Crizanlizumab for Sickle Cell Disease
(STAND Trial)

Recruiting in Palo Alto (17 mi)

+67 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novartis Pharmaceuticals

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this study is to compare the efficacy and safety of 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in adolescent and adult sickle cell disease (SCD) patients with history of vaso-occlusive crisis (VOC) leading to healthcare visit.

Eligibility Criteria

Adolescents and adults aged 12 years and older with sickle cell disease who have had at least two vaso-occlusive crises (VOC) leading to healthcare visits in the past year. Participants must meet specific health criteria, including certain blood counts and organ function levels, but cannot be part of a chronic transfusion program or have had a stem cell transplant.

Inclusion Criteria

I have had a pain crisis needing a doctor's visit and pain medication, with no other cause than a blockage in my blood vessels.

I've been on a stable dose of HU/HC or L-glutamine for 6 months, with at least one pain crisis despite treatment.

I have been diagnosed with Sickle Cell Disease through a blood test.

+13 more

Exclusion Criteria

I have been treated with crizanlizumab or a similar medication.

My family has a history of long QT syndrome or Torsades de Pointes.

History or current diagnosis of ECG abnormalities indicating significant risk of safety such as:

+9 more

Participant Groups

The trial is testing the effectiveness and safety of two different doses of Crizanlizumab (5.0 mg/kg and 7.5 mg/kg) compared to a placebo in reducing VOCs for those with sickle cell disease. Patients are randomly assigned to receive either one of the drug doses or a placebo.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Crizanlizumab (SEG101) at 7.5 mg/kgExperimental Treatment1 Intervention

Participants received Crizanlizumab (SEG101) at 7.5 mg/kg

Group II: Crizanlizumab (SEG101) at 5.0 mg/kgExperimental Treatment1 Intervention

Participants received Crizanlizumab (SEG101) at 5.0 mg/kg

Group III: PlaceboPlacebo Group1 Intervention

Participants received the placebo drug.

Crizanlizumab is already approved in United States for the following indications:

🇺🇸 Approved in United States as Adakveo for: