search
Back to results

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

Primary Purpose

Diabetic Peripheral Neuropathic Pain

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RTA 901
Placebo
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathic Pain focused on measuring RTA 901, Diabetic Peripheral Neuropathic Pain, DPNP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona Research CenterRecruiting
  • Hope Clinical Research, Inc.Recruiting
  • Valley Research - TrialsRecruiting
  • Clinical Research Institute LLCRecruiting
  • Optimus Medical GroupRecruiting
  • Innovative Research of West Florida, Inc.Recruiting
  • Clinical Research of West Florida IncRecruiting
  • Floridian Clinical ResearchRecruiting
  • Finlay Medical ResearchRecruiting
  • Genesis Clinical ResearchRecruiting
  • Clinical Research of West Florida, Inc.Recruiting
  • Baycare Clinical ResearchRecruiting
  • VICIS Clinical ResearchRecruiting
  • Centricity Research Columbus EndocrinologyRecruiting
  • Integrated Clinical Trial Services, Inc.Recruiting
  • Tandem Clinical ResearchRecruiting
  • Tandem Clinical ResearchRecruiting
  • Boston Clinical Trials, LLCRecruiting
  • ActivMed Practices & Research, LLCRecruiting
  • Revival Research Institute, LLC.Recruiting
  • Clinical Research Consultants, LLCRecruiting
  • Excel Clinical ResearchRecruiting
  • ActivMed Practices & Research, LLCRecruiting
  • Carolina Institute for Clinical ResearchRecruiting
  • Diabetes & Endocrinology Associates of Stark County, Inc.Recruiting
  • Remington DavisRecruiting
  • WR-Notus Clinical ResearchRecruiting
  • WR-ClinSearchRecruiting
  • Trinity Clinical Research LLCRecruiting
  • Zenos Clinical ResearchRecruiting
  • Nerve and Muscle Center of TexasRecruiting
  • Biopharma Informatic, LLCRecruiting
  • Shadow Creek Medical ClinicRecruiting
  • VIP TrialsRecruiting
  • Velocity Clinical Research, Salt Lake CityRecruiting
  • Rainier Clinical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Arm Label

Part 1 RTA 901 Dose 1

Part 1 RTA 901 Dose 2

Part 1 Placebo

Part 2 RTA 901 Dose 1

Part 2 RTA 901 Dose 2

Part 2 Placebo

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 13, 2022
Last Updated
October 11, 2023
Sponsor
Biogen
search

1. Study Identification

Unique Protocol Identification Number
NCT05895552
Brief Title
A Phase 2 Study of RTA 901 in Patients With Diabetic Peripheral Neuropathic Pain (CYPRESS)
Acronym
CYPRESS
Official Title
A Phase 2 Study to Evaluate the Safety and Efficacy of RTA 901 in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2023 (Actual)
Primary Completion Date
August 1, 2026 (Anticipated)
Study Completion Date
August 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
This study was previously posted by Reata Pharmaceuticals. In September 2023, sponsorship of the trial was transferred to Biogen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathic Pain
Keywords
RTA 901, Diabetic Peripheral Neuropathic Pain, DPNP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
384 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1 RTA 901 Dose 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 1 RTA 901 Dose 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 1 Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Part 2 RTA 901 Dose 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 2 RTA 901 Dose 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 2 Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
RTA 901
Other Intervention Name(s)
cemdomespib
Intervention Description
RTA 901 capsules will be administered once daily during a fasted state in either Dose 1 or Dose 2.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo capsules will be administered once daily during a fasted state.
Primary Outcome Measure Information:
Title
Measure the change from baseline in average pain intensity as assessed by the Numeric Pain Rating Scale (NPRS)
Description
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.
Time Frame
12 weeks
Title
Count of reported adverse events
Description
Safety and tolerability will be assessed by counting adverse events, as defined by the Medical Dictionary for Regulatory Activities (MedDRA) during the study duration.
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US Biogen Clinical Trial Center
Phone
866-633-4636
Email
clinicaltrials@biogen.com
First Name & Middle Initial & Last Name or Official Title & Degree
Global Biogen Clinical Trial Center
Email
clinicaltrials@biogen.com
Facility Information:
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise Taber, MD
Facility Name
Hope Clinical Research, Inc.
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hessam Aazami, MD
Facility Name
Valley Research - Trials
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Norwood, MD
Facility Name
Clinical Research Institute LLC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celia Brown, MD
Facility Name
Optimus Medical Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shawn Hassler, MD
Facility Name
Innovative Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Trevino, MD
Facility Name
Clinical Research of West Florida Inc
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonard Dunn, MD
Facility Name
Floridian Clinical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Rielo, MD
Facility Name
Finlay Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lilia Rodriguez-Ables, MD
Facility Name
Genesis Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesus Navarro, MD
Facility Name
Clinical Research of West Florida, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lon Lynn, MD
Facility Name
Baycare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaldo Orellana-Molina, MD
Facility Name
VICIS Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hector Fuentes, MD
Facility Name
Centricity Research Columbus Endocrinology
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Leichter, MD
Facility Name
Integrated Clinical Trial Services, Inc.
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Coggi, MD
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary Reiss, MD
Facility Name
Tandem Clinical Research
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adil Fatakia, MD
Facility Name
Boston Clinical Trials, LLC
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Mendes, MD
Facility Name
ActivMed Practices & Research, LLC
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael McCartney, MD
Facility Name
Revival Research Institute, LLC.
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48126
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdulhassan Saad, MD
Facility Name
Clinical Research Consultants, LLC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Awad, MD
Facility Name
Excel Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duane Anderson, MD
Facility Name
ActivMed Practices & Research, LLC
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand Cole, MD
Facility Name
Carolina Institute for Clinical Research
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nitinchandra Desai, MD
Facility Name
Diabetes & Endocrinology Associates of Stark County, Inc.
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arvind Krishna, MD
Facility Name
Remington Davis
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Baird, MD
Facility Name
WR-Notus Clinical Research
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donald Hurley, MD
Facility Name
WR-ClinSearch
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natasha Ballard, MD
Facility Name
Trinity Clinical Research LLC
City
Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37388
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dinesh Gupta, MD
Facility Name
Zenos Clinical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Lilly, MD
Facility Name
Nerve and Muscle Center of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aziz Shaibani, MD
Facility Name
Biopharma Informatic, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Lai, MD
Facility Name
Shadow Creek Medical Clinic
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Murtaza Mussaji, MD
Facility Name
VIP Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Carlos Garza, MD
Facility Name
Velocity Clinical Research, Salt Lake City
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Rizzardi, MD
Facility Name
Rainier Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frances Broyles, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
IPD Sharing URL
https://vivli.org/

Learn more about this trial

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

We'll reach out to this number within 24 hrs