Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
Who is this study for? Patients with Myasthenia Gravis
What treatments are being studied? Nipocalimab
Status: Recruiting
Location: See all (109) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized myasthenia gravis (gMG) as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II a/b, III a/b, or IVa/b at screening
• Myasthenia Gravis - Activities of Daily Living (MG-ADL) score of greater than or equal to (\>=) 6 at screening and baseline
• Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol
• A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and a negative urine pregnancy test at Day 1 prior to administration of study intervention
• A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last administration of study intervention
• For the SC Substudy (Cohort 1 and Cohort 2): Has reasonable abdominal skin area for SC administration
• For the SC Substudy (Cohort 1 and Cohort 2): Participants must be willing to comply with maintaining their stable dose of corticosteroids and/or immunosuppressants for the initial 8 weeks of the SC substudy, that is, through the SC Week 8 visit
Locations
United States
Arizona
Neuromuscular Research Center and Clinic
RECRUITING
Paradise Valley
HonorHealth Neurology
COMPLETED
Scottsdale
California
University of Southern California
COMPLETED
Los Angeles
Stanford University
COMPLETED
Palo Alto
Care Access Research
RECRUITING
Pasadena
Colorado
University of Colorado Anschutz Medical Campus
RECRUITING
Aurora
Connecticut
Yale New Haven Hospital
RECRUITING
New Haven
Florida
FM Clinical Research, LLC South Florida Neurology Associates, P. A.
RECRUITING
Boca Raton
University of Florida Health Jacksonville
COMPLETED
Jacksonville
Medsol Clinical Research Center Inc
RECRUITING
Port Charlotte
University of South Florida
RECRUITING
Tampa
Georgia
Augusta University
COMPLETED
Augusta
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Massachusetts
St. Elizabeth Medical Center
COMPLETED
Boston
Lahey Hospital & Medical Center
COMPLETED
Burlington
Missouri
Washington University School Of Medicine
COMPLETED
St Louis
North Carolina
Duke University School of Medicine
RECRUITING
Durham
Ohio
University of Cincinnati
COMPLETED
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
The Ohio State University
COMPLETED
Columbus
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Tennessee
Wesley Neurology
COMPLETED
Cordova
Texas
UT Southwestern Medical Center
COMPLETED
Dallas
Vermont
University of Vermont
COMPLETED
Burlington
Other Locations
Australia
Melbourne Neurology Group
COMPLETED
North Melbourne
Gold Coast University Hospital
RECRUITING
Southport
Belgium
ULB Hôpital Erasme
RECRUITING
Anderlecht
AZ Sint Jan Brugge Oostende AV
RECRUITING
Bruges
Cliniques Universitaires Saint Luc
RECRUITING
Brussels
AZ Sint-Lucas
RECRUITING
Ghent
University Hospitals Leuven
RECRUITING
Leuven
Canada
McGill University
COMPLETED
Montreal
The Ottawa Hospital Research Institute
RECRUITING
Ottawa
Toronto General Hospital
RECRUITING
Toronto
China
Beijing Hospital
RECRUITING
Beijing
Beijing Tiantan Hospital, Capital Medical University
RECRUITING
Beijing
Xuanwu Hospital ,Capital Medical University
COMPLETED
Beijing
The First Bethune Hospital of Jilin University
RECRUITING
Changchun
Xiangya Hospital Central South University
RECRUITING
Changsha
West China Hospital of Sichuan University
COMPLETED
Chengdu
Fujian Medical University Union Hospital
COMPLETED
Fuzhou
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
COMPLETED
Hangzhou
Qianfoshan hospital of Shandong Province
RECRUITING
Jinan
Qilu Hospital of Shandong University
COMPLETED
Jinan
Huashan Hospital Fudan University
RECRUITING
Shanghai
Tianjin Medical University General Hospital
RECRUITING
Tianjin
The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital
RECRUITING
Xi'an
Denmark
Aalborg University Hospital
COMPLETED
Aalborg
Rigshospitalet
COMPLETED
København Ø
France
Hopital Pierre Wertheimer
RECRUITING
Bron
CHU Grenoble
COMPLETED
Grenoble
Hopital de la Pitie Salpetriere
RECRUITING
Paris
Hopital PASTEUR
COMPLETED
Provence-alpes-côte D'azur
Hopital PASTEUR
RECRUITING
Provence-alpes-côte D'azur
Germany
NeuroCure Clinical Research Center
RECRUITING
Berlin
Universitatsmedizin Gottingen
COMPLETED
Göttingen
Universitaetsklinikum Leipzig
COMPLETED
Leipzig
Universitatsklinikum Schleswig Holstein Campus Lubeck
COMPLETED
Lübeck
Universitatsklinikum Ulm
COMPLETED
Ulm
DKD HELIOS Klinik Wiesbaden, Fachbereich Neurologie
COMPLETED
Wiesbaden
Italy
U.O.P.I. di Psichiatria
COMPLETED
Catania
Fondazione Istituto G. Giglio
RECRUITING
Cefalù
Istituto Neurologico Carlo Besta
RECRUITING
Milan
Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
RECRUITING
Naples
IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione
RECRUITING
Pavia
Azienda ospedaliera Sant'Andrea di Roma- Università di Roma La Sapienza
COMPLETED
Roma
Policlinico Universitario Agostino Gemelli
RECRUITING
Roma
Japan
Chiba University Hospital
COMPLETED
Chiba
General Hanamaki Hospital
RECRUITING
Hanamaki
Hiroshima University Hospital
RECRUITING
Hiroshima
Teikyo University Hospital
RECRUITING
Itabashi Ku
St Marianna University Hospital
RECRUITING
Kawasaki Shi
Kagawa University Hospital
COMPLETED
Kita Gun
Kumamoto University Hospital
COMPLETED
Kumamoto
Iwate Medical University Hospital
RECRUITING
Morioka
National Hospital Organization Nagoya Medical Center
COMPLETED
Nagoya
Niigata City General Hospital
RECRUITING
Niigata
Hyogo College of Medicine Hospital
RECRUITING
Nishinomiya-shi
Hokkaido Medical Center
RECRUITING
Sapporo
Sapporo Medical University Hospital
COMPLETED
Sapporo
National Hospital Organization Sendai Medical Center
RECRUITING
Sendai
Tokushima University Hospital
COMPLETED
Tokushima
Tokyo Medical University Hospital
COMPLETED
Tokyo
Mexico
iBiomed Research Unit
COMPLETED
Aguascalientes
Consultorio Dr. Miguel Cortes
RECRUITING
Cuernavaca
Hospital Civil de Guadalajara Fray Antonio Alcalde
RECRUITING
Guadalajara
Poland
Neurocentrum Bydgoszcz Sp Z O O
RECRUITING
Bydgoszcz
NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis'
RECRUITING
Katowice
Centrum Neurologii Klinicznej Krakowska Akademia Neurologii
RECRUITING
Krakow
Prywatny Gabinet Lekarski
RECRUITING
Lublin
Centrum Medyczne NeuroProtect
RECRUITING
Warsaw
Republic of Korea
Pusan National University Hospital
RECRUITING
Busan
Kyungpook National University Chilgok Hospital
RECRUITING
Daegu
Kyungpook National University Hospital
COMPLETED
Daegu
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
Spain
Hosp. Gral. Univ. de Alicante
RECRUITING
Alicante
Hosp Clinic de Barcelona
RECRUITING
Barcelona
Hosp Univ Vall D Hebron
RECRUITING
Barcelona
Hosp. de La Santa Creu I Sant Pau
RECRUITING
Barcelona
Hosp. Univ. de Basurto
RECRUITING
Bilbao
Hosp. Virgen Del Rocio
COMPLETED
Seville
Hosp. Virgen Macarena
RECRUITING
Seville
Hosp. Univ. I Politecni La Fe
RECRUITING
Valencia
Sweden
Karlstad Central Hospital
COMPLETED
Karlstad
Karolinska Universitetssjukhuset Solna
RECRUITING
Stockholm
Taiwan
China Medical University Hospital
COMPLETED
Taichung
Shin Kong Wu Ho Su Memorial Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2021-07-15
Estimated Completion Date: 2029-03-30
Participants
Target number of participants: 199
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC