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NCT06414954PHASE2Recruiting

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

NMD Pharma A/S

Start Date

5/16/2024

Completion Date

12/1/2026

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

NMD670

DRUG

Placebo

Interested in This Trial?

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Conditions

Myasthenia GravisMyasthenia Gravis, MuSK

Locations

Profound Research LLC

Carlsbad, California 92011

United States

University of California Irvine Medical Center

Irvine, California 92868

United States

University of Colorado Neuromuscular Division

Aurora, Colorado 80045

United States

SFM Clinical Research, LLC

Boca Raton, Florida 33487

United States

Neuromuscular Research Division | University of South Florida

Tampa, Florida 33612

United States

Augusta University, Neuroscience Center

Augusta, Georgia 30912

United States

NextGen Precision Health

Columbia, Missouri 65212

United States

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27599

United States

The Ohio State University

Columbus, Ohio 43221

United States

University of Oregon

Portland, Oregon 97239

United States

Semmes Murphey Clinic

Memphis, Tennessee 38120

United States

UZ Leuven

Leuven,

Belgium

Aarhus University Hospital

Aarhus,

Denmark

Rigshospitalet University of Copenhagen

Copenhagen,

Denmark

Centre de référence des maladies neuromusculaires AOC-CHU de Bordeaux - Hôpital Pellegrin

Bordeaux,

France

Centre de Référence des Maladies Neuromusculaires et de la SLA

Marseille,

France

Centre Hospitalier Universitaire de Nantes - Hôtel Dieu Centre de Référence des Maladies Neuromusculaires Rares -

Nantes,

France

CHU de Nice

Nice,

France

Unité de Recherche Clinique NeuroSciences

Nice,

France

JSC Curatio

Tbilisi,

Georgia

LTD David Tatishvili Health Center

Tbilisi,

Georgia

Ltd New Hospitals

Tbilisi,

Georgia

ASST Papa Giovanni XXIII (Azienda Ospedaliera Papa Giovanni XXIII)

Bergamo, 21127

Italy

IRCCS Istituo delle Scienze neurologiche di Bologna, UOC Clinica neurologica Ospedale

Bologna, 40139

Italy

IRCCS Ospedale Policlinico San Martino

Genova, 16132

Italy

IRCCS Fondazione Istituto Neurologico Carlo Besta, Dipartimento di Ricerca e Sviluppo clinico

Milan, 20133

Italy

DIMER, IRCCS, Ospedale San Raffaele

Milan,

Italy

Centro Sclerosi Multipla Napoli - AOU Vanvitelli

Naples, 80138

Italy

AOU Pisana

Pisa, 56126

Italy

Azienda Ospedaliera Sant'Andrea - Universita di Roma La Sapienza

Roma, 00189

Italy

Leiden Universitair Medisch Centrum (LUMC)

Leiden, 2333

Netherlands

Neurologia Śląska Centrum Medyczne

Katowice,

Poland

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp.z o.o

Krakow,

Poland

Centrum Medyczne Hope Clinic

Lublin, 20701

Poland

Galen Clinic

Lublin,

Poland

NeuroCor Banaszkiewicz, Tomaszewski Lekarze Spółka Partnerska

Myślenice,

Poland

Centrum Medyczne Neuro Protect

Warsaw,

Poland

University Clinical Center of Serbia, Neurology Clinic

Belgrade,

Serbia

University Clinical Center Nis, Neurology Clinic

Niš,

Serbia

Hospìtal Universitari Vall d'Hebrón

Barcelona,

Spain