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Monoclonal Antibodies
Crizanlizumab for Pediatric Sickle Cell Disease
Phase 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Received standard age-appropriate care for SCD, including penicillin prophylaxis, pneumococcal immunization, and parental education
Female of non-childbearing potential or with negative serum pregnancy test on Screening and a negative urine pregnancy test (dipstick) prior to dosing on Day 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, 2 years
Awards & highlights
Study Summary
This trial is studying whether a drug already shown to be safe and effective in adults with sickle cell disease is also safe and effective in children 6 months to 17 years old.
Who is the study for?
This trial is for pediatric patients aged 6 months to <18 years with sickle cell disease who've had at least one pain crisis in the past year. They must have been stable on certain medications if used, and have proper organ function. Those with recent blood transfusions, bleeding disorders, or severe illnesses are excluded.Check my eligibility
What is being tested?
The study tests Crizanlizumab's dosing and safety in children with sickle cell disease over two years. It builds on adult trials by adjusting doses based on kids' responses. This open-label Phase II trial does not use a placebo group.See study design
What are the potential side effects?
While specific side effects for this age group aren't listed, adults taking Crizanlizumab may experience joint pain, backache, fever, and stomach ache. Children might face similar issues; monitoring during the trial will clarify these effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have received all recommended treatments and vaccines for sickle cell disease.
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I am not able to have children or have tested negative for pregnancy.
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My kidney and liver functions are within the required range.
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I can do most activities but may need help, regardless of my age.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months, 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of any adverse events (AEs) as a measure of safety and tolerability
PD (AUCd15) after 1st dose
PD (AUCtau) after multiple dose
+4 moreSecondary outcome measures
Absolute change from baseline in hemoglobin
Annualized rate Vaso Occlusive Crisis (VOC) events leading to healthcare visit in clinic/ER/hospital
Annualized rate Vaso Occlusive Crisis (VOC) events treated at home (based on documentation by health care provider following phone contact with the patient)
+10 moreSide effects data
From 2021 Phase 2 trial • 54 Patients • NCT044351848%
Chest pain
4%
Headache
4%
Diarrhea
4%
Dark and Infrequent Urination
4%
Venous thrombembolism
4%
Altered mental status
100%
80%
60%
40%
20%
0%
Study treatment Arm
Crizanlizumab
Placebo Saline
Trial Design
1Treatment groups
Experimental Treatment
Group I: CrizanlizumabExperimental Treatment1 Intervention
SEG101 (crizanlizumab) administered on Week 1 Day 1, Week3 Day 1 and Day 1 of every 4-week cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Crizanlizumab
2021
Completed Phase 2
~600
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,871 Previous Clinical Trials
4,199,660 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on the same dose of my medication for at least 6 months and plan to keep it the same during the trial.I have been diagnosed with Sickle Cell Disease through blood tests.My kidney and liver functions are within the required range.I have had a stem cell transplant.I have not received any blood products in the last 30 days.I have an active Hepatitis B infection.I do not have a major infection or immune system problem.I have cancer, but any other cancers I had were treated successfully and haven't come back in 2 years.I have had serious heart issues or abnormal heart rhythms recently.I am planning to receive regular transfusions or undergo exchange transfusions/plasmapheresis during the study.I have a bleeding disorder.I am not allergic to the study drug or similar medications.I have not had antibody or immunoglobulin therapy in the last 6 months, nor have I had a bad reaction to such treatments before.I haven't had a stroke, brain bleed, or unexplained neurological symptoms in the last year.I haven't taken strong blood thinners or antiplatelet medications, other than aspirin, in the last 10 days.I was in the hospital within the last week before starting the treatment.I plan to have a major surgery during the study period.I agree to use birth control for 15 weeks after my last dose of the study drug.I have not taken voxelotor in the last 30 days and do not plan to take it during the study.I am between 2 and 18 years old, or between 6 and 24 months old and weigh at least 7 kg for a specific part of the study.My child's brain blood flow test shows a low risk for stroke.I had at least one severe pain crisis in the last year that needed medical attention and strong painkillers.I have received all recommended treatments and vaccines for sickle cell disease.I am not able to have children or have tested negative for pregnancy.I am not currently institutionalized by court or administrative order.I can do most activities but may need help, regardless of my age.I have not taken crizanlizumab or similar medications.I have a history of Hepatitis C.I am not planning to start or stop taking hydroxyurea/hydroxycarbamide or L-glutamine during the study, unless for safety.
Research Study Groups:
This trial has the following groups:- Group 1: Crizanlizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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