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A Phase 3 Study to Evaluate Claseprubart in Adults With Generalized Myasthenia Gravis (EMERGE)

NCT07647510 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2026-07-08

No results posted yet for this study

Summary

The purpose of this Phase 3 study is to demonstrate the efficacy, safety, and tolerability of claseprubart in participants with generalized myasthenia gravis (gMG).

Conditions

  • Myasthenia Gravis, Generalized

Interventions

DRUG

Claseprubart

IV loading dose on Day 1

DRUG

Placebo

IV infusion on Day 1

COMBINATION_PRODUCT

Claseprubart

Prefilled syringe containing claseprubart for SC administration

COMBINATION_PRODUCT

Placebo

Prefilled syringe containing placebo for SC administration

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-12-31
Completion
2031-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07647510 on ClinicalTrials.gov