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

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Polymyositis
• Dermatomyositis

Interventions

Type	Name	Description
DRUG	Ustekinumab 6 mg/kg	Participants will receive body weight-range based IV dosing of 6 mg/kg of ustekinumab at Week 0 in Group 1 and at Week 24 in Group 2.
DRUG	Ustekinumab 90 mg	Participants will receive ustekinumab 90 mg SC at Week 8 and every 8 Weeks (q8w) through Week 72 in Group 1 and q8w Week 32 through Week 72 in Group 2.
DRUG	Placebo IV	Participants will receive IV dosing of placebo at Week 24 in Group 1 and at Week 0 in Group 2.
DRUG	Placebo SC	Participants will receive SC dosing of placebo at Weeks 8,16 and 24.

Timeline

• Start date: 2019-07-26
• Primary completion: 2022-01-24
• Completion: 2022-07-12
• First posted: 2019-06-11
• Last updated: 2025-04-29
• Results posted: 2024-05-13

Locations

32 sites across 1 country: Japan