MedTrace Logo

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 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-04-29

Study results available
· View outcomes & findings →

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

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.

Sponsors & Collaborators

  • Janssen Pharmaceutical K.K.

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutical K.K., Japan Clinical Trial · Janssen Pharmaceutical K.K.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Japan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03981744 on ClinicalTrials.gov