A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

• ClinicalTrials.gov Identifier: NCT04951622
• Recruitment Status: Recruiting
• First Posted: July 7, 2021
• Last Update Posted: May 31, 2023
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Myasthenia Gravis	Drug: Nipocalimab; Drug: Placebo	Phase 3

Expanded Access : An investigational treatment associated with this study is temporarily not available outside the clinical trial.   More info ...

Detailed Description:

Myasthenia gravis (MG) is a rare, heterogeneous, neuromuscular disease characterized by fluctuating, fatigable muscle weakness. MG is caused by pathogenic autoantibodies that impair cholinergic transmission in the postsynaptic membrane at the neuromuscular junction and impair or prevent muscle contraction. Nipocalimab (also referred to as JNJ-80202135 or M281) is a fully human, aglycosylated immunoglobulin (Ig)G1 monoclonal antibody (mAb) designed to selectively bind, saturate, and block the IgG binding site on the endogenous neonatal Fc receptor (FcRn). This study will consist of a screening phase (up to 4 weeks), treatment phase (a 24-week double-blind placebo-controlled phase, and an open-label extension [OLE] phase [up to 2 years]) and a follow-up safety visit (up to 8 weeks after last infusion of study intervention). Efficacy evaluations will include assessments such as Myasthenia Gravis - Activities of Daily Living (MG-ADL) score. Safety evaluations (such as adverse events, physical examination, vital signs, electrocardiogram [ECG], and clinical laboratory tests) will be performed. The overall duration of study will be up to 4 years and 8 months.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 198 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: July 15, 2021
• Estimated Primary Completion Date: November 1, 2023
• Estimated Study Completion Date: April 17, 2026

Arms and Interventions

Arm	Intervention/treatment
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 continue to receive nipocalimab q2w IV infusion till study end.	Drug: Nipocalimab; Nipocalimab will be administered as an IV infusion.; Other Name: JNJ-80202135, M281
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.	Drug: Placebo; Matching placebo will be administered as an IV infusion.

Outcome Measures

Primary Outcome Measures :

1. Average Change from Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score [ Time Frame: Baseline up to Week 24 ]
   Average change from baseline in MG-ADL score over Weeks 22, 23 and 24 of the double-blind placebo-controlled phase will be reported. Averaging over multiple time points (Weeks 22, 23 and 24) will be done to get a single measure. The MG-ADL provides a rapid assessment of the participant's MG symptom severity. Eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, eyelid droop) are rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score will be sum of eight function scores and can range from 0 to 24. A higher score indicates greater symptom severity.

Secondary Outcome Measures :

1. Average Change in Quantitative Myasthenia Gravis (QMG) Score Over Weeks 22 and 24 of the Double-blind Placebo-controlled Phase [ Time Frame: Up to Weeks 22 and 24 ]
   Average change in QMG score over Weeks 22 and 24 of the double-blind placebo-controlled phase will be reported. The QMG test is a standardized quantitative strength assessment comprising 13 components. The quantitative results of each strength component are mapped to the following 4-point scale: 0 equals to (=) none, 1 = mild, 2 = moderate and 3 = severe. The total score will be sum of 13 components scores and can range from 0 to 39. A higher score indicates greater weakness.
2. Percentage of Participants whose Average MG-ADL Total Score Over Weeks 22, 23, and 24 is at least a 2-Point Improvement from Baseline of the Double-blind Placebo-controlled Phase [ Time Frame: Baseline up to Weeks 22, 23 and 24 ]
   Percentage of participants whose average MG-ADL total score over Weeks 22, 23, and 24 is at least a 2-point improvement from baseline of the double-blind placebo-controlled phase will be reported.
3. Percentage of Participants with Improvement in MG-ADL Total Score Greater Than Or Equal to (>=) 2 Points at Week 1 and/or Week 2 of the Double-blind Placebo-controlled Phase [ Time Frame: Weeks 1 and 2 ]
   Percentage of participants with improvement in MG-ADL total score >= 2 points at Week 1 and/or Week 2 of the double-blind placebo-controlled phase will be reported.
4. Percentage of Participants with Improvement in MG-ADL Total Score >= 2 Points at Week 4 through Week 24 of the Double-blind Placebo-controlled Phase with No More Than 2 Non-consecutive Excursions Allowed Between Weeks 6 through Week 23 [ Time Frame: Week 4 up to Week 24 ]
   Percentage of participants with improvement in MG-ADL total score >= 2 points at Week 4 through Week 24 of the double-blind placebo-controlled phase with no more than 2 non-consecutive excursions allowed between Weeks 6 through Week 23 (excursion is defined as loss of improvement in MG-ADL score >= 2 points from baseline) will be reported.
5. Percentage of Participants whose Average Improvement in MG-ADL Total Score Over Weeks 22, 23, and 24 of the Double-blind, Placebo-controlled Phase is at Least a 50% Improvement from Baseline [ Time Frame: Baseline, Weeks 22, 23 and 24 ]
   Percentage of participants whose average improvement in MG-ADL total score over Weeks 22, 23, and 24 of the double-blind, placebo-controlled phase is at least a 50% improvement from baseline will be reported.
6. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to Week 24 of double-blind placebo-controlled phase and up to extension Week 24 of open-label extension phase (up to Week 48) ]
   An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
7. Percentage of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to Week 24 of double-blind placebo-controlled phase and up to extension Week 24 of open-label extension phase (up to Week 48) ]
   A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
8. Percentage of Participants with Adverse Events of Special Interest (AESIs) [ Time Frame: Up to Week 24 of double-blind placebo-controlled phase and up to extension Week 24 of open-label extension phase (up to Week 48) ]
   Percentage of participants with AESIs will be reported. Treatment-emergent AEs associated with the following situations are considered as AESI: 1) severe or medically significant or immediately life-threatening infections requiring intravenous (IV) anti-infective or operative/invasive intervention or requiring hospitalization or prolongation of existing hospitalization; 2) hypoalbuminemia with albumin less than (<) 20 grams per liter (g/L). Treatment-emergent AEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
9. Percentage of Participants with Change in Vital Signs [ Time Frame: Up to Week 24 of double-blind placebo-controlled phase and up to extension Week 24 of open-label extension phase (up to Week 48) ]
   Percentage of participants with change in vital signs (temperature, blood pressure and heart rate) will be reported.
10. Percentage of Participants with Change in Clinical Laboratory Values [ Time Frame: Up to Week 24 of double-blind placebo-controlled phase and up to extension Week 24 of open-label extension phase (up to Week 48) ]
    Percentage of participants with change in clinical laboratory (serum chemistry, hematology, lipid profiles and urinalysis) values will be reported.
11. Percentage of Participants with Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score [ Time Frame: Up to Week 24 of double-blind placebo-controlled phase and up to extension Week 24 of open-label extension phase (up to Week 48) ]
    Percentage of participants with change in C-SSRS scale score will be reported. C-SSRS is semi structured clinician-administered questionnaire designed to solicit the occurrence, severity, and frequency of suicide-related ideation and behaviors. Total score ranges from 1 to 10. Higher scores indicate greater severity.
12. Percentage of Participants with Improvement in QMG Score of >= 3 Points from Baseline at Week 2 through Week 24 of the Double-blind Placebo-controlled Phase with No More than 2 Non-consecutive Excursions Allowed at Weeks 4 through 22 [ Time Frame: Week 2 up to Week 24 ]
    Percentage of participants with improvement in QMG score of >= 3 points from baseline at Week 2 through Week 24 of the double-blind placebo-controlled phase with no more than 2 non-consecutive excursions allowed at weeks 4 through 22 (excursions defined as loss of improvement in QMG score of >= 3 points from baseline) will be reported.
13. Average Change From Baseline in the Fatigue Items of the Quality of Life in Neurological Disorders Scale (Neuro-QoL Fatigue) Total Score Over Weeks 22 and 24 of Double-blind Placebo-controlled Phase [ Time Frame: Baseline up to Weeks 22 and 24 ]
    Average change from baseline in the Neuro-QoL Fatigue total score over Weeks 22 and 24 of double-blind placebo-controlled phase will be reported. Neuro-QoL fatigue is a 19-item questionnaire developed and validated for use in common neurological conditions which assesses patient-reported fatigue and associated impact on physical, mental, and social activities during the past 7 days. Each item included in the Neuro-QoL Fatigue questionnaire is graded on a 5-point Likert-type scale (1=Never; 2=Rarely; 3=Sometimes; 4=Often; 5=Always). The total scores are calculated by summing 19 items score and can range from 19-95. Higher score reflects more fatigue.
14. Average Change from Baseline in the Revised Myasthenia Gravis Quality of Life - 15 Scale (MG-Qol15r) Score Over Weeks 22 And 24 of the Double-blind Placebo-controlled Phase [ Time Frame: Baseline up to Weeks 22 and 24 ]
    Average change from baseline in the MG-QoL15r score over Weeks 22 and 24 of the double-blind placebo-controlled phase will be reported. The MG-QoL15r is a participant-reported outcome instrument that measures MG-specific health-related quality of life. The MG-QoL15r contains 15 items that evaluate patients' experience related to Myasthenia Gravis over the "past few weeks" on a 3-point Likert-type scale (0=Not at all; 1=Somewhat; 2=Very much). The total score of the MG-QoL15r can be calculated by summing 15 items score and can range from 0 to 30. A higher score indicates poorer health related quality of life.
15. Change from Baseline in the Visual Analog Scale (VAS) Score of European Quality of Life (EuroQol) 5-Dimension 5-Level (EQ-5D-5L) Scale Over 24 Weeks of the Double-blind Placebo-controlled Phase [ Time Frame: Baseline up to 24 weeks ]
    Change from baseline in the VAS score of EQ-5D-5L scale over 24 weeks of the double-blind placebo-controlled phase will be reported. EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state). Positive change in score indicates improvement.
16. Change from Baseline in the Health Status Index of the EQ-5D-5L Scale Over 24 Weeks of the Double-blind Placebo-controlled Phase [ Time Frame: Baseline up to 24 weeks ]
    Change from baseline in health status index of EQ-5D-5L scale over 24 weeks of double-blind placebo-controlled phase will be reported. EQ-5D-5L is standardized instrument for use as measure of health outcome, primarily designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ-VAS. EQ-5D-5L descriptive system comprises following 5 dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of 5 dimensions is divided into 5 levels of perceived problems (1 indicating no problem, 2 indicating slight problems, 3 indicating moderate problems, 4 indicating severe problems, 5 indicating extreme problems). Participant selects an answer for each of 5 dimensions considering response that best matches his or her health "today". The responses to 5 dimensions are used to compute a single score ranging from zero (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of the individual.
17. Serum Nipocalimab Concentrations Over Time [ Time Frame: Up to 4 years and 8 months ]
    Serum nipocalimab concentrations over time will be reported.
18. Number of Participants with Antibodies to Nipocalimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [NAbs]) [ Time Frame: Up to 4 years and 8 months ]
    Number of participants with antibodies to nipocalimab (ADAs and NAbs) will be reported.
19. Percentage of Participants with MG-ADL Score of 0 or 1 Over Time in the Double-blind, Placebo-controlled Phase [ Time Frame: Up to Week 24 ]
    Percentage of participants with MG-ADL score of 0 or 1 over time in the double-blind, placebo-controlled phase will be reported.
20. Percentage of Participants with MG-ADL Score of 0 or 1 at Any Time During the Double-blind, Placebo-controlled Phase [ Time Frame: Up to Week 24 ]
    Percentage of participants with MG-ADL score of 0 or 1 at any time during the double-blind, placebo-controlled phase will be reported.
21. Percentage of Participants with MG-ADL Score of 0 or 1 at 50% of Timepoints During the Double-blind, Placebo-controlled Phase [ Time Frame: Up to Week 24 ]
    Percentage of participants with MG-ADL score of 0 or 1 at 50% of timepoints during the double-blind, placebo-controlled phase will be reported.
22. Percentage of Participants with MG-ADL Score of 0 or 1 at 75% of Timepoints During the Double-blind, Placebo-controlled Phase [ Time Frame: Up to Week 24 ]
    Percentage of participants with MG-ADL score of 0 or 1 at 75% of timepoints during the double-blind, placebo-controlled phase will be reported.
23. Change in Total Serum Immunoglobulin G (IgG) Concentrations [ Time Frame: Up to 4 years and 8 months ]
    Change in total serum IgG concentrations will be reported.
24. Change in Levels of Autoantibodies Associated with Generalized Myasthenia Gravis (gMG) [ Time Frame: Up to 4 years and 8 months ]
    Change in levels of autoantibodies associated with gMG will be reported.
25. Change from Baseline in MG-ADL Score as a Function of IgG [ Time Frame: Baseline up to 4 years and 8 months ]
    Change from baseline in MG-ADL score as a function of IgG will be reported.
26. Change from Baseline in QMG Score as a Function of IgG [ Time Frame: Baseline up to 4 years and 8 months ]
    Change from baseline in QMG score as a function of IgG will be reported.
27. Change From Baseline in MG-ADL Score as a Response to Percent Change in Autoantibody Levels, in Seropositive Participants Treated with Nipocalimab [ Time Frame: Baseline up to 4 years and 8 months ]
    Change from baseline in MG-ADL as a response to percent change in autoantibody levels, in seropositive participants (anti-acetylcholine receptor [anti-AChR], anti-muscle-specific kinase [anti-MuSK], anti-lipoprotein-related protein receptor 4 [anti-LRP4]) treated with nipocalimab will be reported.
28. Change From Baseline in QMG Score as a Response to Percent Change in Autoantibody Levels, in Seropositive Participants Treated with Nipocalimab [ Time Frame: Baseline up to 4 years and 8 months ]
    Change from baseline in QMG score as a response to percent change in autoantibody levels, in seropositive participants (anti-AChR, anti-MuSK, anti-LRP4) treated with nipocalimab will be reported.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her gMG, or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
• Has MGFA Class I disease or presence of MG crisis (MGFA Class V) at screening, history of MG crisis within 1 month of screening, or fixed weakness (and/or 'burnt out' MG)
• Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the study
• Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
• Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening

Contacts and Locations

Contacts

Contact: Study Contact; 844-434-4210; Participate-In-This-Study@its.jnj.com

Locations

United States, Arizona

Neuromuscular Research Center and Clinic; Recruiting

Paradise Valley, Arizona, United States, 85028

HonorHealth Neurology; Recruiting

Scottsdale, Arizona, United States, 85251

United States, California

University of Southern California; Recruiting

Los Angeles, California, United States, 90033

Stanford University; Recruiting

Palo Alto, California, United States, 94304

Care Access Research; Recruiting

Pasadena, California, United States, 91101

United States, Colorado

University of Colorado - Anschutz Medical Campus; Recruiting

Aurora, Colorado, United States, 80045

United States, Connecticut

Yale New Haven Hospital; Recruiting

New Haven, Connecticut, United States, 06519

United States, Florida

FM Clinical Research, LLC South Florida Neurology Associates, P. A.; Recruiting

Boca Raton, Florida, United States, 33487

University of Florida Health Jacksonville; Completed

Jacksonville, Florida, United States, 32209

Medsol Clinical Research Center Inc; Recruiting

Port Charlotte, Florida, United States, 33952

University of South Florida; Recruiting

Tampa, Florida, United States, 33612

United States, Georgia

Augusta University; Recruiting

Augusta, Georgia, United States, 30912-3125

United States, Kansas

University of Kansas Medical Center; Recruiting

Kansas City, Kansas, United States, 66160

United States, Massachusetts

St. Elizabeth Medical Center; Recruiting

Boston, Massachusetts, United States, 02135

Lahey Hospital & Medical Center; Recruiting

Burlington, Massachusetts, United States, 01805

United States, Missouri

Washington University School of Medicine; Recruiting

Saint Louis, Missouri, United States, 63110

United States, North Carolina

Duke University School of Medicine; Recruiting

Durham, North Carolina, United States, 27710

United States, Ohio

University of Cincinnati; Recruiting

Cincinnati, Ohio, United States, 45219

Cleveland Clinic; Recruiting

Cleveland, Ohio, United States, 44145

The Ohio State University; Recruiting

Columbus, Ohio, United States, 43210

United States, South Carolina

Medical University of South Carolina; Recruiting

Charleston, South Carolina, United States, 29425

United States, Tennessee

Wesley Neurology; Recruiting

Cordova, Tennessee, United States, 38018

United States, Texas

UT Southwestern Medical Center; Recruiting

Dallas, Texas, United States, 75390

United States, Vermont

University of Vermont; Recruiting

Burlington, Vermont, United States, 05401

Australia

Melbourne Neurology Group; Recruiting

North Melbourne, Australia, 3051

Gold Coast University Hospital; Recruiting

Southport, Australia, 4215

Belgium

ULB Hôpital Erasme; Recruiting

Anderlecht, Belgium, 1070

AZ Sint-Jan Brugge-Oostende AV; Recruiting

Brugge, Belgium, 8000

Cliniques Universitaires Saint Luc; Recruiting

Brussels, Belgium, 1200

AZ Sint-Lucas; Recruiting

Gent, Belgium, 9000

University Hospitals Leuven; Recruiting

Leuven, Belgium, 3000

Canada, Ontario

The Ottawa Hospital Research Institute; Recruiting

Ottawa, Ontario, Canada, K1Y 4E9

Toronto General Hospital; Recruiting

Toronto, Ontario, Canada, M5G 2C4

Canada, Quebec

McGill University; Recruiting

Montreal, Quebec, Canada, H3A 2B4

China

Beijing Tiantan Hospital, Capital Medical University; Recruiting

Beijing, China, 100050

Xuanwu Hospital, Capital Medical University; Recruiting

Beijing, China, 100053

Beijing Hospital; Recruiting

Beijing, China, 100730

The First Bethune Hospital of Jilin University; Recruiting

Changchun, China, 130021

Central South University Xiangya Hospital The First Affiliated Hospital of Hunan Medical College; Recruiting

Changsha, China, 410008

West China Hospital of Sichuan University; Recruiting

Chengdu, China, 610041

Fujian Medical University Union Hospital; Recruiting

Fuzhou, China, 350001

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine; Recruiting

Guangzhou, China, 510405

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; Recruiting

Hangzhou, China, 310020

Qianfoshan hospital of Shandong Province; Recruiting

Jinan, China, 250014

Qilu Hospital of Shandong University; Recruiting

Jinan, China, 250014

Huashan Hospital Fudan University; Recruiting

Shanghai, China, 200040

Tianjin Medical University General Hospital; Recruiting

Tianjin, China, 300052

The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital; Recruiting

Xi'An, China, 710038

Czechia

Neurologie a rehabilitace Skopalíkova; Recruiting

Brno, Czechia, 615 00

Fakultni nemocnice Brno; Recruiting

Brno, Czechia, 625 00

Vseobecna Fakultní Nemocnice; Recruiting

Praha, Czechia, 12808

Denmark

Aalborg University Hospital; Recruiting

Aalborg, Denmark, 9000

Rigshospitalet; Recruiting

København Ø, Denmark, 2100

France

Hopital Pierre Wertheimer; Recruiting

Bron, France, 69500

CHU Grenoble; Recruiting

Grenoble, France, 38043

Hopital de la Pitie Salpetriere; Recruiting

Paris, France, 75013

Hopital PASTEUR; Recruiting

Provence-Alpes-Côte d'Azur, France, 06000

Germany

NeuroCure Clinical Research Center; Recruiting

Berlin, Germany, 10117

Universitätsmedizin Göttingen; Recruiting

Göttingen, Germany, 37075

Universitaetsklinikum Leipzig; Recruiting

Leipzig, Germany, 04103

Universitätsklinikum Schleswig Holstein Campus Lübeck; Recruiting

Lübeck, Germany, 23538

Universitätsklinikum Ulm; Recruiting

Ulm, Germany, 89081

DKD HELIOS Klinik Wiesbaden, Fachbereich Neurologie; Recruiting

Wiesbaden, Germany, 65191

Italy

U.O.P.I. di Psichiatria; Recruiting

Catania, Italy, 95100

Fondazione Istituto G. Giglio; Recruiting

Cefalu, Italy, 90015

Istituto Neurologico Carlo Besta; Recruiting

Milano, Italy, 20133

Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli; Recruiting

Napoli, Italy, 80138

IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione; Recruiting

Pavia, Italy, 27100

Azienda ospedaliera Sant'Andrea di Roma- Università di Roma La Sapienza; Recruiting

Roma, Italy, 00189

Policlinico Universitario Agostino Gemelli; Recruiting

Roma, Italy, 168

Japan

Chiba University Hospital; Recruiting

Chiba, Japan, 260-8677

General Hanamaki Hospital; Recruiting

Hanamaki, Japan, 025-0082

Hiroshima University Hospital; Recruiting

Hiroshima-shi, Japan, 734-8551

St.Marianna University Hospital; Recruiting

Kawasaki-Shi, Japan, 216-8511

Kagawa University Hospital; Recruiting

Kita-Gun, Japan, 761-0793

Kumamoto University Hospital; Recruiting

Kumamoto, Japan, 860-8556

Iwate Medical University Hospital; Recruiting

Morioka-shi, Japan, 020-8505

National Hospital Organization Nagoya Medical Center; Recruiting

Nagoya-shi, Japan, 460-0001

Niigata City General Hospital; Recruiting

Niigata, Japan, 950-1197

Hyogo College of Medicine Hospital; Recruiting

Nishinomiya-Shi, Japan, 663-8501

Sapporo Medical University Hospital; Recruiting

Sapporo, Japan, 0608556

Hokkaido Medical Center; Recruiting

Sapporo, Japan, 063-0005

National Hospital Organization Sendai Medical Center; Recruiting

Sendai-City, Japan, 983-8520

Tokushima University Hospital; Recruiting

Tokushima, Japan, 770-8503

Tokyo Medical University Hospital; Recruiting

Tokyo, Japan, 160-0023

Teikyo University Hospital; Recruiting

Tokyo, Japan, 173-8606

Korea, Republic of

Pusan National University Hospital; Recruiting

Busan, Korea, Republic of, 49241

Kyungpook National University Chilgok Hospital; Recruiting

Daegu, Korea, Republic of, 41404

Kyungpook National University Hospital; Recruiting

Daegu, Korea, Republic of, 41944

Severance Hospital, Yonsei University Health System; Recruiting

Seoul, Korea, Republic of, 120-752

Mexico

iBiomed Research Unit; Completed

Aguascalientes, Mexico, 20010

Consultorio Dr. Miguel Cortes; Recruiting

Cuernavaca, Mexico, 62448

Hospital Civil de Guadalajara Fray Antonio Alcalde; Recruiting

Guadalajara, Mexico, 44280

Poland

Neurocentrum Bydgoszcz Sp Z O O; Recruiting

Bydgoszcz, Poland, 85-796

NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis'; Recruiting

Katowice, Poland, 40-123

Centrum Neurologii Klinicznej, Krakowska Akademia Neurologii; Recruiting

Krakow, Poland, 31-505

Prywatny Gabinet Lekarski; Recruiting

Lublin, Poland, 20-093

Centrum Medyczne NeuroProtect; Recruiting

Warsaw, Poland, 01-684

Spain

Hosp. Gral. Univ. de Alicante; Recruiting

Alicante, Spain, 03010

Hosp. de La Santa Creu I Sant Pau; Recruiting

Barcelona, Spain, 08025

Hosp. Univ. Vall D Hebron; Recruiting

Barcelona, Spain, 08035

Hosp. Clinic I Provincial de Barcelona; Recruiting

Barcelona, Spain, 8036

Hosp. Univ. de Basurto; Recruiting

Bilbao, Spain, 48013

Hosp. Virgen Macarena; Recruiting

Sevilla, Spain, 41009

Hosp. Virgen Del Rocio; Recruiting

Sevilla, Spain, 41013

Hosp. Univ. I Politecni La Fe; Recruiting

Valencia, Spain, 46026

Sweden

Karlstad Central Hospital; Recruiting

Karlstad, Sweden, 651 85

Karolinska Universitetssjukhuset Solna; Recruiting

Stockholm, Sweden, 171 76

Taiwan

China Medical University Hospital; Recruiting

Taichung, Taiwan, 40447

Shin Kong Wu Ho Su Memorial Hospital; Recruiting

Taipei, Taiwan, 111

Taipei Veterans General Hospital; Recruiting

Taipei, Taiwan, 11217

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial; Janssen Research & Development, LLC

More Information

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT04951622
• Other Study ID Numbers: CR109046; 2020-005732-29 ( EudraCT Number ); MOM-M281-011 ( Other Identifier: Janssen Research & Development, LLC )
• First Posted: July 7, 2021
• Last Update Posted: May 31, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
• URL: https://www.janssen.com/clinical-trials/transparency

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Myasthenia Gravis; Muscle Weakness; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases