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NOT YET RECRUITING
NCT06818266
PHASE3

Efficacy and Safety of Tocilizumab for Acute Chest Syndrome Treatment in Patients With Sickle Cell Disease

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine whether a single infusion of tocilizumab is effective in reducing the time to successful weaning from both supplemental oxygen and any respiratory support, in pediatric and adult patients with sickle cell disease (SCD) during acute chest syndrome (ACS).

Official title: Efficacy and Safety of Tocilizumab for Acute Chest Syndrome Treatment in Pediatric and Adult Patients With Sickle Cell Disease

Key Details

Gender

All

Age Range

2 Years - Any

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2025-04

Completion Date

2027-07

Last Updated

2025-03-11

Healthy Volunteers

No

Interventions

DRUG

Tocilizumab (RoActemra®, 20 mg/mL).

One single intravenous infusion at 8 mg/kg (up to a maximum of 800 mg) for patients ≥ 30 kg and 12 mg/kg for patients \< 30 kg

DRUG

Placebo (NaCl 0.9%)

One single intravenous infusion

Locations (1)

Department of General Pediatrics and Sickle Cell Center, Necker-Enfants malades Hospital

Paris, France