A Phase 2 Study to Evaluate DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC)
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Myasthenia Gravis, Generalized
In brief
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).
Key facts
- Study ID
- NCT06282159
- Run by
- Dianthus Therapeutics
- People needed
- 65
- Starts
- 2024-02-23
- Expected to finish
- 2028-10-01
- Last updated by the study team
- 2026-07-27
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Must have given written informed consent before any study-related activities are carried out.
- Adult males and females, 18 to 75 years of age (inclusive) at Screening.
- Weight range between 40-120 kg at Screening.
- 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.
- Myasthenia Gravis Foundation of America (MGFA) Class II-Iva
- Myasthenia Gravis Activities of Daily Living (MG-ADL) score of 6 or more
- 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.
- 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.
- Male participants must be surgically sterile for at least 90 days prior to screening or agree not to donate sperm
You may not qualify if…
- History or presence of significant medical/surgical condition including any acute illness or major surgery considered to be clinically significant
- Prior history (at any time) of N. meningitidis infection.
- 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.
- Any thymic surgery/biopsy within 1 year of Screening.
- Any known or untreated thymoma.
- Any history of thymic carcinoma or thymic malignancy.
- Concurrent or previous use of the following medication within the time periods specified below.
- Rituximab within 6 months (180 days) prior to randomization (Day 1);
- Intravenous immunoglobulin (IVIg) and plasma exchange (PLEX) within 4 weeks (28 days) prior to randomization (Day 1).
- Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent.
Where it is running
- 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 — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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