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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Myasthenia Gravis, Myasthenia Gravis, MuSK

In brief

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.

Key facts

Study ID

NCT06414954

Run by

NMD Pharma A/S

People needed

84

Starts

2024-05-16

Expected to finish

2026-12-01

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Galen Clinic — Lublin, Poland (enrolling)
• NeuroCor Banaszkiewicz, Tomaszewski Lekarze Spółka Partnerska — Myślenice, Poland (enrolling)
• Centrum Medyczne Neuro Protect — Warsaw, Poland (enrolling)
• Augusta University, Neuroscience Center — Augusta, Georgia, United States (enrolling)
• University Clinical Center Nis, Neurology Clinic — Niš, Serbia (enrolling)
• Hospìtal Universitari Vall d'Hebrón — Barcelona, Spain (enrolling)
• NextGen Precision Health — Columbia, Missouri, United States (enrolling)
• The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• The Ohio State University — Columbus, Ohio, United States (enrolling)
• University of Oregon — Portland, Oregon, United States (enrolling)
• Semmes Murphey Clinic — Memphis, Tennessee, United States (enrolling)
• University of California Irvine Medical Center — Irvine, California, United States (enrolling)
• Aarhus University Hospital — Aarhus, Denmark (enrolling)
• Rigshospitalet University of Copenhagen — Copenhagen, Denmark (enrolling)
• Centre de référence des maladies neuromusculaires AOC-CHU de Bordeaux - Hôpital Pellegrin — Bordeaux, France (enrolling)
• Centre de Référence des Maladies Neuromusculaires et de la SLA — Marseille, France (enrolling)
• Centre Hospitalier Universitaire de Nantes - Hôtel Dieu Centre de Référence des Maladies Neuromusculaires Rares - — Nantes, France (enrolling)
• CHU de Nice — Nice, France (enrolling)
• Unité de Recherche Clinique NeuroSciences — Nice, France (enrolling)
• University of Colorado Neuromuscular Division — Aurora, Colorado, United States (enrolling)
• SFM Clinical Research, LLC — Boca Raton, Florida, United States (enrolling)
• Neuromuscular Research Division | University of South Florida — Tampa, Florida, United States (enrolling)
• ASST Papa Giovanni XXIII (Azienda Ospedaliera Papa Giovanni XXIII) — Bergamo, Italy (enrolling)
• IRCCS Istituo delle Scienze neurologiche di Bologna, UOC Clinica neurologica Ospedale — Bologna, Italy (enrolling)
• IRCCS Ospedale Policlinico San Martino — Genova, Italy (enrolling)

Full record on ClinicalTrials.gov

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