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

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ClinicalTrials.gov Identifier: NCT05895552
Recruitment Status : Recruiting
First Posted : June 8, 2023
Last Update Posted : February 2, 2024
Sponsor:
Information provided by (Responsible Party):
Biogen ( Reata, a wholly owned subsidiary of Biogen )

Tracking Information
First Submitted Date  ICMJE October 13, 2022
First Posted Date  ICMJE June 8, 2023
Last Update Posted Date February 2, 2024
Actual Study Start Date  ICMJE August 21, 2023
Estimated Primary Completion Date August 1, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2023)
  • Measure the change from baseline in average pain intensity as assessed by the Numeric Pain Rating Scale (NPRS) [ Time Frame: 12 weeks ]
    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.
  • Count of reported adverse events [ Time Frame: 20 weeks ]
    Safety and tolerability will be assessed by counting adverse events, as defined by the Medical Dictionary for Regulatory Activities (MedDRA) during the study duration.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study of RTA 901 in Patients With Diabetic Peripheral Neuropathic Pain (CYPRESS)
Official Title  ICMJE A Phase 2 Study to Evaluate the Safety and Efficacy of RTA 901 in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
Brief 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.
Detailed Description Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Peripheral Neuropathic Pain
Intervention  ICMJE
  • Drug: RTA 901
    RTA 901 capsules will be administered once daily during a fasted state in either Dose 1 or Dose 2.
    Other Name: cemdomespib
  • Drug: Placebo
    Matching placebo capsules will be administered once daily during a fasted state.
Study Arms  ICMJE
  • Experimental: Part 1 RTA 901 Dose 1
    Subjects will receive study drug once daily during the 2-week Run-in Period. Following randomization, the subjects will receive a dose of RTA 901 once daily for a 12-week treatment duration.
    Intervention: Drug: RTA 901
  • Experimental: Part 1 RTA 901 Dose 2
    Subjects will receive study drug once daily during the 2-week Run-in Period. Following randomization, the subjects will receive a dose of RTA 901 once daily for a 12-week treatment duration.
    Intervention: Drug: RTA 901
  • Placebo Comparator: Part 1 Placebo
    Subjects will receive study drug once daily during the 2-week Run-in Period. Following randomization, the subjects will receive a dose of Placebo once daily for a 12-week treatment duration.
    Intervention: Drug: Placebo
  • Experimental: Part 2 RTA 901 Dose 1
    Subjects will receive study drug once daily during the 2-week Run-in Period. Following randomization, the subjects will receive a dose of RTA 901 once daily for a 12-week treatment duration.
    Intervention: Drug: RTA 901
  • Experimental: Part 2 RTA 901 Dose 2
    Subjects will receive study drug once daily during the 2-week Run-in Period. Following randomization, the subjects will receive a dose of RTA 901 once daily for a 12-week treatment duration.
    Intervention: Drug: RTA 901
  • Placebo Comparator: Part 2 Placebo
    Subjects will receive study drug once daily during the 2-week Run-in Period. Following randomization, the subjects will receive a dose of Placebo once daily for a 12-week treatment duration.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 31, 2023)		 384
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2026
Estimated Primary Completion Date August 1, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05895552
Other Study ID Numbers  ICMJE 901-C-2102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
URL: https://vivli.org/
Current Responsible Party Biogen ( Reata, a wholly owned subsidiary of Biogen )
Original Responsible Party Reata Pharmaceuticals, Inc.
Current Study Sponsor  ICMJE Reata, a wholly owned subsidiary of Biogen
Original Study Sponsor  ICMJE Reata Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Biogen
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP