Nipocalimab

Generic Name: Nipocalimab

Brand Names: -

Drug Type: Biotech

Chemical Formula: -

CAS Number: 2211985-36-1

Unique Ingredient Identifier: 87M90CV8NC

Background: Nipocalimab is under investigation in clinical trial NCT04119050 (Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia).

Associated Conditions: -

Associated Therapies: -

Clinical Trials

Nipocalimab in Moderate to Severe Sjogren's Disease

Phase 3

Recruiting

Conditions: Sjogrens Syndrome

Interventions: Drug: Placebo
Drug: Nipocalimab
Drug: Standard of care treatment

First Posted Date: 2024-12-19

Last Posted Date: 2024-12-19

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 600

Registration Number: NCT06741969

Locations: 🇺🇸
Inland Rheumatology Clinical Trials Inc., Upland, California, United States
🇺🇸
Clinical Investigation Specialists - Clinic of Robert Hozman, Skokie, Illinois, United States
🇺🇸
Altoona Center For Clinical Research, Duncansville, Pennsylvania, United States

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

Phase 3

Not yet recruiting

Conditions: Thrombocytopenia, Neonatal Alloimmune

Interventions: Drug: Nipocalimab
Drug: Intravenous immunoglobulins (IVIG)
Drug: Prednisone

First Posted Date: 2024-08-01

Last Posted Date: 2024-12-18

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 50

Registration Number: NCT06533098

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

Phase 3

Recruiting

Conditions: Thrombocytopenia, Neonatal Alloimmune

Interventions: Drug: Placebo
Drug: Nipocalimab

First Posted Date: 2024-06-10

Last Posted Date: 2024-12-05

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 39

Registration Number: NCT06449651

Locations: 🇫🇷
CHRU Lille, Lille, France
🇭🇺
Semmelweis Egyetem, Budapest, Hungary
🇳🇴
Universitetssykehuset Nord-Norge HF, Tromso, Norway

and more 14 locations

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

Phase 2

Completed

Conditions: Arthritis, Rheumatoid

Interventions: Drug: Placebo
Drug: Nipocalimab
Drug: Certolizumab

First Posted Date: 2023-09-08

Last Posted Date: 2024-12-06

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 103

Registration Number: NCT06028438

Locations: 🇵🇱
NZOZ Lecznica MAK MED S C, Nadarzyn, Poland
🇭🇺
Vital Medical Center Orvosi es Fogaszati Kozpont, Veszprem, Hungary
🇭🇺
Budai Irgalmasrendi Korhaz, Budapest, Hungary

and more 29 locations

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

Phase 3

Recruiting

Conditions: Hemolytic Disease of the Fetus and Newborn

Interventions: Drug: Placebo
Drug: Nipocalimab

First Posted Date: 2023-06-22

Last Posted Date: 2024-12-06

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 120

Registration Number: NCT05912517

Locations: 🇬🇧
Birmingham Women's Hospital, Birmingham, United Kingdom
🇬🇧
St.Mary's Hospital, Manchester, United Kingdom
🇬🇧
John Radcliffe Hospital, Oxford, United Kingdom

and more 37 locations

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

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Nipocalimab
Biological: Tdap
Biological: PPSV23

First Posted Date: 2023-04-25

Last Posted Date: 2024-10-02

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 32

Registration Number: NCT05827874

Locations: 🇩🇪
CRS Clinical Research Services Berlin GmbH, Berlin, Germany

A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies

Phase 2

Active, not recruiting

Conditions: Myositis

Interventions: Drug: Nipocalimab
Other: Placebo
Drug: Glucocorticoids

First Posted Date: 2022-05-18

Last Posted Date: 2024-12-06

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 36

Registration Number: NCT05379634

Locations: 🇺🇸
University of Pennsylvania - Perelman School of Medicine, Philadelphia, Pennsylvania, United States
🇺🇸
Wexner Medical Center at the Ohio State University, Columbus, Ohio, United States
🇺🇸
The Brigham and Women's Hospital, Inc., Boston, Massachusetts, United States

and more 54 locations

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

Phase 2

Recruiting

Conditions: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions: Drug: Nipocalimab
Drug: Placebo

First Posted Date: 2022-04-14

Last Posted Date: 2024-12-06

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 201

Registration Number: NCT05327114

Locations: 🇺🇸
Johns Hopkins Hospital, Baltimore, Maryland, United States
🇨🇳
Chifeng Municipal Hospital, Chifeng, China
🇨🇳
Peking University Third Hospital, Beijing, China

and more 68 locations

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

Phase 2

Recruiting

Conditions: Myasthenia Gravis

Interventions: Drug: Nipocalimab

First Posted Date: 2022-03-03

Last Posted Date: 2024-12-10

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 12

Registration Number: NCT05265273

Locations: 🇺🇸
Penn State Milton S Hershey Medical Ctr, Hershey, Pennsylvania, United States
🇺🇸
Phoenix Children's Hospital, Phoenix, Arizona, United States
🇺🇸
Childrens Hospital Los Angeles, Los Angeles, California, United States

and more 16 locations

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

Conditions: Warm Autoimmune Hemolytic Anemia

First Posted Date: 2022-02-03

Last Posted Date: 2024-12-20

Lead Sponsor: Janssen Research & Development, LLC

Registration Number: NCT05221619

Drug Development Updates

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