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

Description

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).

Conditions

Myasthenia Gravis, Generalized

Talk to us

Study Overview

On this page

Study Details

Study overview

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).

A Phase 2, Randomized, Blinded, Placebo-Controlled, Study to Evaluate Safety, Tolerability, Pharmacometrics, and Efficacy of DNTH103 in Adults with Generalized Myasthenia Gravis (MAGIC)

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

Condition
Myasthenia Gravis, Generalized
Intervention / Treatment

-

Contacts and Locations

Irvine

Clinical Study Site, Irvine, California, United States, 92868

Stamford

Clinical Study Site, Stamford, Connecticut, United States, 06905

Boca Raton

Clinical Study Site, Boca Raton, Florida, United States, 33487

Bradenton

Clinical Study Site, Bradenton, Florida, United States, 34205

Maitland

Clinical Study Site, Maitland, Florida, United States, 32751

Tampa

Clincal Study Site, Tampa, Florida, United States, 33620

O'Fallon

Clinical Study Site, O'Fallon, Illinois, United States, 62269

Kansas City

Clinical Study Site, Kansas City, Kansas, United States, 66103

Lexington

Clinical Study Site, Lexington, Kentucky, United States, 40503

Boston

Clinical Study Site, Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Must have given written informed consent before any study-related activities are carried 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:
  • 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:
  • 9. Male participants must be surgically sterile for at least 90 days prior to screening or agree not to donate sperm
  • 1. History or presence of significant medical/surgical condition including any acute illness 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 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Dianthus Therapeutics,

Study Record Dates

2027-12