drugset / Trial / NCT04675034

A Study of the Efficacy and Safety of MEDI7352 in Participants With Painful Osteoarthritis of the Knee

NCT04675034 ↗

Phase 2 Completed 345 enrolled AstraZeneca
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

EvaluationDrugModalityDoseRoute
Subject MEDI7352 Unknown — Subcutaneous

Indications