Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis

Description

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.

Conditions

Myasthenia Gravis, Myasthenia Gravis, MuSK

Study Overview

Study Details

Study overview

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.

A Phase 2b, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 3 Dose Levels of NMD670 Over 21 Days in Adult Patients With AChR/MuSK-Ab+ Myasthenia Gravis

Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis

Condition
Myasthenia Gravis
Intervention / Treatment

-

Contacts and Locations

Carlsbad

Profound Research LLC, Carlsbad, California, United States, 92011

Boca Raton

SFM Clinical Research, LLC, Boca Raton, Florida, United States, 33487

Columbia

NextGen Precision Health, Columbia, Missouri, United States, 65212

Memphis

Semmes Murphey Clinic, Memphis, Tennessee, United States, 38120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participant must be a male or female being 18 to 75 years (both included), 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 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NMD Pharma A/S,

Study Record Dates

2025-11-01