Health TrialsbyHealthPanel

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

ConditionMyasthenia Gravis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nipocalimab

    Drug

    Nipocalimab will be administered as an IV infusion.

  • Placebo

    Drug

    Matching placebo will be administered as an IV infusion.

  • Nipocalimab SC-LIV

    Drug

    Nipocalimab will be administered subcutaneously.

Treatment groups

199 Participants
are divided into 3 treatment groups
Group A: NipocalimabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: Nipocalimab Subcutaneous (SC)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Average change from baseline over multiple timepoints (Weeks 22, 23, and 24) was reported in this outcome measure. The MG-ADL provided a rapid assessment of the participant's MG symptom severity of 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) rated on a 4-point scale ranging from 0 (normal) to 3 (severe). MG-ADL total score was sum of 8 individual items, which ranging from 0 to 24. A higher score indicated greater symptom severity. Baseline was defined as the average of the screening and Day 1 total scores.

Time frame
Baseline, Weeks 22, 23, and 24
2

Sub Study: Percent Change in Anti-AChR Autoantibody Titer From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57)

Time frame
From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57)
3

Sub Study: Percent Change in Total IgG Levels From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57)

Time frame
From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57)

Secondary outcomes

1

DB Phase: Average Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score Over Weeks 22 and 24

Time frame
Baseline, Weeks 22, and 24
2

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

Time frame
Weeks 22, 23, and 24
3

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

Time frame
Weeks 1 and 2
4

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

Time frame
From Week 4 up to Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Janssen Research & Development, LLC

Lead sponsor

Source ClinicalTrials.gov
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