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Monoclonal Antibodies
Nipocalimab for Myasthenia Gravis
Phase 2 & 3
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing nipocalimab, a medication that lowers certain antibodies, in children and teens with generalized myasthenia gravis who don't respond well to standard treatments. The goal is to see if it helps reduce their symptoms by lowering harmful antibodies in their blood.
Who is the study for?
This trial is for children aged 2 to less than 18 with generalized myasthenia gravis (gMG), who have not responded well to standard treatments. They must meet specific clinical criteria, have certain antibodies present, and maintain a stable use of any herbal or nutritional supplements. Participants need proper venous access for infusions and blood sampling, be within the normal weight range for their age and sex, and females able to bear children must test negative for pregnancy.
What is being tested?
The study tests Nipocalimab's effects on total serum immunoglobulin G (IgG) levels in pediatric patients with gMG. It aims to assess the safety, tolerability, and pharmacokinetics of Nipocalimab in these young participants who are already receiving standard care but need additional treatment.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with monoclonal antibody therapies like Nipocalimab may include allergic reactions such as rash or itching, potential infusion-related reactions like fever or chills, fatigue, headache, nausea or vomiting.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with generalized myasthenia gravis.
Select...
I tested positive for specific antibodies related to my muscle condition.
Select...
My veins can be used for giving medication and taking blood samples.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have an immunodeficiency unrelated to my myasthenia gravis treatment.
Select...
I have had or will have surgery to remove my thymus gland within a year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline in Total Serum Immunoglobulin-G (IgG) Antibodies Levels
Clearance (CL) of Nipocalimab
Half-life (t1/2) of Nipocalimab
+11 moreSecondary study objectives
Change from Baseline in Myasthenia Gravis -Activities of Daily Living (MG-ADL) Score
Change in the Quantitative Myasthenia Gravis (QMG) Score
European Quality of Life 5-Dimension Youth (EQ-5D-Y) Tool Score
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: NipocalimabExperimental Treatment1 Intervention
Participants age 2 to less than (\<) 18 years of age (globally) and 8 to \<18 years of age (for US sites only) will receive nipocalimab once every two weeks for 24 weeks. After Week 24, all participants will have the option to enroll in long term extension (LTE).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nipocalimab
2022
Completed Phase 2
~420
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Myasthenia Gravis (MG) include immunosuppressants, acetylcholinesterase inhibitors, and therapies targeting immunoglobulin G (IgG). Immunosuppressants, such as corticosteroids and azathioprine, reduce the overall immune response, thereby decreasing the production of autoantibodies that attack acetylcholine receptors.
Acetylcholinesterase inhibitors, like pyridostigmine, increase the availability of acetylcholine at the neuromuscular junction, improving muscle contraction. IgG modulation therapies, such as intravenous immunoglobulin (IVIG) and emerging treatments like Nipocalimab, work by altering the activity or levels of IgG antibodies, which are responsible for the autoimmune attack in MG.
These treatments are crucial as they directly address the underlying immune dysfunction, providing symptom relief and improving the quality of life for MG patients.
Update in immunosuppressive therapy of myasthenia gravis.
Update in immunosuppressive therapy of myasthenia gravis.
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
991 Previous Clinical Trials
6,386,839 Total Patients Enrolled
1 Trials studying Myasthenia Gravis
196 Patients Enrolled for Myasthenia Gravis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
757 Previous Clinical Trials
3,962,639 Total Patients Enrolled
1 Trials studying Myasthenia Gravis
196 Patients Enrolled for Myasthenia Gravis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My weight and BMI are within the normal range for my age and sex.I use herbal or traditional remedies, supplements, or medical marijuana with my doctor's approval and can keep the dose the same during the study.I have been diagnosed with generalized myasthenia gravis.I had a heart attack, unstable heart disease, or stroke in the last 3 months.I do not have an immunodeficiency unrelated to my myasthenia gravis treatment.I have had or will have surgery to remove my thymus gland within a year.I do not have severe health issues that could affect my study participation or safety.If you are a woman who could become pregnant, you need to have a negative pregnancy test before starting the study.I tested positive for specific antibodies related to my muscle condition.My veins can be used for giving medication and taking blood samples.You have had a serious allergic reaction to therapeutic proteins in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Nipocalimab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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