Crizanlizumab for Sickle Cell Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a multi-center multi-national rollover study to allow continued access to crizanlizumab for patients with sickle cell disease (SCD) who are on crizanlizumab treatment in a Novartis-sponsored study (parent study) and are benefiting from the treatment as judged by the investigator.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial investigator to understand how your current medications might interact with the study treatment.
Is crizanlizumab safe for humans?
Crizanlizumab has been studied for safety in patients with sickle cell disease, showing similar rates of adverse events (unwanted effects) compared to a placebo. Common side effects include infusion-related reactions, joint pain, diarrhea, and nausea, but no serious treatment-related adverse events were reported.12345
What makes the drug Crizanlizumab unique for treating Sickle Cell Disease?
Crizanlizumab is unique because it targets P-selectin, a protein that plays a key role in the inflammation and blockage of blood vessels in sickle cell disease, helping to reduce pain crises. This mechanism is different from other treatments that primarily focus on managing symptoms or increasing fetal hemoglobin levels.678910
What data supports the effectiveness of the drug crizanlizumab for sickle cell disease?
Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Treatment
Participants continue receiving Crizanlizumab treatment at the same dose/schedule as in the parent study
Safety Follow-up
A safety follow-up visit is conducted 105 days after the last administration of study treatment
Long-term Follow-up
Participants are monitored for continued access to Crizanlizumab until it becomes commercially available or no longer needed
What Are the Treatments Tested in This Trial?
Interventions
- Crizanlizumab
Crizanlizumab is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
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