NCT06282159

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

A Phase 2, Randomized, Blinded, Placebo-Controlled, Study to Evaluate Safety, Tolerability, Pharmacometrics, and Efficacy of DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Dianthus Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study includes the following periods: * Screening (up to 10 weeks) * Randomized, blinded, controlled treatment (RCT) period (13 weeks) * Open-label extension (OLE) period (optional) for eligible participants (52 weeks) * Safety follow-up (40 weeks)

Conditions

• Myasthenia Gravis, Generalized

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-02-23
• Primary completion: 2025-07-28
• Completion: 2027-08-01
• First posted: 2024-02-28
• Last updated: 2025-10-07

Locations

56 sites across 14 countries: United States, Argentina, Canada, Czechia, Denmark, France, Israel, Italy, Netherlands, North Macedonia, Norway, Poland, Serbia, Sweden

Regulatory

• FDA-regulated drug study