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Looking for participantsPhase3

A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia

Sponsor: Novo Nordisk A/S

NCT ID: NCT06609226

View on ClinicalTrials.gov ↗

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 A (drug), Etavopivat B (drug), Etavopivat C (drug)
How long the study runs
Study runs about 71 months (dates as stated)
About the drug or intervention
Etavopivat A — drug: Participants will receive an oral dose of Etavopivat A. · Etavopivat B — drug: Participants will receive an oral dose of Etavopivat B. · Etavopivat C — drug: Participants will receive an oral dose of Etavopivat C.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
2 Years and over
Who
All
Number of participants
480
Started
2025-01-10
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for sickle cell disease
  • • Phase3 - 480 participants
  • • Etavopivat is a new medicine under development for treating blood disorders like sickle cell disease and thalassaemia

Who can take part?

  • • Ages 2 Years and over
  • • Diagnosed with sickle cell disease

Where?

  • • London - Evelina London Children's Hospital - Haemophilia
  • • London - Guy's Hospital - Haematology
  • • London - Guy's Hospital
  • • London - King's College Hospital - Paediatric Research
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

Etavopivat is a new medicine under development for treating blood disorders like sickle cell disease and thalassaemia. Sickle cell disease and thalassaemia are inherited blood disorders that affect haemoglobin. Haemoglobin is the protein that carries oxygen through the body. This study is looking into how safe treatment with etavopivat is and how well it works over a long period of time. The study will last for up to 264 weeks, but it will end earlier if etavopivat is approved in the participant's country.

Sickle Cell DiseaseThalassemia

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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: 2 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ derived clinical benefit from treatment with etavopivat, as determined by the investigator

What the study is looking for

  • ✓Participant must have ongoing participation in an etavopivat parent study for treatment of sickle cell disease (SCD)...
  • ✓Participant must have derived clinical benefit from treatment with etavopivat, as determined by the investigator.
  • ✓Any participant with dose reduction or temporary discontinuation will need to be successfully rechallenged to the...

Who cannot take part

  • ✗Any disorder, except for conditions associated with SCD or thalassaemia, which in the investigator's opinion might...
  • ✗Participant withdrew or had permanent treatment discontinuation from an etavopivat clinical study.
  • ✗Participants on permanent dose reduction (greater than \[\>\] 28 days or more) or ongoing temporary treatment...
  • ✗Use of any of the following within the timeframes prior to the transfer visit as stated:
  • ✗Use of haemoglobin S (HbS) polymerisation inhibitors within participation of the parent study or anticipated need...
See the full criteria
Inclusion Criteria: * Participant must have ongoing participation in an etavopivat parent study for treatment of sickle cell disease (SCD) or thalassaemia and have completed at least a treatment period of the parent study. * Participant must have derived clinical benefit from treatment with etavopivat, as determined by the investigator. * Any participant with dose reduction or temporary discontinuation will need to be successfully rechallenged to the full dose of etavopivat before transferring. * Participants on hydroxyurea (HU), crizanlizumab or l-glutamine oral powder (Endari®) treatment at the time of consent may be eligible if they have been on a stable dose in the parent study as defined at the investigator's discretion. Necessary adjustments related to weight or age are accepted. Participants with temporary dose reductions or pauses due to medical reasons may still be considered to have a stable dose, as determined by the investigator, who will assess the impact of these adjustments based on clinical context and the participant's overall health status. Exclusion Criteria: * Any disorder, except for conditions associated with SCD or thalassaemia, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Participant withdrew or had permanent treatment discontinuation from an etavopivat clinical study. * Participants on permanent dose reduction (greater than \[\>\] 28 days or more) or ongoing temporary treatment discontinuation. * Use of any of the following within the timeframes prior to the transfer visit as stated: * Use of haemoglobin S (HbS) polymerisation inhibitors within participation of the parent study or anticipated need for this agent during this study. * Use of an experimental selectin antagonist (e.g., monoclonal antibody or small molecule) within the parent study or anticipated need for such agents during this study. * Use of erythropoietin or other haematopoietic growth factor treatment for more than 4 consecutive weeks during the parent study or anticipated need of such agents for a maintenance treatment during this study. * Receiving or use of concomitant medications that are strong inducers of cytochrome P450 (CYP) 3A4 within 2 weeks of the transfer visit or anticipated need for such agents during the study. * Current participation in a study that is not a designated parent study, or planned participation in any other clinical study, for the duration of FLORAL.

Where Is This Study? (8 UK sites)

Evelina London Children's Hospital - Haemophilia

London SE1 7EH, United Kingdom

NOT_YET_RECRUITING

Guy's Hospital - Haematology

London SE1 9RT, United Kingdom

Recruiting

Guy's Hospital

London SE1 9RT, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

King's College Hospital - Paediatric Research

London SE5 9RS, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

Kings College Hospital - Haematology

London SE5 9RS, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

Imperial College London

London W12 0NN, United Kingdom

Recruiting
Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

Manchester Royal Infirmary

Manchester M13 9WL, United Kingdom

Recruiting
Hospital R&D contact (matched)

Elizabeth Mainwaring

R&D.applications@mft.nhs.uk0161 276 3340

Royal Hallamshire Hospital

Sheffield S10 2JF, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

How to Get in Touch

Novo Nordisk

Sponsor contact

CONTACT

(+1) 866-867-7178 clinicaltrials@novonordisk.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09