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 While crizanlizumab received conditional marketing authorization from the EMA in October 2020, this approval was revoked in August 2023 due to concerns over the efficacy and safety of the drug.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 ≥16 years old.

Associated Conditions
Vaso-occlusive Crisis

A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE)

Phase 3
Recruiting
Conditions
Sickle Cell Disease
Interventions
First Posted Date
2024-06-03
Last Posted Date
2025-05-20
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
315
Registration Number
NCT06439082
Locations
🇺🇸

Childrens National Hospital, Washington, District of Columbia, United States

🇺🇸

University of Florida, Jacksonville, Florida, United States

🇺🇸

Augusta University Georgia, Augusta, Georgia, United States

and more 5 locations

Crizanlizumab Alone or in Combination With Nivolumab for Glioblastoma and Melanoma With Brain Metastases

Phase 2
Recruiting
Conditions
Metastatic Melanoma in the Central Nervous System
MGMT-Unmethylated Glioblastoma
Advanced Glioblastoma
Interventions
First Posted Date
2023-06-18
Last Posted Date
2023-11-28
Lead Sponsor
Sheba Medical Center
Target Recruit Count
33
Registration Number
NCT05909618
Locations
🇮🇱

Sheba medical center, Ramat Gan, Israel

Crizanlizumab Improves Tissue Oxygen Supply Demand Matching in Patients With Sickle Cell Anemia

Phase 1
Not yet recruiting
Conditions
Sickle Cell Disease
Interventions
Other: control
First Posted Date
2022-07-22
Last Posted Date
2023-08-30
Lead Sponsor
Children's Hospital Los Angeles
Target Recruit Count
30
Registration Number
NCT05469828

An Indian Multi-centric Phase IV Study to Assess the Safety of Crizanlizumab in Sickle Cell Disease Patients

Phase 4
Completed
Conditions
Sickle Cell Disease (SCD)
Interventions
First Posted Date
2020-12-10
Last Posted Date
2025-01-08
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
140
Registration Number
NCT04662931
Locations
🇮🇳

Novartis Investigative Site, Kolkata, West Bengal, India

Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study

Phase 4
Recruiting
Conditions
Sickle Cell Disease
Interventions
First Posted Date
2020-12-08
Last Posted Date
2025-04-11
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
130
Registration Number
NCT04657822
Locations
🇺🇸

University Of Alabama, Birmingham, Alabama, United States

🇺🇸

Childrens National Hospital, Washington, District of Columbia, United States

🇺🇸

Augusta University Georgia, Augusta, Georgia, United States

and more 4 locations

Crizanlizumab for Treatment of Retinal Vasculopathy With Cerebral Leukoencephalopathy (RVCL)

Phase 2
Active, not recruiting
Conditions
RVCL - Retinal Vasculopathy Cerebral Leukoencephalopathy
Interventions
First Posted Date
2020-11-02
Last Posted Date
2023-02-14
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
20
Registration Number
NCT04611880
Locations
🇺🇸

Andria Ford, Saint Louis, Missouri, United States

🇺🇸

Perelman School of Medicine; University of Pennsylvania, Philadelphia, Pennsylvania, United States

Accelerating COVID-19 Therapeutic Interventions and Vaccines 4 ACUTE

Phase 4
Completed
Conditions
Covid19
Interventions
First Posted Date
2020-08-10
Last Posted Date
2024-12-30
Lead Sponsor
Matthew Neal MD
Target Recruit Count
3591
Registration Number
NCT04505774
Locations
🇺🇸

Smidt Heart Institute at Cedars-Sinai, Los Angeles, California, United States

🇺🇸

Ronald Reagan UCLA Medical Center, Los Angeles, California, United States

🇺🇸

Cleveland Clinic Foundation, Cleveland, Ohio, United States

and more 96 locations

Crizanlizumab for Treating COVID-19 Vasculopathy

Phase 2
Completed
Conditions
COVID-19
Interventions
Other: 0.9% saline
First Posted Date
2020-06-17
Last Posted Date
2021-11-09
Lead Sponsor
Johns Hopkins University
Target Recruit Count
54
Registration Number
NCT04435184
Locations
🇺🇸

Johns Hopkins Hospital, Baltimore, Maryland, United States

Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients

First Posted Date
2019-09-20
Last Posted Date
2024-12-04
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
45
Registration Number
NCT04097821
Locations
🇬🇧

Novartis Investigative Site, London, United Kingdom

A Study to Evaluate the Safety and Efficacy of Crizanlizumab in Sickle Cell Disease Related Priapism

Phase 2
Completed
Conditions
Priapism
Interventions
First Posted Date
2019-05-06
Last Posted Date
2025-04-13
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
36
Registration Number
NCT03938454
Locations
🇺🇸

University Of Alabama, Birmingham, Alabama, United States

🇺🇸

University of Connecticut Health Center, Farmington, Connecticut, United States

🇺🇸

Childrens National Hospital, Washington, District of Columbia, United States

and more 10 locations
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