drugset / Trial / NCT03981744

A Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments

NCT03981744

Phase 3 Terminated 51 enrolled Janssen Pharmaceutical K.K.
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active polymyositis (PM)/dermatomyositis (DM) despite receiving 1 or more standard-of-care treatments (for example, glucocorticoids and/or immunomodulators).

Timeline

Start
2019-07-26
Primary completion
2022-01-24
Completion
2022-07-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ustekinumab Monoclonal antibody 6 mg/kg Intravenous
Subject Ustekinumab Monoclonal antibody 90 mg Intravenous

Indications