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M281

DRUG5 trials

Sponsors

Momenta Pharmaceuticals, Inc., Janssen Research & Development, LLC

Conditions

Generalized Myasthenia GravisHealthy VolunteersHemolytic Disease of the Fetus and NewbornWarm Autoimmune Hemolytic Anemia

Phase 1

An Ascending Dose Study to Evaluate M281 Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD)
CompletedNCT02828046
Momenta Pharmaceuticals, Inc.Healthy Volunteers
Start: 2016-05-09End: 2017-08-08Updated: 2019-10-14

Phase 2

A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis
CompletedNCT03772587
Momenta Pharmaceuticals, Inc.Generalized Myasthenia Gravis
Start: 2019-04-10End: 2020-06-25Updated: 2023-06-27
A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
CompletedNCT03842189
Janssen Research & Development, LLCHemolytic Disease of the Fetus and Newborn
Start: 2018-04-05End: 2024-08-05Updated: 2026-03-25
An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis
TerminatedNCT03896295
Momenta Pharmaceuticals, Inc.Generalized Myasthenia Gravis
Start: 2019-08-06End: 2020-12-09Updated: 2023-06-27
Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia
Active, not recruitingNCT04119050
Janssen Research & Development, LLCWarm Autoimmune Hemolytic Anemia
Start: 2019-08-15End: 2028-04-01Updated: 2026-08-31

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