Phase 3 Sickle Cell Disease Trial, Recruiting NCT06818266 Sponsor: Assistance Publique - Hôpitaux de Paris Condition: Sickle Cell Disease
Back to Sickle Cell Disease

Phase 3 Sickle Cell Disease Trial, Recruiting

NCT06818266
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with sickle cell disease of any type (such as SS, SC, S/β0, S/β+, or similar)
  • You are 2 years old or older
  • You are currently in hospital with Acute Chest Syndrome (ACS), which means you have a new abnormal finding on a chest X-ray, ultrasound, or CT scan, along with a fever and/or breathing problems
  • You have needed extra oxygen or breathing support (such as a breathing mask, nasal oxygen tube, or ventilator) for less than 48 hours
  • If you are a girl or woman who could become pregnant, you have a negative pregnancy test
  • You (or your legal guardian) are willing and able to give written consent to take part
  • You are covered by social security or health insurance
  • If you could become pregnant, you agree to use effective contraception for up to 3 months after receiving the study treatment

Who may not be able to join:

  • The study treatment cannot be given within the first 48 hours of needing extra oxygen or breathing support
  • You have a known allergy or sensitivity to tocilizumab (the study drug) or any of its ingredients
  • You currently have a serious active infection, such as tuberculosis, hepatitis B or C, herpes zoster, or another serious bacterial, viral, or fungal infection
  • You have received a live or weakened vaccine in the last 4 weeks
  • You have taken immune-suppressing, anti-rejection, or cell-reducing medications, or have been in another drug trial, within the last 3 months
  • You have had a severe allergic or life-threatening reaction to certain types of antibody-based medicines in the past
  • You have a history of certain bowel conditions, such as diverticulitis, Crohn's disease, or ulcerative colitis, that could increase the risk of bowel complications
  • You have been diagnosed with cancer in the last 3 years
  • You are currently pregnant or breastfeeding
  • In the doctor's opinion, your condition is expected to deteriorate to death very soon
  • Your blood counts or certain blood test results are below safe levels (confirm with trial site)
  • Your liver function tests are significantly above the normal range (confirm with trial site)
  • Your kidneys are not filtering blood well enough (confirm with trial site)
  • You are currently taking part in another clinical drug trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Slimane ALLALI, MD, PhD, Department of General Pediatrics and Sickle Cell Center, Necker-Enfants malades Hospital, Paris, France

Phone: 01 44 49 48 96

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
27 August 2025
Est. completion
1 April 2027

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Time to successful weaning from both supplemental oxygen and any respiratory support

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov