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Study on the Safety and Effectiveness of NMD670 for Adults with Myasthenia Gravis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment called NMD670 for patients with Myasthenia Gravis. Myasthenia Gravis is a condition that causes weakness in the muscles that control movements, often affecting the eyes, face, and swallowing. The study will test three different dose levels of NMD670, which is taken as a tablet, to see how well it works and how safe it is for patients.

The purpose of the study is to evaluate the effectiveness and safety of NMD670 over a period of 21 days. Participants will be randomly assigned to receive either NMD670 or a placebo, which looks like the real medication but does not contain the active substance. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo during the trial.

Throughout the study, participants will take the medication orally and will be monitored by healthcare professionals to assess any changes in their condition. The main goal is to observe any improvements in muscle strength and overall symptoms of Myasthenia Gravis. The study aims to provide valuable information on the potential benefits of NMD670 for managing this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant must meet specific criteria, including being between 18 and 75 years old, having a diagnosis of myasthenia gravis, and being able to swallow tablets.

    Participants must agree to use effective contraception if applicable and provide informed consent.

  2. Step 2

    Randomization and treatment allocation

    Participants are randomly assigned to receive either the medication NMD670 or a placebo. The study is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

  3. Step 3

    Medication administration

    Participants take the assigned treatment orally in the form of a tablet. The study evaluates three different dose levels of NMD670 over a period of 21 days.

  4. Step 4

    Monitoring and assessment

    Throughout the 21-day period, participants are monitored for changes in their condition. The primary measure is the change in the quantitative myasthenia gravis (QMG) total score from the start of the study to day 21.

  5. Step 5

    Completion of the study

    At the end of the 21-day treatment period, participants complete the study. The data collected is used to assess the efficacy, safety, and tolerability of NMD670 compared to the placebo.

Who can join the trial?

7 criteria

  • Participant must be a male or female aged between 18 and 75 years old, including both ages, at the time of signing the informed consent.
  • Must have a diagnosis of Myasthenia Gravis (MG), specifically classified as MGFA class II, III, or IV. MGFA stands for Myasthenia Gravis Foundation of America, which classifies the severity of the condition.
  • Must have a documented positive test for AChR or MuSK antibodies. These are specific proteins in the body that can be tested to help diagnose Myasthenia Gravis.
  • Participant must be able to swallow tablets.
  • Must have a body mass index (BMI) between 18 and 35 kg/m2, inclusive, at screening, and weigh at least 40 kg. BMI is a measure that uses height and weight to estimate body fat.
  • Female participants who are WOCBP (Women of Childbearing Potential) and male participants with partners who are WOCBP must agree to use a highly effective contraception method during the study. This means using reliable birth control to prevent pregnancy.
  • Participant must be capable of and have given signed informed consent, meaning they understand the study and agree to participate.

Who cannot join the trial?

4 criteria

  • Patients who are not diagnosed with Myasthenia Gravis, a condition that causes muscle weakness.
  • Patients who are outside the age range specified for the study.
  • Patients who are not part of the clinical trial groups specified for the study.
  • Patients who are part of a vulnerable population that the study is not designed to include.
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Investigated drugs

NMD670 is an investigational medication being studied for its potential to help patients with a condition called Myasthenia Gravis, which affects the muscles and causes weakness. This medication is being tested to see how effective it is at different dose levels over a period of 21 days. The goal is to determine if it can improve muscle strength and overall symptoms in patients with this condition.

What is already known about the treatment

NMD670 – NMD670 is administered orally and is currently being studied in clinical trials for its potential use in treating Myasthenia Gravis, a condition that causes muscle weakness. The medication is in the experimental phase, with ongoing research to evaluate its effectiveness and safety. It works by targeting specific receptors in the body to improve muscle function. NMD670 is classified as a neuromuscular agent, focusing on enhancing communication between nerves and muscles.

Investigated diseases

Myasthenia Gravis – Myasthenia Gravis is a chronic autoimmune disorder that affects the communication between nerves and muscles, leading to muscle weakness. It occurs when the immune system mistakenly attacks the connections between nerves and muscles, disrupting the transmission of nerve signals. This results in varying degrees of muscle weakness, which can fluctuate throughout the day and often worsens with activity. Commonly affected muscles include those controlling the eyes, face, and swallowing, but it can also impact limb and respiratory muscles. The severity of symptoms can vary widely among individuals, and they may improve with rest. The progression of the disease can be unpredictable, with periods of improvement and worsening.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507539-40-00Protocol codeNMD670-02-0002Estimated enrolment101 patientsSponsorNMD Pharma A/S

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