drugset / Trial / NCT03245008

Efficacy and Safety of MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain

NCT03245008

Phase 2/3 Completed 626 enrolled Tanabe Pharma Corporation
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objective of this study is to verify the superiority of 16 weeks of MT-5547 treatment to placebo, as evidenced by the WOMAC pain score (the efficacy outcome measure), in patients with osteoarthritis of the knee or hip. Additional objectives of the study are to investigate the efficacy, safety, and pharmacokinetics of MT-5547 in long-term use.

Timeline

Start
2017-09-08
Primary completion
2019-12-14
Completion
2021-03-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Fasinumab Monoclonal antibody Subcutaneous

Indications