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Monoclonal Antibodies

NMD670 for Myasthenia Gravis (SYNAPSE-MG Trial)

Phase 2
Recruiting
Research Sponsored by NMD Pharma A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of MG, MGFA class II, III or IV
Documented positive AChR or MuSK antibody test
Must not have
Female patients who plan to become pregnant during the study or are currently pregnant or breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening (day -28 to day -1) until follow up (day 28)

Summary

This trial will test different doses of a drug called NMD670 compared to a placebo in adults with a certain kind of muscle disease. The drug will be given twice a day for 21 days to

Who is the study for?
Adults aged 18-75 with Myasthenia Gravis (MG), specifically those who have muscle weakness and positive AChR or MuSK antibody tests. Participants must be able to swallow tablets, have a BMI of 18-35 kg/m2, weigh at least 40 kg, and use contraception in line with local guidelines.
What is being tested?
The trial is testing the safety and effectiveness of three different doses of NMD670 compared to a placebo in treating MG. The medication or placebo is taken twice daily for three weeks by patients with antibodies against AChR or MuSK.
What are the potential side effects?
Potential side effects are not specified here but generally could include reactions related to the immune system, digestive issues due to oral intake, fatigue from treatment regimen, and any other unexpected responses to the new drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition is moderate to severe myasthenia gravis.
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I tested positive for AChR or MuSK antibodies.
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I can swallow pills.
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I am between 18 and 75 years old.
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My BMI is between 18 and 35, and I weigh at least 40 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening (day -28 to day -1) until follow up (day 28)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening (day -28 to day -1) until follow up (day 28) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline to day 21 in QMG total score for NMD670 vs placebo
Secondary study objectives
Change from baseline to day 21 in MG-ADL total score for NMD670 vs placebo
Change from baseline to day 21 in MG-QOL15r for NMD670 vs placebo
Change from baseline to day 21 in MGC total score for NMD670 vs placebo
+9 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: NMD670 mid doseExperimental Treatment1 Intervention
Group II: NMD670 low doseExperimental Treatment1 Intervention
Group III: NMD670 high doseExperimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

NMD Pharma A/SLead Sponsor
5 Previous Clinical Trials
207 Total Patients Enrolled
1 Trials studying Myasthenia Gravis
24 Patients Enrolled for Myasthenia Gravis
~49 spots leftby Nov 2025
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