Phase 3 Sickle Cell Disease Trial, Recruiting NCT06975865 Sponsor: Sanofi Condition: Sickle Cell Disease
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Phase 3 Sickle Cell Disease Trial, Recruiting

NCT06975865
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 (SCD).
  • You have had at least 2 but no more than 10 painful crises (called vaso-occlusive crises) that were recorded by a doctor in the past 12 months.
  • You are either not currently taking hydroxyurea and/or L-glutamine (and don't plan to during the study), or you have been taking one or both of these medications for at least 6 months and have been on the same dose for at least 3 months, with plans to stay on that same dose throughout the study.
  • Your general health and ability to carry out daily activities meets a certain standard, rated as a grade 2 or lower on a standard medical scale (confirm with trial site).
  • You are willing and able to use appropriate contraception during the study, in line with local guidelines.
  • If you are between 10 and 17 years old, your parent or legal guardian must give written permission before any study activities begin.

Who may not be able to join:

  • You have a history of lymphoma, leukemia, or any other cancer in the past 5 years (certain treated skin cancers with no spread in the last 3 years may be an exception — confirm with trial site).
  • You have a significant heart problem or an abnormal heart reading on an ECG, as judged by the study doctor.
  • You have a history of stroke or have had an abnormal result on a specific type of brain blood-flow test (transcranial Doppler).
  • You have an active or uncontrolled hepatitis B or hepatitis C infection, including if you are currently on antiviral treatment for these conditions.
  • You have HIV infection.
  • You have a history of tuberculosis (TB), whether active or latent (a past infection that was not fully active).
  • You have recently tested positive for COVID-19 on a molecular test.
  • You have taken crizanlizumab (ADAKVEO®) within the past 90 days, or voxelotor (OXBRYTA®) within the past 30 days before your screening visit.

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

Phone: 800-633-1610

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
Sponsor
Registry
ClinicalTrials.gov
Start date
12 August 2025
Est. completion
23 July 2027

Where this trial is recruiting

🇧🇪 Belgium 🇧🇷 Brazil 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇮🇱 Israel 🇮🇹 Italy 🇳🇱 Netherlands Oman 🇪🇸 Spain Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Annualized rate of clinical VOC

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