NCT06439082 - A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE) | Biotech Hunter

Enrollment

315

Participants

Timeline

Start Date

October 24, 2024

Primary Completion Date

March 23, 2029

Study Completion Date

April 19, 2030

Conditions

Sickle Cell Disease

Interventions

BIOLOGICAL

Crizanlizumab

Crizanlizumab is supplied in single use 10 mL glass vials at a concentration of 10 mg/mL. One vial contains 100 mg of crizanlizumab. This is a concentrate for solution for IV infusion.

DRUG

Placebo

Placebo is supplied in single use 10 mL glass vials at a concentration of 0 mg/mL. This is a concentrate for solution for IV infusion.

Trial Locations (12)

10467

RECRUITING

Childrens Hospital at Montefiore, The Bronx

18045

RECRUITING

Spoknwrdclinicaltrials, Easton

20010

RECRUITING

Childrens National Hospital, Washington D.C.

27834

RECRUITING

East Carolina University, Greenville

30274

RECRUITING

WCG Sonar Clinical Research, Riverdale

30912

RECRUITING

Augusta University Georgia, Augusta

32209

RECRUITING

University of Florida, Jacksonville

40202

RECRUITING

Norton Children s Hospital, Louisville

230001

RECRUITING

Novartis Investigative Site, Montería

760012

RECRUITING

Novartis Investigative Site, Santiago de Cali

760046

RECRUITING

Novartis Investigative Site, Santiago de Cali

050001

RECRUITING

Novartis Investigative Site, Medellín