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

Sponsor
Janssen Pharmaceutical K.K.
Study ID
NCT03981744
Phase
PHASE3
Status
Terminated

Conditions

  • Dermatomyositis
  • Polymyositis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab 6 mg/kg — DRUG
    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.
  • Ustekinumab 90 mg — DRUG
    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.
  • Placebo IV — DRUG
    Participants will receive IV dosing of placebo at Week 24 in Group 1 and at Week 0 in Group 2.
  • Placebo SC — DRUG
    Participants will receive SC dosing of placebo at Weeks 8,16 and 24.

Study Details

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).

Key Dates

Start date
Jul 26, 2019
Status verified
Apr 2025
Primary completion
Jan 24, 2022
Completion
Jul 12, 2022

Study Design

Enrollment
51 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: Ustekinumab
    Participants will receive body weight-range based IV dosing of approximately 6 milligram per kilogram (mg/kg) of ustekinumab at Week 0 followed by ustekinumab 90 milligram (mg) subcutaneously (SC) at Week 8 and every 8 Weeks (q8w) administrations through Week 72. At Week 24, participants will receive IV dosing of placebo.
  • Placebo Comparator: Group 2: Placebo
    Participants will receive IV dosing of placebo at Week 0 followed by placebo SC administrations at Weeks 8,16 and 24. At Week 24, participants will receive body weight-range based IV dosing of approximately 6 mg/kg of ustekinumab, followed by ustekinumab 90 mg SC q8w administrations Week 32 through Week 72.

Primary Outcome Measure

Percentage of Participants Who Achieved Minimal Improvement in International Myositis Assessment and Clinical Studies Total Improvement Score (IMACS TIS) at Week 24 [ Time Frame: Week 24 ]

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