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Tests treatment safety and results for Myasthenia Gravis
Official title Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis
ClinicalTrials.gov ID: NCT07217587
What this study is testing
What is Nipocalimab?
Nipocalimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for myasthenia gravis.
Also referred to as JNJ-80202135, JNJ-86507083.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to assess how well nipocalimab works when compared to efgartigimod in participants with generalized myasthenia gravis (a condition in which body's immune system mistakenly attacks and damages the connection between nerves and muscles causing muscle weakness).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74
You may be able to join if
- For all arms:
- Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG)...
- Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized MG (gMG) as defined by the...
- Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of greater than or equal to (\>=) 5 with less than (\ =1 cycle, and the final cycle is...
You likely can't join if
- Any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her gMG, or has a family history of congenital or...
- Had a thymectomy within 1 year prior to baseline, or thymectomy is planned during the study
- Currently has a malignancy or has a history of malignancy within 3 years before baseline Criteria specific to Arms 1 and 2 only: \- Has received...
The study team makes the final eligibility decision.
Where it's taking place
- Fullerton, California, United States
- Pomona, California, United States
- Fort Collins, Colorado, United States
- Farmington, Connecticut, United States
- Boca Raton, Florida, United States
- O'Fallon, Illinois, United States
- Indianapolis, Indiana, United States
- New Orleans, Louisiana, United States
- Detroit, Michigan, United States
- Raleigh, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Dallas, Texas, United States
- Haifa, Israel
- Tel Aviv, Israel
- Sankt Gallen, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fullerton, California, United States; Pomona, California, United States; Fort Collins, Colorado, United States; Farmington, Connecticut, United States; Boca Raton, Florida, United States; O'Fallon, Illinois, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.