Claseprubart: Day 1: IV loading dose Week 1 to Week 11: Claseprubart administered SC every 2 weeks
Placebo: Day 1: IV infusion of placebo Week 1 to Week 11: placebo administered SC every 2 weeks
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 non-childbearing 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.
Primary outcome measure(s)
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs) — Baseline (Day 1) to Week 13 Number of participants with TEAEs and treatment-emergent SAEs will be reported.
Trial sites (56)
Facility
City
Region
Status
Clinical Study Site
Phoenix
Arizona
Clinical Study Site
Irvine
California
Clinical Study Site
Stamford
Connecticut
Clinical Study Site
Boca Raton
Florida
Clinical Study Site
Bradenton
Florida
Clinical Study Site
Maitland
Florida
Clincal Study Site
Tampa
Florida
Clinical Study Site
O'Fallon
Illinois
Clinical Study Site
Kansas City
Kansas
Clinical Study Site
Lexington
Kentucky
Clinical Study Site
Boston
Massachusetts
Clinical Study Site
East Lansing
Michigan
Clinical Study Site
Columbia
Missouri
Clinical Study Site
Cincinnati
Ohio
Clinical Study Site
Columbus
Ohio
Clinical Study Site
Dallas
Texas
Clinical Study Site
Dallas
Texas
Clinical Study Site #2
Houston
Texas
Clinical Study Site
Houston
Texas
Clinical Study Site
Lubbock
Texas
Clinical Study Site
Richmond
Virginia
Clinical Study Site
San Miguel de Tucumán
Tucumán Province
Clinical Study Site
Buenos Aires
Argentina
Clinical Study Site
Buenos Aires
Argentina
Clinical Study Site
Buenos Aires
Argentina
Clinical Study Site
Córdoba
Argentina
Clinical Study Site
Rosario
Argentina
Clinical Study Site
London
Ontario
Clinical Study Site
Ostrava
Czechia
Clinical Study Site
Copenhagen
Denmark
Clinical Study Site
Bordeaux
France
Clinical Study Site
Nice
France
Clinical Study Site
Strasbourg
France
Clinical Study Site
Haifa
Israel
Clinical Study Site
Ramat Gan
Israel
Clinical Study Site
Safed
Israel
Clinical Study Site
Milan
Italy
Clinical Study Site
Naples
Italy
Clinical Study Site
Pisa
Italy
Clinical Study Site
Rome
Italy
+ 16 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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