NCT06414954 Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis
| NCT ID | NCT06414954 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | NMD Pharma A/S |
| Condition | Myasthenia Gravis |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2024-05-16 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 84 participants in total. It began in 2024-05-16 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06414954 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myasthenia Gravis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06414954 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06414954 currently recruiting?
Yes, NCT06414954 is actively recruiting participants. Contact the research team at contact@nmdpharma.com for enrollment information.
Where is the NCT06414954 trial being conducted?
This trial is being conducted at Carlsbad, United States, Irvine, United States, Aurora, United States, Boca Raton, United States and 11 additional locations.
Who is sponsoring the NCT06414954 clinical trial?
NCT06414954 is sponsored by NMD Pharma A/S. The trial plans to enroll 84 participants.