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A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS)

NCT04624659 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2026-04-06

No results posted yet for this study

Summary

This clinical trial is a Phase 2/3 study that will evaluate the efficacy and safety of etavopivat and test how well etavopivat works compared to placebo to improve the amount of hemoglobin in the blood and to reduce the number of vaso-occlusive crises (times when the blood vessels become blocked and cause pain).

Conditions

Interventions

DRUG

Etavopivat Tablets Low dose

200 mg once daily

DRUG

Etavopivat Tablets High dose

400 mg once daily

DRUG

Placebo Tablets

Placebo once daily

DRUG

Etavopivat Tablets

Selected dose once daily

Sponsors & Collaborators

  • This study is currently undergoing a sponsor transition from Forma to Novo Nordisk. Sponsor field will be updated once the transition is complete.

    collaborator UNKNOWN

  • Forma Therapeutics, Inc.

    lead INDUSTRY

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
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-29
Primary Completion
2026-02-06
Completion
2027-03-19
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Egypt
  • France
  • Germany
  • Ghana
  • Greece
  • India
  • Italy
  • Kenya
  • Lebanon
  • Nigeria
  • Oman
  • Saudi Arabia
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT04624659 on ClinicalTrials.gov