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
Status: Recruiting
Location: See all (37) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Profound Research LLC
RECRUITING
Carlsbad
University of California Irvine Medical Center
RECRUITING
Irvine
Colorado
University of Colorado Neuromuscular Division
RECRUITING
Aurora
Florida
SFM Clinical Research, LLC
RECRUITING
Boca Raton
Neuromuscular Research Division | University of South Florida
RECRUITING
Tampa
Georgia
Augusta University, Neuroscience Center
RECRUITING
Augusta
Missouri
NextGen Precision Health
RECRUITING
Columbia
North Carolina
The University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Oregon
University of Oregon
RECRUITING
Portland
Tennessee
Semmes Murphey Clinic
RECRUITING
Memphis
Other Locations
Belgium
UZ Leuven
RECRUITING
Leuven
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Rigshospitalet University of Copenhagen
RECRUITING
Copenhagen
France
Centre de référence des maladies neuromusculaires AOC-CHU de Bordeaux - Hôpital Pellegrin
RECRUITING
Bordeaux
Centre de Référence des Maladies Neuromusculaires et de la SLA
RECRUITING
Marseille
Centre Hospitalier Universitaire de Nantes - Hôtel Dieu Centre de Référence des Maladies Neuromusculaires Rares -
RECRUITING
Nantes
Unité de Recherche Clinique NeuroSciences
RECRUITING
Nice
Georgia
JSC Curatio
RECRUITING
Tbilisi
LTD David Tatishvili Health Center
RECRUITING
Tbilisi
Ltd New Hospitals
RECRUITING
Tbilisi
Italy
ASST Papa Giovanni XXIII (Azienda Ospedaliera Papa Giovanni XXIII)
RECRUITING
Bergamo
IRCCS Istituo delle Scienze neurologiche di Bologna, UOC Clinica neurologica Ospedale
RECRUITING
Bologna
IRCCS Ospedale Policlinico San Martino
RECRUITING
Genova
DIMER, IRCCS, Ospedale San Raffaele
RECRUITING
Milan
IRCCS Fondazione Istituto Neurologico Carlo Besta, Dipartimento di Ricerca e Sviluppo clinico
RECRUITING
Milan
Centro Sclerosi Multipla Napoli - AOU Vanvitelli
RECRUITING
Napoli
AOU Pisana
RECRUITING
Pisa
Azienda Ospedaliera Sant'Andrea - Universita di Roma La Sapienza
RECRUITING
Roma
Netherlands
Leiden Universitair Medisch Centrum (LUMC)
RECRUITING
Leiden
Poland
Neurologia Śląska Centrum Medyczne
RECRUITING
Katowice
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp.z o.o
RECRUITING
Krakow
Centrum Medyczne Hope Clinic
RECRUITING
Lublin
Galen Clinic
RECRUITING
Lublin
Centrum Medyczne Neuro Protect
RECRUITING
Warsaw
Serbia
University Clinical Center of Serbia, Neurology Clinic