Crizanlizumab for Sickle Cell Disease

(STAND Trial)

Recruiting at 67 trial locations

Overseen By Novartis Pharmaceuticals

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.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

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.

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:

Treatment Details

Interventions

• Crizanlizumab (Monoclonal Antibodies)
• Placebo (Other)

Trial Overview 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.

Participant Groups

Group I: Crizanlizumab (SEG101) at 7.5 mg/kg Experimental Treatment 1 Intervention

Participants received Crizanlizumab (SEG101) at 7.5 mg/kg

Group II: Crizanlizumab (SEG101) at 5.0 mg/kg Experimental Treatment 1 Intervention

Participants received Crizanlizumab (SEG101) at 5.0 mg/kg

Group III: Placebo Placebo Group 1 Intervention

Participants received the placebo drug.

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD