Actively Recruiting
A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
Led by Janssen Research & Development, LLC · Updated on 2026-03-13
12
Participants Needed
19
Research Sites
362 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine the effect of nipocalimab on total serum immunoglobulin G (IgG) in pediatric participants 2 to less than (\<) 18 years of age (globally) and 8 to \<18 years of age (for Unites Stated (US) sites only), the safety and tolerability of treatment with nipocalimab in children and adolescents and to evaluate the pharmacokinetics (PK) of nipocalimab in children and adolescents with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing, stable standard-of-care therapy.
CONDITIONS
Official Title
A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For US sites only: Age 8 to less than 18 years
- Diagnosis of myasthenia gravis with generalized muscle weakness meeting MGFA Clinical Classification Class IIa/b, IIIa/b, or IVa/b at screening
- Positive serologic test for acetylcholine receptor (anti-AChR) antibodies or muscle-specific tyrosine kinase (anti-MuSK) antibodies at screening
- Use of herbal, naturopathic, traditional Chinese remedies, ayurvedic or nutritional supplements, or medical marijuana is allowed if stable and acceptable to the Investigator
- Sufficient venous access for drug infusion and blood sampling
- Body weight and body mass index between 5th and 95th percentile for age and sex; obese or underweight participants may participate with medical clearance
- Female participants of childbearing potential must have negative pregnancy tests at screening and Day 1
You will not qualify if you...
- History of severe or uncontrolled liver, gastrointestinal, kidney, lung, heart, psychiatric, neurological, musculoskeletal, or other medical disorders that may affect safety or study validity
- Confirmed or suspected immunodeficiency syndrome not related to gMG treatment, or family history of hereditary immunodeficiency unless excluded in participant
- Thymectomy within 12 months prior to screening or planned during active treatment phase
- Previous severe allergic reaction such as anaphylaxis to therapeutic proteins including monoclonal antibodies
- Myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
3
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States, 94304
Actively Recruiting
4
UCSF Benioff Children's Hospital
San Francisco, California, United States, 94158
Actively Recruiting
5
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
6
University of South Florida Morsani Center for Advanced Healthcare
Tampa, Florida, United States, 33613
Actively Recruiting
7
University of Kansas Medical Center
Lawrence, Kansas, United States, 66045
Completed
8
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
9
Penn State Milton S Hershey Medical Ctr
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
10
Childrens Hospital Of Philadelphia
Philadelphia, Pennsylvania, United States, 19106
Actively Recruiting
11
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15224
Terminated
12
Nagano Children's Hospital
Azumino-shi, Japan, 399-8288
Actively Recruiting
13
Chiba University Hospital
Chiba, Japan, 260 8677
Completed
14
University of Miyazaki Hospital
Miyazaki, Japan, 889-1692
Actively Recruiting
15
Hyogo College of Medicine Hospital
Nishinomiya-Shi, Japan, 663-8501
Actively Recruiting
16
Saitama Prefecture Children's Medical Center
Saitama Shi, Japan, 330-8777
Actively Recruiting
17
Tokyo Women's Medical University Hospital
Shinjuku-ku, Japan, 162-8666
Actively Recruiting
18
Leiden University Medical Center
Leiden, Netherlands, 2333 ZA
Actively Recruiting
19
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80 211
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here