Clinical trial

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis

Name

MOM-M281-004

Description

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.

Trial arms

Trial start

2019-04-10

Estimated PCD

2020-06-25

Trial end

2020-06-25

Status

Completed

Phase

Early phase I

Treatment

M281

M281 administered as IV infusion

Arms:

Group 2, Group 3, Group 4, Group 5

Placebo

Placebo administered as intravenous (IV) infusion

Arms:

Group 1

Size

Primary endpoint

Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability

Up to Day 113

Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)

Up to Day 113

Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)

Up to Day 113

Change From Baseline to Day 57 in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score

Baseline to Day 57

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 68, 'type': 'ACTUAL'}}

Updated at

2023-06-27

1 organization

1 product

1 indication

Organization

Momenta Pharmaceuticals

Product

M281

Indication

Myasthenia Gravis