A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis

Last Updated August 29, 2024

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CR109137

OVERVIEW

Sexes Eligible for Study
all
Age
2+ years
Phase
phase 2

2
Sites
18 Sites
Status

Recruiting

SUMMARY

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

Myasthenia Gravis

ELIGIBILITY

Inclusion Criteria:

* Age: For US sites only: 8 to <18 years
* Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized myasthenia gravis (gMG) as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class IIa/b, IIIa/b, or IVa/b at screening
* Has a positive serologic test for acetylcholine receptor (anti-AChR) antibodies or muscle-specific tyrosine kinase (anti-MuSK) antibodies at screening
* A participant using herbal, naturopathic, traditional Chinese remedies, ayurvedic or nutritional supplements, or medical marijuana (with a doctor's prescription) is eligible if the use of these medications is acceptable to the Investigator. These remedies must remain at a stable dose and regimen throughout the study
* Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol
* Participants should have a body weight and body mass index between 5th and 95th percentile for age and sex. Obese participants greater than 95th percentile and underweight participants below 5th percentile may participate following medical clearance
* A female of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at Screening and a negative urine pregnancy test at Day 1 prior to administration of study intervention

Exclusion Criteria:

* Has a history of severe and/or uncontrolled hepatic (example, viral/alcoholic/ autoimmune hepatitis/ cirrhosis/ and/or metabolic liver disease), gastrointestinal, renal, pulmonary, cardiovascular (including congenital heart diseases), psychiatric, neurological musculoskeletal disorder, any other medical disorder(s) (example, diabetes mellitus), or clinically significant abnormalities in screening laboratory, that might interfere with participant's full participation in the study, and/ or might jeopardize the safety of the participant or the validity of the study results
* Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her generalized myasthenia gravis (gMG), or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
* Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the Active treatment Phase of the study
* Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis to therapeutic proteins (example, monoclonal antibodies)
* Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening

Inclusion Criteria:

More...

DETAILS

LOCATIONS

Locations in:

United States, Japan, Netherlands, Poland

Country (4)	City or Province (18)	Status
United States	Phoenix Phoenix Children's Hospital	RECRUITING
United States	Los Angeles Childrens Hospital Los Angeles	RECRUITING
United States	Palo Alto Lucile Packard Children's Hospital Stanford	RECRUITING
United States	San Francisco UCSF Benioff Children's Hospital	RECRUITING
United States	Aurora Children's Hospital Colorado	RECRUITING
United States	Tampa University of South Florida Morsani Center for Advanced Healthcare	RECRUITING
United States	Lawrence University of Kansas Medical Center	RECRUITING
United States	Ann Arbor C.S. Mott Children's Hospital	RECRUITING
United States	Philadelphia Childrens Hospital Of Philadelphia	RECRUITING
United States	Pittsburgh University of Pittsburgh Medical Center	TERMINATED
Japan	Azumino-shi, Nagano Nagano Children's Hospital	RECRUITING
Japan	Chiba Chiba University Hospital	RECRUITING
Japan	Miyazaki University of Miyazaki Hospital	RECRUITING
Japan	Nishinomiya-Shi Hyogo College of Medicine Hospital	RECRUITING
Japan	Saitama shi Saitama Prefecture Children's Medical Center	RECRUITING
Japan	Shinjuku-ku Tokyo Women's Medical University Hospital	RECRUITING
Netherlands	Leiden Leiden University Medical Center	RECRUITING
Poland	Gdansk Uniwersyteckie Centrum Kliniczne	RECRUITING

Geo Locations

33.44838, -112.07404

34.05223, -118.24368

37.44188, -122.14302

37.77493, -122.41942

39.72943, -104.83192

27.94752, -82.45843

38.97167, -95.23525

42.27756, -83.74088

39.95233, -75.16379

40.44062, -79.99589

36.2849551, 137.9206362

35.6, 140.11667

31.91667, 131.41667

34.71562, 135.33199

35.90807, 139.65657

35.2946, 139.57059

52.15833, 4.49306

54.35205, 18.64637

Indicates 50+ sites in this region: click to zoom in.

Indicates 10+ sites in this region: click to zoom in.

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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