Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT04120402
Eligibility Criteria:
Key Inclusion Criteria:
* Males or females, aged ≥40 years
* Body Mass Index (BMI) ≤ 40.0 kg/m2
* Diagnosis of primary OA of the Index knee, with symptoms present for at least 6 months
* OA severity Grade 2 or 3 (based on Kellgren Lawrence Grading Scale)
* Unsatisfactory pain relief from at least 2 prior standard OA treatments
* Qualifying pain in the Index knee during the baseline period
* Ambulatory (without the need for a cane/other walking aide)
* Female subjects willing to use highly effective birth control methods to prevent pregnancy
* Willing and able to comply with study procedures and restrictions, including abstaining from use of restricted medications.
Key Exclusion Criteria:
* OA of the Index knee due to acute injury or trauma, or unstable joint
* X-ray evidence of chondrocalcinosis
* Diagnosed or suspected ipsilateral hip OA
* Knee pain that is not attributable to OA of the knee
* Any other disorders that impact mobility, strength or sensation, or are a co-existent source of pain or inflammation that interfere with assessment of knee pain and function
* History of infection in the Index knee
* Skin breakdown on the Index knee where the injection will take place
* Total Knee Replacement, or any other surgery (including arthroscopy) for the Index knee within prior 12 months, or planned surgery during the study
* Total Knee Replacement Surgery of the non-Index knee within prior 6 months, or planned surgery (any location) during the study that would require a restricted medication
* IA injection of corticosteroids in any joint within prior 3 months or IA injection of extended-release corticosteroids in any joint within prior 6 months
* IA injection in the Index knee of platelet rich plasma, or other prolotherapy within prior 3 months, or hyaluronic acid within prior 6 months
* Recent, current or planned use of corticosteroids for any indication (except for permitted uses)
* Recent, current or planned use of prohibited medications (including analgesics, marijuana, investigational drugs and devices, immunosuppressive therapy), or unwilling or unable to stop using prohibited medications during the study.
* Conditions including: sarcoidosis, amyloidosis, osteomyelitis, Cushing's Syndrome, hepatic or renal disease, Psychotic disorder, bipolar disorder, symptomatic depressive or anxiety disorders.
* Current malignancy of any type, or history of a malignancy within prior 12 months
* Active or quiescent systemic fungal, bacterial (including tuberculosis) viral (including HIV, Hepatitis B or C) or parasitic infections, or ocular herpes simplex, or any recent infection requiring IV or oral antibiotics
* Laboratory results indicative of adrenal insufficiency, diabetes or renal or hepatic disease.
* Positive urine drug screen for a substance of abuse
* Females who are pregnant, lactating
* Known or suspected hypersensitivity or contraindication to ingredients in the study drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04120402
Study Brief:
Protocol Section:
NCT04120402