A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoa… (NCT05838742) | Clinical Trial Compass
TerminatedPhase 2
A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis (OA) Pain
Stopped: The study met futility criteria at pre-planned interim analysis, showing no clinical efficacy of the investigational drug. Based on the lack of efficacy at the interim data review, the sponsor decided to terminate the study.
United States314 participantsStarted 2023-09-13
Plain-language summary
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 provide the data necessary to select the optimal effective and safe dose(s) of GSK3858279.
Who can participate
Age range40 Years – 80 Years
SexALL
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Inclusion Criteria:
* Participant must be 40 to 80 years of age inclusive
* OA of the index knee as defined by symptomatic for ≥ 6 months with a clinical diagnosis of OA as per American College of Rheumatology (ACR) clinical diagnosis criteria.
* Kellgren and Lawrence (KL) score ≥ 2 on X-ray in the index knee
* An average of the average daily pain score of ≥4 and less than or equal to (≤) 9 by the 11-point NRS (0-10)
* Body mass index (BMI) of \< 40 kilogram per meter square (kg/m\^2) (inclusive).
* Capable of giving signed informed consent.
Exclusion Criteria:
* History or presence of cardiovascular, renal, gastrointestinal, lymphatic disorders which in the opinion of the investigator would interfere with the study procedures and/or assessments.
* History or current evidence of any inflammatory arthritis such as rheumatoid arthritis, infective arthritis, Paget's disease, osteonecrosis, osteoporotic fracture, or any other joint disease that in the Investigator's opinion would interfere with the assessment of pain and other symptoms of osteoarthritis.
* History of significant trauma or surgery to a knee or hip within the last 6 months.
* Current immunodeficiency diseases including but not limited to acquired immunodeficiency disorder or immunoglobulin deficiency.
* Current or previous active Mycobacterium tuberculosis
* History or evidence of clinically significant multiple or severe drug allergies
* History of malignancy within the last 5 years, except for basal cell or sq…
What they're measuring
1
Change From Baseline in Weekly Average of Average Daily Knee Pain Intensity Using Numeric Rating Scale at Week 12
Timeframe: Baseline (Day -7 to Day -1) and at Week 12