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Monoclonal Antibodies

Crizanlizumab for Sickle Cell Disease (STAND Trial)

Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must meet the following central laboratory values prior to Week 1 Day 1: Absolute Neutrophil Count ≥1.0 x 109/L Platelet count ≥75 x 109/L Hemoglobin: for adults (Hb) ≥4.0 g/dL and for adolescents (Hb) ≥5.5 g/dL Glomerular filtration rate ≥ 45 mL/min/1.73 m2 using CKD-EPI formula in adults, and Shwartz formula in adolescents Direct (conjugated) bilirubin < 2.0 x ULN Alanine transaminase (ALT) < 3.0 x ULN ECOG performance status ≤2.0 for adults and Karnofsky ≥ 50% for adolescents
Experienced at least 2 VOCs leading to healthcare visit within the 12 months prior to screening visit as determined by medical history. Prior VOC leading to healthcare visit must resolve at least 7 days prior to Week 1 Day 1 and must include: Pain crisis defined as an acute onset of pain for which there is no other medically determined explanation other than vaso- occlusion - which requires a visit to a medical facility and/or healthcare professional, and receipt of oral/parenteral opioids or parenteral nonsteroidal anti-inflammatory drug (NSAID) analgesia Acute chest syndrome (ACS), priapism and hepatic or splenic sequestration will be considered VOC in this study
Must not have
Received prior treatment with crizanlizumab or other selectin targeting agent
History of familial long QT syndrome or know family history of Torsades de Pointes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new drug to see if it can help people with sickle cell disease who have had previous problems with pain crises.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects may include allergic reactions due to hypersensitivity, infusion-related reactions similar to other monoclonal antibodies, as well as any risks associated with medications that affect blood cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've had at least 2 pain crises or other sickle cell complications requiring medical attention in the last year.
Select...
My kidney function, measured by a specific test, is within a healthy range.
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I can care for myself but may not be able to do active work.
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I am 12 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with crizanlizumab or a similar medication.
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My family has a history of long QT syndrome or Torsades de Pointes.
Select...
I do not have serious heart rhythm problems without a pacemaker.
Select...
I have had a stem cell transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Annualized Rate of Vaso-occlusive Crisis (VOC) Events Leading to a Healthcare Visit
Secondary study objectives
Absolute Change From Baseline in Hemoglobin
Annualized Days of Visits to Clinic, Emergency Room (ER) and Hospitalizations, Both Overall and VOC-related Over the First-year Post-randomization
Annualized Rate of All VOCs Leading to a Healthcare Visit and Treated at Home Over 5 Years Post Randomization (Key Secondary)
+20 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,912 Previous Clinical Trials
4,252,450 Total Patients Enrolled
2 Trials studying Sickle Cell Anemia
310 Patients Enrolled for Sickle Cell Anemia

Media Library

Crizanlizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03814746 — Phase 3
Sickle Cell Anemia Research Study Groups: Crizanlizumab (SEG101) at 7.5 mg/kg, Crizanlizumab (SEG101) at 5.0 mg/kg, Placebo
Sickle Cell Anemia Clinical Trial 2023: Crizanlizumab Highlights & Side Effects. Trial Name: NCT03814746 — Phase 3
Crizanlizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03814746 — Phase 3
~40 spots leftby Nov 2025
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