A Phase 2 Study to Evaluate DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC)
NCT ID: NCT06282159
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
65 participants
INTERVENTIONAL
2024-02-23
2027-08-31
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Day 1: IV infusion of placebo Week 1 to Week 11: placebo administered SC every 2 weeks
DNTH103 low dose Q2W
DNTH103
Day 1: IV loading dose Week 1 to Week 11: DNTH103 administered SC every 2 weeks
DNTH103 high dose Q2W
DNTH103
Day 1: IV loading dose Week 1 to Week 11: DNTH103 administered SC every 2 weeks
Interventions
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DNTH103
Day 1: IV loading dose Week 1 to Week 11: DNTH103 administered SC every 2 weeks
Placebo
Day 1: IV infusion of placebo Week 1 to Week 11: placebo administered SC every 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Adult males and females, 18 to 75 years of age (inclusive) at Screening.
3. Weight range between 40-120 kg at Screening.
4. Diagnosis of gMG by the following tests:
Acetylcholine receptor antibody (AChR Ab) positive, and
One of the following:
i. History of abnormal neuromuscular transmission test; ii. History of positive anticholinesterase test; iii. Clinical response to acetylcholinesterase inhibitors.
5. Myasthenia Gravis Foundation of America (MGFA) Class II-Iva
6. Myasthenia Gravis Activities of Daily Living (MG-ADL) score of 6 or more
7. Vaccination against N. meningitidis with the quadrivalent meningococcal vaccine, and where available, meningococcal serotype B vaccine within 3 years prior to, or at the time of, initiating study drug.
8. Female participants must:
Be of non-childbearing potential, or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception.
9. Male participants must be surgically sterile for at least 90 days prior to screening or agree not to donate sperm
Exclusion Criteria
2. Prior history (at any time) of N. meningitidis infection.
3. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies during Screening.
4. Any thymic surgery/biopsy within 1 year of Screening.
5. Any known or untreated thymoma.
6. Any history of thymic carcinoma or thymic malignancy.
7. Concurrent or previous use of the following medication within the time periods specified below.
1. Rituximab within 6 months (180 days) prior to randomization (Day 1);
2. Intravenous immunoglobulin (IVIg) and plasma exchange (PLEX) within 4 weeks (28 days) prior to randomization (Day 1).
8. Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent.
18 Years
75 Years
ALL
No
Sponsors
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Dianthus Therapeutics
INDUSTRY
Responsible Party
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Locations
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Clinical Study Site
Phoenix, Arizona, United States
Clinical Study Site
Irvine, California, United States
Clinical Study Site
Stamford, Connecticut, United States
Clinical Study Site
Boca Raton, Florida, United States
Clinical Study Site
Bradenton, Florida, United States
Clinical Study Site
Maitland, Florida, United States
Clincal Study Site
Tampa, Florida, United States
Clinical Study Site
O'Fallon, Illinois, United States
Clinical Study Site
Kansas City, Kansas, United States
Clinical Study Site
Lexington, Kentucky, United States
Clinical Study Site
Boston, Massachusetts, United States
Clinical Study Site
East Lansing, Michigan, United States
Clinical Study Site
Columbia, Missouri, United States
Clinical Study Site
Cincinnati, Ohio, United States
Clinical Study Site
Columbus, Ohio, United States
Clinical Study Site
Dallas, Texas, United States
Clinical Study Site
Dallas, Texas, United States
Clinical Study Site #2
Houston, Texas, United States
Clinical Study Site
Houston, Texas, United States
Clinical Study Site
Lubbock, Texas, United States
Clinical Study Site
Richmond, Virginia, United States
Clinical Study Site
San Miguel de Tucumán, Tucumán Province, Argentina
Clinical Study Site
Buenos Aires, , Argentina
Clinical Study Site
Buenos Aires, , Argentina
Clinical Study Site
Buenos Aires, , Argentina
Clinical Study Site
Córdoba, , Argentina
Clinical Study Site
Rosario, , Argentina
Clinical Study Site
London, Ontario, Canada
Clinical Study Site
Ostrava, , Czechia
Clinical Study Site
Copenhagen, , Denmark
Clinical Study Site
Bordeaux, , France
Clinical Study Site
Nice, , France
Clinical Study Site
Strasbourg, , France
Clinical Study Site
Haifa, , Israel
Clinical Study Site
Ramat Gan, , Israel
Clinical Study Site
Safed, , Israel
Clinical Study Site
Milan, , Italy
Clinical Study Site
Napoli, , Italy
Clinical Study Site
Pisa, , Italy
Clinical Study Site
Rome, , Italy
Clinical Study Site
Rome, , Italy
Clinical Study Site
Amsterdam, , Netherlands
Clinical Study Site
Skopje, , North Macedonia
Clinical Study Site
Bergen, , Norway
Clinical Study Site
Bydgoszcz, , Poland
Clinical Study Site
Katowice, , Poland
Clinical Study Site
Krakow, , Poland
Clinical Study Site
Krakow, , Poland
Clinical Study Site
Lublin, , Poland
Clinical Study Site
Warsaw, , Poland
Clinical Study Site
Warsaw, , Poland
Clinical Study Site
Belgrade, , Serbia
Clinical Study Site
Kragujevac, , Serbia
Clinical Study Site
Niš, , Serbia
Clinical Study Site
Novi Sad, , Serbia
Clinical Study Site
Malmo, , Sweden
Countries
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Other Identifiers
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2024-512865-15-00
Identifier Type: CTIS
Identifier Source: secondary_id
DNTH103-MG-201
Identifier Type: -
Identifier Source: org_study_id
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