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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

STAND 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.Check my eligibility
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.See study design
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.

STAND Trial 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.
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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.

STAND Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Annualized Rate of Vaso-occlusive Crisis (VOC) Events Leading to a Healthcare Visit
Secondary outcome measures
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

STAND 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
2,855 Previous Clinical Trials
4,197,102 Total Patients Enrolled

Media Library

Crizanlizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03814746 — Phase 3
Sickle Cell Disease Research Study Groups: Crizanlizumab (SEG101) at 7.5 mg/kg, Crizanlizumab (SEG101) at 5.0 mg/kg, Placebo
Sickle Cell Disease 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other scientific research has been done using Crizanlizumab (SEG101)?

"Crizanlizumab (SEG101) was first researched in 2017 at East Carolina University. Out of the 18290 completed clinical trials, 9 are ongoing with several based out of Charlotte, North carolina."

Answered by AI

Are there different hospitals conducting this research within the state?

"At the moment, there are 5 centres where this trial is being conducted. They can be found in cities such as Charlotte and Boston, with other sites located in Memphis and 5 additional locations. If you decide to participate in this study, try to choose a clinic that is close to reduce travel time requirements."

Answered by AI

Are patients currently being recruited for this research project?

"This study is not actively recruiting at the moment. The listing for this trial was first created on July 26th, 2019 and updated most recently on November 3rd, 2022. However, if you are looking for other studies, there are currently 201 trials seeking patients with anemia and 9 trials for Crizanlizumab (SEG101)."

Answered by AI

Has this type of trial been conducted before?

"Since 2017, medical researchers have been studying Crizanlizumab (SEG101). In the initial study, 57 people participated and it was sponsored by Novartis Pharmaceuticals. The success of the 2017 trial resulted in Phase 2 drug approval for Crizanlizumab (SEG101). Currently, 9 studies are ongoing in 130 cities across 25 countries."

Answered by AI

Has Crizanlizumab (SEG101) been cleared for use by the FDA?

"Crizanlizumab (SEG101) has been determined to be a safe medication by our team at Power. This is due to the fact that this drug is currently in Phase 3 trials, indicating that not only does some data support its efficacy, but multiple rounds of testing have also shown it to be safe."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Two Doses of Crizanlizumab Versus Placebo in Adolescent and Adult Sickle Cell Disease Patients
2019. "Study of Two Doses of Crizanlizumab Versus Placebo in Adolescent and Adult Sickle Cell Disease Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03814746.
All > Sickle Cell Disease > Sickle Cell Anemia
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