RECRUITINGPhase 2INTERVENTIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Participant must be a male or female being 18 or more, at the time of signing the willing to sign a consent form
- 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 willing to sign a consent form
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
NMD670
Tablets taken twice a day for 21 days
DRUG
Placebo
Tablets taken twice a day for 21 days
Locations (20)
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