Phase 3 Sickle Cell Disease Trial, Recruiting
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:
- People aged 12 years or older at the time of signing the consent form, including both adolescents (12 to under 18 years) and adults (18 and older).
- People who have a confirmed diagnosis of sickle cell disease (SCD), based on specific blood tests (Hb electrophoresis or HPLC) — all types of SCD are eligible.
- People who have had between 4 and 12 painful crises (called VOCs) managed by a healthcare professional in the 12 months before the screening visit, with these episodes recorded in their medical history.
- People who are taking a medicine called hydroxyurea (HU/HC) must have been on it for at least 6 months and at a stable dose for at least 3 months before screening, with plans to continue at the same dose for at least 52 weeks of the study; those who started it 6–12 months before screening must show it has not been controlling their pain well enough, with at least 2 crises in the last 6 months while on it (confirm with trial site).
- People taking an erythropoietin-stimulating agent must have been on it for at least 6 months before screening and plan to continue at the same dose for at least 52 weeks of the study.
- People who are not taking hydroxyurea or an erythropoietin-stimulating agent must not have taken either of these medicines for at least 6 months before the screening visit.
Who may not be able to join:
- People who have had fewer than 4 or more than 12 healthcare-managed painful crises in the 12 months before the screening visit.
- People who have previously had a stem cell transplant or gene therapy.
- People who have received blood products within 30 days before the first dose of the study treatment.
- People who have a documented history of a stroke, bleeding in the brain, or a neurological symptom that has not been investigated in the past 12 months (note: silent infarcts seen only on imaging scans do not exclude someone from joining).
- People who are on a planned, ongoing transfusion programme for prevention purposes, or who plan to have an exchange transfusion during the study (emergency transfusions for worsened anaemia or a painful crisis are allowed).
- People who have a known allergy or serious sensitivity to the study drug, similar types of drugs, or any of their ingredients, or who have had a severe allergic reaction to a similar type of medication (monoclonal antibodies) that the trial doctor considers a safety risk.
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.
Contact this trial
Phone: 1-888-669-6682
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
Where this trial is recruiting
Primary endpoints
Annualized rate of VOCs that are healthcare professional (HCP)-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) in each treatment arm
Can't join this trial?
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.