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NOT YET RECRUITING
NCT07647510
PHASE3

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

Sponsor: Dianthus Therapeutics

View on ClinicalTrials.gov

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).

Official title: A Phase 3 Global, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Demonstrate the Efficacy, Safety, and Tolerability of Claseprubart (DNTH103) in Patients With Generalized Myasthenia Gravis (EMERGE)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

195

Start Date

2026-07

Completion Date

2031-09

Last Updated

2026-06-15

Healthy Volunteers

No

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