Evaluating NMD670 for treating Myasthenia Gravis in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: NMD Pharma A/S
• Email: contact@nmdpharma.com
• Phone: contact@nmdpharma.com

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• MG patient registry to track long-term experiences and treatment patterns

  This registry collects information from adults with myasthenia gravis to see how symptoms and quality of life change over time and how treatments relate to those changes.

  Recruiting Autoimmune Neurology Alliance · Framingham, Massachusetts · NCT07761026

• Registry for people living with Myasthenia Gravis

  This study is collecting information from people with Myasthenia Gravis to understand their experiences, symptoms, and treatments over time.

  Recruiting Myasthenia Gravis Foundation of America · Westborough, Massachusetts · NCT06617741

• Ublituximab maintenance after efgartigimod response in myasthenia gravis

  This study tests whether giving ublituximab as maintenance after a positive response to efgartigimod helps adults with myasthenia gravis.

  Recruiting at 7 sites Phase 2 TG Therapeutics, Inc. · Colorado Springs, Colorado and 6 other locations · NCT07673744

• Pregnant Women with Neuroimmune Diseases: A long-term follow-up study

  This study follows women with neuroimmune diseases and healthy controls through pregnancy and up to ten years to see how pregnancy affects disease activity and outcomes for both mother and baby.

  Recruiting Third Affiliated Hospital, Sun Yat-Sen University · Guangzhou, Guangdong · NCT07653984

• Early ravulizumab for adults with myasthenic crisis in the ICU

  This project will test whether giving ravulizumab early to adults with AChR-positive generalized myasthenia gravis who are in the ICU for a myasthenic crisis helps speed recovery.

  Recruiting at 5 sites Centre Hospitalier Universitaire de Nice · Nice, Alpes-maritimes and 7 other locations · NCT07411963

• KITE-363 treatment for relapsed or refractory autoimmune neurologic diseases

  This study will test whether KITE-363 is safe and can help people with relapsed or treatment-resistant autoimmune neurologic diseases such as MS, CIDP, and myasthenia gravis.

  Recruiting at 10 sites Phase 1 Gilead Sciences · Newport Beach, California and 9 other locations · NCT07304154

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.