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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

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

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ not applicable - study completion

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Number of participants with treatment emergent adverse events

Side effects data

From 2021 Phase 2 trial • 54 Patients • NCT04435184

Chest pain

Headache

Diarrhea

Dark and Infrequent Urination

Venous thrombembolism

Altered mental status

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,857 Previous Clinical Trials

4,197,671 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

Frequently Asked Questions

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

Is recruitment still taking place for this experiment?

"Affirmative. The information on clinicaltrials.gov reveals that this trial, which was first advertised in June 2021 is currently enrolling patients. 130 individuals must be recruited from 7 different sites for the study to reach completion."

Answered by AI

Is this an innovative approaches to trial design?

"To date, 10 clinical trials of Crizanlizumab are being conducted across 36 countries and 144 cities. Novartis Pharmaceuticals initiated the first trial in 2017 with 57 participants; this study completed Phase 2 drug approval before a couple more studies were run afterwards."

Answered by AI

What other trials have demonstrated the effect of Crizanlizumab?

"At present, 10 clinical trials for Crizanlizumab are underway, with one of them in its third phase. Greenville, South carolina is the predominant location involved in this research; however, a total of 401 sites have been identified to conduct studies on this medication."

Answered by AI

How many participants have been accepted for inclusion in this trial?

"This clinical trial necessitates 130 participants that meet the outlined qualifications. These patients can participate from various medical centres, such as Children's Hospital of Philadelphia Patient Treatment in Birmingham, Alabama and Cook Childrens Medical Center in Fort Worth, Texas."

Answered by AI

In which geographical locations can this clinical investigation be accessed?

"This medical trial has 7 locations available for enrolment, including Children's Hospital of Philadelphia Patient Treatment in Birmingham, Cook Childrens Medical Center in Fort Worth and University of Alabama 1600 7th ave in Greenville. Four more sites are at the ready to participate as well."

Answered by AI