A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05379634
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Myositis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nipocalimab — DRUG
    Nipocalimab will be administered intravenously in double-blind period and LTE period.
  • Placebo — OTHER
    Nipocalimab matching placebo will be administered intravenously in double-blind period.
  • Glucocorticoids — DRUG
    Prednisone or equivalent will be administered orally as Glucocorticoid.

Study Details

The purpose of this study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (IIM).

Key Dates

Start date
Jul 5, 2022
Status verified
Jun 2026
Primary completion
Sep 4, 2025
Completion
Sep 16, 2026

Study Design

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

Arms

  • Experimental: Nipocalimab
    Participants will receive Nipocalimab at Week 0 (Baseline) and then every 2 weeks (Q2W) up to Week 50 during double-blind period. Participants on glucocorticoids (GC) at baseline will receive a stable dose of oral GC (prednisone or equivalent) from 4 weeks prior to the first administration of study intervention to Week 0. No changes in GC doses are allowed between Week 0 and Week 24. From Week 24 to Week 44, GC doses will be tapered. No changes to GC doses will be allowed from Week 44 to Week 52. Eligible participants will enter long-term extension (LTE) period and continue receiving Nipocalimab starting from Week 52 up to Week 98 and will be followed up to Week 106.
  • Placebo Comparator: Placebo
    Participants will receive Nipocalimab matching placebo at Week 0 (Baseline) and then Q2W up to Week 50 during double-blind period. Participants on GC at baseline will receive a stable dose of oral GC (prednisone or equivalent) from 4 weeks prior to the first administration of study intervention to Week 0. No changes in GC doses are allowed between Week 0 and Week 24. From Week 24 to Week 44, GC doses will be tapered. No changes to GC doses will be allowed from Week 44 to Week 52. Eligible participants will enter LTE period and will receive Nipocalimab treatment Q2W starting from Week 52 up to Week 98 and will be followed up to Week 106.

Primary Outcome Measure

Percentage of Participants who Achieve at Least Minimal Improvement (Greater Than or Equal to [>=] 20) in IMACS TIS and on Less Than or Equal to (<=) 5 Milligrams per day (mg/day) of Oral Prednisone (or Equivalent) From Week 44 Through Week 52 [ Time Frame: At Week 52 ]

Locations (19)

FacilityCityStateZIPSite coordinators
Arizona Arthritis and Rheumatology Research PLLCPhoenixArizona85032-
HonorHealth NeurologyScottsdaleArizona85251-
Attune Health Autoimmune and Inflamation Care and ResearchBeverly HillsCalifornia90211-
University of California Irvine Medical CenterOrangeCalifornia92868-
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorranceCalifornia90502-
FM Clinical Research, LLC South Florida Neurology Associates, P. A.Boca RatonFlorida33487-
Integral Rheumatology And Immunology SpecialistsPlantationFlorida33324-
University of South FloridaTampaFlorida33612-
Augusta UniversityAugustaGeorgia30912-
University of Kansas Medical CenterKansas CityKansas66160-
Johns Hopkins UniversityBaltimoreMaryland21224-
The Brigham and Women's Hospital, Inc.BostonMassachusetts02115-
Clinical Research Institute of Michigan, LLCSaint Clair ShoresMichigan48081-
Wexner Medical Center at the Ohio State UniversityColumbusOhio43203-
Oregon Health and Science UniversityPortlandOregon97239-
University of Pennsylvania - Perelman School of MedicinePhiladelphiaPennsylvania19104-
ACME Research Arthritis and Osteoporosis CenterOrangeburgSouth Carolina29118-
Nervie and Muscle Center of TexasHoustonTexas77030-
University of Texas at Houston Medical SchoolHoustonTexas77030-

Find similar trials in Phoenix, AZ

By research site
Arizona Arthritis and Rheumatology Research PLLC· Phoenix, AZHonorHealth Neurology· Scottsdale, AZAttune Health Autoimmune and Inflamation Care and Research· Beverly Hills, CAUniversity of California Irvine Medical Center· Orange, CALundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center· Torrance, CAFM Clinical Research, LLC South Florida Neurology Associates, P. A.· Boca Raton, FL

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