Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06414954

Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis

Led by NMD Pharma A/S · Updated on 2026-04-13

84

Participants Needed

40

Research Sites

102 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 40 locations

1

Profound Research LLC

Carlsbad, California, United States, 92011

Withdrawn

2

University of California Irvine Medical Center

Irvine, California, United States, 92868

Actively Recruiting

3

University of Colorado Neuromuscular Division

Aurora, Colorado, United States, 80045

Actively Recruiting

4

SFM Clinical Research, LLC

Boca Raton, Florida, United States, 33487

Actively Recruiting

5

Neuromuscular Research Division | University of South Florida

Tampa, Florida, United States, 33612

Actively Recruiting

6

Augusta University, Neuroscience Center

Augusta, Georgia, United States, 30912

Actively Recruiting

7

NextGen Precision Health

Columbia, Missouri, United States, 65212

Actively Recruiting

8

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

9

The Ohio State University

Columbus, Ohio, United States, 43221

Actively Recruiting

10

University of Oregon

Portland, Oregon, United States, 97239

Actively Recruiting

11

Semmes Murphey Clinic

Memphis, Tennessee, United States, 38120

Actively Recruiting

12

UZ Leuven

Leuven, Belgium

Withdrawn

13

Aarhus University Hospital

Aarhus, Denmark

Actively Recruiting

14

Rigshospitalet University of Copenhagen

Copenhagen, Denmark

Actively Recruiting

15

Centre de référence des maladies neuromusculaires AOC-CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, France

Actively Recruiting

16

Centre de Référence des Maladies Neuromusculaires et de la SLA

Marseille, France

Actively Recruiting

17

Centre Hospitalier Universitaire de Nantes - Hôtel Dieu Centre de Référence des Maladies Neuromusculaires Rares -

Nantes, France

Actively Recruiting

18

CHU de Nice

Nice, France

Actively Recruiting

19

Unité de Recherche Clinique NeuroSciences

Nice, France

Actively Recruiting

20

JSC Curatio

Tbilisi, Georgia

Actively Recruiting

21

LTD David Tatishvili Health Center

Tbilisi, Georgia

Actively Recruiting

22

Ltd New Hospitals

Tbilisi, Georgia

Actively Recruiting

23

ASST Papa Giovanni XXIII (Azienda Ospedaliera Papa Giovanni XXIII)

Bergamo, Italy, 21127

Actively Recruiting

24

IRCCS Istituo delle Scienze neurologiche di Bologna, UOC Clinica neurologica Ospedale

Bologna, Italy, 40139

Actively Recruiting

25

IRCCS Ospedale Policlinico San Martino

Genova, Italy, 16132

Actively Recruiting

26

IRCCS Fondazione Istituto Neurologico Carlo Besta, Dipartimento di Ricerca e Sviluppo clinico

Milan, Italy, 20133

Actively Recruiting

27

DIMER, IRCCS, Ospedale San Raffaele

Milan, Italy

Actively Recruiting

28

Centro Sclerosi Multipla Napoli - AOU Vanvitelli

Naples, Italy, 80138

Actively Recruiting

29

AOU Pisana

Pisa, Italy, 56126

Actively Recruiting

30

Azienda Ospedaliera Sant'Andrea - Universita di Roma La Sapienza

Roma, Italy, 00189

Actively Recruiting

31

Leiden Universitair Medisch Centrum (LUMC)

Leiden, Netherlands, 2333

Actively Recruiting

32

Neurologia Śląska Centrum Medyczne

Katowice, Poland

Actively Recruiting

33

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp.z o.o

Krakow, Poland

Actively Recruiting

34

Centrum Medyczne Hope Clinic

Lublin, Poland, 20701

Actively Recruiting

35

Galen Clinic

Lublin, Poland

Actively Recruiting

36

NeuroCor Banaszkiewicz, Tomaszewski Lekarze Spółka Partnerska

Myślenice, Poland

Actively Recruiting

37

Centrum Medyczne Neuro Protect

Warsaw, Poland

Actively Recruiting

38

University Clinical Center of Serbia, Neurology Clinic

Belgrade, Serbia

Actively Recruiting

39

University Clinical Center Nis, Neurology Clinic

Niš, Serbia

Actively Recruiting

40

Hospìtal Universitari Vall d'Hebrón

Barcelona, Spain

Actively Recruiting

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Research Team

N

NMD Pharma A/S

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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