Tests NMD670 at 3 dose levels in adults with myasthenia gravis
Tests 3 doses of NMD670 against placebo in adults with myasthenia gravis.
Key facts
- Who runs it
- NMD Pharma A/S
- Where
- Belgrade and Niš, SerbiaSee the 2 sitesAlso in 9 other countries, 38 sites
- Trial code
- Registry title
- Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 84 people, planned
- Started
- 16 May 2024
- Expected to end
- Dec 2026
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- NMD670
- Placebo
- Record updated
- 21 August 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 with myasthenia gravis who have a positive AChR or MuSK antibody test. They take NMD670 or a placebo twice a day for 21 days.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- Myasthenia gravis, MGFA class II, III or IV
- Earlier treatment
- Cannot have received an investigational medical product within 30 days or 5 half-lives of the drug, whichever is longer, before Day 1.
- Biomarker or test result
- A documented positive AChR or MuSK antibody test
Main reasons for not taking part
- Another medical or psychological condition that may get in the way of taking part or add risk
- Other significant clinical or lab findings that may affect the study
- Investigational medical product within 30 days or 5 half-lives before Day 1
- History of poor compliance with myasthenia gravis therapy
- Pregnant, breastfeeding, or planning to become pregnant during the study
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Participant must be a male or female being 18 or more, at the time of signing the informed consent
- Diagnosis of MG, MGFA class II, III or IV
- Documented positive AChR or MuSK antibody test
- Participant must be able to swallow tablets
- Body mass index between 18 and 35 kg/m2, inclusive, at screening, and with a minimum weight of 40 kg
- Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- Participant is capable of and has given signed informed consent
Who cannot take part
- Participants that received treatment with an investigational medical product within 30 days or 5 half-lives of the medication, whichever is longer prior to Day 1
- Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the patient's full participation in the study, pose any additional risk for the patient, or confound the assessment of the patient or outcome of the study
- Participants with history of poor compliance with relevant MG therapy
- Participants with other significant clinical and/or laboratory safety findings that may interfere with the conduction or interpretation of the study
- Female patients who plan to become pregnant during the study or are currently pregnant or breastfeeding
Where in Serbia
Also in 9 other countries, 38 sites
- University Clinical Center of Serbia, Neurology ClinicBelgrade, SerbiaContact: NMD Pharma A/SNo longer taking part
- University Clinical Center Nis, Neurology ClinicNiš, SerbiaContact: Gordana DjordjevicTaking people
About the trial
What the trial wants to find out
This Phase 2 proof-of-concept, dose range finding study aims to evaluate the safety and efficacy of 3 dose levels of NMD670 vs placebo in adult patients with MG with antibodies against AChR or MuSK, administered twice a day (BID) for 21 days.
The 4 groups in the trial
- NMD670 high doseTreatment being tested
Treatment: NMD670
- NMD670 mid doseTreatment being tested
Treatment: NMD670
- NMD670 low doseTreatment being tested
Treatment: NMD670
- PlaceboPlacebo, for comparison
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.
- Official title
- A Phase 2b, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 3 Dose Levels of NMD670 Over 21 Days in Adult Patients With AChR/MuSK-Ab+ Myasthenia Gravis
- Plain-language title
- Tests NMD670 at 3 dose levels in adults with myasthenia gravisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Publications
- The Neuromuscular Junction: A Shared Vulnerability in Aging and Disease.The Journal of neuroscience : the official journal of the Society for Neuroscience, 2025
- Record updated
- 21 August 2026