Study of Efficacy, Safety and Tolerability of DFV890 in Patients With Knee Osteoarthritis (NCT04886258) | Clinical Trial Compass
CompletedPhase 2
Study of Efficacy, Safety and Tolerability of DFV890 in Patients With Knee Osteoarthritis
United States115 participantsStarted 2021-09-20
Plain-language summary
This was a double-blinded, two-arm, phase 2a study to assess efficacy, safety and tolerability of DFV890 in participants with symptomatic knee osteoarthritis.
Who can participate
Age range50 Years – 80 Years
SexALL
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Key Inclusion Criteria:
* Male and female participants \>= 50 and \<= 80 years old on the day of Informed Consent signature.
* Participants must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 35 kg/m2 at screening. BMI = Body weight (kg) / \[Height (m)\]2
* High sensitivity C-reactive protein (hsCRP) \>=1.8 mg/L at screening
* Symptomatic OA with pain (corresponding to Numeric Rating Scale \[NRS\] 5-9, inclusive) in the target knee for the majority of days in the last 3 months prior to screening
* KOOS pain sub-scale score \<= 60 in index knee at screening and baseline
* Radiographic disease: K\&L grade 2 or 3 knee osteoarthritis in the target knee, confirmed by X-ray at screening.
* Active synovial inflammation at screening (defined a summary score of ≥7 with at least one region scoring 2) on contrast enhanced MRI (CE-MRI) of the whole knee for synovitis detection from 11 sites.
Key Exclusion Criteria:
* Total WBC count \< 3,000/µL, absolute peripheral blood neutrophil count (ANC) \< 1,000/µL, hemoglobin \< 8.5 g/dL (85 g/L) or platelet count \< 100,000/µL at Screening
* Known autoimmune disease with inflammatory arthritis (including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus), crystal-induced arthritis (gout, pseudogout associated arthritis), active acute or chronic infection or past infection of the knee joint, Lyme disease involving …
What they're measuring
1
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale