Recruiting
Phase 2

NMD670

Sponsor:

NMD Pharma A/S

Code:

NCT06414954

Conditions

Myasthenia Gravis

Myasthenia Gravis, MuSK

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NMD670

Placebo

Study Details

Brief 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.

Conditions

Myasthenia Gravis

Myasthenia Gravis, MuSK

Study ID

NCT06414954

Start date

May 16, 2024

Status verified date

Nov, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NMD670 high dose

experimental: NMD670 mid dose

experimental: NMD670 low dose

placebo comparator: Placebo

Interventions

NMD670

Tablets taken twice a day for 21 days

Placebo

Tablets taken twice a day for 21 days

Primary outcome measure

  • Change from baseline to day 21 in QMG total score for NMD670 vs placebo [ Time Frame: Baseline to day 21 ]

Central Contacts and Locations

Central contacts

NMD Pharma A/S

contact@nmdpharma.comcontact@nmdpharma.com

Locations

University of California Irvine Medical Center

Recruiting

Irvine, California, United States, 92868

Contacts

Siddhant Partap

650-224-2637spratap1@hs.uci.edu

Principal Investigator:

Ali Amer Habib

University of Colorado Neuromuscular Division

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Alexis Shepardson

303-724-4644neuroresearch@cuanschutz.edu

Principal Investigator:

Stacy Dixon, MD

SFM Clinical Research, LLC

Recruiting

Boca Raton, Florida, United States, 33487

Contacts

Gabrielle DeMaria

(561) 939-0333

Principal Investigator:

Marc Feinberg, MD

Neuromuscular Research Division | University of South Florida

Recruiting

Tampa, Florida, United States, 33612

Contacts

Jessica Shaw

813-974-9413jessshaw@usf.edu

Principal Investigator:

Tuan H Vu

Augusta University, Neuroscience Center

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Brandy Quarles

706-721-0390neuromuscular_research@augusta.edu

Principal Investigator:

Michael Rivner

NextGen Precision Health

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Neetha Gali

(573) 882-3065ngdcd@health.missouri.edu

Principal Investigator:

David Arnold

The University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Manisha Chopra

1-919-843-7857chopram@neurology.unc.edu

Principal Investigator:

James Howard

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43221

Contacts

Lischele Watkins,, MACPR

614-293-1737Lischele.Watkins@osumc.edu

University of Oregon

Recruiting

Portland, Oregon, United States, 97239

Contacts

Katie Lewis

503-494-5236lewiskat@ohsu.edu

Principal Investigator:

Nizar Chahin

More Information

Sponsor

NMD Pharma A/S

Last update posted

Aug 21, 2026

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by NMD Pharma A/S on 2026-08-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.