Crizanlizumab for Sickle Cell Disease (SPARKLE Trial)

Phase 3

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Key

Participants must be aged 12 years and older on the day of signing informed consent. Adolescents include participants aged 12 to <18 years old and adults include participants aged 18 years and older.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Pivotal Trial

Summary

"This trial is testing a new drug called crizanlizumab to see if it can help reduce the number of painful episodes in adolescent and adult patients with Sickle Cell Disease. The study

Who is the study for?

This trial is for adolescents and adults aged 12 years and older with confirmed Sickle Cell Disease (SCD). They must have experienced 4 to 12 vaso-occlusive crises (VOCs) in the past year. If they're on hydroxyurea/hydroxycarbamide, it should be a stable dose for at least 3 months before the study.

What is being tested?

The SPARKLE study is testing Crizanlizumab (5 mg/kg) against a placebo to see if it's effective and safe in reducing VOCs in SCD patients. This includes those taking hydroxyurea/hydroxycarbamide, with participants randomly assigned to either group.

What are the potential side effects?

Possible side effects of Crizanlizumab may include joint pain, back pain, nausea, fever, abdominal pain or discomfort. Side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 12 years old or older.

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I have been diagnosed with sickle cell disease through a blood test.

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I haven't taken hydroxyurea, hydroxycarbamide, or erythropoietin for the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Annualized rate of VOCs that are healthcare professional (HCP)-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) in each treatment arm

Secondary study objectives

Absolute change from baseline in hemoglobin

Annualized rate of VOC by subtype of management in each treatment arm over the planned 52-week period.

Duration of VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) in each treatment arm over the planned 52-week treatment period.

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