DNTH103 for Myasthenia Gravis (MAGIC Trial)

Phase 2

Recruiting

Research Sponsored by Dianthus Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day 1) to safety follow-up visit (up to week 40)

Summary

"This trial aims to test the safety, effectiveness, and dosage of DNTH103 in people with generalized myasthenia gravis."

Who is the study for?

Adults aged 18-75 with generalized myasthenia gravis (gMG), a muscle weakness condition, can join this trial. They must have an MG-ADL score of 6+, be AChR antibody positive, and fall within the MGFA Class II-Iva. Participants need to agree to contraception if applicable and should weigh between 40-120 kg.

What is being tested?

The study is testing DNTH103's safety and effectiveness for gMG patients compared to a placebo. It will look at how well the drug works, its side effects, and how it moves through the body.

What are the potential side effects?

While specific side effects are not listed here, typical concerns may include reactions at injection sites, fatigue, headache or other pain symptoms. The trial aims to assess these potential adverse events in detail.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1) to safety follow-up visit (up to week 40)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 1) to safety follow-up visit (up to week 40)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) to safety follow-up visit (up to week 40) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence, severity, and relationship of TEAEs (including treatment discontinuation due to adverse events [AEs]) [Time Frame: Baseline (Day 1) to Safety Follow-Up Visit (up to Week 40)]

Incidence, severity, and relationship of adverse events of special interest (AESI)

Number of participants with changes from baseline in ECG parameters

+1 more

Secondary study objectives

Antidrug antibody (ADA) levels against DNTH103

Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) scale score

Change from baseline in Quantitative Myasthenia Gravis (QMG) scale score

+2 more