drugset / Trial / NCT04675034
A Study of the Efficacy and Safety of MEDI7352 in Participants With Painful Osteoarthritis of the Knee
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a Phase IIb randomised, double-blind, placebo-controlled, dose-response study in participants with painful osteoarthritis (OA) of the knee. The study will assess the safety and efficacy of multiple doses of MEDI7352 compared to placebo, as well as the pharmacokinetics, pharmacodynamics and immunogenicity of MEDI7352 in participants with moderate to severe chronic pain persistent for 3 months or more not adequately controlled by standard of care treatments.
Timeline
- Start
- 2020-12-02
- Primary completion
- 2023-08-16
- Completion
- 2023-08-16
Outcome
Met primary endpoint
registry analysis (superiority test); MEDl7352 Dose Level 2 vs Placebo; p = 0.029; Combined estimate for LS mean -0.80 (95% CI -1.619 to 0.027); ANCOVA NCT04675034 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MEDI7352 | Unknown | — | Subcutaneous |