Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis
Purpose
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.
Conditions
- Myasthenia Gravis
- Myasthenia Gravis, MuSK
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental NMD670 high dose |
|
|
|
Experimental NMD670 mid dose |
|
|
|
Experimental NMD670 low dose |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
University of California Irvine Medical Center
Irvine, California 92868
Irvine, California 92868
University of Colorado Neuromuscular Division
Aurora, Colorado 80045
Aurora, Colorado 80045
SFM Clinical Research, LLC
Boca Raton, Florida 33487
Boca Raton, Florida 33487
Contact:
Gabrielle DeMaria
(561) 939-0333
Gabrielle DeMaria
(561) 939-0333
Neuromuscular Research Division | University of South Florida
Tampa, Florida 33612
Tampa, Florida 33612
Augusta University, Neuroscience Center
Augusta, Georgia 30912
Augusta, Georgia 30912
NextGen Precision Health
Columbia, Missouri 65212
Columbia, Missouri 65212
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
The Ohio State University
Columbus, Ohio 43221
Columbus, Ohio 43221
Semmes Murphey Clinic
Memphis, Tennessee 38120
Memphis, Tennessee 38120
More Details
- NCT ID
- NCT06414954
- Status
- Recruiting
- Sponsor
- NMD Pharma A/S