Trial Title:
Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis
NCT ID:
NCT06414954
Condition:
Myasthenia Gravis
Myasthenia Gravis, MuSK
Conditions: Official terms:
Myasthenia Gravis
Muscle Weakness
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
NMD670
Description:
Tablets taken twice a day for 21 days
Arm group label:
NMD670 high dose
Arm group label:
NMD670 low dose
Arm group label:
NMD670 mid dose
Intervention type:
Drug
Intervention name:
Placebo
Description:
Tablets taken twice a day for 21 days
Arm group label:
Placebo
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.
Criteria for eligibility:
Criteria:
Inclusion 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
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Profound Research LLC
Address:
City:
Carlsbad
Zip:
92011
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lupe Sanchez
Phone:
619-432-0954
Email:
Lupe@profoundresearch.io
Facility:
Name:
SFM Clinical Research, LLC
Address:
City:
Boca Raton
Zip:
33487
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gabrielle DeMaria
Phone:
561-939-0333
Facility:
Name:
NextGen Precision Health
Address:
City:
Columbia
Zip:
65212
Country:
United States
Status:
Recruiting
Contact:
Last name:
Neetha Gali
Phone:
573-882-3065
Email:
ngdcd@health.missouri.edu
Facility:
Name:
Semmes Murphey Clinic
Address:
City:
Memphis
Zip:
38120
Country:
United States
Status:
Recruiting
Contact:
Last name:
Courtney Berryman
Phone:
901-260-6111
Email:
cberryman@semmes-murphey.com
Facility:
Name:
Aarhus University Hospital
Address:
City:
Aarhus
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Josefine Nielsen
Phone:
+45 23 88 25 83
Email:
josenl@rm.dk
Facility:
Name:
Centre de référence des maladies neuromusculaires AOC-CHU de Bordeaux - Hôpital Pellegrin
Address:
City:
Bordeaux
Country:
France
Status:
Recruiting
Contact:
Last name:
Zahra Hamzi
Phone:
+33 7 67 02 63 35
Email:
zahra.hamzi@chu-bordeaux.fr
Facility:
Name:
Centre Hospitalier Universitaire de Nantes - Hôtel Dieu Centre de Référence des Maladies Neuromusculaires Rares -
Address:
City:
Nantes
Country:
France
Status:
Recruiting
Contact:
Last name:
Yann Pereon
Phone:
+33 2 40 08 37 04
Email:
Yann.Pereon@univ-nantes.fr
Facility:
Name:
IRCCS Istituo delle Scienze neurologiche di Bologna
Address:
City:
Bologna
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Rocco Liguori
Phone:
+390514966917
Email:
Rocco.liguori@unibo.it
Facility:
Name:
IRCCS Ospedale Policlinico San Martino
Address:
City:
Genova
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Grandis Marina
Phone:
+390103537562
Email:
mgrandis@neurologia.unige.it
Facility:
Name:
Neurologia Śląska Centrum Medyczne
Address:
City:
Katowice
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Marek Smilowski
Phone:
+48500282494
Email:
Marek.smilowski2@gmail.com
Facility:
Name:
Hospìtal Universitari Vall d'Hebrón
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Consuelo Garcia
Phone:
+ 34667255502
Email:
consuelo.garcia@vhir.org
Start date:
May 16, 2024
Completion date:
November 1, 2025
Lead sponsor:
Agency:
NMD Pharma A/S
Agency class:
Industry
Source:
NMD Pharma A/S
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06414954
