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

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT06818266
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab (RoActemra®, 20 mg/mL). — DRUG
    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
  • Placebo (NaCl 0.9%) — DRUG
    One single intravenous infusion

Study Details

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).

Key Dates

First listed
Feb 10, 2025
Start date
Aug 27, 2025
Status verified
Jun 2026
Primary completion
Apr 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arms A : 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.
  • Placebo Comparator: Arm B : Placebo (NaCl 0.9%)
    One single intravenous infusion

Primary Outcome Measure

Time to successful weaning from both supplemental oxygen and any respiratory support [ Time Frame: During hospitalization for ACS, from randomization until day 28 after randomization ]

Central Contacts

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