Tests claseprubart for generalized myasthenia gravis in adults
Tests claseprubart against a placebo in adults with generalized myasthenia gravis.
Plain-language title generated from the registry record
Registry title: A Phase 3 Study to Evaluate Claseprubart in Adults With Generalized Myasthenia Gravis (EMERGE)
Key facts
- Where
- Pisa and Rome, ItalySee the 2 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07647510, who can take part
Where in Italy
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyNot yet recruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Dianthus Therapeutics
- Trial code
- NCT07647510EU 2026-525298-38-00
- Record updated
- 30 October 2026
- Original description
The purpose of this Phase 3 study is to demonstrate the efficacy, safety, and tolerability of claseprubart in participants with generalized myasthenia gravis (gMG).Read full original descriptionShow less
A Phase 3 Global, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Demonstrate the Efficacy, Safety, and Tolerability of Claseprubart (DNTH103) in Patients With Generalized Myasthenia Gravis (EMERGE)
The purpose of this Phase 3 study is to demonstrate the efficacy, safety, and tolerability of claseprubart in participants with generalized myasthenia gravis (gMG).
Inclusion: Must have given written informed consent before any study-related activities are carried out; Weight range between 40-130 kg at Screening; Diagnosis of gMG by the following tests:; Acetylcholine receptor antibody (AChR Ab) positive, and; One of the following:; History of abnormal neuromuscular transmission test; ii. History of positive anticholinesterase test; iii. Clinical response to acetylcholinesterase inhibitors; Myasthenia Gravis Foundation of America (MGFA) Class II-IVa; MG-ADL scale score of 6 or more; QMG scale score of 10 or more; Documented vaccinations against encapsulated bacteria in accordance with local requirements and based on vaccine availability; 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; Male participants agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception.
Exclusion: Prior history (at any time) of N. meningitidis infection; Previous treatment with claseprubart (DNTH103) or participation in a clinical trial with claseprubart. [; Any thymic surgery/biopsy within 1 year of Screening; History of active malignancy within 5 years prior to Screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone; Concurrent or previous use of the following medication within the time periods specified below; Rituximab or other B-cell targeting therapies (ie, inebilizumab) within 6 months (180 days) prior to randomization (Day 1); Intravenous immunoglobulin (IVIg) and plasma exchange (PLEX) within 4 weeks (28 days) prior to randomization (Day 1); Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent; History or presence of significant medical/surgical condition including any acute illness, mental illness, or major surgery considered to be clinically significant or that could have potential impact on safety/efficacy or study procedures; Participants with known seropositivity or who test positive for an active viral infection with human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B (HBV; except participants who are seropositive because of HBV vaccination) or hepatitis C virus (HCV) during Screening; Any history of thymic carcinoma or thymic malignancy; Known complement deficiency; Any known or untreated thymoma; Diagnosis of systemic lupus erythematosus (SLE) or family history (defined as a parent, sibling, or child) of SLE.