Evaluating NMD670 for treating Myasthenia Gravis in adults
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
This study is testing if a new medication called NMD670 can help adults with Myasthenia Gravis feel better by comparing different doses to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NMD Pharma A/S Industry-sponsored |
| Locations | 40 sites (Carlsbad, California and 39 other locations) |
| Trial ID | NCT06414954 on ClinicalTrials.gov |
What this trial studies
This Phase 2 proof-of-concept study investigates the safety and efficacy of three different dose levels of NMD670 compared to a placebo in adult patients diagnosed with Myasthenia Gravis who have antibodies against AChR or MuSK. Participants will receive the treatment twice daily for a duration of 21 days. The study aims to determine the optimal dose that balances safety and effectiveness in managing symptoms of this condition.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of Myasthenia Gravis and positive AChR or MuSK antibody tests.
Not a fit: Patients with other significant medical or psychological conditions that may interfere with study participation or outcomes may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of Myasthenia Gravis symptoms in affected patients.
How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in evaluating new treatments for Myasthenia Gravis.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Carlsbad, California and 39 other locations
- Profound Research LLC — Carlsbad, California, United States (Withdrawn)
- University of California Irvine Medical Center — Irvine, California, United States (Recruiting)
- University of Colorado Neuromuscular Division — Aurora, Colorado, United States (Recruiting)
- SFM Clinical Research, LLC — Boca Raton, Florida, United States (Recruiting)
- Neuromuscular Research Division | University of South Florida — Tampa, Florida, United States (Recruiting)
- Augusta University, Neuroscience Center — Augusta, Georgia, United States (Recruiting)
- NextGen Precision Health — Columbia, Missouri, United States (Recruiting)
- The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- The Ohio State University — Columbus, Ohio, United States (Recruiting)
- University of Oregon — Portland, Oregon, United States (Recruiting)
- Semmes Murphey Clinic — Memphis, Tennessee, United States (Recruiting)
- UZ Leuven — Leuven, Belgium (Withdrawn)
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Rigshospitalet University of Copenhagen — Copenhagen, Denmark (Recruiting)
- Centre de référence des maladies neuromusculaires AOC-CHU de Bordeaux - Hôpital Pellegrin — Bordeaux, France (Recruiting)
- Centre de Référence des Maladies Neuromusculaires et de la SLA — Marseille, France (Recruiting)
- Centre Hospitalier Universitaire de Nantes - Hôtel Dieu Centre de Référence des Maladies Neuromusculaires Rares - — Nantes, France (Recruiting)
- CHU de Nice — Nice, France (Recruiting)
- Unité de Recherche Clinique NeuroSciences — Nice, France (Recruiting)
- JSC Curatio — Tbilisi, Georgia (Recruiting)
- LTD David Tatishvili Health Center — Tbilisi, Georgia (Recruiting)
- Ltd New Hospitals — Tbilisi, Georgia (Recruiting)
- ASST Papa Giovanni XXIII (Azienda Ospedaliera Papa Giovanni XXIII) — Bergamo, Italy (Recruiting)
- IRCCS Istituo delle Scienze neurologiche di Bologna, UOC Clinica neurologica Ospedale — Bologna, Italy (Recruiting)
- IRCCS Ospedale Policlinico San Martino — Genova, Italy (Recruiting)
- IRCCS Fondazione Istituto Neurologico Carlo Besta, Dipartimento di Ricerca e Sviluppo clinico — Milan, Italy (Recruiting)
- DIMER, IRCCS, Ospedale San Raffaele — Milan, Italy (Recruiting)
- Centro Sclerosi Multipla Napoli - AOU Vanvitelli — Naples, Italy (Recruiting)
- AOU Pisana — Pisa, Italy (Recruiting)
- Azienda Ospedaliera Sant'Andrea - Universita di Roma La Sapienza — Roma, Italy (Recruiting)
- Leiden Universitair Medisch Centrum (LUMC) — Leiden, Netherlands (Recruiting)
- Neurologia Śląska Centrum Medyczne — Katowice, Poland (Recruiting)
- Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp.z o.o — Krakow, Poland (Recruiting)
- Centrum Medyczne Hope Clinic — Lublin, Poland (Recruiting)
- Galen Clinic — Lublin, Poland (Recruiting)
- NeuroCor Banaszkiewicz, Tomaszewski Lekarze Spółka Partnerska — Myślenice, Poland (Recruiting)
- Centrum Medyczne Neuro Protect — Warsaw, Poland (Recruiting)
- University Clinical Center of Serbia, Neurology Clinic — Belgrade, Serbia (Recruiting)
- University Clinical Center Nis, Neurology Clinic — Niš, Serbia (Recruiting)
- Hospìtal Universitari Vall d'Hebrón — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: NMD Pharma A/S
- Email: contact@nmdpharma.com
- Phone: contact@nmdpharma.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.