GSK3858279 for Diabetic Neuropathy

(NEPTUNE-17 Trial)

No longer recruiting at 103 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, GSK3858279 (an experimental drug), for individuals with chronic diabetic nerve pain who haven't found relief from other medications. Researchers aim to determine if this drug can reduce pain and is safe to use. Participants will receive either GSK3858279 or a placebo (a substance with no therapeutic effect) for comparison. This study is ideal for those with Type I or Type II diabetes who have experienced persistent, painful nerve symptoms for at least six months. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

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

Is there any evidence suggesting that GSK3858279 is likely to be safe for humans?

Research has shown that GSK3858279 has a good safety record in earlier studies. For instance, it was tested in people with knee osteoarthritis, a joint disease, and reduced pain without causing serious side effects, indicating it was well-tolerated by patients. Another study with healthy participants also examined its safety, further supporting its tolerability.

While these results are promising, it's important to note that this treatment is still being tested for diabetic neuropathic pain. The current study focuses on determining the safety and effectiveness of GSK3858279 for this specific condition. Overall, existing data suggests that GSK3858279 is generally safe, but ongoing trials will provide more detailed information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for diabetic neuropathy?

Researchers are excited about GSK3858279 for diabetic neuropathy because it targets the root causes of nerve pain differently than current treatments like pain relievers or antidepressants. While most existing options focus on symptom relief, GSK3858279 may work by addressing the underlying mechanisms of nerve damage, potentially offering more lasting relief. This unique approach could not only improve symptoms but also enhance overall nerve health, setting it apart from traditional therapies.

What evidence suggests that GSK3858279 might be an effective treatment for Diabetic Neuropathy?

Research shows that GSK3858279 might help reduce pain for people with Diabetic Peripheral Neuropathic Pain (DPNP). Earlier studies suggest this treatment works by blocking a protein called CCL17, which is thought to be involved in feeling pain. In other conditions, like knee osteoarthritis (OA), GSK3858279 has lessened pain and improved movement, demonstrating good safety and few side effects. Although specific data for DPNP is still being collected, these early results offer hope for those struggling to manage their pain. Participants in this trial will receive either GSK3858279 at one of two doses or a placebo to evaluate its effectiveness and safety for DPNP. ^{1 2 3 5 6}

Who Is on the Research Team?

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: GSK3858279 60 mg Experimental Treatment 1 Intervention

Participants received GSK3858279 SC injection 60 milligram (mg) once per week for 12 weeks.

Group II: GSK3858279 360 mg Experimental Treatment 1 Intervention

Participants received GSK3858279 SC injection 360 mg once per week for 12 weeks.

Group III: Placebo Placebo Group 1 Intervention

Participants received matching placebo subcutaneous (SC) injection once per week for 12 weeks.

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

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05838755

A Study to Evaluate Efficacy and Safety of GSK3858279 in ... This is a multicenter randomized, double-blind, placebo-controlled phase 2 study to evaluate efficacy, safety, tolerability, pharmacokinetics, and target ...

2. clinicaltrial.be clinicaltrial.be/en/details/284450?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

A Study to Evaluate Efficacy and Safety of GSK3858279 in... The primary objective of the study is to assess the efficacy of GSK3858279 in participants with DPNP who have been unable to sufficiently manage ...

3. clinicaltrials.eu clinicaltrials.eu/trial/study-on-gsk3858279-for-adults-with-chronic-diabetic-nerve-pain/

Study on GSK3858279 for Adults with Chronic Diabetic ... The purpose of the study is to assess how well GSK3858279 works in managing pain associated with DPNP. Participants in the study will receive either the new ...

4. ard.bmj.com ard.bmj.com/content/early/2024/10/17/ard-2023-225434

Efficacy, safety and tolerability of GSK3858279, an anti ... GSK3858279 improved pain intensity and WOMAC pain and function scores in adults with knee OA pain and demonstrated favourable safety and tolerability.

5. hra.nhs.uk hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/safety-and-efficacy-of-gsk3858279-in-diabetic-peripheral-neuropathic-pain/

Safety and efficacy of GSK3858279 in Diabetic Peripheral ... Previous research has shown that GSK3858279 blocks the activity of a protein called CCL17 and may reduce pain. It is hoped that blocking CCL17 may reduce pain ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03485365

Study Details | NCT03485365 | A Safety, Tolerability, ... Approximately 48 healthy participants will be enrolled in 6 cohorts and randomized to 3:1 ratio (GSK3858279 or placebo). Part B will evaluate safety, ...