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A Phase 2 Study to Evaluate DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC)

NCT06282159 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-10-07

No results posted yet for this study

Summary

The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with generalized myasthenia gravis (gMG).

Conditions

  • Myasthenia Gravis, Generalized

Interventions

DRUG

DNTH103

Day 1: IV loading dose Week 1 to Week 11: DNTH103 administered SC every 2 weeks

DRUG

Placebo

Day 1: IV infusion of placebo Week 1 to Week 11: placebo administered SC every 2 weeks

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-02-23
Primary Completion
2025-07-28
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Canada
  • Czechia
  • Denmark
  • France
  • Israel
  • Italy
  • Netherlands
  • North Macedonia
  • Norway
  • Poland
  • Serbia
  • Sweden

Study Locations

More Related Trials

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 NCT06282159 on ClinicalTrials.gov