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Small Molecule

Etavopivat for Sickle Cell Disease

Phase 2 & 3
Recruiting
Research Sponsored by Forma Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients taking hydroxyurea, must demonstrate a stable dose for at least 90 days prior to start of study treatment
At least 2 episodes of vaso-occlusive crises in the past 12 months
Must not have
Severe renal dysfunction or on chronic dialysis
Hepatic dysfunction characterized by: Alanine aminotransferase (ALT) > 4.0 × upper limit of normal (ULN), Direct bilirubin > 3.0 × ULN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks

Summary

This trial is testing a drug called etavopivat to see if it can help people with sickle cell disease. The drug aims to improve blood health and reduce pain by making red blood cells work better. The study includes patients aged 12 to 65.

Who is the study for?
This trial is for adults and adolescents with sickle cell disease who have had at least 2 pain crises in the past year. They must be on a stable dose of certain medications, not pregnant or breastfeeding, without severe liver, kidney, heart or blood vessel problems. Participants need to use effective contraception.
What is being tested?
The study tests low and high doses of Etavopivat tablets against placebo tablets to see if they can increase hemoglobin levels and reduce pain crises caused by blocked blood vessels in patients with sickle cell disease.
What are the potential side effects?
Potential side effects are not detailed here but may include reactions related to altering hemoglobin function and typical drug-related side effects such as digestive issues, headaches, fatigue or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on a stable dose of hydroxyurea for at least 90 days.
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I have had at least 2 pain crises due to sickle cell in the last year.
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I have been diagnosed with sickle cell disease.
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I'm sorry, I cannot summarize the screening criterion as it is incomplete. Please provide more information.

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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My liver tests show high levels of ALT and bilirubin.
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I have an active hepatitis B or C infection.
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I haven't had serious heart or lung issues in the last 6 months.
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I am currently pregnant or breastfeeding.
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I've had over 10 pain crises due to sickle cell in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Annualized vaso-occlusive crisis
Hemoglobin response rate
Secondary study objectives
Absolute reticulocyte count
Hemoglobin
Lactate dehydrogenase
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Open label etavopivatExperimental Treatment1 Intervention
Open label etavopivat
Group II: Double blind placeboExperimental Treatment1 Intervention
Double blind placebo
Group III: Double blind etavopivat Low DoseExperimental Treatment2 Interventions
Double blind etavopivat Low Dose
Group IV: Double blind etavopivat High DoseExperimental Treatment2 Interventions
Double blind etavopivat High Dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo Tablets
2014
Completed Phase 4
~7380

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SIndustry Sponsor
1,553 Previous Clinical Trials
2,445,192 Total Patients Enrolled
Forma Therapeutics, Inc.Lead Sponsor
12 Previous Clinical Trials
877 Total Patients Enrolled
Vandy Black, MDStudy DirectorForma Therapeutics, Inc.

Media Library

Etavopivat (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT04624659 — Phase 2 & 3
~82 spots leftby Mar 2026
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