At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Etavopivat (drug), Placebo (drug)
- How long the study runs
- Study runs about 54 months (dates as stated)
- About the drug or intervention
- Etavopivat — drug: Etavopivat will be administered orally. · Placebo — drug: Placebo matching Etavopivat will be administered orally.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 12 Years and over
- Who
- All
- Number of participants
- 510
- Started
- 2025-02-17
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for sickle cell disease
- • Phase3 - 510 participants
- • This study is conducted to confirm whether etavopivat works well at reducing the number of Vaso-occlusive crisis VOCs (sickle cell pain crises) caused by obstructions in blood vessels in adults and adolescents living with sickle cell disease
Who can take part?
- • Ages 12 Years and over
- • Diagnosed with sickle cell disease
Where?
- • Cambridge - Addenbrooke's Hospital - Haemophilia and Thrombophilia
- • London - Whittington Hospital
- • London - Guy's Hospital - Haematology
- • London - King's College Hospital - Paediatric Research
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study is conducted to confirm whether etavopivat works well at reducing the number of Vaso-occlusive crisis VOCs (sickle cell pain crises) caused by obstructions in blood vessels in adults and adolescents living with sickle cell disease. The study will also evaluate how well etavopivat can reduce the damage to different organs, improve your exercise tolerance and reduce fatigue in people with sickle cell disease.The participants will either get etavopivat or placebo. Which treatment the participants will get is decided by chance. Etavopivat is a new medicine and is currently being tested in other studies in addition to this one. The study will last for about 2 years.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 12 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Male or female.
- ✓Age 12 years or above at the time of signing the agreement to take part.
- ✓Hb greater than or equal to (≥) 5.0 and less than or equal to (≤) 10.0 g/dL (greater than or equal to (≥) 50 and...
Who cannot take part
- ✗Use of voxelotor or similar agent within 28 days prior to starting study treatment or anticipated need for this...
- ✗Use of erythropoietin or other haematopoietic growth factor treatment within 28 days of starting study treatment or...
- ✗Receipt of prior cellular-based therapy (e.g., haematopoietic cell transplant, gene modification therapy).
- ✗liver dysfunction characterized by:
- ✗Alanine aminotransferase (liver enzymes) greater than 4.0 × upper limit of normal (ULN) or
See the full criteria
Where Is This Study? (6 UK sites)
Addenbrooke's Hospital - Haemophilia and Thrombophilia
Cambridge CB2 0QQ, United Kingdom
Whittington Hospital
London N19 5NF, United Kingdom
Guy's Hospital - Haematology
London SE1 9RT, United Kingdom
King's College Hospital - Paediatric Research
London SE5 9RS, United Kingdom
Kings College Hospital - Haematology
London SE5 9RS, United Kingdom
Imperial College London
London W12 0NN, United Kingdom
How to Get in Touch
Novo Nordisk
Sponsor contactCONTACT
