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

Launched by NMD PHARMA A/S · May 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called NMD670 to see how safe it is and how well it works for adults with Myasthenia Gravis (MG), a condition that affects muscle strength. The trial will test three different doses of NMD670, given twice a day for 21 days, and compare the results to a placebo (a pill that has no active medication). This study is specifically looking for adults aged 18 to 75 who have been diagnosed with MG and have certain antibodies in their blood.

To be eligible for this trial, participants must be able to swallow tablets, have a body mass index within a specific range, and provide informed consent to join. It’s important to note that there are some criteria that would exclude a person from participating, such as having certain medical conditions or being pregnant. Those who join can expect regular check-ins and monitoring to ensure their safety throughout the study. This trial is currently recruiting participants, and it represents a step towards finding new treatment options for individuals living with Myasthenia Gravis.

Gender

ALL

Eligibility 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