314 Participants Needed

GSK3858279 for Osteoarthritis Pain

(MARS-17 Trial)

Recruiting at 100 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

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.12345

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

GC

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.
See 3 more

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.
See 9 more

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
5Treatment groups
Experimental Treatment
Placebo Group
Group I: GSK3858279 Dose 4Experimental Treatment1 Intervention
Participants will receive GSK3858279 dose 4.
Group II: GSK3858279 Dose 3Experimental Treatment1 Intervention
Participants will receive GSK3858279 dose 3.
Group III: GSK3858279 Dose 2Experimental Treatment1 Intervention
Participants will receive GSK3858279 dose 2.
Group IV: GSK3858279 Dose 1Experimental Treatment1 Intervention
Participants will receive GSK3858279 dose 1.
Group V: 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 profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

References

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]
Genome-wide association study of knee pain identifies associations with GDF5 and COL27A1 in UK Biobank. [2023]
Tropomyosin-related kinase A (TrkA) inhibition for the treatment of painful knee osteoarthritis: results from a randomized controlled phase 2a trial. [2023]
Alteration of sensory neurons and spinal response to an experimental osteoarthritis pain model. [2022]
Single Nucleotide Polymorphism in the COL11A2 Gene Associated with Heat Pain Sensitivity in Knee Osteoarthritis. [2022]
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