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Monoclonal Antibodies

Crizanlizumab for Sickle Cell Disease

Phase 4
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must not have
SCD patients who do not meet parent study protocol criteria to continue with crizanlizumab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day of first dose of study medication to 105 days after last dose of study medication
Awards & highlights

Summary

This trial will allow continued access to the drug crizanlizumab for patients with sickle cell disease who are benefiting from the treatment.

Who is the study for?
This trial is for patients with Sickle Cell Disease who are already participating in a Novartis-sponsored Crizanlizumab study and have seen benefits. They must have completed the previous study's treatment schedule, shown commitment to visit schedules, and be willing to continue visits. Pregnant or nursing women, those not using effective contraception, or anyone with unresolved severe side effects from prior treatments cannot join.
What is being tested?
The trial provides continued access to Crizanlizumab for individuals with Sickle Cell Disease who benefited from earlier trials. It's designed as a rollover study where participants receive ongoing Crizanlizumab therapy under the supervision of investigators at multiple centers internationally.
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse events related to Crizanlizumab use. Those with Grade 3 (severe) or higher side effects from previous studies are excluded unless resolved.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have SCD and cannot continue with crizanlizumab as per the main study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~not applicable - study completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and not applicable - study completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Not Applicable as this protocol is to provide an option for continued access to crizanlizumab for patients with Sickle Cell Disease who have completed a prior Novartis-sponsored Crizanlizumab study
Secondary study objectives
Number of participants with treatment emergent adverse events

Side effects data

From 2021 Phase 2 trial • 54 Patients • NCT04435184
8%
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
All participants will receive crizanlizumab (SEG101) at the same dose/schedule as in the parent study.
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
2,889 Previous Clinical Trials
4,201,874 Total Patients Enrolled

Media Library

Crizanlizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04657822 — Phase 4
Sickle Cell Disease Clinical Trial 2023: Crizanlizumab Highlights & Side Effects. Trial Name: NCT04657822 — Phase 4
Crizanlizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04657822 — Phase 4
Sickle Cell Disease Research Study Groups: Crizanlizumab
~87 spots leftby Oct 2031
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