A Phase 2 Study of RTA 901 in Patients With Diabetic Peripheral Neuropathic Pain (CYPRESS)
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: RTA 901
RTA 901 capsules will be administered once daily during a fasted state in either Dose 1 or Dose 2.
Other Names:
|
| 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. |
Drug: RTA 901
RTA 901 capsules will be administered once daily during a fasted state in either Dose 1 or Dose 2.
Other Names:
|
| 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. |
Drug: Placebo
Matching placebo capsules will be administered once daily during a fasted state.
|
| 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. |
Drug: RTA 901
RTA 901 capsules will be administered once daily during a fasted state in either Dose 1 or Dose 2.
Other Names:
|
| 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. |
Drug: RTA 901
RTA 901 capsules will be administered once daily during a fasted state in either Dose 1 or Dose 2.
Other Names:
|
| 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. |
Drug: Placebo
Matching placebo capsules will be administered once daily during a fasted state.
|
Outcome Measures
Primary Outcome Measures
- Measure the change from baseline in average pain intensity as assessed by the Numeric Pain Rating Scale (NPRS) [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 [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.
Eligibility Criteria
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);
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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;
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NPRS pain intensity score ≥ 4 on an 11-point scale at Screening.
Exclusion Criteria:
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Has neuropathy from a cause other than type 1 diabetes mellitus or type 2 diabetes mellitus;
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Has a condition other than DPNP that could confound the assessment of pain (eg, fibromyalgia or regional pain caused by lumbar or cervical compression);
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Diabetic foot ulceration or infection within 90 days prior to Screening;
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Has had more than 1 episode of ketoacidosis or hyperosmolar state requiring hospitalization within 90 days prior to Screening;
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Has had more than 3 episodes of hypoglycemia requiring medical assistance within 90 days prior to Screening;
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Serum aminotransferase (alanine aminotransferase or aspartate aminotransferase) levels
1.5× the upper limit of normal (ULN);
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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;
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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;
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Women who are pregnant or breastfeeding;
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Use of the prohibited medications, devices, or procedures.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Reata Pharmaceuticals, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 901-C-2102