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NCT05265273 | RECRUITING | Myasthenia Gravis

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

Janssen Research & Development, LLC

Brief 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.

Condition or disease

Myasthenia Gravis

Intervention/treatment

Nipocalimab

Phase

PHASE2

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 12 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2022-07-20
Estimated Primary Completion Date : 2026-06-30
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 2 Years to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key 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
  • Key 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), risk factors for thrombosis events (example, a history of venous thromboembolism \[VTE\] or antiphospholipid syndrome, or a personal or family history of heritable coagulation disorder such as factor V leiden, protein S or protein C deficiency, atrial fibrillation/flutter, major orthopedic surgery or significant trauma that may increase the risk of VTE, is expected to be immobilized for prolonged periods of time), or has 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
A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis

Location Details

NCT05265273

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Phoenix Children's Hospital

Phoenix, Arizona, United States, 85016

RECRUITING

United States, California

Childrens Hospital Los Angeles

Los Angeles, California, United States, 90027

RECRUITING

United States, California

Lucile Packard Children's Hospital Stanford

Palo Alto, California, United States, 94304

RECRUITING

United States, California

UCSF Benioff Children's Hospital

San Francisco, California, United States, 94158

RECRUITING

United States, Colorado

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

RECRUITING

United States, Florida

University of South Florida Morsani Center for Advanced Healthcare

Tampa, Florida, United States, 33613

RECRUITING

United States, Kansas

University of Kansas Medical Center

Lawrence, Kansas, United States, 66045

RECRUITING

United States, Road cancer

C.S. Mott Children's Hospital

Ann Arbor, Road cancer, United States, 48109

RECRUITING

United States, Pennsylvania

Penn State Milton S Hershey Medical Ctr

Hershey, Pennsylvania, United States, 17033

RECRUITING

United States, Pennsylvania

Childrens Hospital Of Philadelphia

Philadelphia, Pennsylvania, United States, 19106

TERMINATED

United States, Pennsylvania

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15224

RECRUITING

Japan,

Nagano Children's Hospital

Azumino-it, Japan, 399-8288

RECRUITING

Japan,

Chiba University Hospital

Chiba, Japan, 260 8677

RECRUITING

Japan,

University of Miyazaki Hospital

Miyazaki, Japan, 889-1692

RECRUITING

Japan,

Hyogo College of Medicine Hospital

Mr. Nishinomiya, Japan, 663-8501

RECRUITING

Japan,

Saitama Prefecture Children's Medical Center

Saitama, Japan, 330-8777

RECRUITING

Japan,

Tokyo Women's Medical University Hospital

Shinjuku Ward, Japan, 162-8666

RECRUITING

Netherlands,

Leiden University Medical Center

Leiden, Netherlands, 2333 for

RECRUITING

Poland,

University Clinical Center

Gdansk, Poland, 80 211