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New hope for kids with rare Muscle-Weakening disease?

NCT ID NCT05265273

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study tests a drug called nipocalimab in children aged 2 to 18 with generalized myasthenia gravis, a condition that causes muscle weakness. The goal is to see if the drug safely lowers certain immune proteins (IgG) and improves daily activities. About 12 children will receive the drug alongside their current standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

myasthenia gravis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myasthenia gravis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • C.S. Mott Children's Hospital

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Chiba University Hospital

    COMPLETED

    Chiba, 260 8677, Japan

  • Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Childrens Hospital Los Angeles

    COMPLETED

    Los Angeles, California, 90027, United States

  • Childrens Hospital Of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19106, United States

  • Hyogo College of Medicine Hospital

    RECRUITING

    Nishinomiya-Shi, 663-8501, Japan

  • Leiden University Medical Center

    RECRUITING

    Leiden, 2333 ZA, Netherlands

  • Lucile Packard Children's Hospital Stanford

    RECRUITING

    Palo Alto, California, 94304, United States

  • Nagano Children's Hospital

    RECRUITING

    Azumino-shi, 399-8288, Japan

  • Penn State Milton S Hershey Medical Ctr

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Phoenix Children's Hospital

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Saitama Prefecture Children's Medical Center

    RECRUITING

    Saitama Shi, 330-8777, Japan

  • Tokyo Women's Medical University Hospital

    RECRUITING

    Shinjuku-ku, 162-8666, Japan

  • UCSF Benioff Children's Hospital

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Kansas Medical Center

    COMPLETED

    Lawrence, Kansas, 66045, United States

  • University of Miyazaki Hospital

    RECRUITING

    Miyazaki, 889-1692, Japan

  • University of Pittsburgh Medical Center

    TERMINATED

    Pittsburgh, Pennsylvania, 15224, United States

  • University of South Florida Morsani Center for Advanced Healthcare

    RECRUITING

    Tampa, Florida, 33613, United States

  • Uniwersyteckie Centrum Kliniczne

    RECRUITING

    Gdansk, 80 211, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.