 16)
- Secondary Outcome Measures
Name Time Method Number of Participants who Achieved at Least a 50% Decrease From Baseline in the Average NPRS Score at Week 12 Week 12 The NPRS of pain intensity is a numeric scale, ranging from 0 (representing no pain at all) to 10 (representing the worst pain imaginable). The participant will select a whole number (0 to 10) that best indicates the intensity of his/her pain in the past 24 hours. Lower scores indicate less pain.
Duration of Rescue Medications Used During the Treatment Period Up to Week 12 Number of Participants who Achieved at Least a 30% Decrease From Baseline in the Average NPRS Score at Week 12 Week 12 The NPRS of pain intensity is a numeric scale, ranging from 0 (representing no pain at all) to 10 (representing the worst pain imaginable). The participant selects a whole number (0 to 10) that best indicates the intensity of his/her pain in the past 24 hours. Lower scores indicate less pain.
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 Change From Baseline in the Average Daily Sleep Interference Scale (DSIS) score at Week 12 Baseline, Week 12 DSIS is a participant reported outcome that was developed to quantify sleep interference due to pain. The DSIS will be completed daily by participants upon waking (3-minute self-administered questionnaire), preferably in the morning, to accurately capture variability in sleep interference due to pain, thus minimizing recall bias. Using the e-diary, participants will assess how pain has interfered with their sleep during the past 24 hours. This score ranges from 0 to 10; 0 representing no interference with sleep to 10 representing complete inability to sleep. Lower score indicates less pain interference during sleep.
Trial Locations
- Locations (68)
Centricity Research Phoenix Multispecialty
🇺🇸Mesa, Arizona, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Hope Clinical Research, Inc.
🇺🇸Canoga Park, California, United States
Valley Research - Trials
🇺🇸Fresno, California, United States
Clinical Research Institute
🇺🇸Los Angeles, California, United States
Acclaim Clinical Research
🇺🇸San Diego, California, United States
Optimus Medical Group
🇺🇸San Francisco, California, United States
PIH Health Whittier Hospital
🇺🇸Whittier, California, United States
Denver Endocrinology Diabetes and Thyroid Center PC
🇺🇸Englewood, Colorado, United States
Paradigm Clinical Research
🇺🇸Wheat Ridge, Colorado, United States
Innovative Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
Clinical Research of West Florida Inc
🇺🇸Clearwater, Florida, United States
East Coast Institute for Research, LLC
🇺🇸Macon, Georgia, United States
Multi Specialty Research Associates, LLC
🇺🇸Lake City, Florida, United States
3 Sync LLC
🇺🇸Kingwood, Texas, United States
Floridian Clinical Research
🇺🇸Miami Lakes, Florida, United States
Finlay Medical Research
🇺🇸Miami, Florida, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
IMA Clinical Research, PC
🇺🇸Saint Petersburg, Florida, United States
Genesis Clinical Research
🇺🇸Tampa, Florida, United States
Clinical Research of West Florida, Inc.
🇺🇸Tampa, Florida, United States
Baycare Clinical Research
🇺🇸Tampa, Florida, United States
VICIS Clinical Research
🇺🇸Tampa, Florida, United States
Clinical Site Partners, Orlando
🇺🇸Winter Park, Florida, United States
Conquest Research, LLC
🇺🇸Winter Park, Florida, United States
Agile Clinical Research Trials, LLC
🇺🇸Atlanta, Georgia, United States
Centricity Research Columbus Endocrinology
🇺🇸Columbus, Georgia, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
MediSphere Medical Research Center, LLC
🇺🇸Evansville, Indiana, United States
Integrated Clinical Trial Services, Inc.
🇺🇸West Des Moines, Iowa, United States
Tandem Clinical Research
🇺🇸Metairie, Louisiana, United States
Boston Clinical Trials, LLC
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
ActivMed Practices & Research, LLC
🇺🇸Portsmouth, New Hampshire, United States
Revival Research Institute, LLC.
🇺🇸Sterling Heights, Michigan, United States
Clinical Research Consultants, LLC
🇺🇸Kansas City, Missouri, United States
StudyMetrix Research
🇺🇸Saint Peters, Missouri, United States
Velocity Clinical Research, Inc.
🇺🇸Norfolk, Nebraska, United States
Las Vegas Endocrinology
🇺🇸Henderson, Nevada, United States
Jubilee Clinical Research Inc
🇺🇸Las Vegas, Nevada, United States
Excel Clinical Research
🇺🇸Las Vegas, Nevada, United States
Columbia University
🇺🇸New York, New York, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Carolina Institute for Clinical Research, LLC
🇺🇸Fayetteville, North Carolina, United States
Diabetes & Endocrinology Associates of Stark County, Inc.
🇺🇸Canton, Ohio, United States
Velocity Clinical Research, Cincinnati
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Remington-Davis, Inc.
🇺🇸Columbus, Ohio, United States
Meta Medical Research Institute
🇺🇸Dayton, Ohio, United States
Velocity Clinical Research, Providence
🇺🇸East Greenwich, Rhode Island, United States
Notus Clinical Research
🇺🇸Charleston, South Carolina, United States
WR-ClinSearch, LLC
🇺🇸Chattanooga, Tennessee, United States
Trinity Clinical Research LLC
🇺🇸Tullahoma, Tennessee, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States
REX Clinical Trials, LLC
🇺🇸Beaumont, Texas, United States
Zenos Clinical Research
🇺🇸Dallas, Texas, United States
Care United Research, LLC
🇺🇸Forney, Texas, United States
Diabetes and Thyroid Center of Fort Worth
🇺🇸Fort Worth, Texas, United States
Nerve and Muscle Center of Texas
🇺🇸Houston, Texas, United States
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
Endocrine IPS, PLLC
🇺🇸Houston, Texas, United States
Amir A Hassan, MD, PA
🇺🇸Houston, Texas, United States
Epic Clinical Research
🇺🇸Lewisville, Texas, United States
Shadow Creek Medical Clinic
🇺🇸Pearland, Texas, United States
Diabetes & Glandular Disease Clinic, P.A.
🇺🇸San Antonio, Texas, United States
VIP Trials
🇺🇸San Antonio, Texas, United States
Velocity Clinical Research, Salt Lake City
🇺🇸West Jordan, Utah, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States