NCT06612268

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

A Global Phase 3, Randomised, Double-blind and Placebo-controlled Study Evaluating the Efficacy and Safety of Etavopivat in Adolescents and Adults With Sickle Cell Disease

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 408 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	Etavopivat	Etavopivat will be administered orally.
DRUG	Placebo	Placebo matching Etavopivat will be administered orally.

Timeline

• Start date: 2025-02-17
• Primary completion: 2027-08-27
• Completion: 2029-03-12
• First posted: 2024-09-25
• Last updated: 2026-03-24

Locations

172 sites across 21 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

Regulatory

• FDA-regulated drug study