A Phase 2 interventional study of Claseprubart and Placebo in Myasthenia Gravis, Generalized, sponsored by Dianthus Therapeutics. Active, not recruiting at 56 sites in 14 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Dianthus Therapeutics · Phase 2, Interventional, and Treatment
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).
The study includes the following periods:
324 studies on the registry are indexed under Myasthenia Gravis; 146 are open to participants now.
This study's enrollment of 65 is above the median of 44 across 212 interventional studies indexed under Myasthenia Gravis.
Browse Myasthenia Gravis studies →Dianthus Therapeutics is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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.
Exclusion Criteria:
Concurrent or previous use of the following medication within the time periods specified below.
Drug: Placebo
Drug: Claseprubart
Drug: Claseprubart
Day 1: IV loading dose Week 1 to Week 11: Claseprubart administered SC every 2 weeks
Also known as: DNTH103
Day 1: IV infusion of placebo Week 1 to Week 11: placebo administered SC every 2 weeks
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.
Time frame: Baseline (Day 1) to Week 13
Change from Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score
The MG-ADL score is an 8-item patient reported outcome (PRO) instrument. The MG-ADL targets symptoms of disability across ocular, bulbar, respiratory, and axial symptoms. The item responses are scored from 0 to 3, and the total score of the MG-ADL is the sum of the 8 items and ranges from 0 to 24, with a higher score indicating more disability.
Time frame: Baseline (Day 1) to Week 13
Change from Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score
The QMG is a clinician-reported assessment to evaluate muscle strength. The QMG consists of 13 items that measure endurance or fatiguability, with each item having a possible score that ranges from 0 - 3. The total possible QMG scores range from 0 - 39, with a higher score indicating greater disease burden.
Time frame: Baseline (Day 1) to Week 13
Change from Baseline to Week 13 in Myasthenia Gravis Composite (MGC) Scale Score
The MGC is a validated assessment tool for measuring clinical status of participants with MG. The range of total MGC score is 0 to 50, with higher scores indicating more severe disease. A clinically meaningful improvement is reflected by a 3-point improvement in MGC score. The MGC assesses 10 important functional areas most frequently affected by MG and the scales are weighted for clinical significance that incorporates patient-reported outcomes.
Time frame: Baseline (Day 1) to Week 13
Incidence of TEAEs and Treatment-Emergent SAEs
Number of participants with TEAEs and treatment-emergent SAEs will be reported.
Time frame: Through OLE completion, an average of 117 weeks
Serum Concentrations of Claseprubart
Blood samples will be collected for measurement of serum concentrations of claseprubart at various timepoints both pre- and post-dose.
Time frame: Baseline (Day 1) through end of SFU, for a maximum of 197 weeks
Change from Baseline in Complement Total Blood Test (CH50)
Blood samples will be collected to determine changes in CH50 at various timepoints.
Time frame: Baseline (Day 1) through end of SFU, for a maximum of 197 weeks
Incidence and Titer of Antidrug Antibody (ADAs) Against Claseprubart
Blood samples will be collected to measure ADA against claseprubart at various timepoints.
Time frame: Baseline (Day 1) through end of SFU, for a maximum of 197 weeks
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Dianthus Therapeutics