RTA 901 for Diabetic Neuropathy

(CYPRESS Trial)

Recruiting at 84 trial locations

Overseen By Louise A. Taber MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Reata, a wholly owned subsidiary of Biogen

Disqualifiers: Non-diabetic neuropathy, Fibromyalgia, Diabetic foot ulcer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

384 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called RTA 901 to see if it can help people with nerve pain caused by diabetes. The drug likely works by calming down the nerves that are causing the pain. The study will compare different doses of the drug to find out which dose works best.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What makes the drug RTA 901 unique for treating diabetic neuropathy?

RTA 901, also known as BIIB143 or Cemdomespib, is unique because it is being studied specifically for its potential to address the underlying mechanisms of diabetic neuropathy, unlike most current treatments that primarily focus on symptom relief. This novel approach could offer a new avenue for managing the condition beyond just alleviating pain. ^{1 2 3 4 5}

Research Team

Medical Director

Principal Investigator

Biogen

Eligibility Criteria

Adults over 18 with type 1 or type 2 diabetes for at least a year and suffering from diabetic nerve pain in the lower extremities can join. They must have a certain level of pain despite taking one standard pain medication. Pregnant women, those not using birth control, people with recent severe liver issues, cancer history, frequent hypoglycemia needing medical help, or other major health problems are excluded.

Inclusion Criteria

Your pain score is 4 or higher on a scale of 0 to 10 at the screening.

I am on a stable dose of one standard pain medication for my nerve pain.

I have diabetes-related nerve pain in my legs or feet that feels burning or electric.

Exclusion Criteria

I have neuropathy not caused by type 1 or type 2 diabetes.

You needed help from a doctor for low blood sugar more than 3 times in the last 90 days.

I have had a diabetic foot ulcer or infection in the last 90 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Run-in

Participants receive study drug once daily to assess initial response and eligibility for randomization

2 weeks

Treatment

Participants receive randomized treatment with either RTA 901 or placebo once daily

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• RTA 901

Trial Overview The trial is testing RTA 901 against a placebo to see if it's safe and effective for diabetic nerve pain. Participants will be randomly assigned to receive either RTA 901 at two different doses or a placebo during the study which lasts about 20 weeks including screening, treatment period and follow-up.

Participant Groups

Group I: Part 2 RTA 901 Dose 2 Experimental Treatment 1 Intervention

Participants will receive study drug, QD, during the 2-week Run-in Period. Following randomization, the participants will receive a dose of RTA 901, QD, for a 12-week treatment duration.

Group II: Part 2 RTA 901 Dose 1 Experimental Treatment 1 Intervention

Participants will receive study drug, QD, during the 2-week Run-in Period. Following randomization, the participants will receive a dose of RTA 901, QD, for a 12-week treatment duration.

Group III: Part 1 RTA 901 Dose 2 Experimental Treatment 1 Intervention

Participants will receive study drug, QD, during the 2-week Run-in Period. Following randomization, the participants will receive a dose of RTA 901, QD, for a 12-week treatment duration.

Group IV: Part 1 RTA 901 Dose 1 Experimental Treatment 1 Intervention

Participants will receive study drug, once daily (QD), during the 2-week Run-in Period. Following randomization, the participants will receive a dose of RTA 901, QD, for a 12-week treatment duration.

Group V: Part 1 RTA 901-Matching Placebo Placebo Group 1 Intervention

Participants will receive study drug, QD, during the 2-week Run-in Period. Following randomization, the participants will receive a dose of RTA 901-matching placebo, QD, for a 12-week treatment duration.

Group VI: Part 2 RTA 901-Matching Placebo Placebo Group 1 Intervention

Participants will receive study drug, QD, during the 2-week Run-in Period. Following randomization, the participants will receive a dose of RTA 901-matching placebo, QD, for a 12-week treatment duration.

Who Is Running the Clinical Trial?

Reata, a wholly owned subsidiary of Biogen

Lead Sponsor

Trials

52

Recruited

7,400+

Biogen

Lead Sponsor

Trials

655

Recruited

468,000+

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

Graduated from Queen's University, Kingston, Ontario, Canada

Reata Pharmaceuticals, Inc.

Lead Sponsor

Trials

52

Recruited

6,900+

Findings from Research

In a 52-week open-label extension study involving 214 Asian patients with diabetic peripheral neuropathic pain (DPNP), mirogabalin demonstrated long-term safety and efficacy, with most patients experiencing a decrease in pain scores over time.

The most common side effects were mild to moderate, including nasopharyngitis and dizziness, with a treatment discontinuation rate of 13.1% due to adverse events, indicating that mirogabalin is generally well-tolerated in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of mirogabalin in Asian patients with diabetic peripheral neuropathic pain. Baba, M., Matsui, N., Kuroha, M., et al.[2022]

Around 50% of diabetic patients develop painful peripheral neuropathy within 25 years, primarily due to metabolic and vascular factors that damage nerves, making tight glycemic control essential for management.

While there is currently no drug to reverse diabetic neuropathy, treatments like tricyclic antidepressants, SNRIs, and certain anticonvulsants have shown efficacy in symptom relief, with ongoing research into newer therapies such as NMDA antagonists and aldose reductase inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Painful diabetic neuropathy: an update. Kaur, S., Pandhi, P., Dutta, P.[2022]

Strict blood glucose control is essential for managing diabetic neuropathy, but it can lead to complications like hypoglycemia; thus, a multifaceted approach to treatment is necessary.

Current evidence supports the use of tricyclic antidepressants and anticonvulsants for short-term pain relief, with combination therapies showing better efficacy than single treatments, alongside promising non-pharmacological options like electrical nerve stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Painful diabetic neuropathy management. Khalil, H.[2013]

At least 25% of diabetic patients suffer from distal symmetric polyneuropathy, which can cause severe pain and significantly reduce quality of life, highlighting the need for effective treatment strategies.

Current treatment options include managing blood sugar levels, using available medications like alpha-lipoic acid and newer analgesics such as duloxetine and pregabalin, but challenges remain in effectively managing chronic pain associated with diabetic neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of diabetic neuropathy and neuropathic pain: how far have we come? Ziegler, D.[2022]

In a systematic review of 21 studies involving 2425 patients with painful diabetic neuropathy, the average placebo response showed a significant reduction in pain intensity, with a moderate effect size of 0.72, indicating that many patients experienced relief even without active treatment.

The study found that over half (53.3%) of patients in the placebo groups reported adverse events, with 5.1% dropping out due to these events, highlighting the importance of understanding both the benefits and potential risks associated with placebo treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo and nocebo responses in painful diabetic neuropathy: systematic review and meta-analysis. Frisaldi, E., Vollert, J., Al Sultani, H., et al.[2023]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of mirogabalin in Asian patients with diabetic peripheral neuropathic pain. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Painful diabetic neuropathy: an update. [2022]

3. Australia pubmed.ncbi.nlm.nih.gov

Painful diabetic neuropathy management. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Treatment of diabetic neuropathy and neuropathic pain: how far have we come? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Placebo and nocebo responses in painful diabetic neuropathy: systematic review and meta-analysis. [2023]