Trial Title:
A Phase 2 Study to Evaluate DNTH103 in Adults with Generalized Myasthenia Gravis (MAGIC)
NCT ID:
NCT06282159
Condition:
Myasthenia Gravis, Generalized
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:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
DNTH103
Description:
Day 1: IV loading dose Week 1 to Week 11: DNTH103 administered SC every 2 weeks
Arm group label:
DNTH103 high dose Q2W
Arm group label:
DNTH103 low dose Q2W
Intervention type:
Drug
Intervention name:
Placebo
Description:
Day 1: IV infusion of placebo Week 1 to Week 11: placebo administered SC every 2 weeks
Arm group label:
Placebo
Summary:
The purpose of this Phase 2 study is to evaluate the safety, tolerability,
pharmacometrics, and efficacy of DNTH103 in participants with generalized myasthenia
gravis (gMG).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Must have given written informed consent before any study-related activities are
carried out.
2. Adult males and females, 18 to 75 years of age (inclusive) at Screening.
3. Weight range between 40-120 kg at Screening.
4. Diagnosis of gMG by the following tests:
Acetylcholine receptor antibody (AChR Ab) positive, and
One of the following:
i. History of abnormal neuromuscular transmission test; ii. History of positive
anticholinesterase test; iii. Clinical response to acetylcholinesterase inhibitors.
5. Myasthenia Gravis Foundation of America (MGFA) Class II-Iva
6. Myasthenia Gravis Activities of Daily Living (MG-ADL) score of 6 or more
7. Vaccination against N. meningitidis with the quadrivalent meningococcal vaccine, and
where available, meningococcal serotype B vaccine within 3 years prior to, or at the
time of, initiating study drug.
8. Female participants must:
Be of nonchildbearing potential, or if of childbearing potential, must agree not to
donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse
with a male partner, must agree to use a highly effective method of contraception.
9. Male participants must be surgically sterile for at least 90 days prior to screening
or agree not to donate sperm
Exclusion Criteria:
1. History or presence of significant medical/surgical condition including any acute
illness or major surgery considered to be clinically significant
2. Prior history (at any time) of N. meningitidis infection.
3. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2),
hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies during
Screening.
4. Any thymic surgery/biopsy within 1 year of Screening.
5. Any known or untreated thymoma.
6. Any history of thymic carcinoma or thymic malignancy.
7. Concurrent or previous use of the following medication within the time periods
specified below.
1. Rituximab within 6 months (180 days) prior to randomization (Day 1);
2. Intravenous immunoglobulin (IVIg) and plasma exchange (PLEX) within 4 weeks (28
days) prior to randomization (Day 1).
8. Participation in another clinical study of an investigational drug within 90 days or
5 half-lives of the investigational agent.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinical Study Site
Address:
City:
Irvine
Zip:
92868
Country:
United States
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Stamford
Zip:
06905
Country:
United States
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Boca Raton
Zip:
33487
Country:
United States
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Bradenton
Zip:
34205
Country:
United States
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Maitland
Zip:
32751
Country:
United States
Status:
Recruiting
Facility:
Name:
Clincal Study Site
Address:
City:
Tampa
Zip:
33620
Country:
United States
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
O'Fallon
Zip:
62269
Country:
United States
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Kansas City
Zip:
66103
Country:
United States
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Lexington
Zip:
40503
Country:
United States
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
East Lansing
Zip:
48824
Country:
United States
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Columbia
Zip:
65212
Country:
United States
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Cincinnati
Zip:
45219
Country:
United States
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Dallas
Zip:
75206
Country:
United States
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Dallas
Zip:
75243
Country:
United States
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Lubbock
Zip:
79414
Country:
United States
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Richmond
Zip:
23219
Country:
United States
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
London
Zip:
N6A 5W9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Ostrava
Zip:
70852
Country:
Czech Republic
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Milano
Zip:
20133
Country:
Italy
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Bergen
Zip:
5021
Country:
Norway
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Bydgoszcz
Zip:
85-065
Country:
Poland
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Katowice
Zip:
40123
Country:
Poland
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Lublin
Zip:
20-093
Country:
Poland
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Warsaw
Zip:
01-684
Country:
Poland
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Warsaw
Zip:
02-657
Country:
Poland
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Belgrade
Zip:
11000
Country:
Serbia
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Kragujevac
Zip:
34000
Country:
Serbia
Status:
Recruiting
Facility:
Name:
Clinical Study Site
Address:
City:
Novi Sad
Zip:
21000
Country:
Serbia
Status:
Recruiting
Start date:
February 23, 2024
Completion date:
December 2027
Lead sponsor:
Agency:
Dianthus Therapeutics
Agency class:
Industry
Source:
Dianthus Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06282159
