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NCT04951622

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

StatusRecruiting
PhasePhase 3
Primary completion
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

The 50 most recent of 64 versions: 41 with changes below, 9 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 35 words
    • Secondary endpoints: details revised at 3 of 45 entries
    • Site details revised at 6 of 112 sites
  2. Study completion date: Mar 30, 2029 to Mar 29, 2029
    • Study sites revised (112)
    v63
  3. Trial status: Active, Not Recruiting to Recruitingv62 Show 6 more changesShow less
    • Eligibility criteria expanded, about 36 words
    • Primary endpoints: 1 to 3
    • Enrollment target: 219 to 199
    • Study sites: 111 to 112
    • Study completion date: Apr 17, 2026 to Mar 30, 2029
    • Secondary endpoints: 28 to 45
  4. Interventions: Nipocalimab (Drug), Placebo (Drug) to Nipocalimab (Drug), Nipocalimab SC-LIV (Drug), Placebo (Drug)
    • Study arms: 2 to 3
    v58
  5. Results first posted: Jul 23, 2025v57
Show 36 earlier versionsHide 36 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 196 to confirmed 219
    • Study sites: 112 to 111
    • Secondary endpoints revised (28)
    v56
  2. Study sites: 111 to 112v55
  3. Site details revised at 1 of 111 sitesv54
  4. Site details revised at 2 of 111 sitesv53
  5. Study sites revised (111)v52
  6. Study sites revised (111)v51
  7. Site details revised at 3 of 111 sitesv50
  8. Enrollment target: 198 to 196
    • Site details revised at 1 of 111 sites
    v46
  9. Study sites revised (111)v45
  10. Site details revised at 5 of 111 sitesv44
  11. Study sites revised (111)v43
  12. Study sites revised (111)v42
  13. Site details revised at 3 of 111 sitesv41
  14. Site details revised at 4 of 111 sitesv40
  15. Study sites revised (111)v39
  16. Study sites revised (111)v38
  17. Study sites revised (111)v37
  18. Primary completion date changed from estimate of Nov 1, 2023 to Nov 17, 2023
    • Study sites revised (111)
    v36
  19. Study sites revised (111)v35
  20. Site details revised at 1 of 111 sitesv34
  21. Study sites revised (111)v33
  22. Study sites revised (111)v29
  23. Enrollment target: 190 to 198v28
  24. Study sites: 135 to 111v27
  25. Study sites revised (135)v26
  26. Site details revised at 3 of 135 sitesv25
  27. Secondary endpoints: 24 to 28
    • Study sites revised (135)
    v24
  28. Study sites revised (135)v23
  29. Study sites revised (135)v22
  30. Enrollment target: 180 to 190
    • Primary completion date: Feb 21, 2024 to Nov 1, 2023
    • Site details revised at 3 of 135 sites
    v21
  31. Site details revised at 9 of 135 sitesv20
  32. Site details revised at 2 of 135 sitesv19
  33. Site details revised at 16 of 135 sitesv18
  34. Study sites: 149 to 135v17
  35. Study sites: 148 to 149v16
  36. Site details revised at 4 of 148 sitesv15
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

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
Timeframe: Baseline, Weeks 22, 23, and 24
Sub Study: Percent Change in Anti-AChR Autoantibody Titer From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57)
Timeframe: From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57)
Sub Study: Percent Change in Total IgG Levels From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57)
Timeframe: From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57)

Secondary (45)

DB Phase: Average Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score Over Weeks 22 and 24
DB Phase: Percentage of Participants Who Had Achieved at Least a 2-point Average Improvement From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24
DB Phase: Percentage of Participants Who Had Achieved an Improvement of Greater Than or Equal to (>=) 2 Points in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score at Week 1 and/or Week 2
DB Phase: Percentage of Participants Who Had an Improvement of >= 2 Points in the MG-ADL Total Score From Week 4 Through Week 24 With no More Than 2 Non-consecutive Excursions Allowed Between Weeks 6 Through 23
DB Phase: Percentage of Participants Who Had Achieved at Least a 50 Percent (%) Average Improvement From Baseline in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24
Show 40 moreShow less
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Percentage of Participants With AEs of Special Interest (AESIs)
Number of Participants With Change in Vital Signs
Number of Participants With Change in Clinical Laboratory Values
Number of Participants With Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score
DB Phase: Percentage of Participants Who Had an Improvement of >= 3 Points in Quantitative Myasthenia Gravis (QMG) Score From Baseline, at Week 2 Through Week 24, With No More Than 2 Non-consecutive Excursions Allowed Between at Weeks 4 Through Week 22
DB Phase: Average Change From Baseline in the Fatigue Items of the Quality of Life in Neurological Disorders (Neuro-QoL) Fatigue Scale Total Score Over Weeks 22 and 24
DB Phase: Average Change From Baseline in the Revised Myasthenia Gravis Quality of Life (Revised) Instrument (MG-Qol15r) Score Over Weeks 22 And 24
DB Phase: 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
DB Phase: Change From Baseline in the Health Status Index of the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Scale Over 24 Weeks
DB Phase: Percentage of Participants With Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score of 0 or 1 Over Time
DB Phase: Percentage of Participants With Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score of 0 or 1 at Any Time
DB Phase: Percentage of Participants With Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score of 0 or 1 at 50% of Timepoints
DB Phase: Percentage of Participants With Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score of 0 or 1 at 75% of Timepoints
Serum Concentrations of Nipocalimab Over Time
Number of Participants With Antibodies to Nipocalimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [NAbs])
Percent Change From Baseline in Total Serum Immunoglobulin G (IgG) Concentrations
Change From Baseline in Levels of Autoantibodies Associated With Generalized Myasthenia Gravis (gMG)
Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score as a Function of IgG
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score as a Function of Immunoglobulin G (IgG)
Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score as a Response to Percent Change in Autoantibody Levels in Seropositive Participants Treated With Nipocalimab
Change From Baseline in QMG Score as a Response to Percent Change in Autoantibody Levels in Seropositive Participants Treated With Nipocalimab
Sub Study: Number of Participants With Treatment-Emergent AEs
Sub Study: Number of Participants With Abnormalities in Vital Signs
Sub Study: Number of Participants With Abnormalities in Physical Examinations
Sub Study: Number of Participants With Abnormalities in Laboratory Parameters
Sub Study: Numeric Pain Rating Scale (NPRS) Assessment With SC Use of Nipocalimab
Sub Study: Number of Participants With Injection Site-Reactions
Sub Study: Change From Baseline in MG-ADL Clinician-Reported Outcome Measures up to Week 8 (Day 57)
Sub Study: Change From Baseline in QMG Clinician-Reported Outcome Measures up to Week 8 (Day 57)
Sub Study: Change From Baseline in Myasthenia Gravis Foundation of America (MGFA) Clinician-Reported Measures up to Week 8 (Day 57)
Sub Study: Change From Baseline in C-SSRS Clinician-Reported Outcome Measures up to Week 8 (Day 57)
Sub Study: Change From Baseline in Neuro-QoL Participant-Reported Outcome Measures up to Week 8 (Day 57)
Sub Study: Change From Baseline in Patient Global Impression of Severity (PGIS) Scale Score up to Week 8 (Day 57)
Sub Study: Change From Baseline in Patient Global Impression of Change (PGIC) Scale Score up to Week 8 (Day 57)
Sub Study: Change From Baseline in MG-QoL Participant-Reported Outcome Measures up to Week 8 (Day 57)
Sub Study: Change From Baseline in EQ-5D-5L Participant-Reported Outcome Measures up to Week 8 (Day 57)
Sub Study: Percent Change in Total IgG Levels From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57)
Sub Study: Percent Change in Anti-AChR Autoantibody Titer From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57)

Arms and interventions

NipocalimabExperimental

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.

PlaceboPlacebo comparator

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.

Nipocalimab Subcutaneous (SC)Experimental

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.

Drugs: Nipocalimab, Placebo, Nipocalimab SC-LIV

Sites

112 sites in 17 countries

United States 24, Japan 16, China 14, Spain 8, Italy 7, Germany 6, Belgium 5, France 5, Poland 5, South Korea 4, Canada 3, Czechia 3, Mexico 3, Taiwan 3, Australia 2, Denmark 2, Sweden 2