Sickle Cell DiseasePhase 2GLADIOLUSNCT04987489
A Study of Etavopivat in Patients With Thalassemia or Sickle Cell Disease
A Phase 2 study testing Etavopivat tablets in people with Sickle Cell Disease and Thalassemia, run by Forma Therapeutics, Inc. at 32 sites in 6 countries.
Trial summary
This clinical trial is a Phase 2 study that will evaluate the safety and clinical activity of etavopivat in patients with thalassemia or sickle cell disease and test how well etavopivat works to lower the number of red blood cell transfusions required and increase hemoglobin. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Sickle Cell Disease, Thalassemia
- What is being tested?
- Etavopivat tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 32 sitesin 6 countries
- Study dates
- 28 Mar 2022to 24 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Provision of consent
- Female patients of childbearing potential must use acceptable methods of contraception, male patients are willing to use barrier methods of contraception
- Cohort A (Sickle Cell Disease Transfusion Cohort)
- Confirmed diagnosis of sickle cell disease
- Chronically red blood cell transfused (sample or exchange [manual or via electrophoresis]) for primary stroke prevention or due to previous stroke. Chronic red blood cell transfusion is defined as: ≥ 6 red blood cell units in the previous 24 weeks before the first dose of study treatment and no transfusion-free period for > 35 days during that period
- At least 24 months of chronic monthly red blood cell transfusions for secondary stroke prevention/treatment of primary stroke (initial completed overt clinical stroke with documented infarction on brain computed tomography [CT] or magnetic resonance imaging [MRI])
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- Prior to screening OR at least 12 months of chronic RBC transfusions for primary stroke prevention (abnormal TCD) prior to screening
- Documented adequate monthly transfusions with average HbS ≤ 45% (the upper limit of the established academic community standard) for the previous 12 weeks of red blood cell transfusions before the first dose of study treatment
- Cohort B (Thalassemia Transfusion Cohort)
- Documented diagnosis of β-thalassemia, Hemoglobin E/ β-thalassemia or Hemoglobin H (α-thalassemia), or other thalassemia variant
- Chronically transfused, defined as: ≥ 6 red blood cell units in the previous 24 weeks before the first dose of study treatment and no transfusion-free period for > 35 days during that period
- Cohort C (Thalassemia Non-transfused Cohort)
- Documented diagnosis of β-thalassemia, Hemoglobin E/ β-thalassemia or Hemoglobin H (α-thalassemia), or other thalassemia variant
- Hemoglobin ≤ 10 g/dL
Who cannot join
- Female who is breast feeding or pregnant
- Hepatic dysfunction characterized by:
- Alanine aminotransferase (ALT) > 4.0 × upper limit of normal (ULN)
- Direct bilirubin > 3.0 × ULN
- History of cirrhosis
- Known human immunodeficiency virus (HIV) positivity
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- Active hepatitis B or hepatitis C infection
- Severe renal dysfunction or on chronic dialysis
- History of malignancy within the past 2 years prior to treatment Day 1 requiring systemic chemotherapy and/or radiation.
- Patients with malignancy considered surgically cured are eligible (eg, non- melanoma skin cancer, cancer of the cervix in-situ, ductal carcinoma in situ [Stage 1], Grade 1 endometrial cancer)
- History of unstable or deteriorating cardiac or pulmonary disease within 6 months prior to consent including but not limited to the following:
- Unstable angina pectoris or myocardial infarction or elective coronary intervention
- Congestive heart failure requiring hospitalization
- Uncontrolled clinically significant arrhythmias
- Symptomatic pulmonary hypertension
Trial locations and contacts
32 sites in 6 countries.
32 sites in 6 countries
United States14 sites
Children's Hospital of Atlanta
Atlanta, Georgia, 30342
TOI Clinical Research
Cerritos, California, 90703
[Legal] Children's Hospital Medical Center dba Cincinnati Children's
Cincinnati, Ohio, 45229
[Legal] Dr. Vince Clinical Research, LLC and Dr. Vince Clinical Research, P.A.
Detroit, Michigan, 48201-2018
Duke University
Durham, North Carolina, 27710
East Carolina University
Greenville, North Carolina, 27858
[Legal] Children's Hospital Los Angeles
Los Angeles, California, 90027
University of Californ LA-UCLA
Los Angeles, California, 90095
Weill Medical College of Cornell University
New York, New York, 10065
UCSF Oakland Benioff ChildHosp
Oakland, California, 94609
[Legal] Children's Hospital of Orange County on behalf of CHOC Children's Hospital of Orange County
Orange, California, 92868
UCI Health
Orange, California, 92868
Children's Hosptl Philadelphia
Philadelphia, Pennsylvania, 19104
Children's National Health Hospital
Washington D.C., District of Columbia, 20010
United Kingdom6 sites
Sandwell and West Birmingham NHS Trust SCAT/ haematology
Birmingham, B18 7QH
Barts Health NHS Trust - The Royal London Hospital
London, E1 1FR
University College Hospital - University College London Hospitals NHS Foundation Trust
London, NW1 2PG
Kings College London
London, SE5 9RS
Hammersmith Hospital - London
London, W12 0HS
Manchester University NHS Foundation Trust
Manchester, M13 9WL
Canada4 sites
Master Centre for Canada
Mississauga, Ontario, L4W 4XI
CHU Sainte-Justine Mother and Child University Hospital
Montreal, Quebec, H3T 1C5
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
University Health Network - Toronto General Hospital
Toronto, Ontario, M5G 2C4
Italy4 sites
Galliera Hospital Centro Anemie Congenite
Genova, 16128
Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
AORN A. Cardarelli
Naples, 80131
A.O.U. Università Studi della Campania "Luigi Vanvitelli"
Naples, 80138
Egypt2 sites
Cairo University
Cairo, 12613
Abu El-Reesh El-Mounira Children University Hospital
Cairo, Egypt, 4241317
Lebanon2 sites
Chronic Care Center
Baabda, RGWX 4CG
Hospital Nini
Tripoli, 1434
About this study
Official title: A Phase 2 Open-Label Study to Evaluate Safety and Clinical Activity of Etavopivat in Patients With Thalassemia or Sickle Cell Disease
This clinical trial is a Phase 2 study that will evaluate the safety and clinical activity of etavopivat in patients with thalassemia or sickle cell disease and test how well etavopivat works to lower the number of red blood cell transfusions required and increase hemoglobin.
Read the detailed description
Etavopivat is a potent, selective, orally bioavailable, small-molecule activator of pyruvate kinase red blood cell (PKR) being developed by Forma Therapeutics, Inc and is intended for use as a treatment for patients with sickle cell disease (SCD) or other inherited hemoglobinopathies or refractory anemias. This study is a multicenter, Phase 2, open-label, multiple-cohort study examining the safety and efficacy of etavopivat for the treatment of patients, age 12 to 65 years, with SCD or thalassemia. Three treatment cohorts based on the patients hemoglobinopathy (SCD or thalassemia) and transfusion requirements will be evaluated.
- Conditions
- Sickle Cell Disease, Thalassemia
- Being tested
- Etavopivat tablets
- Keywords
- SCD, sickle cell disease, sickle cell, anemia, sickle cell anemia, hemolytic, hemoglobin, vaso-occlusive crisis, VOC, vaso-occlusive events, sickle cell crisis, pain crisis, pain episode, congenital anemia, hemolytic anemia, hematologic disease, hemoglobinopathy, hemoglobinopathies, genetic disease, inborn disease
- Medical subject headings
- Anemia, Sickle Cell, Thalassemia, Anemia, Hemolysis, Vaso-Occlusive Crises, Anemia, Hemolytic, Hematologic Diseases, Hemoglobinopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etavopivat tabletsDrug
Also called FT-4202
Etavopivat 400 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Etavopivat 400 mg daily - SCD with transfusions | Experimental | Patients with sickle cell disease on chronic red blood cell transfusions Receives: Drug: Etavopivat tablets |
| Etavopivat 400 mg daily - Thalassemia with transfusions | Experimental | Patients with thalassemia on chronic red blood cell transfusions Receives: Drug: Etavopivat tablets |
| Etavopivat 400 mg daily - Thalassemia | Experimental | Patients with thalassemia not on chronic red blood cell transfusions Receives: Drug: Etavopivat tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohorts A: Proportion of patients with ≥ 20% reduction in red blood cell transfusions over a continuous 12-week treatment period versus baseline red blood cell transfusion history
Proportion of patients with ≥ 20% reduction in red blood cell transfusions over a continuous 12-week treatment period versus baseline red blood cell transfusion history
Measured: 12 weeks
Cohorts B: Proportion of patients with ≥ 20% reduction in red blood cell transfusions over a continuous 12-week treatment period versus baseline red blood cell transfusion history
Proportion of patients with ≥ 20% reduction in red blood cell transfusions over a continuous 12-week treatment period versus baseline red blood cell transfusion history
Measured: 12 weeks
Cohort C: Hemoglobin response rate at Week 12 (increase of ≥ 1.0 g/dL from baseline)
Hemoglobin response rate at Week 12 (increase of ≥ 1.0 g/dL from baseline)
Measured: 12 weeks
Secondary outcomes (17)
Cohort A: Proportion of patients with ≥ 33% reduction in red blood cell transfusion over a continuous 12-week treatment period versus baseline red blood cell transfusion history
Proportion of patients with ≥ 33% reduction in red blood cell transfusion over a continuous 12-week treatment period versus baseline red blood cell transfusion history
Measured: 12 weeks
Cohort B: Proportion of patients with ≥ 33% reduction in red blood cell transfusion over a continuous 12-week treatment period versus baseline red blood cell transfusion history
Proportion of patients with ≥ 33% reduction in red blood cell transfusion over a continuous 12-week treatment period versus baseline red blood cell transfusion history
Measured: 12 weeks
Cohort A: Reduction in red blood cell transfusions over 12 weeks
Reduction in red blood cell transfusions over 12 weeks
Measured: 12 weeks
Cohort A: Reduction in red blood cell transfusions over 24 weeks
Reduction in red blood cell transfusions over 24 weeks
Measured: 24 weeks
Cohort A: Reduction in red blood cell transfusions over 48 weeks
Reduction in red blood cell transfusions over 48 weeks
Measured: 48 weeks
Cohort B: Reduction in red blood cell transfusions over 12 weeks
Reduction in red blood cell transfusions over 12 weeks
Measured: 12 weeks
Cohort B: Reduction in red blood cell transfusions over 24 weeks
Reduction in red blood cell transfusions over 24 weeks
Measured: 24 weeks
Cohort B: Reduction in red blood cell transfusions over 48 weeks
Reduction in red blood cell transfusions over 48 weeks
Measured: 48 weeks
Cohort C: Hemoglobin response rate at Week 24 (increase of ≥ 1.0 g/dL from baseline).
Hemoglobin response rate at Week 24 (increase of ≥ 1.0 g/dL from baseline).
Measured: 24 weeks
Cohort C: Hemoglobin response rate at Week 48 (increase of ≥ 1.0 g/dL from baseline).
Hemoglobin response rate at Week 48 (increase of ≥ 1.0 g/dL from baseline).
Measured: 48 weeks
Change from baseline in hemoglobin over 12 weeks
Change from baseline in hemoglobin over 12 weeks
Measured: 12 weeks
Change from baseline in hemoglobin over 24 weeks
Change from baseline in hemoglobin over 24 weeks
Measured: 24 weeks
Change from baseline in hemoglobin over 48 weeks
Change from baseline in hemoglobin over 48 weeks
Measured: 48 weeks
Changes in serum ferritin levels at 12 weeks versus baseline
Changes in serum ferritin levels at 12 weeks versus baseline
Measured: 12 weeks
Changes in serum ferritin levels at 24 weeks versus baseline
Changes in serum ferritin levels at 24 weeks versus baseline
Measured: 24 weeks
Changes in serum ferritin levels at 48 weeks versus baseline
Changes in serum ferritin levels at 48 weeks versus baseline
Measured: 48 weeks
Changes in liver iron concentration at 48 weeks versus baseline
Changes in liver iron concentration at 48 weeks versus baseline
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start28 Mar 2022
- Primary completion3 Sep 2025
- Study completion24 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forma Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987489
- Sponsor's protocol ID
- 4202-HEM-201
- Acronym
- GLADIOLUS
- Status last verified
- Dec 2025
- First submitted
- 22 Jul 2021
- Last updated
- 16 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-Label Study to Evaluate Safety and Clinical Activity of Etavopivat in Patients With Thalassemia or Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT04987489
- Acronym / sponsor ID
- GLADIOLUS / 4202-HEM-201
- Conditions
- Sickle Cell Disease, Thalassemia
- Keywords
- SCD, sickle cell disease, sickle cell, anemia, sickle cell anemia, hemolytic, hemoglobin, vaso-occlusive crisis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Forma Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is a Phase 2 study that will evaluate the safety and clinical activity of etavopivat in patients with thalassemia or sickle cell disease and test how well etavopivat works to lower the number of red blood cell transfusions required and increase hemoglobin.
Detailed description
Etavopivat is a potent, selective, orally bioavailable, small-molecule activator of pyruvate kinase red blood cell (PKR) being developed by Forma Therapeutics, Inc and is intended for use as a treatment for patients with sickle cell disease (SCD) or other inherited hemoglobinopathies or refractory anemias. This study is a multicenter, Phase 2, open-label, multiple-cohort study examining the safety and efficacy of etavopivat for the treatment of patients, age 12 to 65 years, with SCD or thalassemia. Three treatment cohorts based on the patients hemoglobinopathy (SCD or thalassemia) and transfusion requirements will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Etavopivat 400 mg daily - SCD with transfusions | Experimental | Drug: Etavopivat tabletsPatients with sickle cell disease on chronic red blood cell transfusions |
| Etavopivat 400 mg daily - Thalassemia with transfusions | Experimental | Drug: Etavopivat tabletsPatients with thalassemia on chronic red blood cell transfusions |
| Etavopivat 400 mg daily - Thalassemia | Experimental | Drug: Etavopivat tabletsPatients with thalassemia not on chronic red blood cell transfusions |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Provision of consent
- Female patients of childbearing potential must use acceptable methods of contraception, male patients are willing to use barrier methods of contraception
- Cohort A (Sickle Cell Disease Transfusion Cohort)
- Confirmed diagnosis of sickle cell disease
- Chronically red blood cell transfused (sample or exchange [manual or via electrophoresis]) for primary stroke prevention or due to previous stroke. Chronic red blood cell transfusion is defined as: ≥ 6 red blood cell units in the previous 24 weeks before the first dose of study treatment and no transfusion-free period for > 35 days during that period
Key exclusion criteria (15 listed)
- Female who is breast feeding or pregnant
- Hepatic dysfunction characterized by:
- Known human immunodeficiency virus (HIV) positivity
- Active hepatitis B or hepatitis C infection
- Severe renal dysfunction or on chronic dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etavopivat tabletsAlso: FT-4202Etavopivat 400 mg once daily | Drug | Etavopivat 400 mg daily - SCD with transfusions, Etavopivat 400 mg daily - Thalassemia, Etavopivat 400 mg daily - Thalassemia with transfusions |
Primary outcome
Cohorts A: Proportion of patients with ≥ 20% reduction in red blood cell transfusions over a continuous 12-week treatment period versus baseline red blood cell transfusion history
Time frame: 12 weeks
Proportion of patients with ≥ 20% reduction in red blood cell transfusions over a continuous 12-week treatment period versus baseline red blood cell transfusion history
Cohorts B: Proportion of patients with ≥ 20% reduction in red blood cell transfusions over a continuous 12-week treatment period versus baseline red blood cell transfusion history
Time frame: 12 weeks
Proportion of patients with ≥ 20% reduction in red blood cell transfusions over a continuous 12-week treatment period versus baseline red blood cell transfusion history
Cohort C: Hemoglobin response rate at Week 12 (increase of ≥ 1.0 g/dL from baseline)
Time frame: 12 weeks
Hemoglobin response rate at Week 12 (increase of ≥ 1.0 g/dL from baseline)
17 secondary outcomes
Cohort A: Proportion of patients with ≥ 33% reduction in red blood cell transfusion over a continuous 12-week treatment period versus baseline red blood cell transfusion history
Time frame: 12 weeks
Cohort B: Proportion of patients with ≥ 33% reduction in red blood cell transfusion over a continuous 12-week treatment period versus baseline red blood cell transfusion history
Time frame: 12 weeks
Cohort A: Reduction in red blood cell transfusions over 12 weeks
Time frame: 12 weeks
Cohort A: Reduction in red blood cell transfusions over 24 weeks
Time frame: 24 weeks
Cohort A: Reduction in red blood cell transfusions over 48 weeks
Time frame: 48 weeks
Cohort B: Reduction in red blood cell transfusions over 12 weeks
Time frame: 12 weeks
Cohort B: Reduction in red blood cell transfusions over 24 weeks
Time frame: 24 weeks
Cohort B: Reduction in red blood cell transfusions over 48 weeks
Time frame: 48 weeks
Cohort C: Hemoglobin response rate at Week 24 (increase of ≥ 1.0 g/dL from baseline).
Time frame: 24 weeks
Cohort C: Hemoglobin response rate at Week 48 (increase of ≥ 1.0 g/dL from baseline).
Time frame: 48 weeks
Change from baseline in hemoglobin over 12 weeks
Time frame: 12 weeks
Change from baseline in hemoglobin over 24 weeks
Time frame: 24 weeks
Change from baseline in hemoglobin over 48 weeks
Time frame: 48 weeks
Changes in serum ferritin levels at 12 weeks versus baseline
Time frame: 12 weeks
Changes in serum ferritin levels at 24 weeks versus baseline
Time frame: 24 weeks
Changes in serum ferritin levels at 48 weeks versus baseline
Time frame: 48 weeks
Changes in liver iron concentration at 48 weeks versus baseline
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
32 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Etavopivat tablets in people with Sickle Cell Disease and Thalassemia, run by Forma Therapeutics, Inc. at 32 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, United Kingdom, Canada, Italy, Egypt and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohorts A: Proportion of patients with ≥ 20% reduction in red blood cell transfusions over a continuous 12-week treatment period versus baseline red blood cell transfusion history (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.