Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UC Irvine
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

Myasthenia Gravis, Myasthenia Gravis, MuSK, Muscle Weakness, NMD670

Eligibility

You can join if…

Open to people ages 18-75

  • 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

You 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 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

Locations

  • University of California Irvine Medical Center accepting new patients
    Irvine California 92868 United States
  • Profound Research LLC accepting new patients
    Carlsbad California 92011 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NMD Pharma A/S
ID
NCT06414954
Phase
Phase 2 Myasthenia Gravis Research Study
Study Type
Interventional
Participants
Expecting 84 study participants
Last Updated