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Clinical Trials in the USA / NCT06414954
Recruiting Phase 2

Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis

NCT06414954 · tracked via the Priya Life Science USA tracker
Sponsor
NMD Pharma A/S
Phase
Phase 2
Started
2024-05-16
Last updated
2026-08-21

Condition(s) studied

Myasthenia GravisMyasthenia Gravis, MuSK

Investigational drug(s) / intervention(s)

NMD670Placebo

NMD670: Tablets taken twice a day for 21 days

Placebo: Tablets taken twice a day for 21 days

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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 other significant clinical and/or laboratory safety findings that may interfere with the conduction or interpretation of the study * 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 * Participants with history of poor compliance with relevant MG therapy * Female patients who plan to become pregnant during the study or are currently pregnant or breastfeeding

Primary outcome measure(s)

Trial sites (40)

FacilityCityRegionStatus
Profound Research LLC Carlsbad California Withdrawn
University of California Irvine Medical Center Irvine California Recruiting
University of Colorado Neuromuscular Division Aurora Colorado Recruiting
SFM Clinical Research, LLC Boca Raton Florida Recruiting
Neuromuscular Research Division | University of South Florida Tampa Florida Recruiting
Augusta University, Neuroscience Center Augusta Georgia Recruiting
NextGen Precision Health Columbia Missouri Recruiting
The University of North Carolina at Chapel Hill Chapel Hill North Carolina Recruiting
The Ohio State University Columbus Ohio Recruiting
University of Oregon Portland Oregon Recruiting
Semmes Murphey Clinic Memphis Tennessee Withdrawn
UZ Leuven Leuven Belgium Withdrawn
Aarhus University Hospital Aarhus Denmark Recruiting
Rigshospitalet University of Copenhagen Copenhagen Denmark Recruiting
Centre de référence des maladies neuromusculaires AOC-CHU de Bordeaux - Hôpital Pellegrin Bordeaux France Recruiting
Centre de Référence des Maladies Neuromusculaires et de la SLA Marseille France Recruiting
Centre Hospitalier Universitaire de Nantes - Hôtel Dieu Centre de Référence des Maladies Neuromusculaires Rares - Nantes France Recruiting
CHU de Nice Nice France Recruiting
Unité de Recherche Clinique NeuroSciences Nice France Recruiting
JSC Curatio Tbilisi Georgia Active Not Recruiting
LTD David Tatishvili Health Center Tbilisi Georgia Active Not Recruiting
Ltd New Hospitals Tbilisi Georgia Active Not Recruiting
ASST Papa Giovanni XXIII (Azienda Ospedaliera Papa Giovanni XXIII) Bergamo Italy Recruiting
IRCCS Istituo delle Scienze neurologiche di Bologna, UOC Clinica neurologica Ospedale Bologna Italy Recruiting
IRCCS Ospedale Policlinico San Martino Genova Italy Recruiting
IRCCS Fondazione Istituto Neurologico Carlo Besta, Dipartimento di Ricerca e Sviluppo clinico Milan Italy Recruiting
DIMER, IRCCS, Ospedale San Raffaele Milan Italy Recruiting
Centro Sclerosi Multipla Napoli - AOU Vanvitelli Naples Italy Recruiting
AOU Pisana Pisa Italy Recruiting
Azienda Ospedaliera Sant'Andrea - Universita di Roma La Sapienza Roma Italy Recruiting
Leiden Universitair Medisch Centrum (LUMC) Leiden Netherlands Recruiting
Neurologia Śląska Centrum Medyczne Katowice Poland Recruiting
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp.z o.o Krakow Poland Recruiting
Centrum Medyczne Hope Clinic Lublin Poland Recruiting
Galen Clinic Lublin Poland Recruiting
NeuroCor Banaszkiewicz, Tomaszewski Lekarze Spółka Partnerska Myślenice Poland Recruiting
Centrum Medyczne Neuro Protect Warsaw Poland Recruiting
University Clinical Center of Serbia, Neurology Clinic Belgrade Serbia Withdrawn
University Clinical Center Nis, Neurology Clinic Niš Serbia Recruiting
Hospìtal Universitari Vall d'Hebrón Barcelona Spain Recruiting

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 NCT06414954 on ClinicalTrials.gov ↗ ← All trials in the USA