MedPath

Crizanlizumab

Generic Name
Crizanlizumab
Brand Names
Adakveo
Drug Type
Biotech
CAS Number
1690318-25-2
Unique Ingredient Identifier
L7451S9126
Background

Crizanlizumab is a humanized IgG2 monoclonal antibody used to reduce the frequency of vaso-occlusive crises in patients with sickle cell disease. Sickle cell disease is a genetically inherited condition prevalent in the Middle East, Africa, and certain parts of India. The genetic mutation associated with this disease leads to the formation of abnormal, sickle shaped red blood cells that aggregate and block blood vessels throughout the body, causing vaso-occlusive crises. Sickle cell disease can lead to excruciating pain, stroke, infection, and various other complications arising from the blockage of blood vessels.

Currently, patients are prescribed hydroxyurea to raise levels of fetal hemoglobin as a method of reducing morbidity and mortality. Though hydroxyurea has been shown to reduce the frequency of vaso-occlusive crises, adherence to this therapy is difficult due to adverse effects and the high variability of response to the drug between patients. Crizanlizumab, or SEG101, is given once every 4 weeks and may improve patient adherence. It was developed by Novartis and was granted FDA approval on November 15, 2019. While crizanlizumab received conditional marketing authorization from the EMA in October 2020, this approval was revoked in August 2023 due to concerns over the efficacy and safety of the drug.

Indication

Crizanlizumab is indicated to reduce the frequency of vaso-occlusive crisis in patients with sickle cell diseases who are โ‰ฅ16 years old.

Associated Conditions
Vaso-occlusive Crisis

Study of Two Doses of Crizanlizumab Versus Placebo in Adolescent and Adult Sickle Cell Disease Patients

Phase 3
Active, not recruiting
Conditions
Sickle Cell Disease (SCD)
Interventions
First Posted Date
2019-01-24
Last Posted Date
2025-05-22
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
259
Registration Number
NCT03814746
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Childrens Healthcare of Atlanta, Atlanta, Georgia, United States

๐Ÿ‡บ๐Ÿ‡ธ

Boston Medical Center, Boston, Massachusetts, United States

๐Ÿ‡บ๐Ÿ‡ธ

Levine Cancer Insitute Carolinas Healthcare System, Charlotte, North Carolina, United States

and more 3 locations

MAP to Provide Access to Crizanlizumab, for Sickle Cell Disease Patients

Conditions
Sickle Cell Disease
First Posted Date
2018-10-25
Last Posted Date
2024-10-28
Lead Sponsor
Novartis Pharmaceuticals
Registration Number
NCT03720626

Study of Dose Confirmation and Safety of Crizanlizumab in Pediatric Sickle Cell Disease Patients

Phase 2
Active, not recruiting
Conditions
Sickle Cell Disease (SCD)
Interventions
First Posted Date
2018-03-23
Last Posted Date
2024-12-19
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
118
Registration Number
NCT03474965
Locations
๐Ÿ‡บ๐Ÿ‡ธ

University Of Alabama, Birmingham, Alabama, United States

๐Ÿ‡บ๐Ÿ‡ธ

Univ of Florida College of Medicine, Gainesville, Florida, United States

๐Ÿ‡บ๐Ÿ‡ธ

Joe DiMaggio Childrens Hospital, Hollywood, Florida, United States

and more 10 locations

Pharmacokinetics and Pharmacodynamics Study of SEG101 (Crizanlizumab) in Sickle Cell Disease (SCD) Patients With Vaso- Occlusive Crisis (VOC)

Phase 2
Completed
Conditions
Sickle Cell Disease (SCD)
Interventions
First Posted Date
2017-08-29
Last Posted Date
2024-10-09
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
57
Registration Number
NCT03264989
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Childrens Healthcare of Atlanta ., Atlanta, Georgia, United States

๐Ÿ‡บ๐Ÿ‡ธ

University of Maryland Medical Ctr, Baltimore, Maryland, United States

๐Ÿ‡บ๐Ÿ‡ธ

East Carolina University East Carolina University, Greenville, North Carolina, United States

and more 8 locations

Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Pain Crises

Phase 2
Completed
Conditions
Sickle Cell Disease
Interventions
Drug: Placebo
First Posted Date
2013-07-10
Last Posted Date
2020-01-31
Lead Sponsor
Reprixys Pharmaceutical Corporation
Target Recruit Count
198
Registration Number
NCT01895361
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