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GSK3858279 for Osteoarthritis Pain (MARS-17 Trial)

Phase 2
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 31 weeks
Awards & highlights

MARS-17 Trial Summary

This trial will test a new drug for knee OA pain, to find the best safe and effective dose. #medtrial #OA

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not specified here, potential side effects may include reactions at the injection site if applicable, gastrointestinal issues like nausea or diarrhea, headaches, dizziness or allergic reactions among others based on similar medications.

MARS-17 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 31 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 31 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline at Week 12 in weekly average of average daily knee pain intensity, assessed on the Numeric Rating Scale (NRS)
Secondary outcome measures
Area under the time-concentration curve (AUC) over the dosing interval (0-tau) (AUC[0-tau]) of GSK3858279
Average concentration over a dosing interval (Cavg) of GSK3858279
Change from Baseline in Haematology Parameters: Red blood cell (RBC) count, (Trillion cells per liter)
+14 more

MARS-17 Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GSK3858279
2022
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,755 Previous Clinical Trials
8,070,396 Total Patients Enrolled
23 Trials studying Pain
3,067 Patients Enrolled for Pain
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,510 Total Patients Enrolled
20 Trials studying Pain
2,854 Patients Enrolled for Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must be met for prospective participants to be eligible for this clinical trial?

"This clinical trial seeks 420 participants aged between 40 and 80 who are suffering from pain."

Answered by AI

Is senior participation possible in this clinical experiment?

"This trial is limited to those aged 40-80, while there are 91 separate clinical trials for youth and 896 specifically for seniors."

Answered by AI

Has the FDA authorized GSK3858279 Dose 4 for public consumption?

"Our team at Power graded GSK3858279 Dose 4's safety as a 2, since it is currently in its second phase of clinical testing. Thus far there have been some findings supporting the drug's security profile but none underlining effectiveness."

Answered by AI

To what extent is enrollment open for this experiment?

"Affirmative, it appears that this trial is still open for recruitment. According to clinicaltrials.gov, the study was initially posted on September 13th 2023 and subsequently refreshed on October 11th 2023. The research expects 420 patients across 86 sites to partake in trials."

Answered by AI

Are there any vacant spots in this clinical trial available for enrollment?

"Clinicaltrials.gov affirms that recruitment for this trial is currently underway. It was officially posted on September 13th 2023 and its details were last edited on October 11st of the same year."

Answered by AI

Are there any institutions in North America executing this experiment?

"At the moment, this clinical trial is running at 86 sites. These locations span from Huntington Beach to Cooper City and beyond. For your convenience, it is recommended that you choose a clinic situated nearby in order to reduce travel strain."

Answered by AI

Who else is applying?

What site did they apply to?
Other
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

Pain stopping me to be active.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis Pain
2023. "A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05838742.
All > Knee Osteoarthritis
~280 spots leftby Jul 2025
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