Phase 3 Sickle Cell Disease Trial, Recruiting NCT05431088 Sponsor: Pfizer Condition: Sickle Cell Disease
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Phase 3 Sickle Cell Disease Trial, Recruiting

NCT05431088
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 sickle cell disease (SCD)
  • Your hemoglobin (a measure of red blood cells) levels are considered stable by your doctor
  • If you are taking hydroxyurea and/or L-glutamine, your dose has been unchanged for at least 90 days before joining and is not expected to change during the study
  • You are between 12 and 65 years old (for the main study portion called Part B)
  • You have had 2 or more, but no more than 10, pain crises (called vaso-occlusive crises, or VOCs) in the past 12 months (for Part B)
  • You have already completed Part B of the study (to be eligible for the follow-on open-label extension portion)

Who may not be able to join:

  • You have had more than 10 pain crises (VOCs) in the past 12 months
  • You are currently pregnant or breastfeeding
  • You receive regular red blood cell transfusions, or you have had a red blood cell transfusion for any reason in the past 90 days
  • You were hospitalized for a sickle cell crisis or related painful event within the past 14 days before signing up, or at any point during the screening period

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: Pfizer CT.gov Call Center, Pfizer

Phone: 1-800-718-1021

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
22 September 2022
Est. completion
30 December 2030

Where this trial is recruiting

🇧🇷 Brazil 🇮🇳 India Kenya Nigeria 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Part A; Part B; OLE

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