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

NCT ID: NCT06414954

Last Updated: 2026-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-16

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myasthenia Gravis Myasthenia Gravis, MuSK

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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NMD670 high dose

Group Type EXPERIMENTAL

NMD670

Intervention Type DRUG

Tablets taken twice a day for 21 days

NMD670 mid dose

Group Type EXPERIMENTAL

NMD670

Intervention Type DRUG

Tablets taken twice a day for 21 days

NMD670 low dose

Group Type EXPERIMENTAL

NMD670

Intervention Type DRUG

Tablets taken twice a day for 21 days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablets taken twice a day for 21 days

Interventions

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NMD670

Tablets taken twice a day for 21 days

Intervention Type DRUG

Placebo

Tablets taken twice a day for 21 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NMD Pharma A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Profound Research LLC

Carlsbad, California, United States

Site Status ACTIVE_NOT_RECRUITING

University of California Irvine Medical Center

Irvine, California, United States

Site Status RECRUITING

University of Colorado Neuromuscular Division

Aurora, Colorado, United States

Site Status RECRUITING

SFM Clinical Research, LLC

Boca Raton, Florida, United States

Site Status RECRUITING

Neuromuscular Research Division | University of South Florida

Tampa, Florida, United States

Site Status RECRUITING

Augusta University, Neuroscience Center

Augusta, Georgia, United States

Site Status RECRUITING

NextGen Precision Health

Columbia, Missouri, United States

Site Status RECRUITING

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status RECRUITING

The Ohio State University

Columbus, Ohio, United States

Site Status RECRUITING

University of Oregon

Portland, Oregon, United States

Site Status RECRUITING

Semmes Murphey Clinic

Memphis, Tennessee, United States

Site Status RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

Aarhus University Hospital

Aarhus, , Denmark

Site Status RECRUITING

Rigshospitalet University of Copenhagen

Copenhagen, , Denmark

Site Status RECRUITING

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

Bordeaux, , France

Site Status RECRUITING

Centre de Référence des Maladies Neuromusculaires et de la SLA

Marseille, , France

Site Status RECRUITING

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

Nantes, , France

Site Status RECRUITING

CHU de Nice

Nice, , France

Site Status RECRUITING

Unité de Recherche Clinique NeuroSciences

Nice, , France

Site Status RECRUITING

JSC Curatio

Tbilisi, , Georgia

Site Status RECRUITING

LTD David Tatishvili Health Center

Tbilisi, , Georgia

Site Status RECRUITING

Ltd New Hospitals

Tbilisi, , Georgia

Site Status RECRUITING

ASST Papa Giovanni XXIII (Azienda Ospedaliera Papa Giovanni XXIII)

Bergamo, , Italy

Site Status RECRUITING

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

Bologna, , Italy

Site Status RECRUITING

IRCCS Ospedale Policlinico San Martino

Genova, , Italy

Site Status RECRUITING

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

Milan, , Italy

Site Status RECRUITING

DIMER, IRCCS, Ospedale San Raffaele

Milan, , Italy

Site Status RECRUITING

Centro Sclerosi Multipla Napoli - AOU Vanvitelli

Napoli, , Italy

Site Status RECRUITING

AOU Pisana

Pisa, , Italy

Site Status RECRUITING

Azienda Ospedaliera Sant'Andrea - Universita di Roma La Sapienza

Roma, , Italy

Site Status RECRUITING

Leiden Universitair Medisch Centrum (LUMC)

Leiden, , Netherlands

Site Status RECRUITING

Neurologia Śląska Centrum Medyczne

Katowice, , Poland

Site Status RECRUITING

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

Krakow, , Poland

Site Status RECRUITING

Centrum Medyczne Hope Clinic

Lublin, , Poland

Site Status RECRUITING

Galen Clinic

Lublin, , Poland

Site Status RECRUITING

Centrum Medyczne Neuro Protect

Warsaw, , Poland

Site Status RECRUITING

University Clinical Center of Serbia, Neurology Clinic

Belgrade, , Serbia

Site Status RECRUITING

University Clinical Center Nis, Neurology Clinic

Niš, , Serbia

Site Status RECRUITING

Hospìtal Universitari Vall d'Hebrón

Barcelona, , Spain

Site Status RECRUITING

Countries

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United States Belgium Denmark France Georgia Italy Netherlands Poland Serbia Spain

Central Contacts

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NMD Pharma A/S

Role: CONTACT

Facility Contacts

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Siddhant Partap

Role: primary

650-224-2637

Alexis Shepardson

Role: primary

303-724-4644

Gabrielle DeMaria

Role: primary

(561) 939-0333

Jessica Shaw

Role: primary

813-974-9413

Brandy Quarles

Role: primary

706-721-0390

Neetha Gali

Role: primary

(573) 882-3065

Manisha Chopra

Role: primary

1-919-843-7857

Lischele Watkins,, MACPR

Role: primary

614-293-1737

Katie Lewis

Role: primary

503-494-5236

Courtney Berryman

Role: primary

901-260-6111

Kristl Claeys

Role: primary

Josefine Nielsen

Role: primary

+45 23 88 25 83

Nicolai Preisler

Role: primary

+45 3545 9473

Zahra Hamzi

Role: primary

+33 7 67 02 63 35

Shahram Attarian

Role: primary

+33 0491386579

Yann Pereon

Role: primary

+33 2 40 08 37 04

Prof. Sabrina Sacconi

Role: primary

+33492037267

Saskia Bresch

Role: primary

+33 04 92 03 89 05

Anna Gauarashvili

Role: primary

995 593 35 54 04

George Chakhava

Role: primary

+995598359525

Margania Temur

Role: primary

+995 577 753 204

Manlio Sgarzi

Role: primary

+393356462101

Prof. Rocco Liguori

Role: primary

+390514966917

Dr. Marina Grandis

Role: primary

+390103537562

Carlo Antozzi

Role: primary

+ 39 3356157625

Dr.ssa Claudia Panciroli

Role: primary

Alvino Bisecco

Role: primary

+39 0815665252

Maestr Tassoni

Role: primary

+ 39050995519

Matteo Garibaldi

Role: primary

+390633775937

Jan Verschuuren

Role: primary

Marek Smilowski

Role: primary

+48500282494

Jan Kubicki

Role: primary

+48 12 6468 778

Dr. Sebastian Szklener

Role: primary

48 666165103

Urszula Chyrchel-Paszkiewicz

Role: primary

+ 48602102105

Grudniak Mariusz

Role: primary

+48 22 699 60 15

Stojan Peric

Role: primary

+381631094549

Gordana Djordjevic

Role: primary

+381631094549

Consuelo Garcia

Role: primary

+ 34667255502

Other Identifiers

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2023-507539-40

Identifier Type: OTHER

Identifier Source: secondary_id

NMD670-02-0002

Identifier Type: -

Identifier Source: org_study_id

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