← Back to Search

Monoclonal Antibodies

DNTH103 high dose Q2W 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)

Awards & highlights

MAGIC Trial 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.Check my eligibility

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.See study design

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.

MAGIC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

MAGIC Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: DNTH103 high dose Q2WActive Control1 Intervention

Group II: DNTH103 low dose Q2WActive Control1 Intervention

Group III: PlaceboPlacebo Group1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Dianthus TherapeuticsLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this research study currently open and accepting participants?

"According to the details on clinicaltrials.gov, this particular research study is actively in search of eligible participants. The trial was initially made available on February 23rd, 2024 and its most recent update was recorded on April 4th, 2024."

Answered by AI

What is the risk level of DNTH103 at a high dosage every two weeks for individuals?

"Based on our analysis, the safety rating for DNTH103 high dose Q2W in this Phase 2 trial is a moderate 2. This indicates that while there is existing data supporting its safety profile, evidence to support effectiveness is currently lacking."

Answered by AI

What is the primary goal of conducting this clinical trial?

"The primary aim of this trial, to be evaluated from Day 1 up to Week 40 at the Safety Follow-Up Visit, is to monitor alterations in clinical laboratory parameters among participants. Secondary objectives include measuring serum concentrations of DNTH103 through blood samples taken before and after administration, assessing changes in Quantitative Myasthenia gravis (QMG) scale score which offers insight into patients' MG-related functional status using a range of scores from 0 to 50 with meaningful improvement set at a 3-point change, and evaluating variations in complement total blood test (CH50) levels via collected blood samples over different time points."

Answered by AI

What is the current number of individuals being admitted into this particular medical trial?

"Indeed, the information found on clinicaltrials.gov indicates an ongoing patient recruitment for this study. The trial was initially posted on February 23, 2024, and its most recent update was made on April 4, 2024. A total of 60 participants are being sought across two designated locations."

Answered by AI

Is the study seeking participation from individuals aged 65 and older?

"Individuals aged between 18 and 75 are eligible for participation in this research study. Additionally, there are a total of 12 trials designated for those under 18 years old and an additional 78 studies catering to individuals over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Phase 2 Study to Evaluate DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06282159.

All > Orlando > Fort Worth