A Phase 2 Study to Evaluate DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC)
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)
2 other identifiers
interventional
65
12 countries
54
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2024
Typical duration for phase_2
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2023
CompletedStudy Start
First participant enrolled
February 23, 2024
CompletedFirst Posted
Study publicly available on registry
February 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
ExpectedOctober 7, 2025
October 1, 2025
1.4 years
December 15, 2023
October 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)
Number of participants with TEAEs and treatment-emergent SAEs will be reported.
Baseline (Day 1) to Week 13
Secondary Outcomes (7)
Change from Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score
Baseline (Day 1) to Week 13
Change from Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score
Baseline (Day 1) to Week 13
Change from Baseline to Week 13 in Myasthenia Gravis Composite (MGC) Scale Score
Baseline (Day 1) to Week 13
Incidence of TEAEs and Treatment-Emergent SAEs
Baseline (Day 1) up to Week 52 of the OLE
Serum Concentrations of DNTH103
Baseline (Day 1) to Week 52 of the OLE
- +2 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORDNTH103 low dose Q2W
EXPERIMENTALDNTH103 high dose Q2W
EXPERIMENTALInterventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
Clinical Study Site
Phoenix, Arizona, 85028, United States
Clinical Study Site
Irvine, California, 92868, United States
Clinical Study Site
Stamford, Connecticut, 06905, United States
Clinical Study Site
Boca Raton, Florida, 33487, United States
Clinical Study Site
Bradenton, Florida, 34205, United States
Clinical Study Site
Maitland, Florida, 32751, United States
Clincal Study Site
Tampa, Florida, 33620, United States
Clinical Study Site
O'Fallon, Illinois, 62269, United States
Clinical Study Site
Kansas City, Kansas, 66103, United States
Clinical Study Site
Lexington, Kentucky, 40503, United States
Clinical Study Site
Boston, Massachusetts, 02215, United States
Clinical Study Site
East Lansing, Michigan, 48824, United States
Clinical Study Site
Columbia, Missouri, 65212, United States
Clinical Study Site
Cincinnati, Ohio, 45219, United States
Clinical Study Site
Columbus, Ohio, 43221, United States
Clinical Study Site
Dallas, Texas, 75206, United States
Clinical Study Site
Dallas, Texas, 75243, United States
Clinical Study Site #2
Houston, Texas, 77030, United States
Clinical Study Site
Houston, Texas, 77030, United States
Clinical Study Site
Lubbock, Texas, 79414, United States
Clinical Study Site
Richmond, Virginia, 23219, United States
Clinical Study Site
San Miguel de Tucumán, Tucumán Province, T4000, Argentina
Clinical Study Site
Buenos Aires, 20/11/1902, Argentina
Clinical Study Site
Buenos Aires, C1012AAR, Argentina
Clinical Study Site
Buenos Aires, C1015ABR, Argentina
Clinical Study Site
Córdoba, X5004CDT, Argentina
Clinical Study Site
Rosario, 2000, Argentina
Clinical Study Site
London, Ontario, N6A 5W9, Canada
Clinical Study Site
Ostrava, 70852, Czechia
Clinical Study Site
Copenhagen, 02100, Denmark
Clinical Study Site
Bordeaux, 33076, France
Clinical Study Site
Nice, 06001, France
Clinical Study Site
Strasbourg, 67000, France
Clinical Study Site
Haifa, 3109601, Israel
Clinical Study Site
Ramat Gan, Israel
Clinical Study Site
Safed, 13100, Israel
Clinical Study Site
Milan, 20133, Italy
Clinical Study Site
Napoli, 80131, Italy
Clinical Study Site
Pisa, 56126, Italy
Clinical Study Site
Rome, 00168, Italy
Clinical Study Site
Rome, 00189, Italy
Clinical Study Site
Amsterdam, Netherlands
Clinical Study Site
Skopje, 1000, North Macedonia
Clinical Study Site
Bergen, 5021, Norway
Clinical Study Site
Bydgoszcz, 85-065, Poland
Clinical Study Site
Katowice, 40123, Poland
Clinical Study Site
Krakow, 31-202, Poland
Clinical Study Site
Krakow, 31-503, Poland
Clinical Study Site
Lublin, 20-093, Poland
Clinical Study Site
Warsaw, 01-684, Poland
Clinical Study Site
Warsaw, 02-657, Poland
Clinical Study Site
Belgrade, 11000, Serbia
Clinical Study Site
Kragujevac, 34000, Serbia
Clinical Study Site
Niš, 18000, Serbia
Clinical Study Site
Novi Sad, 21000, Serbia
Clinical Study Site
Malmo, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2023
First Posted
February 28, 2024
Study Start
February 23, 2024
Primary Completion
July 28, 2025
Study Completion (Estimated)
August 1, 2027
Last Updated
October 7, 2025
Record last verified: 2025-10