GSK3858279 for Diabetic Neuropathy
(NEPTUNE-17 Trial)

Recruiting in Palo Alto (17 mi)

+94 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: GlaxoSmithKline

Prior Safety Data

Trial Summary

What is the purpose of this trial?This is a multicenter randomized, double-blind, placebo-controlled phase 2 study to evaluate efficacy, safety, tolerability, pharmacokinetics, and target engagement of GSK3858279 in adult participants with chronic Diabetic Peripheral Neuropathic Pain (DPNP). The primary objective of the study is to assess the efficacy of GSK3858279 in participants with DPNP who have been unable to sufficiently manage their pain.

Eligibility Criteria

Adults aged 18-75 with Type I or II diabetes and chronic pain from Diabetic Peripheral Neuropathic Pain (DPNP) can join this study. They should have a BMI of 18-40 kg/m^2, experience consistent pain intensity, and be able to consent. Those with cardiovascular, renal, gastrointestinal issues or other causes of neuropathy are excluded.

Inclusion Criteria

I am between 18 and 75 years old.

I have diabetes with painful nerve damage in my hands and feet for at least 6 months.

My average daily pain level is between 4 and 9 out of 10.

+3 more

Exclusion Criteria

I do not have heart, kidney, stomach, or lymph system conditions that would affect the study.

I have nerve pain in my hands or feet not caused by diabetes.

History of significant allergies to monoclonal antibodies.

+2 more

Participant Groups

The trial is testing GSK3858279's effectiveness in managing DPNP against a placebo. It's randomized and double-blind, meaning neither the participants nor the researchers know who gets the real drug versus the placebo until after results are collected.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: GSK3858279 Dose 2Experimental Treatment1 Intervention

Participants will receive GSK3858279 dose 2.

Group II: GSK3858279 Dose 1Experimental Treatment1 Intervention

Participants will receive GSK3858279 dose 1.

Group III: PlaceboPlacebo Group1 Intervention

Participants will receive placebo.