RecruitingPhase 2NCT06414954

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

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

Sponsor

NMD Pharma A/S

Enrollment

84 participants

Start Date

May 16, 2024

Study Type

INTERVENTIONAL

Conditions

Myasthenia Gravis Myasthenia Gravis, MuSK

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called NMD670 and a drug called Placebo for people with myasthenia gravis and myasthenia gravis, musk. The study is currently recruiting participants at 40 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNMD670

Tablets taken twice a day for 21 days

DRUGPlacebo

Tablets taken twice a day for 21 days

Locations(40)

Profound Research LLC

Carlsbad, California, United States

University of California Irvine Medical Center

Irvine, California, United States

University of Colorado Neuromuscular Division

Aurora, Colorado, United States

SFM Clinical Research, LLC

Boca Raton, Florida, United States

Neuromuscular Research Division | University of South Florida

Tampa, Florida, United States

Augusta University, Neuroscience Center

Augusta, Georgia, United States

NextGen Precision Health

Columbia, Missouri, United States

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

The Ohio State University

Columbus, Ohio, United States

University of Oregon

Portland, Oregon, United States

Semmes Murphey Clinic

Memphis, Tennessee, 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, Italy

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

Bologna, Italy

IRCCS Ospedale Policlinico San Martino

Genova, Italy

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

Milan, Italy

DIMER, IRCCS, Ospedale San Raffaele

Milan, Italy

Centro Sclerosi Multipla Napoli - AOU Vanvitelli

Naples, Italy

AOU Pisana

Pisa, Italy

Azienda Ospedaliera Sant'Andrea - Universita di Roma La Sapienza

Roma, Italy

Leiden Universitair Medisch Centrum (LUMC)

Leiden, 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, 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

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NCT06414954

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