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

Last updated: March 25, 2025
Sponsor: Dianthus Therapeutics
Overall Status: Active - Recruiting

Phase

2

Condition

Polymyositis (Inflammatory Muscle Disease)

Neuropathy

Sarcopenia

Treatment

DNTH103

Placebo

Clinical Study ID

NCT06282159
DNTH103-MG-201
  • Ages 18-75
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Must have given written informed consent before any study-related activities arecarried out.

  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 positiveanticholinesterase 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, andwhere available, meningococcal serotype B vaccine within 3 years prior to, or at thetime of, initiating study drug.

  8. Female participants must: Be of non-childbearing potential, or if of childbearing potential, must agree not todonate ova, not to attempt to become pregnant and, if engaging in sexual intercoursewith 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 screeningor agree not to donate sperm

Exclusion

Exclusion Criteria:

  1. History or presence of significant medical/surgical condition including any acuteillness or major surgery considered to be clinically significant

  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 duringScreening.

  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 periodsspecified below.

  8. Rituximab within 6 months (180 days) prior to randomization (Day 1);

  9. Intravenous immunoglobulin (IVIg) and plasma exchange (PLEX) within 4 weeks (28days) prior to randomization (Day 1).

  10. Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: DNTH103
Phase: 2
Study Start date:
February 23, 2024
Estimated Completion Date:
December 31, 2027

Study Description

The study includes the following periods:

  • 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)

Connect with a study center

  • Clinical Study Site

    San Miguel de Tucuman, Tucuman T4000
    Argentina

    Active - Recruiting

  • Clinical Study Site

    Buenos Aires, C1015ABR
    Argentina

    Active - Recruiting

  • Clinical Study Site

    Cordoba, X5004CDT
    Argentina

    Active - Recruiting

  • Clinical Study Site

    Rosario, 2000
    Argentina

    Active - Recruiting

  • Clinical Study Site

    London, Ontario N6A 5W9
    Canada

    Active - Recruiting

  • Clinical Study Site

    Ostrava, 70852
    Czech Republic

    Active - Recruiting

  • Clinical Study Site

    Ostrava, 70852
    Czechia

    Active - Recruiting

  • Clinical Study Site

    Copenhagen, 02100
    Denmark

    Active - Recruiting

  • Clinical Study Site

    Bordeaux Cedex, 33076
    France

    Active - Recruiting

  • Clinical Study Site

    Nice, 06001
    France

    Active - Recruiting

  • Clinical Study Site

    Strasbourg, 67000
    France

    Active - Recruiting

  • Clinical Study Site

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Clinical Study Site

    Ramat Gan,
    Israel

    Active - Recruiting

  • Clinical Study Site

    Rambam, 3109601
    Israel

    Site Not Available

  • Clinical Study Site

    Zefat, 13100
    Israel

    Active - Recruiting

  • Clinical Study Site

    Milano, 20133
    Italy

    Active - Recruiting

  • Clinical Study Site

    Napoli, 80131
    Italy

    Active - Recruiting

  • Clinical Study Site

    Pisa, 56126
    Italy

    Active - Recruiting

  • Clinical Study Site

    Rome, 00189
    Italy

    Active - Recruiting

  • Clinical Study Site

    Skopje, 1000
    Macedonia, The Former Yugoslav Republic of

    Active - Recruiting

  • Clinical Study Site

    Amsterdam,
    Netherlands

    Active - Recruiting

  • Clinical Study Site

    Skopje, 1000
    North Macedonia

    Active - Recruiting

  • Clinical Study Site

    Bergen, 5021
    Norway

    Active - Recruiting

  • Clinical Study Site

    Bydgoszcz, 85-065
    Poland

    Active - Recruiting

  • Clinical Study Site

    Katowice, 40123
    Poland

    Active - Recruiting

  • Clinical Study Site

    Krakow, 31-503
    Poland

    Active - Recruiting

  • Clinical Study Site

    Kraków, 31-202
    Poland

    Active - Recruiting

  • Clinical Study Site

    Kralkow, 31-503
    Poland

    Site Not Available

  • Clinical Study Site

    Lublin, 20-093
    Poland

    Active - Recruiting

  • Clinical Study Site

    Warsaw, 01-684
    Poland

    Active - Recruiting

  • Clinical Study Site

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • Clinical Study Site

    Kragujevac, 34000
    Serbia

    Active - Recruiting

  • Clinical Study Site

    Nis, 18000
    Serbia

    Active - Recruiting

  • Clinical Study Site

    Novi Sad, 21000
    Serbia

    Active - Recruiting

  • Clinical Study Site

    Malmö,
    Sweden

    Active - Recruiting

  • Clinical Study Site

    Phoenix, Arizona 85028
    United States

    Active - Recruiting

  • Clinical Study Site

    Irvine, California 92868
    United States

    Active - Recruiting

  • Clinical Study Site

    Stamford, Connecticut 06905
    United States

    Active - Recruiting

  • Clinical Study Site

    Boca Raton, Florida 33487
    United States

    Active - Recruiting

  • Bradenton Research Center

    Bradenton, Florida 34205
    United States

    Active - Recruiting

  • Clinical Study Site

    Bradenton, Florida 34205
    United States

    Active - Recruiting

  • Research Site

    Bradenton, Florida 34205
    United States

    Active - Recruiting

  • Clinical Study Site

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Clincal Study Site

    Tampa, Florida 33620
    United States

    Active - Recruiting

  • Clinical Study Site

    O'Fallon, Illinois 62269
    United States

    Active - Recruiting

  • Clinical Study Site

    Kansas City, Kansas 66103
    United States

    Active - Recruiting

  • Clinical Study Site

    Lexington, Kentucky 40503
    United States

    Active - Recruiting

  • Clinical Study Site

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Clinical Study Site

    East Lansing, Michigan 48824
    United States

    Active - Recruiting

  • Clinical Study Site

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • Clinical Study Site

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Clinical Study Site

    Columbus, Ohio 43221
    United States

    Active - Recruiting

  • Clinical Study Site

    Dallas, Texas 75243
    United States

    Active - Recruiting

  • Texas Neurology

    Dallas, Texas 75206
    United States

    Active - Recruiting

  • Clinical Study Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Clinical Study Site #2

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Nerve And Muscle Center Of Texas (NMCT)

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Clinical Study Site

    Lubbock, Texas 79414
    United States

    Active - Recruiting

  • Research Site

    Lubbock, Texas 79414
    United States

    Active - Recruiting

  • West Texas Neurology Clinic

    Lubbock, Texas 79414
    United States

    Active - Recruiting

  • Clinical Study Site

    Richmond, Virginia 23219
    United States

    Active - Recruiting

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