A Phase 2 Study of RTA 901 in Patients With Diabetic Peripheral Neuropathic Pain (CYPRESS)

Diabetic Peripheral Neuropathic Pain Clinical Trial

— CYPRESS  

Official title:

A Phase 2 Study to Evaluate the Safety and Efficacy of RTA 901 in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05895552
• Other study ID #: 901-C-2102
• Status: Recruiting
• Phase: Phase 2
• Start date: August 21, 2023
• Est. completion date: August 1, 2026

Study information

• Verified date: February 2024
• Source: Biogen
• Contact: US Biogen Clinical Trial Center
• Phone: 866-633-4636
• Email: clinicaltrials[@]biogen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a 2-part, randomized, placebo-controlled, double-blind, Phase 2 study to evaluate the safety, tolerability, efficacy, and PK of RTA 901 in qualified subjects with DPNP. Each study part will be randomized into 3 treatment arms; 2 different doses of RTA 901 and a 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 subjects will be randomized in this study. Each part will have 192 subjects, with 64 subjects 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 subjects 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 384
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult male and female subjects = 18 years of age upon study consent;

• Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) at least 1 year prior to Screening;

• Clinical diagnosis of Diabetic Peripheral Neuropathic Pain (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);

• Currently taking only 1 allowed prescribed standard-of-care pain medication for managing DPNP at a stable dose (not exceeding the maximum dose in the prescribing information) for approximately 4 weeks prior to Screening;

• NPRS pain intensity score = 4 on an 11-point scale at Screening.

Exclusion Criteria:

• Has neuropathy from a cause other than type 1 diabetes mellitus or type 2 diabetes mellitus;

• 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;

• Has had more than 1 episode of ketoacidosis or hyperosmolar state requiring hospitalization within 90 days prior to Screening;

• Has had more than 3 episodes of hypoglycemia requiring medical assistance within 90 days prior to Screening;

• Serum aminotransferase (alanine aminotransferase or aspartate aminotransferase) levels > 1.5× the upper limit of normal (ULN);

• History of malignancy within 3 years prior to Screening, except for non-melanoma skin tumor, cervical carcinomas in situ, or successfully treated malignancies in remission;

• Unwilling to practice methods of birth control during Screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested;

• Women who are pregnant or breastfeeding;

• Use of the prohibited medications, devices, or procedures.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathic Pain
• Neuralgia

Intervention

Drug:
• RTA 901
RTA 901 capsules will be administered once daily during a fasted state in either Dose 1 or Dose 2.
• Placebo
Matching placebo capsules will be administered once daily during a fasted state.

Locations

Country	Name	City	State
United States	Boston Clinical Trials, LLC	Boston	Massachusetts
United States	Hope Clinical Research, Inc.	Canoga Park	California
United States	Diabetes & Endocrinology Associates of Stark County, Inc.	Canton	Ohio
United States	WR-Notus Clinical Research	Charleston	South Carolina
United States	WR-ClinSearch	Chattanooga	Tennessee
United States	Clinical Research of West Florida Inc	Clearwater	Florida
United States	Innovative Research of West Florida, Inc.	Clearwater	Florida
United States	Centricity Research Columbus Endocrinology	Columbus	Georgia
United States	Remington Davis	Columbus	Ohio
United States	Zenos Clinical Research	Dallas	Texas
United States	Carolina Institute for Clinical Research	Fayetteville	North Carolina
United States	Valley Research - Trials	Fresno	California
United States	Biopharma Informatic, LLC	Houston	Texas
United States	Nerve and Muscle Center of Texas	Houston	Texas
United States	Clinical Research Consultants, LLC	Kansas City	Missouri
United States	Excel Clinical Research	Las Vegas	Nevada
United States	Clinical Research Institute LLC	Los Angeles	California
United States	Tandem Clinical Research	Marrero	Louisiana
United States	Tandem Clinical Research	Metairie	Louisiana
United States	ActivMed Practices & Research, LLC	Methuen	Massachusetts
United States	Finlay Medical Research	Miami	Florida
United States	Floridian Clinical Research	Miami Lakes	Florida
United States	Shadow Creek Medical Clinic	Pearland	Texas
United States	Arizona Research Center	Phoenix	Arizona
United States	ActivMed Practices & Research, LLC	Portsmouth	New Hampshire
United States	Rainier Clinical Research Center	Renton	Washington
United States	VIP Trials	San Antonio	Texas
United States	Optimus Medical Group	San Francisco	California
United States	Revival Research Institute, LLC.	Sterling Heights	Michigan
United States	Baycare Clinical Research	Tampa	Florida
United States	Clinical Research of West Florida, Inc.	Tampa	Florida
United States	Genesis Clinical Research	Tampa	Florida
United States	VICIS Clinical Research	Tampa	Florida
United States	Trinity Clinical Research LLC	Tullahoma	Tennessee
United States	Integrated Clinical Trial Services, Inc.	West Des Moines	Iowa
United States	Velocity Clinical Research, Salt Lake City	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Reata, a wholly owned subsidiary of Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the change from baseline in average pain intensity as assessed by the Numeric Pain Rating Scale (NPRS)	The efficacy of RTA 901 will be assessed using the NPRS for patients receiving active drug compared to patients receiving placebo. The NPRS is an 11-point numeric scale, which ranges from '0' representing 'no pain' to '10' representing the 'worst pain imaginable'. Lower scores indicate less pain.	12 weeks
Primary	Count of reported adverse events	Safety and tolerability will be assessed by counting adverse events, as defined by the Medical Dictionary for Regulatory Activities (MedDRA) during the study duration.	20 weeks