Clinical trial NCT05895552: A Phase 2 Study of RTA 901 (BIIB143) in Participants With Diabetic Peripheral Neuropathic Pain (CYPRESS)
Official title: A Phase 2 Study to Evaluate the Safety and Efficacy of RTA 901 in Patients With Diabetic Peripheral Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetic Peripheral Neuropathic Pain
Keywords: RTA 901
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2023-06-08
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Run-in Inclusion Criteria:

* 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 Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change From Baseline in Average Daily Pain Intensity as Assessed by the Numeric Pain Rating Scale (NPRS) at Week 12
timeFrame: Baseline, Week 12
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During and Following the Treatment Period
timeFrame: From the first day of dosing up to end of follow-up period (Week 16)
measure: Number of Participants With Clinically Significant Abnormality in Physical Examinations
timeFrame: Baseline up to Week 16
measure: Number of Participants With Clinically Significant Abnormality in Vital Sign
timeFrame: Baseline up to Week 16
measure: Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG)
timeFrame: Baseline up to Week 16
measure: Number of Participants With Clinically Significant Abnormality in Clinical Laboratory Measurement
timeFrame: Baseline up to Week 16
measure: Number of Participants With Clinically Significant Abnormality in Body Weight
timeFrame: Baseline up to Week 16
Secondary outcomes:
measure: Number of Participants who Achieved at Least a 30% Decrease From Baseline in the Average NPRS Score at Week 12
timeFrame: Week 12
measure: Number of Participants who Achieved at Least a 50% Decrease From Baseline in the Average NPRS Score at Week 12
timeFrame: Week 12
measure: Number of Participants Using Rescue Medications During the Treatment Period
timeFrame: Up to Week 12
measure: Amount of Rescue Medications Used During the Treatment Period
timeFrame: Up to Week 12
measure: Duration of Rescue Medications Used During the Treatment Period
timeFrame: Up to Week 12
measure: Change From Baseline in the Average Daily Sleep Interference Scale (DSIS) score at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Centricity Research Phoenix Multispecialty
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Canoga Park
country: United States
facility: Hope Clinical Research, Inc.
state: California
city: Fresno
country: United States
facility: Valley Research - Trials
state: California
city: Los Angeles
country: United States
facility: Clinical Research Institute
state: California
city: San Diego
country: United States
facility: Acclaim Clinical Research
state: California
city: San Francisco
country: United States
facility: Optimus Medical Group
state: California
city: Whittier
country: United States
facility: PIH Health Whittier Hospital
state: California
city: Englewood
country: United States
facility: Denver Endocrinology Diabetes and Thyroid Center PC
state: Colorado
city: Wheat Ridge
country: United States
facility: Paradigm Clinical Research
state: Colorado
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Inc.
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida Inc
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: Lake City
country: United States
facility: Multi Specialty Research Associates, LLC
state: Florida
city: Lake Worth
country: United States
facility: 3 Sync LLC
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Clinical Research
state: Florida
city: Miami
country: United States
facility: Finlay Medical Research
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Saint Petersburg
country: United States
facility: IMA Clinical Research, PC
state: Florida
city: Sunrise
country: United States
facility: 3 Sync LLC
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Tampa
country: United States
facility: Baycare Clinical Research
state: Florida
city: Tampa
country: United States
facility: VICIS Clinical Research
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners, Orlando
state: Florida
city: Winter Park
country: United States
facility: Conquest Research, LLC
state: Florida
city: Atlanta
country: United States
facility: Agile Clinical Research Trials, LLC
state: Georgia
city: Canton
country: United States
facility: East Coast Institute for Research, LLC
state: Georgia
city: Columbus
country: United States
facility: Centricity Research Columbus Endocrinology
state: Georgia
city: Macon
country: United States
facility: East Coast Institute for Research, LLC
state: Georgia
city: Peoria
country: United States
facility: Methodist Medical Center of Illinois
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: West Des Moines
country: United States
facility: Integrated Clinical Trial Services, Inc.
state: Iowa
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Metairie
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Boston
country: United States
facility: Boston Clinical Trials, LLC
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Methuen
country: United States
facility: ActivMed Practices & Research, LLC
state: Massachusetts
city: Sterling Heights
country: United States
facility: Revival Research Institute, LLC.
state: Michigan
city: Kansas City
country: United States
facility: Clinical Research Consultants, LLC
state: Missouri
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Lincoln
country: United States
facility: Velocity Clinical Research, Inc.
state: Nebraska
city: Norfolk
country: United States
facility: Velocity Clinical Research, Inc.
state: Nebraska
city: Henderson
country: United States
facility: Las Vegas Endocrinology
state: Nevada
city: Las Vegas
country: United States
facility: Jubilee Clinical Research Inc
state: Nevada
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: Portsmouth
country: United States
facility: ActivMed Practices & Research, LLC
state: New Hampshire
city: New York
country: United States
facility: Columbia University
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research, LLC
state: North Carolina
city: Canton
country: United States
facility: Diabetes & Endocrinology Associates of Stark County, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research, Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Remington-Davis, Inc.
state: Ohio
city: Dayton
country: United States
facility: Meta Medical Research Institute
state: Ohio
city: East Greenwich
country: United States
facility: Velocity Clinical Research, Providence
state: Rhode Island
city: Charleston
country: United States
facility: Notus Clinical Research
state: South Carolina
city: Chattanooga
country: United States
facility: WR-ClinSearch, LLC
state: Tennessee
city: Tullahoma
country: United States
facility: Trinity Clinical Research LLC
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Beaumont
country: United States
facility: REX Clinical Trials, LLC
state: Texas
city: Dallas
country: United States
facility: Zenos Clinical Research
state: Texas
city: Forney
country: United States
facility: Care United Research, LLC
state: Texas
city: Fort Worth
country: United States
facility: Diabetes and Thyroid Center of Fort Worth
state: Texas
city: Houston
country: United States
facility: Nerve and Muscle Center of Texas
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: Endocrine IPS, PLLC
state: Texas
city: Houston
country: United States
facility: Amir A Hassan, MD, PA
state: Texas
city: Kingwood
country: United States
facility: 3 Sync LLC
state: Texas
city: Lewisville
country: United States
facility: Epic Clinical Research
state: Texas
city: Pearland
country: United States
facility: Shadow Creek Medical Clinic
state: Texas
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Clinic, P.A.
state: Texas
city: San Antonio
country: United States
facility: VIP Trials
state: Texas
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City
state: Utah
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: