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A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

StatusRecruiting
PhasePhase 3
Started2021-07-15
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 62 times since 2021-06-30; most recent filed 2026-07-23. The 50 most recent of 63 record versions are listed below. See every version on ClinicalTrials.gov ↗

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-31.

2026-07-23
Amendment Study Status, Contacts/Locations v62
2026-02-09
Amendment Active, Not Recruiting→Recruiting Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, Participant Flow, Outcome Measures (Results) v61
2025-11-06
Amendment Study Status v60
2025-10-09
Amendment Study Status v59
2025-09-11
Amendment Study Status v58
2025-08-20
Amendment Study Status, Study Description, Arms and Interventions, Eligibility, IPDSharing v57
2025-07-03
Amendment Study Status, Participant Flow, Baseline Characteristics, Adverse Events v56
2025-05-27
Amendment Recruiting→Active, Not Recruiting Study Status, Study Design, Outcome Measures, Contacts/Locations, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v55
2025-04-25
Amendment Study Status, Contacts/Locations v54
2025-04-02
Amendment Study Identification, Study Status, Contacts/Locations v53
2025-03-03
Amendment Study Status, Contacts/Locations v52
2025-02-07
Amendment Study Status, Contacts/Locations v51
2025-01-09
Amendment Study Status, Contacts/Locations v50
2024-12-05
Amendment Study Status, Contacts/Locations v49
2024-12-04
Amendment Study Status v48
2024-10-28
Amendment Study Status v47
2024-10-08
Amendment Study Status v46
2024-09-10
Amendment Study Status, Study Design, Contacts/Locations v45
2024-09-04
Amendment Study Status, Study Description, Contacts/Locations v44
2024-08-13
Amendment Study Status, Contacts/Locations v43
2024-07-16
Amendment Study Status, Contacts/Locations v42
2024-06-18
Amendment Study Status, Contacts/Locations v41
2024-05-22
Amendment Study Status, Contacts/Locations v40
2024-04-23
Amendment Study Status, Contacts/Locations v39
2024-03-26
Amendment Study Identification, Study Status, Contacts/Locations v38
2024-02-27
Amendment Study Status, Contacts/Locations v37
2024-01-30
Amendment Study Status, Contacts/Locations v36
2024-01-02
Amendment Study Status, Contacts/Locations v35
2023-11-08
Amendment Study Status, Contacts/Locations v34
2023-10-10
Amendment Study Status, Contacts/Locations v33
2023-09-12
Amendment Study Status, Contacts/Locations v32
2023-08-15
Amendment Study Status v31
2023-07-19
Amendment Study Status v30
2023-06-28
Amendment Study Status v29
2023-05-30
Amendment Study Status, Contacts/Locations v28
2023-05-02
Amendment Study Status, Study Design v27
2023-04-11
Amendment Study Status, Contacts/Locations v26
2023-03-14
Amendment Study Status, Contacts/Locations v25
2023-02-14
Amendment Study Status, Contacts/Locations v24
2023-02-10
Amendment Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations v23
2022-12-20
Amendment Study Status, Contacts/Locations v22
2022-11-22
Amendment Study Status, Contacts/Locations v21
2022-10-25
Amendment Study Status, Study Design, Contacts/Locations v20
2022-09-27
Amendment Study Status, Contacts/Locations v19
2022-08-30
Amendment Study Status, Contacts/Locations v18
2022-08-19
Amendment Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations v17
2022-07-05
Amendment Study Status, Contacts/Locations v16
2022-06-07
Amendment Study Status, Contacts/Locations v15
2022-05-10
Amendment Study Status, Contacts/Locations v14
2022-04-12
Amendment Study Status, Contacts/Locations v13
Trial Details
NCT Number NCT04951622
Lead Sponsor Janssen Research & Development, LLC
Conditions Myasthenia Gravis
Enrollment 199 participants
Start Date 2021-07-15
Primary Completion 2023-11-17 (estimated)
Study Completion 2029-03-29 (estimated)
Updated on ClinicalTrials.gov 2026-07-27