ACTIVE_NOT_RECRUITING

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

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Conditions

Myasthenia Gravis, Generalized

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2024-02-23
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06282159

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Must have given written informed consent before any study-related activities are carried out.
  2. 2. Adult males and females, 18 to 75 years of age (inclusive) at Screening.
  3. 3. Weight range between 40-120 kg at Screening.
  4. 4. Diagnosis of gMG by the following tests:
  5. 5. Myasthenia Gravis Foundation of America (MGFA) Class II-Iva
  6. 6. Myasthenia Gravis Activities of Daily Living (MG-ADL) score of 6 or more
  7. 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. 8. Female participants must:
  9. 9. Male participants must be surgically sterile for at least 90 days prior to screening or agree not to donate sperm
  1. 1. History or presence of significant medical/surgical condition including any acute illness or major surgery considered to be clinically significant
  2. 2. Prior history (at any time) of N. meningitidis infection.
  3. 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. 4. Any thymic surgery/biopsy within 1 year of Screening.
  5. 5. Any known or untreated thymoma.
  6. 6. Any history of thymic carcinoma or thymic malignancy.
  7. 7. Concurrent or previous use of the following medication within the time periods specified below.
  8. 1. Rituximab within 6 months (180 days) prior to randomization (Day 1);
  9. 2. Intravenous immunoglobulin (IVIg) and plasma exchange (PLEX) within 4 weeks (28 days) prior to randomization (Day 1).
  10. 8. Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent.

Contacts and Locations

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Dianthus Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-23
Study Completion Date2027-08

Study Record Updates

Study Start Date2024-02-23
Study Completion Date2027-08

Terms related to this study

Additional Relevant MeSH Terms

  • Myasthenia Gravis, Generalized