Nipocalimab for Myasthenia Gravis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Leiden University Medical Center, Leiden, NetherlandsMyasthenia GravisNipocalimab - Drug
Eligibility
2 - 17
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Myasthenia Gravis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

14 Primary · 9 Secondary · Reporting Duration: Up to 3 years

Up to 3 years
Change from Baseline in Myasthenia Gravis -Activities of Daily Living (MG-ADL) Score
Change from Baseline in Total Serum Immunoglobulin-G (IgG) Antibodies Levels
Change in the Quantitative Myasthenia Gravis (QMG) Score
Clearance (CL) of Nipocalimab
European Quality of Life 5-Dimension Youth (EQ-5D-Y) Tool Score
Half-life (t1/2) of Nipocalimab
Neurological Quality of Life (Neuro-QoL) Pediatric Fatigue Score
Number of Participants with Abnormalities in Clinical Laboratory Tests
Number of Participants with Abnormalities in Physical Examination
Number of Participants with Abnormalities in Vital Signs
Number of Participants with Adverse Events of Special Interests (AESIs)
Number of Participants with Anti-Drug Antibodies [ADAs] to Nipocalimab
Number of Participants with Infectious Adverse Events (AEs)
Number of Participants with Neutralizing Antibodies (NAbs) to Nipocalimab
Number of Participants with Serious AEs (SAEs)
Number of Participants with Vaccine Antibody Titers to Diphtheria or Tetanus
Patient Global Impression of Change (PGI-C) Score
Patient Global Impression of Severity (PGI-S) Score
Serum Concentration of Nipocalimab over Time
Steady-state Area Under the Curve (AUCss) of Nipocalimab
Steady-state Peak Concentration (Cpeak,ss) of Nipocalimab
Steady-state Trough concentration (Ctrough,ss) of Nipocalimab
Volume of Distribution (V) of Nipocalimab

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Nipocalimab
1 of 1

Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: Nipocalimab · No Placebo Group · Phase 2 & 3

Nipocalimab
Drug
Experimental Group · 1 Intervention: Nipocalimab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nipocalimab
2022
Completed Phase 2
~220

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
933 Previous Clinical Trials
6,368,719 Total Patients Enrolled
1 Trials studying Myasthenia Gravis
190 Patients Enrolled for Myasthenia Gravis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
716 Previous Clinical Trials
3,950,860 Total Patients Enrolled
1 Trials studying Myasthenia Gravis
190 Patients Enrolled for Myasthenia Gravis

Eligibility Criteria

Age 2 - 17 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You can still join the study even if you use herbal, naturopathic, traditional Chinese remedies, ayurvedic or nutritional supplements or medical marijuana prescribed by a doctor. However, you must maintain a consistent dose and usage pattern throughout the study.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.