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Clinical Trials in the USA / NCT06282159
Active, not recruiting Phase 2

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

NCT06282159 · tracked via the Priya Life Science USA tracker
Sponsor
Dianthus Therapeutics
Phase
Phase 2
Started
2024-02-23
Last updated
2026-07-27

Condition(s) studied

Myasthenia Gravis, Generalized

Investigational drug(s) / intervention(s)

ClaseprubartPlacebo

Claseprubart: Day 1: IV loading dose Week 1 to Week 11: Claseprubart administered SC every 2 weeks

Placebo: Day 1: IV infusion of placebo Week 1 to Week 11: placebo administered SC every 2 weeks

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion 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: 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. 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: 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. 9. Male participants must be surgically sterile for at least 90 days prior to screening or agree not to donate sperm Exclusion Criteria: 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.

Primary outcome measure(s)

Trial sites (56)

FacilityCityRegionStatus
Clinical Study Site Phoenix Arizona
Clinical Study Site Irvine California
Clinical Study Site Stamford Connecticut
Clinical Study Site Boca Raton Florida
Clinical Study Site Bradenton Florida
Clinical Study Site Maitland Florida
Clincal Study Site Tampa Florida
Clinical Study Site O'Fallon Illinois
Clinical Study Site Kansas City Kansas
Clinical Study Site Lexington Kentucky
Clinical Study Site Boston Massachusetts
Clinical Study Site East Lansing Michigan
Clinical Study Site Columbia Missouri
Clinical Study Site Cincinnati Ohio
Clinical Study Site Columbus Ohio
Clinical Study Site Dallas Texas
Clinical Study Site Dallas Texas
Clinical Study Site #2 Houston Texas
Clinical Study Site Houston Texas
Clinical Study Site Lubbock Texas
Clinical Study Site Richmond Virginia
Clinical Study Site San Miguel de Tucumán Tucumán Province
Clinical Study Site Buenos Aires Argentina
Clinical Study Site Buenos Aires Argentina
Clinical Study Site Buenos Aires Argentina
Clinical Study Site Córdoba Argentina
Clinical Study Site Rosario Argentina
Clinical Study Site London Ontario
Clinical Study Site Ostrava Czechia
Clinical Study Site Copenhagen Denmark
Clinical Study Site Bordeaux France
Clinical Study Site Nice France
Clinical Study Site Strasbourg France
Clinical Study Site Haifa Israel
Clinical Study Site Ramat Gan Israel
Clinical Study Site Safed Israel
Clinical Study Site Milan Italy
Clinical Study Site Naples Italy
Clinical Study Site Pisa Italy
Clinical Study Site Rome Italy

+ 16 more sites — see the full list on the official registry below.

More Dianthus Therapeutics trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06282159 on ClinicalTrials.gov ↗ ← All trials in the USA