A Study of Nipocalimab in Children Aged 2 to less than 18 Years with Generalized Myasthenia Gravis

Last Updated   November 23, 2022 - 00:00

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OVERVIEW

  • Gender
    all
  • Age
    2 - 17 years
  • Phase
    phase 3
    The drug or treatment is given to large groups of people to confirm its effectiveness, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
  • Sites
    25 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, 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:

  • • 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

DETAILS

LOCATIONS

Locations in:
United States, Poland, Netherlands, Japan, Canada
Country (5) City or Province (25) Status
United States Ann Arbor, MI C.S. Mott Children’s Hospital
Recruiting
United States Aurora, CO Children’s Hospital Colorado
Not yet recruiting
United States Charleston, SC Medical University of South Carolina
Not yet recruiting
United States Dallas, TX Children's Health Specialty Center
Withdrawn
United States Hershey, PA Penn State Milton S. Hershey Medical Ctr.
Not yet recruiting
United States Lawrence, KS University of Kansas Medical Center
Recruiting
United States Los Angeles, CA Childrens Hospital Los Angeles
Not yet recruiting
United States Palo Alto, CA Lucile Packard Children's Hospital Stanford
Recruiting
United States Pasadena, CA Care Access Research
Withdrawn
United States Philadelphia, PA Childrens Hospital Of Philadelphia
Not yet recruiting
United States Phoenix, AZ Phoenix Children's Hospital
Recruiting
United States Pittsburgh, PA University of Pittsburgh Medical Center
Not yet recruiting
United States San Francisco, CA UCSF Benioff Children's Hospital
Not yet recruiting
United States Tampa, FL University of South Florida Morsani Center for Advanced Healthcare
Not yet recruiting
Poland Gdansk Uniwersyteckie Centrum Kliniczne
Not yet recruiting
Poland Katowice NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis'
Not yet recruiting
Netherlands Leiden Leiden University Medical Center
Recruiting
Japan Azumino-shi, Nagano, 20 Nagano Children's Hospital
Recruiting
Japan Chiba Chiba University Hospital
Recruiting
Japan Miyazaki, 45 University of Miyazaki Hospital
Recruiting
Japan Saitama-shi, 11 Saitama Prefecture Children's Medical Center
Recruiting
Japan Shinjuku-ku, 13 Tokyo Women's Medical University Hospital
Not yet recruiting
Canada London, ON Western University
Withdrawn
Canada Quebec, QC CHU de Québec Université Laval
Withdrawn
Canada Vancouver, BC British Columbia Children's Hospital
Withdrawn
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50

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10

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5

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

Corresponds to individual site.

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