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
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

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

Start date
Apr 30, 2025
Status verified
Mar 2025
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

Related Studies