A Study of RTA 901 (BIIB143) in Participants With Diabetic Peripheral Neuropathic Pain

Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT05895552

Acronym / sponsor ID

CYPRESS / 297DP201

Conditions

Diabetic Peripheral Neuropathic Pain

Keywords

RTA 901

Phase

Phase 2

Study type

Interventional

Recruitment status

TerminatedReason stopped: Sponsor decision to close study early; not due to safety concerns.

Enrolment

209 participants (actual)

Lead sponsor

Reata, a wholly owned subsidiary of BiogenIndustry (pharma, biotech, devices)

Study start

28 Jul 2023 (actual)

Primary completion

15 Nov 2024 (actual)

Study completion

15 Nov 2024 (actual)

First posted

8 Jun 2023 (actual)

Results

Posted 15 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

Quadruple blind (participant, care provider, investigator, outcomes assessor)

Number of arms

6

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Change From Baseline in Weekly Average Pain Intensity Assessed by the Numeric Pain Rating Scale (NPRS) at Week 12

   Time frame: Baseline, Week 12

   The NPRS of pain intensity is an 11-point numeric scale, ranging from 0 (representing no pain at all) to 10 (representing the worst pain imaginable). The participants were asked to select a whole number (0 to 10) that best indicates the intensity of his/her neuropathic pain in the past 24 hours. The weekly average score of NPRS was defined as the sum of non-missing daily scores divided by the number of days with non-missing scores for that week. Negative change from baseline indicates decreased pain intensity.

2. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) During and Following the Treatment Period

   Time frame: From the first dose of study drug up to end of follow-up period (up to 16 weeks)

   An adverse event (AE) was any unfavorable and unintended sign (including any CS abnormal laboratory test result), symptom, or disease temporally associated with use of the study drug, whether or not it is considered to be study drug related. An SAE was any untoward medical occurrence that at any dose resulted in death, in the view of Investigator, placed participant at immediate risk of death, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a birth defect. AEs that presented, or worsened in intensity or frequency, following the initiation of study treatment were categorized as TEAEs.

3. Number of Participants With Clinically Significant Abnormalities in Physical Examinations

   Time frame: From the first dose of study drug up to end of follow-up period (up to 16 weeks)

   Clinically significant abnormalities in physical examinations were based on investigator discretion.

4. Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters

   Time frame: From the first dose of study drug up to end of follow-up period (up to 16 weeks)

   Vital sign parameters included temperature, pulse rate systolic blood pressure, diastolic blood pressure, and respiratory rate. As pre-specified in protocol, the criteria for determining potentially clinically relevant abnormalities in vital signs included: temperature < 36.0 and > 38.0 degrees Celsius (c), pulse rate < 60 and > 100 beats per minute (bpm), systolic blood pressure < 90, > 140 and > 160 millimeters of mercury (mmHg), diastolic blood pressure < 50, > 90 and > 100 mmHg, weight (7% or more increase from baseline, 7% or more decrease from baseline) and respiratory rate < 12 and > 20 breaths per minute. The categories with at least one participant with clinically significant vital sign abnormalities are reported.

5. Number of Participants With Shift From Baseline in Clinically Significant Abnormalities in Electrocardiogram (ECG)

   Time frame: From the first dose of study drug up to end of follow-up period (up to 16 weeks)

   Clinical significance of abnormalities in ECG was determined based on the investigator's discretion.

6. Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters)

   Time frame: From the first dose of study drug up to end of follow-up period (up to 16 weeks)

   Hematology parameters included hematocrit, hemoglobin, erythrocytes, leukocytes, neutrophils, lymphocytes, monocytes, basophils, eosinophils, platelets, mean corpuscular hemoglobin, mean corpuscular volume, and mean corpuscular hemoglobin concentration. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available. Here, shift to low indicated values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high postbaseline values. The categories with at least one participant with shift from baseline in these parameters are reported.

7. Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters)

   Time frame: From the first dose of study drug up to end of follow-up period (up to 16 weeks)

   Parameters included alanine aminotransferase (ALT), aspartate aminotransferase (AST), cholesterol, choriogonadotropin beta, follicle stimulating hormone (FSH), estimated glomerular filtration rate (eGFR), ferritin, creatine kinase, blood urea nitrogen, creatinine, bilirubin(total and direct), alkaline phosphatase, amylase, lipase, sodium, potassium, calcium, phosphorus, uric acid, total protein, glucose, albumin, lactate dehydrogenase, magnesium, chloride, bicarbonate, and gamma-glutamyl transferase. These parameters were flagged as low, normal or high relative to parameter's normal range or as unknown if no result was available, by Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high values postbaseline. Categories with at least one participant with shift from baseline in these parameters are reported.

8. Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis)

   Time frame: From the first dose of study drug up to end of follow-up period (up to 16 weeks)

   Urinalysis included assessments of bacteria, Bilirubin, Calcium Oxalate Crystals, Choriogonadotropin Beta, Color, Erythrocytes, Glucose, Granular Casts, Hyaline Casts, Ketones, Leukocyte Esterase, Leukocytes, Nitrite, Occult Blood, Protein, red blood cells (RBC) Casts, Renal Epithelial Cells, Specific Gravity, Specimen Appearance, Squamous Epithelial Cells, Transitional Epithelial Cells, Triple Phosphate Crystals, Uric Acid Crystals, white blood cells (WBC) Casts and pH. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high postbaseline. The categories with at least one participant with shift from baseline in these parameters are reported.

9. Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Coagulation Parameters)

   Time frame: From the first dose of study drug up to end of follow-up period (up to 16 weeks)

   Coagulation included assessments of prothrombin. The parameter was flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high postbaseline.

10. Number of Participants With Clinically Significant Abnormality in Body Weight

    Time frame: From the first dose of study drug up to end of follow-up period (up to 16 weeks)

    Weight decrease was characterized by a decrease of ≥7% from baseline and weight increase was characterized by an increase of ≥7% from baseline.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

75 sites in 1 country: see every site and its status.