RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis

Quick Facts

Study Start:2022-07-20
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05265273

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Age: For US sites only: 8 to \<18 years
  2. * 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
  3. * Has a positive serologic test for acetylcholine receptor (anti-AChR) antibodies or muscle-specific tyrosine kinase (anti-MuSK) antibodies at screening
  4. * 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
  5. * Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol
  6. * 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
  7. * 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
  1. * 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
  2. * 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
  3. * Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the Active treatment Phase of the study
  4. * Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis to therapeutic proteins (example, monoclonal antibodies)
  5. * Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening

Contacts and Locations

Study Contact

Study Contact
CONTACT
844-434-4210
Participate-In-This-Study@its.jnj.com

Principal Investigator

Janssen Research & Development, LLC Clinical Trial
STUDY_DIRECTOR
Janssen Research & Development, LLC

Study Locations (Sites)

Phoenix Children's Hospital
Phoenix, Arizona, 85016
United States
Childrens Hospital Los Angeles
Los Angeles, California, 90027
United States
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
United States
UCSF Benioff Children's Hospital
San Francisco, California, 94158
United States
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
University of South Florida Morsani Center for Advanced Healthcare
Tampa, Florida, 33613
United States
University of Kansas Medical Center
Lawrence, Kansas, 66045
United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109
United States
Childrens Hospital Of Philadelphia
Philadelphia, Pennsylvania, 19106
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15224
United States

Collaborators and Investigators

Sponsor: Janssen Research & Development, LLC

  • Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-20
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2022-07-20
Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

  • Pediatric

Additional Relevant MeSH Terms

  • Myasthenia Gravis