A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Part of paid clinical trials in Paradise Valley, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04951622
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Myasthenia Gravis

Eligibility Criteria

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

Interventions

  • Nipocalimab — DRUG
    Nipocalimab will be administered as an IV infusion.
  • Placebo — DRUG
    Matching placebo will be administered as an IV infusion.
  • Nipocalimab SC-LIV — DRUG
    Nipocalimab will be administered subcutaneously.

Study Details

The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG). The purpose of the subcutaneous substudy is to evaluate how well it works in the body (pharmacodynamic \[PD\]) when given as an injection under the skin (subcutaneous) compared to when given through a vein (intravenous) in participants with gMG.

Key Dates

Start date
Jul 15, 2021
Status verified
Feb 2026
Primary completion
Nov 17, 2023
Completion
Mar 30, 2029

Study Design

Enrollment
199 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nipocalimab
    Double-blind Placebo-controlled Phase: Participants will receive nipocalimab intravenous (IV) infusions once every 2 weeks (q2w) up to 24 weeks during double-blind placebo-controlled phase. Open-label Extension (OLE) Phase: Participants who complete the double-blind placebo-controlled phase will enter the OLE phase and will have the option to continue to receive nipocalimab q2w IV infusion till study end or enter the nipocalimab SC substudy.
  • Placebo Comparator: Placebo
    Double-blind Placebo-controlled Phase: Participants will receive matching placebo of nipocalimab IV infusion q2w up to 24 weeks during double-blind placebo-controlled phase.
  • Experimental: Nipocalimab Subcutaneous (SC)
    OLE Phase: Participants from Cohort 1 will receive nipocalimab subcutaneous liquid in vial (SC-LIV) qw until Week 8. Participants with gMG from Cohort 2 who have not received nipocalimab previously, will receive nipocalimab SC-LIV until Week 8. Participants who complete the 8-week treatment period will have the opportunity to continue receiving nipocalimab SC-LIV qw in the Long term extension (LTE) period.

Primary Outcome Measure

Double-blind (DB) Phase: Average Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24 [ Time Frame: Baseline, Weeks 22, 23, and 24 ]

Central Contacts

Locations (24)

FacilityCityStateZIPSite coordinators
Neuromuscular Research Center and ClinicParadise ValleyArizona85028-
HonorHealth NeurologyScottsdaleArizona85251-
University of Southern CaliforniaLos AngelesCalifornia90033-
Stanford UniversityPalo AltoCalifornia94304-
Care Access ResearchPasadenaCalifornia91101-
University of Colorado Anschutz Medical CampusAuroraColorado80045-
Yale New Haven HospitalNew HavenConnecticut06519-
FM Clinical Research, LLC South Florida Neurology Associates, P. A.Boca RatonFlorida33487-
University of Florida Health JacksonvilleJacksonvilleFlorida32209-
Medsol Clinical Research Center IncPort CharlotteFlorida33952-
University of South FloridaTampaFlorida33612-
Augusta UniversityAugustaGeorgia30912-3125-
University of Kansas Medical CenterKansas CityKansas66160-
St. Elizabeth Medical CenterBostonMassachusetts02135-
Lahey Hospital & Medical CenterBurlingtonMassachusetts01805-
Washington University School Of MedicineSt LouisMissouri63110-
Duke University School of MedicineDurhamNorth Carolina27710-
University of CincinnatiCincinnatiOhio45219-
Cleveland ClinicClevelandOhio44145-
The Ohio State UniversityColumbusOhio43210-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Wesley NeurologyCordovaTennessee38018-
UT Southwestern Medical CenterDallasTexas75390-
University of VermontBurlingtonVermont05401-

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By research site
Neuromuscular Research Center and Clinic· Paradise Valley, AZHonorHealth Neurology· Scottsdale, AZUniversity of Southern California· Los Angeles, CAStanford University· Palo Alto, CACare Access Research· Pasadena, CAUniversity of Colorado Anschutz Medical Campus· Aurora, CO

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