Eculizumab

Generic Name
Eculizumab
Brand Names
Soliris, Epysqli, Bekemv
Drug Type
Biotech
Chemical Formula
-
CAS Number
219685-50-4
Unique Ingredient Identifier
A3ULP0F556
Background

Eculizumab is a monoclonal antibody that targets complement protein C5. Binding to this protein prevents the activation of a complement terminal complex, which is used to treat a number of autoimmune conditions.
...

Indication

Eculizumab is indicated in the US to treat paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy, and neuromyelitis optica spectrum disorder (NMOSD). It is also indicated in EU to treat PNH in both adult and pediatric patients.

Associated Conditions
Generalized Myasthenia Gravis, Neuromyelitis Optica Spectrum Disorders, Paroxysmal Nocturnal Haemoglobinuria (PNH), Thrombotic Microangiopathies
Associated Therapies
-
Clinical Trials
Related News

A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG)

First Posted Date
2018-11-30
Last Posted Date
2024-12-11
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
12
Registration Number
NCT03759366
Locations
🇯🇵

Research Site, Shinjuku-ku, Japan

Pharmacokinetic, Safety, Tolerability, Immunogenicity, and Pharmacodynamic Study of SB12 in Healthy Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Eculizumab
First Posted Date
2018-10-26
Last Posted Date
2020-01-09
Lead Sponsor
Samsung Bioepis Co., Ltd.
Target Recruit Count
240
Registration Number
NCT03722329
Locations
🇩🇪

PAREXEL International GmbH, Early Phase Clinical Unit - Berlin, Berlin, Germany

Eculizumab to Treat Thrombotic Microangiopathy/Atypical Hemolytic Uremic Syndrome -Associated Multiple Organ Dysfunction Syndrome in Hematopoietic Stem Cell Transplant Recipients

First Posted Date
2018-05-08
Last Posted Date
2023-09-21
Lead Sponsor
Children's Hospital Medical Center, Cincinnati
Target Recruit Count
23
Registration Number
NCT03518203
Locations
🇺🇸

Children's Hospital Los Angeles (CHLA), Los Angeles, California, United States

🇺🇸

Children's Hospital of Philadelphia (CHOP), Philadelphia, Pennsylvania, United States

🇺🇸

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

Study of Danicopan in Participants With Paroxysmal Nocturnal Hemoglobinuria With Inadequate Response to Eculizumab

First Posted Date
2018-03-21
Last Posted Date
2023-12-12
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
12
Registration Number
NCT03472885
Locations
🇬🇧

Clinical Study Site, London, United Kingdom

Pilot Trial of Eculizumab Therapy to Reduce Preservation Injury in Human Macrosteatotic Liver Transplantation

Early Phase 1
Withdrawn
Conditions
End Stage Liver Disease
Interventions
Other: No intervention
Drug: Eculizumab
First Posted Date
2018-03-16
Last Posted Date
2021-04-08
Lead Sponsor
Yale University
Registration Number
NCT03468140
Locations
🇺🇸

Ochsner Clinic Foundation, New Orleans, Louisiana, United States

Complement Inhibitor Eculizumab in Clinical Islet Transplantation

Phase 2
Completed
Conditions
Diabetes Mellitus
Interventions
Drug: Eculizumab
First Posted Date
2016-04-04
Last Posted Date
2018-10-04
Lead Sponsor
Uppsala University
Target Recruit Count
3
Registration Number
NCT02727608
Locations
🇸🇪

Dept of Surgical Sciences, Section of Transplantation Surgery, University Hospital, Uppsala, Sweden

Identification and Treatment of Thrombotic Microangiopathies in Allogeneic Stem Cell Transplants

First Posted Date
2015-11-13
Last Posted Date
2018-03-30
Lead Sponsor
Weill Medical College of Cornell University
Target Recruit Count
200
Registration Number
NCT02604420
Locations
🇺🇸

New York Presbyterian Hospital, New York, New York, United States

Study Assessing an Algorithm-based Strategy of Eculizumab Discontinuation in Children and Adults With aHUS

Phase 4
Completed
Conditions
Atypical Hemolytic Uremic Syndrome
Interventions
Drug: eculizumab
First Posted Date
2015-10-12
Last Posted Date
2019-12-06
Lead Sponsor
Nantes University Hospital
Target Recruit Count
58
Registration Number
NCT02574403
Locations
🇫🇷

CHU Amiens, Amiens, France

🇫🇷

CHU Caen, Caen, France

🇫🇷

CHU Bordeaux, Bordeaux, France

and more 19 locations

JET-GBS - Japanese Eculizumab Trial for GBS

Phase 2
Completed
Conditions
Gullain Barre Syndrome
Interventions
Drug: Placebo
Drug: Eculizumab
First Posted Date
2015-07-09
Last Posted Date
2017-10-11
Lead Sponsor
Chiba University
Target Recruit Count
34
Registration Number
NCT02493725
Locations
🇯🇵

Nagoya University Hospital, Nagoya, Aichi, Japan

🇯🇵

Hokkaido University Hospital, Sapporo, Hokkaido, Japan

🇯🇵

Dokkyo Medical University Hospital, Mibu, Tochigi, Japan

and more 10 locations

Complement Inhibition Using Eculizumab to Overcome Platelet Transfusion Refractoriness in Patients With Severe Thrombocytopenia

First Posted Date
2014-11-24
Last Posted Date
2019-01-03
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Target Recruit Count
10
Registration Number
NCT02298933
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

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