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Overview

Assessment of pharmacokinetics/pharmacodynamics of crizanlizumab (SEG101) (CSEG101A2202) (NCT03264989)

Crizanlizumab (SEG101)

A Phase II study for adult sickle cell disease patients with vaso-occlusive crisis

Patients & Caregivers

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Health Care Professionals

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STUDY GOAL

The main goals of the study are to describe how crizanlizumab (SEG101) works, how it moves through the body, and to measure its safety and effectiveness.

Participants in the study must be adult sickle cell disease patients with vaso-occlusive crises.

You may be eligible to participate if you

  • Are 18 to 70 years of age (inclusive) on the day of signing informed consent
  • Have a confirmed diagnosis of sickle cell disease
  • Experienced at least 1 vaso-occlusive crisis within the last 12 months prior to screening
  • Meet other eligibility criteria

 

LEARN MORE ABOUT YOUR ELIGIBILITY

 

Clinical Study Overview

Here is some information that may help you gain a better understanding of this study and its goals. By learning more about this study, you'll be able to make an informed decision with your doctor.

What are the possible drugs that I would receive in this study?

You will receive the investigational study drug crizanlizumab (SEG101).

In which disease is the investigational drug being studied?

Crizanlizumab (SEG101) is being studied in adult sickle cell disease patients with vaso-occlusive crises.

What should I know about the investigational drug in this study?

Crizanlizumab (SEG101) is a type of drug called a monoclonal antibody. It binds to specific molecules, called P-selectin, that have been linked to sickle cell vaso-occlusive crises.

Crizanlizumab (SEG101) is given as an intravenous (IV) infusion directly into a vein and is administered by a health care provider.

How many patients will participate in this study?

Up to 55 patients will participate in this study.

How long will I participate in this study?

Your treatment with the study drug will continue as long as it helps you, until you experience side effects that you can’t handle, until you decide not to participate in the study anymore, until the study reaches its end points, or until Novartis stops the study. Your study doctor can also decide to withdraw you from the study if he/she feels that this is best for you.

 

To learn more about this study, visit clinicaltrials.gov.