GSK3858279 for Osteoarthritis Pain

(MARS-17 Trial)

No longer recruiting at 110 trial locations

Overseen By EU GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: GlaxoSmithKline

Disqualifiers: Cardiovascular, Renal, Inflammatory arthritis, 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 explores different doses of a new treatment, GSK3858279, to determine the most effective dose for easing moderate to severe knee osteoarthritis pain. Participants will receive one of four doses or a placebo (a substance with no active treatment) to identify the most effective and safest dose. Ideal candidates have experienced knee osteoarthritis symptoms for at least six months and endure daily pain that significantly impacts their life. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

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 study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier research found GSK3858279 to be safe and well-tolerated by adults with knee osteoarthritis pain. Participants experienced less pain and improved movement without major safety issues. The treatment was well-received, and no serious side effects were reported. This suggests that GSK3858279 has generally been safe for people in these studies. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for osteoarthritis?

Researchers are excited about GSK3858279 for osteoarthritis pain because it introduces a potentially novel approach to managing this common condition. Unlike standard treatments such as NSAIDs or corticosteroids, which can have limited long-term efficacy and potential side effects, GSK3858279 could offer a new mechanism of action. This experimental drug might work by targeting specific pain pathways more effectively, potentially providing better pain relief with fewer side effects. By offering multiple dosing options, it could also allow for more personalized treatment strategies, catering to different patient needs.

What evidence suggests that this trial's treatments could be effective for osteoarthritis pain?

Research suggests that GSK3858279, which participants in this trial may receive, may help reduce knee pain and improve movement for people with osteoarthritis. Some studies found that this treatment lessened pain and improved mobility. It is generally safe, and most people tolerate it well. However, other research did not find clear evidence that it was better than a placebo at reducing pain or improving movement. Overall, GSK3858279 shows potential, but the results have been mixed. ^{1 2 4 6 7}

Who Is on the Research Team?

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

Adults aged 40-80 with moderate to severe knee osteoarthritis pain, meeting specific clinical criteria and having a BMI under 40. Excluded are those with recent significant knee/hip trauma or surgery, certain cardiovascular, renal, gastrointestinal disorders, immunodeficiency diseases, active tuberculosis, recent malignancy (except certain skin cancers), liver abnormalities or drug allergies.

Inclusion Criteria

My knee X-ray shows moderate to severe arthritis.

I am between 40 and 80 years old.

My daily pain level is between 4 and 9 on a scale of 0 to 10.

Exclusion Criteria

I have not had major knee or hip surgery or injury in the past 6 months.

I don't have heart, kidney, stomach, or lymph system problems that would affect the study.

My kidney function is reduced, with a creatinine clearance below 60 mL/min.

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 dose-finding over 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

19 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GSK3858279
• Placebo

Trial Overview The trial is testing different doses of GSK3858279 compared to a placebo in adults with knee osteoarthritis pain. The goal is to find the most effective and safe dose for reducing pain associated with osteoarthritis.

How Is the Trial Designed?

Group I: GSK3858279 - 60 mg weekly Experimental Treatment 1 Intervention

Participants received GSK3858279 60 milligram (mg) SC injection once per week for 16 weeks.

Group II: GSK3858279 - 360 mg weekly Experimental Treatment 1 Intervention

Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.

Group III: GSK3858279 - 240 mg weekly Experimental Treatment 1 Intervention

Participants received GSK3858279 240 mg SC injection once per week for 16 weeks.

Group IV: GSK3858279 - 240 mg every 2 weeks Experimental Treatment 1 Intervention

Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding.

Group V: Placebo Placebo Group 1 Intervention

Participants received placebo subcutaneous (SC) injection once per week for 16 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. 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.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496724005582

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.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05838742

NCT05838742 | A Dose-Finding Study to Evaluate the ... This is dose-finding study of GSK3858279 in participants with moderate to severe knee osteoarthritis pain. The purpose of this study is to investigate and ...

4. hra.nhs.uk hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/mars-17-study-in-adults-with-pain-due-to-osteoarthritis-of-the-knee/

MARS-17 Study in Adults with Pain due to Osteoarthritis of ... Researchers concluded that the study did not find clear evidence that GSK3858279 worked better than placebo in reducing knee pain or improving movement. The ...

5. acrabstracts.org acrabstracts.org/abstract/efficacy-safety-pharmacokinetics-and-immunogenicity-of-repeated-dosing-of-gsk3858279-in-patients-with-knee-osteoarthritis-a-phase-i-randomized-double-blind-placebo-controlled-study/

Efficacy, Safety, Pharmacokinetics and Immunogenicity of ... Weekly dosing for 8 weeks with GSK3858279 has clinical activity (improved pain scores) and a favourable safety profile in patients with OA knee 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, ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05838742/a-dose-finding-study-to-evaluate-the-efficacy-and-safety-of-gsk3858279-in-adults-with-knee-osteoarthritis-pain

A Dose-Finding Study to Evaluate the Efficacy and Safety ... This is dose-finding study of GSK3858279 in participants with moderate to severe knee osteoarthritis pain. The purpose of this study is to ...