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
NMD Pharma A/S
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 Exclus…
Interventions
- DrugNMD670
Tablets taken twice a day for 21 days
- DrugPlacebo
Tablets taken twice a day for 21 days
Locations (40)
- Profound Research LLCCarlsbad, California
- University of California Irvine Medical CenterIrvine, California
- University of Colorado Neuromuscular DivisionAurora, Colorado
- SFM Clinical Research, LLCBoca Raton, Florida
- Neuromuscular Research Division | University of South FloridaTampa, Florida
- Augusta University, Neuroscience CenterAugusta, Georgia