Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis
NCT ID: NCT06414954
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
84 participants
INTERVENTIONAL
2024-05-16
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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NMD670 high dose
NMD670
Tablets taken twice a day for 21 days
NMD670 mid dose
NMD670
Tablets taken twice a day for 21 days
NMD670 low dose
NMD670
Tablets taken twice a day for 21 days
Placebo
Placebo
Tablets taken twice a day for 21 days
Interventions
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NMD670
Tablets taken twice a day for 21 days
Placebo
Tablets taken twice a day for 21 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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NMD Pharma A/S
INDUSTRY
Responsible Party
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Locations
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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
Napoli, , 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
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
Countries
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Central Contacts
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Facility Contacts
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Gabrielle DeMaria
Role: primary
Other Identifiers
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2023-507539-40
Identifier Type: OTHER
Identifier Source: secondary_id
NMD670-02-0002
Identifier Type: -
Identifier Source: org_study_id
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