GSK3858279 for Diabetic Neuropathy

(NEPTUNE-17 Trial)

Recruiting at 94 trial locations

Overseen By EU GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: GlaxoSmithKline

Disqualifiers: Cardiovascular, Renal, Gastrointestinal, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

147 Participants Needed

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.

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

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 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.

I am able to understand and sign the consent form.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GSK3858279 or placebo for efficacy, safety, tolerability, pharmacokinetics, and target engagement assessment

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 weeks

Treatment Details

Interventions

• GSK3858279

Trial Overview 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.

Participant Groups

Group I: GSK3858279 Dose 2 Experimental Treatment 1 Intervention

Participants will receive GSK3858279 dose 2.

Group II: GSK3858279 Dose 1 Experimental Treatment 1 Intervention

Participants will receive GSK3858279 dose 1.

Group III: Placebo Placebo Group 1 Intervention

Participants will receive placebo.

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

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Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School