GSK3858279 for Osteoarthritis Pain

(MARS-17 Trial)

Recruiting at 100 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

314 Participants Needed

Trial Summary

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.

How is the drug GSK3858279 different from other osteoarthritis pain treatments?

GSK3858279 is unique because it targets tropomyosin receptor kinase A (TrkA), which is involved in pain signaling, potentially offering a new way to manage osteoarthritis pain compared to traditional pain relievers that do not target this pathway. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing a new medication called GSK3858279 to find the best dose for reducing knee pain in people with moderate to severe osteoarthritis. The goal is to determine how much of the medication is needed to be effective and safe. This will help in managing knee pain better for those who suffer from this condition.

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: GSK3858279 Dose 4 Experimental Treatment 1 Intervention

Participants will receive GSK3858279 dose 4.

Group II: GSK3858279 Dose 3 Experimental Treatment 1 Intervention

Participants will receive GSK3858279 dose 3.

Group III: GSK3858279 Dose 2 Experimental Treatment 1 Intervention

Participants will receive GSK3858279 dose 2.

Group IV: GSK3858279 Dose 1 Experimental Treatment 1 Intervention

Participants will receive GSK3858279 dose 1.

Group V: 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

**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

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of intra-articular injection of tropomyosin receptor kinase A inhibitor in painful knee osteoarthritis: a randomized, double-blind and placebo-controlled study. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Genome-wide association study of knee pain identifies associations with GDF5 and COL27A1 in UK Biobank. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Tropomyosin-related kinase A (TrkA) inhibition for the treatment of painful knee osteoarthritis: results from a randomized controlled phase 2a trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Alteration of sensory neurons and spinal response to an experimental osteoarthritis pain model. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Single Nucleotide Polymorphism in the COL11A2 Gene Associated with Heat Pain Sensitivity in Knee Osteoarthritis. [2022]