147 Participants Needed

GSK3858279 for Diabetic Neuropathy

(NEPTUNE-17 Trial)

Recruiting at 94 trial locations
UG
EG
Overseen ByEU GSK Clinical Trials Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: GlaxoSmithKline
Prior Safety DataThis treatment has passed at least one previous human trial

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

GC

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.
See 2 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.
See 2 more

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
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
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Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

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Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

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