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NCT03896295 · ClinicalTrials.gov registry record · Phase 2

An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis

A Phase 2 study, sponsored by Momenta Pharmaceuticals.

Terminated
Registry status
Phase 2
Development phase
37
Enrollment target

NCT03896295: Clinical Trial Phase 2 study, sponsored by Momenta Pharmaceuticals.

NCT03896295 is a Phase 2 study that was terminated before completion, run by Momenta Pharmaceuticals. The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03896295, a Phase 2 study, was terminated before completion, sponsored by Momenta Pharmaceuticals.

TERMINATED
Registry status
Phase 2
Development phase
37 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the long-term safety and tolerability of M281 in participants with generalized myasthenia gravis (gMG)

Primary Outcome

Number of participants with TEAEs were reported. An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug in this study.

Interventions

  • DRUG M281

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2019-08-06
Est. Completion 2020-12-09
Phase Phase 2
Momenta Pharmaceuticals

8 total trials

Why NCT03896295 stopped before completion

NCT03896295 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).

The record links to 0 conditions, and to 1 intervention - of which M281 is the first listed.

NCT03896295 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03896295 about?

NCT03896295 is a clinical study titled "An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis". The purpose of this study is to evaluate the long-term safety and tolerability of M281 in participants with generalized myasthenia gravis (gMG)

What is the current status of trial NCT03896295?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2019-08-06. Estimated completion is 2020-12-09.

What interventions are being tested in trial NCT03896295?

The interventions under investigation include: M281 (DRUG).

Who is sponsoring clinical trial NCT03896295?

This trial is sponsored by Momenta Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03896295's enrollment target sits among peer trials

37 1484th of 2000 higher than 505 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03896295, the US trial registry maintained by the National Library of Medicine. NCT03896295 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.