Taking peoplePhase 3
Tests claseprubart for generalized myasthenia gravis in adults
Tests claseprubart against a placebo in adults with generalized myasthenia gravis.
Key facts
- Who runs it
- Dianthus Therapeutics
- Where
- Almada, Braga, Coimbra, Lisbon, and Porto, PortugalSee the 6 sitesAlso in 13 other countries, 49 sites
- Trial code
- Registry title
- A Phase 3 Study to Evaluate Claseprubart in Adults With Generalized Myasthenia Gravis (EMERGE)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 195 people, planned
- Started
- 29 Jun 2026
- Expected to end
- Sept 2031
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Claseprubart
- Placebo
- Record updated
- 30 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 80 with generalized myasthenia gravis who test positive for acetylcholine receptor antibodies and have moderate to severe symptoms.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Generalized myasthenia gravis, MGFA Class II-IVa, with an MG-ADL score of 6 or more and a QMG score of 10 or more.
- Earlier treatment
- Must have documented vaccinations against encapsulated bacteria. Cannot have had rituximab or other B-cell targeting therapies within 6 months, or IVIg or plasma exchange within 4 weeks, before randomization. No earlier treatment with claseprubart (DNTH103).
- Biomarker or test result
- Acetylcholine receptor antibody (AChR Ab) positive, plus a history of abnormal neuromuscular transmission test, a history of positive anticholinesterase test, or a clinical response to acetylcholinesterase inhibitors.
Main reasons for not taking part
- Known complement deficiency
- Past N. meningitidis infection
- Positive for HIV, hepatitis B or hepatitis C
- Thymoma, thymic cancer, or thymic surgery or biopsy within 1 year
- Systemic lupus erythematosus (SLE), or a parent, sibling or child with SLE
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in Portugal
Also in 13 other countries, 49 sites
- Unidade Local De Saude De Almada-Seixal E.P.E.Almada, PortugalNot yet recruiting
- CCAB Centro Clinico Academico Braga AssociacaoBraga, PortugalNot yet recruiting
- Unidade Local de Saúde de Coimbra, E.P.E.Coimbra, PortugalNot yet recruiting
- Unidade Local De Saude De Santa Maria E.P.E.Lisbon, PortugalNot yet recruiting
- Unidade Local De Saude De Sao Jose E.P.E.Lisbon, PortugalNot yet recruiting
- Unidade Local De Saude De Santo Antonio E.P.E.Porto, PortugalNot yet recruiting
About the trial
What the trial wants to find out
The purpose of this Phase 3 study is to demonstrate the efficacy, safety, and tolerability of claseprubart in participants with generalized myasthenia gravis (gMG).
The 3 groups in the trial
- PlaceboPlacebo, for comparison
Intravenous (IV) infusion of Placebo on Day 1 followed by subcutaneous (SC) injections of Placebo every 2 weeks (Q2W) starting at Week 1 (Day 8).
- Claseprubart Q2WTreatment being tested
IV loading dose of claseprubart on Day 1 followed by SC injections of claseprubart Q2W starting at Week 1 (Day 8).
Treatment: Claseprubart
- Claseprubart Every 4 weeks (Q4W)Treatment being tested
IV loading dose of claseprubart on Day 1 followed by SC injections of claseprubart or Placebo Q2W starting at Week 1 (Day 8), with doses alternating between claseprubart and placebo.
Treatment: Claseprubart and Placebo
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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)
- Plain-language title
- Tests claseprubart for generalized myasthenia gravis in adultsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07647510, who can take part
- Record updated
- 30 October 2026