Efficacy and Safety of 3 Doses of S201086/GLPG1972 Administered Orally Once Daily in Patients with Knee Osteoarthritis. A 52-Week International, Multi-Regional, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study.

Updated on 23 November 2020


An investigational product administered orally for patients with osteoarthritis of the knee.



  • Three dose ranges of investigational product versus Placebo.
  • Patients can remain on their NSAID throughout the trial.
  • Details
    Condition Osteoarthritis
    Clinical Study IdentifierTX217835
    Last Modified on23 November 2020


    Yes No Not Sure

    Inclusion Criteria

    Is your age between 40 yrs and 75 yrs?
    Gender: Male or Female
    Do you have Osteoarthritis?
    Male/Female patients of non-childbearing potential. (women must be surgically sterile or postmenopausal)
    Age 40-75 (inclusive)
    BMI less than 40
    OA Dx – which includes: knee pain, presence of osteophytes, and at least 1 of the following: Age >50, Morning Stiffness <30 Min. Duration, OR Crepitus on active motion
    Kellgren Lawrence grade 2 or 3 knees
    Must have 4 MRIs during trial

    Exclusion Criteria

    Excludes fibromyalgia, inflammatory/rheumatic joint diseases
    Excludes history of malignancy in the past 5 years except basal/squamous cell, cervical/prostate in situ treatment less than two years
    Excludes chronic use of strong opioids
    No bisphosphonates or denozumab in previous 12 months
    Excludes history of other severe or unstable diseases which may be assessed by the Principal/Sub Investigator
    No Arthroscopy of the target knee less than six mo. of screening
    No corticosteroid or visco injections less than three months
    Clear my responses

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    Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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    If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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    Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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