BridgeMD
New treatment option for Myasthenia Gravis
Official title A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
ClinicalTrials.gov ID: NCT04951622
What this study is testing
What is Nipocalimab?
Nipocalimab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for myasthenia gravis.
Also referred to as JNJ-80202135, M281.
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 evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG). The purpose of the subcutaneous substudy is to evaluate how well it works in the body (pharmacodynamic [PD]) when given as an injection under the skin (subcutaneous) compared to when given through a vein (intravenous) in participants with gMG.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized myasthenia gravis (gMG) as defined...
- Myasthenia Gravis - Activities of Daily Living (MG-ADL) score of greater than or equal to (\>=) 6 at screening and baseline
- Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol
- A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and a...
- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last...
You likely can't join if
- Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her gMG, or has a family history of congenital or...
- Has MGFA Class I disease or presence of MG crisis (MGFA Class V) at screening, history of MG crisis within 1 month of screening, or fixed weakness...
- Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the study
- Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
- Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening
- For the SC Substudy (Cohort 1): Participants who have undergone a recent tapering of their concomitant MG medication in the OLE
See the full eligibility criteria
- 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...
- Myasthenia Gravis - Activities of Daily Living (MG-ADL) score of greater than or equal to (\>=) 6 at screening and baseline
- Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol
- A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test at Day 1 prior to administration of study...
- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last administration of study intervention
- For the SC Substudy (Cohort 1 and Cohort 2): Has reasonable abdominal skin area for SC administration
- For the SC Substudy (Cohort 1 and Cohort 2): Participants must be willing to comply with maintaining their stable dose of corticosteroids and/or immunosuppressants for the initial 8 weeks of the SC substudy, that is...
- Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her gMG, or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
- Has MGFA Class I disease or presence of MG crisis (MGFA Class V) at screening, history of MG crisis within 1 month of screening, or fixed weakness (and/or 'burnt out' MG)
- Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the study
- Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
- Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening
- For the SC Substudy (Cohort 1): Participants who have undergone a recent tapering of their concomitant MG medication in the OLE
- For the SC Substudy (Cohort 1): Participants deteriorating during the OLE in the month prior to SC Dose 1 of the SC substudy such that they meet the criteria for clinical deterioration
- For the SC Substudy (Cohort 2): History of an unprovoked pulmonary embolism within 1 year prior to screening or history of recurrent deep vein thrombosis (DVT)
The study team makes the final eligibility decision.
Where it's taking place
- Paradise Valley, Arizona, United States
- Scottsdale, Arizona, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Pasadena, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Boca Raton, Florida, United States
- Jacksonville, Florida, United States
- Port Charlotte, Florida, United States
- Tampa, Florida, United States
- Augusta, Georgia, United States
- Kansas City, Kansas, United States
- Boston, Massachusetts, United States
- Burlington, Massachusetts, United States
- St Louis, Missouri, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
+ 80 more site(s).
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paradise Valley, Arizona, United States; Scottsdale, Arizona, United States; Los Angeles, California, United States; Palo Alto, California, United States; Pasadena, California, United States; Aurora, Colorado, United States and 94 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.