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VIVACITY-MG3 open-label extension results

Study design
MG-ADL
QMG
Steroid reduction
MSE

Participants who completed the Phase 3, double-blind VIVACITY-MG3 trial were eligible to continue in the OLE phase1

OLE design summaryOLE design summary

137 antibody-positive participants in the OLE phase received IMAAVY every 2 weeks.1,2

Eligible participants for the OLE were1,2:

  • Patients who took IMAAVY + SOC in the pivotal trial and continued on IMAAVY in the OLE
  • Patients who took placebo + SOC in the pivotal trial and started IMAAVY on Day 1 of the OLE

Tapering of SOC therapy in the OLE was allowed if patients’ gMG was stable in the prior 4 weeks as reflected by MG-ADL score and investigator discretion.1

‡SOC therapies included AChEIs, steroids, or NSISTs, taken together or separately. At pivotal trial double-blind baseline, in each group, 85% of patients received AChE inhibitors, 66% of patients received steroids, and 54% of patients received NSISTs at stable doses.3

All patients were observed for safety 1-hour post infusion for the first 3 IMAAVY infusions.3

*All participants enrolling in the OLE phase were to receive IMAAVY 15 mg/kg given every 2 weeks by IV infusion, starting on Day 1 of the OLE phase. Assessment done at the Week 24 visit of the double-blind, placebo-controlled phases served as baseline (first visit) of the OLE phase, and participants received their first infusion of open-label IMAAVY during the same visit after completion of the Week 24 visit assessments. There were 2 arms: patients who had taken IMAAVY in the Phase 3 trial and continued taking IMAAVY in the OLE study (n=88) and patients who had taken placebo in the VIVACITY-MG3 trial and switched to IMAAVY for the OLE phase (n=88).2,4

†This trial included patients with the 2 most common subtypes of gMG, AChR+ and MuSK+. Eighty-eight percent (n=134) of patients were positive for anti-AChR antibodies and 10% (n=16) were positive for anti-MuSK antibodies. These subtypes account for ~90% of all patients living with gMG.3,5

§Participants who withdraw or discontinue after receiving any amount of study intervention will be required to complete a safety follow-up visit.2,3

||For participants outside the EU, treatment with IMAAVY is to continue until 2 years after marketing authorization in a participant’s local country/
territory or until IMAAVY becomes available commercially or via other continued access program, whichever came first. EU participants will continue treatment until 192 weeks after the double-blind phase of the study has been completed.5

References: 1. Antozzi C, Vu T, Ramchandren S, et al. Long-term safety and efficacy of nipocalimab: approximately 2 years follow-up results from the open-label extension phase of Vivacity-MG3 study. Poster presented at: American Academy of Neurology (AAN) Annual Meeting; April 18–22, 2026; Chicago, IL. 2. Antozzi C, Vu T, Ramchandren S, et al. Supplement to: Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2025;24(2):105–116. doi:10.1016/S14N4-4422(24)00498-8 3. IMAAVY [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 4. Katzberg H, Ait-Tihyaty M, Turkoz I, et al. Safety profile of nipocalimab, a new neonatal fragment crystallizable receptor blocker in the phase 3 Vivacity study. Poster presented at: 15th Myasthenia Gravis Foundation of America (MGFA) International Conference 2025; May 13–15, 2025; The Hague, The Netherlands. 5. Antozzi C, Vu T, Ramchandren S, et al. Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2025;24(2):105–116. doi:10.1016/S1474-4422(24)00498-8

In an interim analysis from the ongoing open-label extension (OLE) study

IMAAVY® + SOC was evaluated to 120 weeks, showing results consistent with the double-blind phase1*

IMAAVY/IMAAVY vs placebo/IMAAVY MG-ADL total score: mean changes from DB baseline
View OLE safety data
IMAAVY/IMAAVY vs placebo/IMAAVY MG-ADL total score: mean changes from DB baseline
View OLE safety data

After Week 24, patients and doctors knew that all patients were on IMAAVY (open-label design and no placebo comparator), which may have affected the results. This exploratory endpoint was not adjusted for multiplicity. Therefore, statistical significance has not been established.

  • At OLE Week 96, mean change from baseline (Week 0 of DB phase) in
    MG-ADL total score     was -6.47 in the IMAAVY to IMAAVY + SOC group and -6.69 in the placebo to IMAAVY + SOC group1
  • At OLE Week 96, mean change from baseline (Week 0 of DB phase) in
    MG-ADL total score for the all IMAAVY + SOC group was -6.581
  • In the OLE phase, results specific to the IMAAVY to IMAAVY + SOC group and placebo to IMAAVY + SOC group are not shown in the graph1

DB=double-blind; MG-ADL=Myasthenia Gravis Activities of Daily Living; OL=open-label; SE=standard error; SOC=standard of care; W=week.

*Includes 24-week, DB phase and OLE Week 96, among patients with data available up to indicated timepoints.1

†The all IMAAVY + SOC group includes patients who continued IMAAVY treatment from the DB phase into OLE and patients who crossed over from placebo to IMAAVY at OLE.1

Reference: 1. Antozzi C, Vu T, Ramchandren S, et al. Long-term safety and efficacy of nipocalimab: approximately 2 years follow-up results from the open-label extension phase of Vivacity-MG3 study. Poster presented at: American Academy of Neurology (AAN) Annual Meeting; April
18-22, 2026; Chicago, IL. Janssen Biotech, Inc.

In an interim analysis from the ongoing open-label extension (OLE) study

IMAAVY® + SOC was evaluated to 120 weeks, showing results consistent with the double-blind phase1*

IMAAVY/IMAAVY vs placebo/IMAAVY QMG total score: mean changes from DB baseline
View OLE safety data
IMAAVY/IMAAVY vs placebo/IMAAVY QMG total score: mean changes from DB baseline
View OLE safety data

After Week 24, patients and doctors knew that all patients were on IMAAVY (open-label design and no placebo comparator), which may have affected the results. This exploratory endpoint was not adjusted for multiplicity. Therefore, statistical significance has not been established.

  • At OLE Week 96, mean change from baseline (Week 0 of double-blind phase) in QMG total score was -5.97 in the IMAAVY to IMAAVY + SOC group and -5.81 in the placebo to IMAAVY + SOC group1
  • At OLE Week 96, mean change from baseline (Week 0 of double-blind phase) in QMG total score for the all IMAAVY + SOC group was -5.891
  • In the OLE phase, results specific to the IMAAVY to IMAAVY + SOC group and placebo to IMAAVY + SOC group are not shown in the graph1

DB=double-blind; OL=open-label; QMG=Quantitative Myasthenia Gravis; SE=standard error; SOC=standard of care; W=week.

*Includes 24-week, DB phase and OLE Week 96, among patients with data available up to indicated timepoints.1

†The all IMAAVY + SOC group includes patients who continued IMAAVY treatment from the DB phase into OLE and patients who crossed over from placebo to IMAAVY at OLE.1

Reference: 1. Antozzi C, Vu T, Ramchandren S, et al. Long-term safety and efficacy of nipocalimab: approximately 2 years follow-up results from the open-label extension phase of Vivacity-MG3 study. Poster presented at: American Academy of Neurology (AAN) Annual Meeting; April
18-22, 2026; Chicago, IL. Janssen Biotech, Inc.

In an interim analysis from the ongoing open-label extension (OLE) study

Corticosteroid use in patients treated with IMAAVY® + SOC was evaluated in the open-label phase1

Prespecified Exploratory Endpoint1*

OLE MG-ADL GraphOLE MG-ADL Graph

After Week 24, patients and doctors knew that all patients were on IMAAVY (open-label design and no placebo comparator), which may have affected the results. This prespecified exploratory endpoint was not adjusted for multiplicity. Therefore, statistical significance has not been established.

These analyses include patients who were receiving corticosteroids at OLE baseline (n=89). This includes patients who continued IMAAVY + SOC treatment from the double-blind phase into the OLE phase, and patients who crossed over from placebo + SOC to IMAAVY + SOC at the OLE phase.1

DB=double-blind; MG=myasthenia gravis; MG-ADL=Myasthenia Gravis Activities of Daily Living; OL=open-label; Q4W=every 4 weeks; SOC=standard of care.

*Data cutoff as of August 2024.1

†Tapering one of the subjects’ concomitant MG medications Q4W was allowed in the OLE phase if disease was stable over the previous 4 weeks based on MG-ADL scores and on investigator's discretion. When decision was made to taper a concomitant corticosteroid medication, the following occurred: 1) For subjects on corticosteroid dose >30 mg per day, the dose was decreased by ≤10 mg Q4W, until a dose of ≤30 mg per day was reached. 2) For subjects on a corticosteroid dose of ≤30 mg per day, the dose was decreased by ≤5 mg Q4W.1,2

References: 1. Antozzi C, Vu T, Ramchandren S, et al. Long-term safety and efficacy of nipocalimab: approximately 2 years follow-up results from the open-label extension phase of Vivacity-MG3 study. Poster presented at: American Academy of Neurology (AAN) Annual Meeting; April 18-22, 2026; Chicago, IL. Janssen Biotech, Inc. 2. Antozzi C, Vu T, Ramchandren S, et al. Supplement to: Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2025;24(2):105–116. doi:10.1016/S1474-4422(24)00498-8

In an interim analysis from the ongoing open-label extension (OLE) study

The proportion of patients reaching minimal symptom expression (MSE) was evaluated1,2

Prespecified Exploratory Endpoint

OLE MSE GraphOLE MSE Graph

Post Hoc Analysis

OLE MSE GraphOLE MSE Graph

After Week 24, patients and doctors knew that all patients were on IMAAVY + SOC (open-label design and no placebo comparator), which may have affected the results. This exploratory endpoint and post hoc analysis were not adjusted for multiplicity. Therefore, statistical significance has not been established.

MSE was defined as an MG-ADL score of 0 or 1.

“All patients” includes patients who continued IMAAVY + SOC treatment from the double-blind phase into the OLE phase, and patients who crossed over from placebo + SOC to IMAAVY + SOC at the OLE phase. In the double-blind period, 11 patients treated with placebo + SOC reached MSE at any time, and 10 of those patients continued into the OLE phase, where they were treated with IMAAVY + SOC. These 10 patients reached MSE at any time in the OLE period. In the double-blind period, 4 patients treated with placebo + SOC reached sustained MSE for ≥8 weeks and continued into the OLE where they were treated with IMAAVY + SOC. These 4 patients reached sustained MSE for ≥8 weeks in the OLE period.1,2

DB=double-blind; MG-ADL=Myasthenia Gravis Activities of Daily Living; SOC=standard of care.

*Any patient without a score at the given week was considered as not meeting the MSE conditions.1

References: 1. Antozzi C, Vu T, Ramchandren S, et al. Long-term safety and efficacy of nipocalimab: approximately 2 years follow-up results from the open-label extension phase of Vivacity-MG3 Study. Poster presented at: American Academy of Neurology (AAN) Annual Meeting; April
18-22, 2026; Chicago, IL. Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.