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Monoclonal Antibodies

crizanlizumab for Sickle Cell Disease

Phase 2
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 through end of treatment (approximately 24 months)
Awards & highlights

Study Summary

This trial was a Phase II, multicenter, open-label study to assess the PK and PD of SEG101/crizanlizumab in SCD patients, and to evaluate the safety and efficacy of SEG101/crizanlizumab.

Eligible Conditions
  • Sickle Cell Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 through end of treatment (approximately 24 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 through end of treatment (approximately 24 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacodynamics (PD): Percentage of P-selectin inhibition and PD-AUC inhibition of crizanlizumab at 5.0 mg/kg in SCD patients
To characterize PK (AUC) of crizanlizumab at 5.0 mg/kg in SCD patients.
To characterize PK (Cmax) of crizanlizumab at 5.0 mg/kg in SCD patients.
+1 more
Secondary outcome measures
Annualized days of ER/hospitalization (both total and VOC-related) over time.
Therapeutic procedure
Annualized rate of VOC events leading to healthcare visit in clinic/ER/hospital over time.
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: crizanlizumab 5 mg/kgExperimental Treatment1 Intervention
SEG101 (crizanlizumab) drug at a dose of 5.0 mg/kg (or 7.5 mg/kg for exploratory group) by IV infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
crizanlizumab
2017
Completed Phase 4
~240

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,293 Total Patients Enrolled

Frequently Asked Questions

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

Has a similar investigation ever been conducted before?

"Since 2017, Novartis Pharmaceuticals have sponsored research exploring crizanlizumab's efficacy. After the first Phase 1 trial involving 57 patients in 2017, it recieved approval for Phase 2 testing. Currently 10 studies are underway across 144 cities and 36 countries worldwide."

Answered by AI

To whom is this research offering participation?

"For this medical trial, 57 individuals aged 16 to 70 who have anemia and sickle cell will be enrolled. Participants must also satisfy the following conditions: 6 month HU/HC or erythropoietin stimulating agent use prior to screening; male or female between ages 16-70 (inclusive); experienced at least one VOC within preceding 12 months before screening according to their medical history; ECOG performance status of no more than 2."

Answered by AI

How many locales are hosting this research endeavor?

"This research study is accepting enrollees at Medical University of South carolina, M Francisco Gonzalez MD PA in Columbia, Georgia and Carolina Blood and Cancer Care of South Carolina in Rock Hill. Additionally, 12 other medical centres are recruiting patients for this trial."

Answered by AI

Does this research program accept geriatric applicants?

"According to the requirements of this medical trial, only individuals from 16 years old and above 70 can participate."

Answered by AI

To what extent does crizanlizumab pose a hazard to patients?

"Although there is some supportive data regarding safety, crizanlizumab earned a score of 2 on the Power scale due to lack of efficacy evidence in Phase 2 trials."

Answered by AI

Could you elucidate other experiments conducted with crizanlizumab?

"At the current moment, 10 clinical studies are in progress for crizanlizumab with 1 existing trial at phase 3. Despite being primarily based in Greenville, South carolina, 401 sites across various locations have taken on these trials."

Answered by AI

What is the sample size of this trial's research participants?

"Currently, this investigation is not recruiting patients. It was opened on December 19th 2017 and last updated April 25th 2022. However, a search of anemia studies reveals 197 trials actively seeking participants while 10 clinical research projects are open for crizanlizumab applicants."

Answered by AI

What are the expected results of this research endeavor?

"As displayed on Novartis Pharmaceuticals' clinical trial page, the primary outcome measured over a Week1 Day1 Pre-dose, 0.5hr, 1hr, 2hr, 4hr, 6hr and 24hrs; Week15 Day1 Pre-dose, 0.5 hr., 1 hr., 2 hr., 4 hr., 6 hrs. and 24 hrs period is to assess crizanlizumab's pharmacokinetics (AUC) at 5 mg/kg in SCD patients. Further objectives will include analyzing efficacy with regards to home VOC treatments documentation by health care providers after phone contact with patient"

Answered by AI

Is this research initiative currently looking for participants?

"This research trial is not currently open to recruitment. It was originally posted on December 19th 2017 and last updated on April 25th 2022. Fortunately, there are 197 active clinical trials that require patients with anemia or sickle cell and 10 other studies recruiting participants for crizanlizumab interventions."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pharmacokinetics and Pharmacodynamics Study of SEG101 (Crizanlizumab) in Sickle Cell Disease (SCD) Patients With Vaso- Occlusive Crisis (VOC)
2017. "Pharmacokinetics and Pharmacodynamics Study of SEG101 (Crizanlizumab) in Sickle Cell Disease (SCD) Patients With Vaso- Occlusive Crisis (VOC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03264989.
~8 spots leftby Apr 2025
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