nipocalimab
nipocalimab: sourced relationships with 1 company · 12 clinical trials tracked.
nipocalimab evidence translation
What we can confirm
12 tracked trials
What it means
What to watch
Prepared research question
How could nipocalimab → MNTA affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence4 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (1)
| Company | Dated record stage |
|---|---|
| MOMENTA PHARMACEUTICALS INC (MNTA) generalized myasthenia gravis (gMG) and hemolytic disease of… | Phase 2 |
Clinical Trial Registry Records (12)showing 10 most recent
A Phase 1, Open-Label, Lactation Study to Assess Concentrations of Nipocalimab in Breast Milk of Healthy Lactating Women
Primary endpoint: Concentration of Nipocalimab in Breast Milk
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
Primary endpoint: Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 52
Efficacy and Safety of Nipocalimab vs Efgartigimod for Patients With Generalized Myasthenia Gravis in a Randomized, Open-label, Phase 3b, Interventional Trial Including Within Class Switching From Efgartigimod to Nipocalimab
Primary endpoint: Arms 1 and 2: Averaged Mean Percent Change from Baseline in Total Immunoglobulin G (IgG) Levels Over Weeks 8, 10 and 12
Multicenter, Open-Label, Randomized Study of Nipocalimab or IVIG in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Primary endpoint: Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L
A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 3 Protocol to Assess the Efficacy and Safety of Nipocalimab in Adults With Moderate to Severe Sjogren's Disease (SjD)
Primary endpoint: Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48
Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies
Primary endpoint: Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L
A Phase 3 Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
Primary endpoint: Percentage of Pregnancies That did not Result in Fetal Loss, Intrauterine Transfusion (IUT), Hydrops Fetalis, or Neonatal Death
Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Primary endpoint: Stage B: Time to First Occurrence of a Relapse Event
An Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
Primary endpoint: Change from Baseline in Total Serum Immunoglobulin-G (IgG) Levels
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies
Primary endpoint: Percentage of Participants who Achieve at Least Minimal Improvement (Greater Than or Equal to [>=] 20) in IMACS TIS and on Less Than or Equal to (<=) 5 Milligrams per day (mg/day) of Oral Prednisone (or Equivalent) From Week 44 Through Week 52
Frequently asked questions
Which companies have sourced relationships with nipocalimab?
nipocalimab has dated SEC/FDA relationship records for MOMENTA PHARMACEUTICALS INC.
How many clinical trials involve nipocalimab?
BioSniper tracks 12 clinical trials involving nipocalimab.