Nipocalimab

DRUG20 trials

Sponsors

Janssen Research & Development, LLC

Conditions

Arthritis, RheumatoidHealthyHemolytic Disease of the Fetus and NewbornLupus Erythematosus, SystemicLupus NephritisMyasthenia GravisMyositisPolyradiculoneuropathy, Chronic Inflammatory Demyelinating

Phase 1

A Study of Nipocalimab in Healthy Male and Female Participants

CompletedNCT04848558

Janssen Research & Development, LLCHealthy

Start: 2021-05-25End: 2022-05-26Updated: 2023-07-03

A Study of Nipocalimab With Co-administration of Etanercept or Hydroxychloroquine in Healthy Participants

CompletedNCT04973566

Janssen Research & Development, LLCHealthy

Start: 2021-08-31End: 2022-05-27Updated: 2025-03-04

A Study of JNJ-80202135 in Healthy Chinese Adult Participants

CompletedNCT05151692

Janssen Research & Development, LLCHealthy

Start: 2022-05-30End: 2022-09-09Updated: 2022-10-26

A Study on the Effect of Nipocalimab on Vaccine Responses in Healthy Participants

CompletedNCT05827874

Janssen Research & Development, LLCHealthy

Start: 2023-04-12End: 2023-10-04Updated: 2025-03-04

Phase 2

A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus

CompletedNCT04882878

Janssen Research & Development, LLCSystemic Lupus Erythematosus

Start: 2021-08-20End: 2024-12-26Updated: 2025-12-08

A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis

WithdrawnNCT04883619

Janssen Research & Development, LLCLupus Nephritis

Start: 2026-01-15End: 2028-02-28Updated: 2026-02-27

A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)

CompletedNCT04968912

Janssen Research & Development, LLCSjogren's Syndrome

Start: 2021-09-21End: 2023-11-30Updated: 2025-11-05

A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis

CompletedNCT04991753

Janssen Research & Development, LLCArthritis, Rheumatoid

Start: 2021-10-14End: 2022-08-10Updated: 2025-08-22

A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis

RecruitingNCT05265273

Janssen Research & Development, LLCMyasthenia Gravis

Start: 2022-07-20End: 2029-07-02Target: 12Updated: 2026-03-13

Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

RecruitingNCT05327114

Janssen Research & Development, LLCPolyradiculoneuropathy, Chronic Inflammatory Demyelinating

Start: 2022-09-23End: 2028-07-11Target: 201Updated: 2026-03-13

A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies

Active, not recruitingNCT05379634

Janssen Research & Development, LLCMyositis

Start: 2022-07-05End: 2026-09-16Updated: 2026-03-13

A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis

CompletedNCT06028438

Janssen Research & Development, LLCArthritis, Rheumatoid

Start: 2023-08-15End: 2024-10-29Updated: 2025-10-16

Phase 3

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

RecruitingNCT04951622

Janssen Research & Development, LLCMyasthenia Gravis

Start: 2021-07-15End: 2029-03-30Target: 199Updated: 2026-03-03

A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

RecruitingNCT05912517

Janssen Research & Development, LLCHemolytic Disease of the Fetus and Newborn

Start: 2023-12-20End: 2029-07-10Target: 120Updated: 2026-03-13

A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

RecruitingNCT06449651

Janssen Research & Development, LLCThrombocytopenia, Neonatal Alloimmune

Start: 2024-11-11End: 2029-12-05Target: 39Updated: 2026-03-12

A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

RecruitingNCT06533098

Janssen Research & Development, LLCThrombocytopenia, Neonatal Alloimmune

Start: 2025-02-10End: 2029-12-05Target: 50Updated: 2026-03-13

Nipocalimab in Moderate to Severe Sjogren's Disease

Active, not recruitingNCT06741969

Janssen Research & Development, LLCSjogrens Syndrome

Start: 2024-12-04End: 2029-08-02Updated: 2026-03-13

Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis

RecruitingNCT07217587

Janssen Research & Development, LLCMyasthenia Gravis

Start: 2026-01-05End: 2028-12-11Target: 115Updated: 2026-03-13

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

RecruitingNCT07438496

Janssen Research & Development, LLCLupus Erythematosus, Systemic

Start: 2026-03-05End: 2031-11-07Target: 600Updated: 2026-03-13

Unknown Phase

Post-trial Access for Nipocalimab in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)

Janssen Research & Development, LLCWarm Autoimmune Hemolytic Anemia

Updated: 2026-01-16

Related Papers

Efficacy and safety of nipocalimab in patients with moderate-to-severe Sjögren's disease (DAHLIAS): a randomised, phase 2, placebo-controlled, double-blind trial.

2025-10-242 citations

An evaluation of nipocalimab for the treatment of generalized myasthenia gravis.

2025-09-30

Design of a Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Nipocalimab in Pregnancies at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia

American Journal of Perinatology2025-07-283 citations

Psychometric analysis of the Neuro-QoL Fatigue in generalized Myasthenia Gravis (gMG) using data from a phase 3 trial.

2025-06-14

Pharmacokinetics, Pharmacodynamics, and Safety of Nipocalimab in Healthy Chinese Volunteers: A Single-Dose, Phase I Study.

2025-05-19

A randomized, open-label study on the effect of nipocalimab on vaccine responses in healthy participants

Human Vaccines & Immunotherapeutics2025-04-156 citations

OA25 Efficacy and safety of nipocalimab, an anti-FcRn monoclonal antibody, in primary Sjogren’s disease: results from a Phase 2, multicenter, randomized, placebo-controlled, double-blind study (DAHLIAS)

Lara D. Veeken2025-04-012 citations

Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study.

2025-02-0130 citations

Design of a Phase 3, Multicenter, Randomized, Open-Label Study of Nipocalimab or IVIG in Pregnancies at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia (FREESIA-3)

Blood2024-11-052 citations

Efficacy and Safety of Nipocalimab in Patients with Generalised Myasthenia Gravis: Top Line Results from the Double-Blind, Placebo-Controlled, Randomised Phase III Vivacity-MG3 Study

EMJ Neurology2024-08-136 citations

Nipocalimab meets primary endpoint in Sjögren’s syndrome

2024-07-29

Nipocalimab, an anti-FcRn monoclonal antibody, in participants with moderate to severe active rheumatoid arthritis and inadequate response or intolerance to anti-TNF therapy: results from the phase 2a IRIS-RA study

RMD Open2024-06-0114 citations

OA04 Efficacy and safety of nipocalimab in patients with moderate to severe active rheumatoid arthritis: the multicenter, randomised, double-blinded, placebo-controlled phase 2a IRIS-RA study

Lara D. Veeken2024-04-013 citations

2581 Vivacity MG phase 3 study: clinical trial of nipocalimab administered to adults with generalized myasthenia gravis

2023-08-01

LP-195 Design of a Phase 2 study evaluating the efficacy and safety of nipocalimab in adult patients with active systemic lupus erythematosus

2023-07-011 citations

Design of a Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Nipocalimab in Participants with Active Idiopathic Inflammatory Myopathies (SPIREA) (P10-5.007)

Neurology2023-04-25

A Phase 2/3 Placebo-Controlled, Parallel Group, Randomized Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab for Adults with Chronic Inflammatory Demyelinating Polyneuropathy: the ARISE study (P14-8.006)

Neurology2023-04-25

Vivacity MG Phase 3 Study: Clinical Trial of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Neurology2022-12-055 citations

611 Efficacy and safety of nipocalimab in adult patients with active systemic lupus erythematosus: design of a phase 2 study

2022-12-01

PO.6.137 Design of a phase 2, multicenter, randomized, placebo-controlled, parallel-group, double-blind study to assess the efficacy and safety of nipocalimab in adults with active systemic lupus erythematosus

2022-09-27