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Monoclonal Antibodies

Nipocalimab for Myasthenia Gravis

Q: Has this research been conducted before?

<p>Janssen Research &#x26; Development, LLC sponsored the first trial for Nipocalimab in 2019, which completed its Phase 2 &#x26; 3 stages that year. Since then, 5 more trials have been conducted across 103 cities and 33 countries. In total, 18291 studies involving Nipocalimab have been completed.</p>

Phase 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

Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol

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 II a/b, III a/b, or IVa/b at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years and 8 months

Awards & highlights

Study Summary

This trial will test if nipocalimab is more effective and safe than placebo for treating generalized myasthenia gravis.

Who is the study for?

Adults with generalized myasthenia gravis (MG) who have a certain level of muscle weakness and can undergo infusions and blood sampling. Women must not be pregnant, and men agree to not donate sperm during the study. Participants should not have had recent thymectomy or MG crisis, nor should they have heart issues or allergies to the trial drug.Check my eligibility

What is being tested?

The trial is testing nipocalimab's effectiveness compared to a placebo in improving symptoms of generalized myasthenia gravis. Patients will receive either the actual medication or a placebo without knowing which one they are getting.See study design

What are the potential side effects?

While specific side effects for nipocalimab aren't listed here, common ones may include reactions at the infusion site, potential allergic responses, general discomfort, fatigue, and possibly changes in immune system function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can receive medication through a vein and provide blood samples as needed.

Select...

I have been diagnosed with generalized myasthenia gravis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years and 8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years and 8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years and 8 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Average Change from Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score

Secondary outcome measures

Nervous system disorder

Average Change from Baseline in the Revised Myasthenia Gravis Quality of Life - 15 Scale (MG-Qol15r) Score Over Weeks 22 And 24 of the Double-blind Placebo-controlled Phase

Average Change in Quantitative Myasthenia Gravis (QMG) Score Over Weeks 22 and 24 of the Double-blind Placebo-controlled Phase

+25 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NipocalimabExperimental Treatment1 Intervention

Double-blind Placebo-controlled Phase: Participants will receive nipocalimab intravenous (IV) infusions once every 2 weeks (q2w) up to 24 weeks during double-blind placebo-controlled phase. Open-label Extension (OLE) Phase: Participants who complete the double-blind placebo-controlled phase will enter the OLE phase and continue to receive nipocalimab q2w IV infusion till study end.

Group II: PlaceboPlacebo Group1 Intervention

Double-blind Placebo-controlled Phase: Participants will receive matching placebo of nipocalimab IV infusion q2w up to 24 weeks during double-blind placebo-controlled phase.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nipocalimab

2022

Completed Phase 2

~420

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,110 Total Patients Enrolled

1 Trials studying Myasthenia Gravis

12 Patients Enrolled for Myasthenia Gravis

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

745 Previous Clinical Trials

3,959,707 Total Patients Enrolled

1 Trials studying Myasthenia Gravis

12 Patients Enrolled for Myasthenia Gravis

Media Library

Nipocalimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04951622 — Phase 3

Myasthenia Gravis Research Study Groups: Placebo, Nipocalimab

Myasthenia Gravis Clinical Trial 2023: Nipocalimab Highlights & Side Effects. Trial Name: NCT04951622 — Phase 3

Nipocalimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04951622 — Phase 3

Frequently Asked Questions

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

Nipocalimab has not been FDA approved, correct?

"There is some evidence, from both Phase 3 trials and other data sources, to support the safety of Nipocalimab."

Answered by AI

Are people currently being signed up for this clinical trial?

"Yes, that is correct. The listing on clinicaltrials.gov affirms that this research project is currently looking for participants. This study was first made public on 7/15/2021 and the most recent update occurred on 10/25/2022. In total, 190 people are needed across 27 different locations."

Answered by AI

Are there many study sites open in North America for this research?

"Currently, this research is being conducted at 27 different centres. These locations are situated in Jacksonville, Cincinnati and Charleston as well as 24 other cities. To reduce the amount of travel required, it may be best to choose a location nearest you."

Answered by AI

How many people fit the qualifications for this research project?

"190 willing and eligible patients are required for this clinical trial. The University of Florida in Jacksonville, Florida and the University of Cincinnati in Cincinnati, Ohio have been approved as potential participant sites."

Answered by AI

Has this research been conducted before?

"Janssen Research & Development, LLC sponsored the first trial for Nipocalimab in 2019, which completed its Phase 2 & 3 stages that year. Since then, 5 more trials have been conducted across 103 cities and 33 countries. In total, 18291 studies involving Nipocalimab have been completed."

Answered by AI

What does the research say about Nipocalimab's effectiveness?

"Nipocalimab was first researched in 2019 at Impar Servicos Hospitalares S/A - Hospital Brasília. Since then, there have been 18291 completed studies and 5 active ones. Most of the current research is based out of Jacksonville, Florida."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

2021. "A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04951622.

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