Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNMD Pharma A/S
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- NMD670
- Placebo
Treatment groups
84 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov