A Randomized, Two-arm, Placebo-controlled, Participant and Investigator-blinded Study Investigating the Efficacy, Safety and Tolerability of DFV890 in Patients With Symptomatic Knee Osteoarthritis
Who is this study for? Patients with symptomatic knee osteoarthritis
What treatments are being studied? DFV890
Status: Completed
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a double-blinded, two-arm, phase II study to assess efficacy, safety and tolerability of DFV890 in participants with symptomatic knee osteoarthritis. The study includes a screening period, a treatment period and a follow-up period. At most, the study duration is 21 weeks.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.