Phase 2 N=68 Randomized Quadruple-blind Treatment

A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis

Generalized Myasthenia Gravis

Bottom Line

View on ClinicalTrials.gov: NCT03772587 ↗

Enrolled (actual)

Serious AEs

4.4%

Results posted

Oct 2021

Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability — 11; 12; 9; 12 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: M281 (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Momenta Pharmaceuticals, Inc.
Primary completion: Jun 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability	11; 12; 9; 12; 12	—
PRIMARY Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)	2; 0; 1; 0; 0	—
PRIMARY Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)	0; 0; 0; 0; 0	—
PRIMARY Change From Baseline to Day 57 in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score	-1.8; -2.5; -3.9; -1.5; -3.9	—
SECONDARY Change From Baseline in Total MG-ADL Score as a Function of Total Serum Immunoglobulin G (IgG) at Day 57	-0.30	—
SECONDARY Change From Baseline in Total MG-ADL Score as a Response to Percent Change in Total Serum IgG, for Participants Positive for Anti-acetylcholine Receptor (Anti-AChR) Antibodies, at Day 57	-0.33	—
SECONDARY Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score as a Function of Total Serum IgG at Day 57	-0.38	—
SECONDARY Change From Baseline in Total QMG Score as a Response to Percent Change in Total Serum IgG, for Participants Positive for Anti-acetylcholine Receptor (Anti-AChR) Antibodies, at Day 57	-0.45	—
SECONDARY Number of Participants With a 2-, 3-, 4-, 5-, 6-, 7-, or Greater Than or Equal to (>=) 8-point Improvement in Total MG-ADL Score at Day 57	7; 9; 10; 7; 12; 5	—
SECONDARY Change From Baseline in Total QMG Score at Day 57	-3.7; -3.5; -4.1; -1.5; -5.9	—
SECONDARY Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57	8; 6; 6; 4; 10; 5	—
SECONDARY Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 (MG-QoL-15r) Scale Score at Day 57	-2.0; -1.7; -6.8; -1.2; -3.7	—
SECONDARY Change From Baseline in Total Serum IgG at Day 57	-0.3; -1.5; -3.4; -1.7; -7.6	—
SECONDARY Change From Baseline in Total MG-ADL Score at Day 85 and Day 113	-2.2; -2.1; -3.7; -1.9; -3.6; -2.6	—
SECONDARY Change From Baseline in Total QMG Score at Day 85 and Day 113	-4.0; -3.6; -4.8; -2.0; -5.1; -4.7	—
SECONDARY Change From Baseline in Total MG-QoL15r Score at Day 85 and Day 113	-2.5; -2.9; -6.5; -0.7; -3.5; -3.2	—
SECONDARY Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57	6; 3; 7; 4; 7; 6	—
SECONDARY Number of Participants With Shift From Baseline in MGFA Classification to Day 113	3; 2; 3; 2; 3; 6	—
SECONDARY Change From Baseline in Total Serum IgG at Day 85 and Day 113	-0.5; -1.4; -3.8; -1.2; -5.7; -0.6	—
SECONDARY Serum Concentrations of Nipocalimab	0.0; 0.00; 0.0; 0.0; 117.75; 746.80	—

Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of M281 administered to participants with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing standard of care therapy.

Eligibility Criteria

Participants must be ≥18 years of age with a documented history of Generalized Myasthenia Gravis (gMG) and clinical signs/symptoms of gMG, not pregnant or breastfeeding, and no history of any neurologic disorder other than MG that might interfere with the accuracy of study assessments. Additional, more specific criteria are defined in the protocol.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03772587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.