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Tests treatment safety and results for Myasthenia Gravis
Official title Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis
ClinicalTrials.gov ID: NCT06414954
What this study is testing
What is NMD670?
NMD670 is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for myasthenia gravis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the patient's full...
- 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...
- 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
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Carlsbad, California, United States
- Irvine, California, United States
- Aurora, Colorado, United States
- Boca Raton, Florida, United States
- Tampa, Florida, United States
- Augusta, Georgia, United States
- Columbia, Missouri, United States
- Chapel Hill, North Carolina, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Memphis, Tennessee, United States
- Leuven, Belgium
- Aarhus, Denmark
- Copenhagen, Denmark
- Bordeaux, France
- Marseille, France
- Nantes, France
- Nice, France
- Tbilisi, Georgia
- Bergamo, Italy
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Carlsbad, California, United States; Irvine, California, United States; Aurora, Colorado, United States; Boca Raton, Florida, United States; Tampa, Florida, United States; Augusta, Georgia, United States and 29 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.