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

Momenta Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Generalized Myasthenia Gravis

Treatments: Other: Placebo; Drug: M281

Study type: Interventional

Funder types: Industry

Identifiers

NCT03772587

MOM-M281-004

2018-002247-28 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 5 patient groups, including a placebo group

Group 1

Placebo Comparator group

Treatment:

Other: Placebo

Group 2

Experimental group

Treatment:

Drug: M281

Group 3

Experimental group

Treatment:

Drug: M281

Group 4

Experimental group

Treatment:

Drug: M281

Group 5

Experimental group

Treatment:

Drug: M281