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A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease

NCT06612268 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2026-04-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Etavopivat

Etavopivat will be administered orally.

DRUG

Placebo

Placebo matching Etavopivat will be administered orally.

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency (dept. 2834) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-17
Primary Completion
2027-08-27
Completion
2029-03-12
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Colombia
  • France
  • Ghana
  • Greece
  • India
  • Italy
  • Kenya
  • Lebanon
  • Netherlands
  • Nigeria
  • Oman
  • Saudi Arabia
  • Spain
  • Turkey (Türkiye)
  • Uganda
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06612268 on ClinicalTrials.gov