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Etavopivat for Sickle Cell Disease (Hibiscus 2 Trial)

Phase 3

Waitlist Available

Research Sponsored by Novo Nordisk A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 12 years or above at the time of signing the informed consent

Confirmed diagnosis of sickle cell disease with documentation of SCD genotype (HbSS, HbSβ0-thalassemia or other sickle cell syndrome variants)

Must not have

Severe renal dysfunction or on chronic dialysis

Recent use or anticipated need for voxelotor or similar agent within 28 days prior to starting study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 0) to week 52

Awards & highlights

Summary

"This trial aims to see if a new medication called etavopivat can reduce the number of sickle cell pain crises in adults and adolescents with sickle cell disease. It will also look at

Who is the study for?

This trial is for adults and adolescents with sickle cell disease. Participants should be experiencing vaso-occlusive crises, which are painful episodes due to blood vessel blockages. The study aims to include those who could benefit from reduced organ damage, improved exercise tolerance, and less fatigue.

What is being tested?

The trial is testing Etavopivat's effectiveness in reducing the frequency of pain crises and improving overall health in sickle cell patients compared to a placebo. Patients will be randomly assigned to receive either Etavopivat or a placebo over approximately two years.

What are the potential side effects?

As Etavopivat is new, side effects are still being studied but may include typical drug reactions such as nausea, headaches, or potential risks specific to its mechanism of action on red blood cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 12 years old or older.

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I have a confirmed diagnosis of sickle cell disease with a known genotype.

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I have had 1-15 pain crises due to sickle cell in the last year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe kidney problems or am on long-term dialysis.

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I haven't used, nor do I plan to use voxelotor or similar drugs within 28 days before starting the study treatment.

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I haven't had a blood transfusion in the last 60 days or my HbA1c is under 10%.

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I haven't taken strong CYP3A4 inducers in the last 2 weeks.

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My liver tests are not within normal limits.

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I have received cell-based therapy before.

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I haven't used erythropoietin or blood cell growth factors in the last 28 days.

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I have had 6 or more blood transfusions in the last year.

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I walked less than 100 meters in a 6-minute walk test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 0) to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 0) to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0) to week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in distance travelled during the 6-minute walking test (6MWT)

Change in standardised T-score on the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a Scale

Number of adjudicated Vaso-occlusive crisis (VOC) events with a medical contact

+1 more

Secondary study objectives

Change in Haemoglobin (Hb) greater than 1 grams per decilitre (g/dL)

Change in N-terminal pro b-type natriuretic peptide (NT-pro-BNP)

Change in absolute reticulocyte count

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EtavopivatExperimental Treatment1 Intervention

Participants will be randomised to receive oral dose of Etavopivat.

Group II: PlaceboPlacebo Group1 Intervention

Participants will be randomised to receive oral dose of placebo.

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor

1,546 Previous Clinical Trials

2,443,501 Total Patients Enrolled

Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S

127 Previous Clinical Trials

152,033 Total Patients Enrolled

~272 spots leftby Dec 2025

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