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Monoclonal Antibodies

Nipocalimab for Myasthenia Gravis

Q: Why was this clinical trial created?

The goal of this clinical trial is to observe the changes in Total Serum Immunoglobulin-G (IgG) Antibodies Levels over a period of up to 3 years. Secondary outcomes being assessed include Patient Global Impression of Severity (PGI-S) Score, European Quality of Life 5-Dimension Youth (EQ-5D-Y) Tool Score, and Number of Participants with Neutralizing Antibodies (NAbs) to Nipocalimab.

Q: How many people are allowed to sign up for this experiment?

That is correct. The information available from clinicaltrials.gov verifies that this trial is still open and looking for participants. 12 patients are needed in total, with the recruitment happening at 11 different hospitals or clinics.

Q: How can I become a subject in this clinical trial?

This clinical trial is looking for 12 child participants that have been diagnosed with <a href="https://www.withpower.com/clinical-trials/myasthenia-gravis">myasthenia gravis</a>. The requirements for enrolment are as follows: 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 <a href="https://www.withpower.com/clinical-trials/marijuana">marijuana</a> (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

Q: Is this research being conducted in more than one location within the city limits?

Currently, this study has 11 enrolling patients from locations such as University of South <a href="https://www.withpower.com/clinical-trials/florida">Florida</a> Morsani Center for Advanced Healthcare in Tampa, University of <a href="https://www.withpower.com/clinical-trials/kansas">Kansas</a> Medical Center in Lawrence, Lucile Packard Children's Hospital Stanford in Palo Alto, and 11 other centres.

Q: Does this research include elderly patients in its population sample?

Eligibility for this trial requires that patients are aged 2-17. Out of the 84 clinical trials, 72 are for people older than 65 and 12 are specifically designed for those under 18.

Q: Are new volunteers being enrolled in this experiment at present?

That is correct. According to the information on clinicaltrials.gov, this study was originally posted on 7/20/2022 and is presently looking for 12 participants that meet specific criteria from 11 locations.

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

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 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial will study the effect of nipocalimab on total serum immunoglobulin G (IgG) in children with myasthenia gravis who have not responded well to other treatments.

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.Check my eligibility

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.See study design

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 below

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My weight and BMI are within the normal range for my age and sex.

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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.

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I have been diagnosed with generalized myasthenia gravis.

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I tested positive for specific antibodies related to my muscle condition.

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My veins can be used for giving medication and taking blood samples.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline in Total Serum Immunoglobulin-G (IgG) Antibodies Levels

Clearance (CL) of Nipocalimab

Half-life (t1/2) of Nipocalimab

+11 more

Secondary outcome measures

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 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: NipocalimabExperimental Treatment1 Intervention

Participants aged 2 to less than [<] 18 years of age 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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,296 Total Patients Enrolled

1 Trials studying Myasthenia Gravis

198 Patients Enrolled for Myasthenia Gravis

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

745 Previous Clinical Trials

3,959,893 Total Patients Enrolled

1 Trials studying Myasthenia Gravis

198 Patients Enrolled for Myasthenia Gravis

Media Library

Nipocalimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05265273 — Phase 2 & 3

Myasthenia Gravis Research Study Groups: Nipocalimab

Myasthenia Gravis Clinical Trial 2023: Nipocalimab Highlights & Side Effects. Trial Name: NCT05265273 — Phase 2 & 3

Nipocalimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05265273 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Why was this clinical trial created?

"The goal of this clinical trial is to observe the changes in Total Serum Immunoglobulin-G (IgG) Antibodies Levels over a period of up to 3 years. Secondary outcomes being assessed include Patient Global Impression of Severity (PGI-S) Score, European Quality of Life 5-Dimension Youth (EQ-5D-Y) Tool Score, and Number of Participants with Neutralizing Antibodies (NAbs) to Nipocalimab."

Answered by AI

How many people are allowed to sign up for this experiment?

"That is correct. The information available from clinicaltrials.gov verifies that this trial is still open and looking for participants. 12 patients are needed in total, with the recruitment happening at 11 different hospitals or clinics."

Answered by AI

How can I become a subject in this clinical trial?

"This clinical trial is looking for 12 child participants that have been diagnosed with myasthenia gravis. The requirements for enrolment are as follows: 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"

Answered by AI

Is this research being conducted in more than one location within the city limits?

"Currently, this study has 11 enrolling patients from locations such as University of South Florida Morsani Center for Advanced Healthcare in Tampa, University of Kansas Medical Center in Lawrence, Lucile Packard Children's Hospital Stanford in Palo Alto, and 11 other centres."

Answered by AI

Does this research include elderly patients in its population sample?

"Eligibility for this trial requires that patients are aged 2-17. Out of the 84 clinical trials, 72 are for people older than 65 and 12 are specifically designed for those under 18."

Answered by AI

Are new volunteers being enrolled in this experiment at present?

"That is correct. According to the information on clinicaltrials.gov, this study was originally posted on 7/20/2022 and is presently looking for 12 participants that meet specific criteria from 11 locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05265273.

All > Myasthenia Gravis