Sickle Cell DiseasePhase 3NCT04935879
A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises
A Phase 3 study testing Inclacumab in people with Sickle Cell Disease and Vaso-occlusive Pain Episode in Sickle Cell Disease, run by Pfizer at 58 sites in 12 countries.
Trial summary
This Phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (VOCs) in approximately 240 adult and adolescent participants (≥ 12 years of age) with sickle cell disease (SCD). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Sickle Cell Disease, Vaso-occlusive Pain Episode in Sickle Cell Disease, Vaso-occlusive Crisis
- What is being tested?
- Inclacumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 241 participants
- Where
- 58 sitesin 12 countries
- Study dates
- 4 Oct 2021to 6 Jun 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participant has a confirmed diagnosis of SCD (HbSS, HbSC, HbSB0 thalassemia, or HbSB+ thalassemia genotype).
- Documentation of SCD genotype is required and may be based on documented history of laboratory testing or confirmed by laboratory testing during Screening.
- Participant is male or female, ≥ 12 years of age at the time of informed consent.
- Participant has experienced between 2 and 10 VOCs within the 12 months prior to the Screening Visit as determined by documented medical history. A prior VOC is defined as an acute episode of pain which:
- Has no medically determined cause other than a vaso-occlusive event, and
- Results in a visit to a medical facility (hospital, emergency department, urgent care center, outpatient clinic, or infusion center) or results in a remote contact with a healthcare provider; and
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- Requires parenteral narcotic agents, parenteral nonsteroidal anti- inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics.
- Participants receiving erythropoiesis-stimulating agents (ESA, e.g., erythropoietin [EPO]) must be on a stable dose for at least 90 days prior to the Screening Visit and expected to continue with the stabilized regimen throughout the course of the study.
- Participants receiving hydroxyurea (HU), L-glutamine, or voxelotor (Oxbryta®) must be on a stable dose for at least 30 days prior to the Screening Visit and expected to continue with the stabilized regimen throughout the course of the study.
Who cannot join
- Participant is receiving regularly scheduled red blood cell (RBC) transfusion therapy (also termed chronic, prophylactic, or preventative transfusion).
- Participant is taking or has received crizanlizumab (ADAKVEO®) within 90 days prior to the Screening Visit
- Participant weighs > 133 kg (292 lbs.).
- Other protocol-defined Inclusion/Exclusion may apply.
Trial locations and contacts
58 sites in 12 countries.
58 sites in 12 countries
United States22 sites
University of Michigan Hospitals - Michigan Medicine
Ann Arbor, Michigan, 48109
Dana-Farber Cancer Institute IDS Pharmacy
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Hospital Pharmacy Services- Investigational Drug Services
Chicago, Illinois, 60612
Rush University Medical Center Investigator Pharmacy
Chicago, Illinois, 60612
Rush University Medical Center
Chicago, Illinois, 60612
University of Illinois Clinical Research Center (CRC)
Chicago, Illinois, 60612
University of Illinois Hospital and Health Sciences System(UI Health)
Chicago, Illinois, 60612
Duke University Medical Center
Durham, North Carolina, 27705
DUMC Investigational Drug Services Pharmacy
Durham, North Carolina, 27710
Uconn Health/Uconn John Dempsey Hospital/Neag Comprehensive Cancer Center/New England Sickle Cell
Farmington, Connecticut, 06030
McGovern Medical School/Health Science Center Houston
Houston, Texas, 77030
Memorial Hermann - TMC Investigational Drugs, IDS Pharmacy
Houston, Texas, 77030
Memorial Hermann Hospital, Texas Medical Center - Clinical Research Unit (CRU)
Houston, Texas, 77030
UT Physicians Comprehensive Sickle Cell Clinic
Houston, Texas, 77030
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
University of South Alabama Children's and Women's Hospital
Mobile, Alabama, 36604
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, 36604
University of South Alabama Strada Patient Care Center
Mobile, Alabama, 36604
UC Irvine Health
Orange, California, 92868
UCI Center for clinical research
Orange, California, 92868
Jacobi Medical Center
The Bronx, New York, 10461
Brazil9 sites
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Multihemo Serviços Médicos S/A
Recife, Pernambuco, 50070-460
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto, São Paulo, 14051-140
Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti - HEMORIO
Rio de Janeiro, 20211-030
Instituto D'Or de Pesquisa e Ensino - Hospital São Rafael
Salvador, Estado de Bahia, 41253-190
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, 15090-000
Hospital Samaritano Higienópolis/Esho Empresa De Servicos Hospitalares S.A
São Paulo, 01232-010
Casa de Saúde Santa Marcelina
São Paulo, 08270-070
CEPEC-Centro de Pesquisa Clinica
São Paulo, 08270-120
Nigeria8 sites
National Hospital Abuja
Abuja, Federal Capital Territory, 900211
University of Calabar Teaching Hospital
Calabar, Cross River State, 540242
University of Nigeria Teaching Hospital
Enugu, 460000
University of Abuja Teaching Hospital
Gwagwalada, Federal Capital Territory, 902101
Barau Dikko Teaching Hospital/Kaduna State University
Kaduna, 800212
Aminu Kano Teaching Hospital
Kano, 700233
Department of Pediatrics, College of Medicine, Lagos University Teaching Hospital
Lagos, 100254
Ahmadu Bello University Teaching Hospital
Zaria, Kaduna State, 1100011
Kenya5 sites
International Cancer Institute
Eldoret, 30100
KEMRI/CRDR, Siaya, KEMRI Clinical Research Annex
Kisumu, Siaya County, 40600
Gertrude's Children Hospital
Nairobi, 00100
Kenya Medical Research Institute- Center for Respiratory Disease Research
Nairobi, 00100
Strathmore University Medical Center - Center for Research in Therapeutic Sciences(CREATES)
Nairobi, 00200
Turkey (Türkiye)3 sites
Baskent University Hospital
Adana, Yuregir, 01250
Acibadem Adana Hastanesi Cocuk Hematoloji Onkoloji
Adana, 01130
Mersin Universitesi Tip Fakultesi Saglik Arastirma ve Uygulama Merkezi Hastanesi
Yenişehir, Mersin, 33343
Colombia2 sites
Clinica de la Costa Ltda.
Barranquilla, Atlántico, 080020
Sociedad de Oncologia y hematologia del Cesar S.A.S.
Valledupar, Cesar Department, 200001
Egypt2 sites
Faculty of Medicine Cairo University
Cairo, 11562
AinShams University Hospital
Cairo, 11588
France2 sites
Hôpital Henri Mondor
Créteil, 94010
Institut Universitaire du Cancer de Toulouse-Oncopole
Toulouse, 31059
Lebanon2 sites
American University of Beirut Medical Center
Hamra, Beirut
Nini Hospital
Tripoli, North Lebanon
Saudi Arabia1 site
Prince Mohammed bin Nasser Hospital
Jizan, Southern, 82943
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises
This Phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (VOCs) in approximately 240 adult and adolescent participants (≥ 12 years of age) with sickle cell disease (SCD). Participants will be randomized to receive inclacumab or placebo.
Read the detailed description
Eligible participants will be administered inclacumab or placebo intravenous (IV) every 12 weeks.
The total duration of treatment for each participant will be 48 weeks.
Participants that complete the study through Week 48 will be provided the opportunity to enroll in an open-label extension (OLE) study.
- Conditions
- Sickle Cell Disease, Vaso-occlusive Pain Episode in Sickle Cell Disease, Vaso-occlusive Crisis
- Being tested
- Inclacumab, Placebo
- Keywords
- blood disorders, hemoglobin, red blood cells, sickle-like shape, mutation in hemoglobin gene, sickle-cell trait, sickle-cell crisis, Sickle Cell Disease, SCD, Vaso-occlusive Crises, VOC, SCA, RBCs
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises, Hematologic Diseases, Sickle Cell Trait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InclacumabDrug
Inclacumab will be supplied in single use 10 mL vials at a concentration of 50 mg/mL. One vial contains 500 mg of inclacumab. This is a liquid concentrate for IV infusion.
PlaceboDrug
Placebo will be supplied in single use 10 mL vials containing the same ingredients without the active drug. Placebo will be prepared as a liquid concentrate for IV infusion and administered in the same manner as active study drug
| Study group | Role | What they receive |
|---|---|---|
| inclacumab, 30 mg/kg | Experimental | Participants will receive inclacumab 30 mg/kg administered IV every 12 weeks Receives: Drug: Inclacumab |
| placebo | Placebo comparator | Participants will receive placebo administered IV every 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Vaso-occlusive Crises (VOCs) [Adjudicated] Through Week 48
A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral nonsteroidal anti-inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics. The rate of VOC was defined as number of VOC events per 48 weeks and presented in this outcome measure.
Measured: Randomization (Day 1) up to Week 48
Secondary outcomes (6)
Time to First VOC Through Week 48
A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral NSAIDs, or an increase in treatment with oral narcotics. Time to first VOC was the time between randomization date and onset date of first VOC event during 48 weeks. Kaplan-Meier method was used for estimation.
Measured: Randomization (Day 1) up to Week 48
Time to Second VOC Through Week 48
A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral NSAIDs, or an increase in treatment with oral narcotics. Time to second VOC was the time between randomization date and onset date of second VOC event during 48 weeks. Kaplan-Meier method was used for estimation.
Measured: Randomization (Day 1) up to Week 48
Percentage of Participants With no VOCs Through Week 48
A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral NSAIDs, or an increase in treatment with oral narcotics. Participants without an observed VOC who discontinued the study prior to the end of the 48-week treatment period were assumed to had experienced at least one VOC.
Measured: Randomization (Day 1) up to Week 48
Rate of VOCs Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication [Adjudicated] Through Week 48
A VOC that required admission to a healthcare facility and treatment with parenteral pain medication where admission included: a hospital admission or an admission to an emergency room, observation unit, or infusion center for >= 12 hours, or 2 visits to an emergency room, observation unit, or infusion center over a 72-hour period. The rate of VOC was defined as number of VOC events per 48 weeks; rate of VOCs which required admission to a healthcare facility and treatment with parenteral pain medication is presented in this outcome measure.
Measured: Randomization (Day 1) up to Week 48
Rate of Inpatient Hospitalization Days for a VOC Through Week 48
A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility hospitalization. For each VOC event requiring inpatient hospitalization (regardless of treatment received) during the 48-week, the number of days hospitalized were determined based on the hospital admission and discharge dates. The rate of inpatient hospitalization days was defined as number of inpatient hospitalization days for a VOC per 48 weeks and presented in this outcome measure.
Measured: Randomization (Day 1) up to Week 48
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. A TEAE was defined as an AE with an onset after the initiation of dosing for the first dose of study drug. A serious adverse events (SAE) or serious suspected adverse reaction is an AE or suspected adverse reaction that, at any dose, in the view of the either the investigator or sponsor, results in any of the following outcomes: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization and congenital anomaly/birth defect. AEs included both serious and all non-SAEs.
Measured: Day 1 up to Week 60 (12 week of follow-up post Week 48)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start4 Oct 2021
- Primary completion6 Jun 2024
- Study completion6 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935879
- Sponsor's protocol ID
- GBT2104-131
- Other IDs
- 2020-005286-13, C5361001
- Status last verified
- Nov 2025
- First submitted
- 26 May 2021
- Last updated
- 2 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises
- ClinicalTrials.gov ID
- NCT04935879
- Acronym / sponsor ID
- GBT2104-131
- Conditions
- Sickle Cell Disease, Vaso-occlusive Pain Episode in Sickle Cell Disease, Vaso-occlusive Crisis
- Keywords
- blood disorders, hemoglobin, red blood cells, sickle-like shape, mutation in hemoglobin gene, sickle-cell trait, sickle-cell crisis, Sickle Cell Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 6 Jun 2024 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Posted 2 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (VOCs) in approximately 240 adult and adolescent participants (≥ 12 years of age) with sickle cell disease (SCD). Participants will be randomized to receive inclacumab or placebo.
Detailed description
Eligible participants will be administered inclacumab or placebo intravenous (IV) every 12 weeks.
The total duration of treatment for each participant will be 48 weeks.
Participants that complete the study through Week 48 will be provided the opportunity to enroll in an open-label extension (OLE) study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inclacumab, 30 mg/kg | Experimental | Drug: InclacumabParticipants will receive inclacumab 30 mg/kg administered IV every 12 weeks |
| placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo administered IV every 12 weeks. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Participant has a confirmed diagnosis of SCD (HbSS, HbSC, HbSB0 thalassemia, or HbSB+ thalassemia genotype).
- Documentation of SCD genotype is required and may be based on documented history of laboratory testing or confirmed by laboratory testing during Screening.
- Participant is male or female, ≥ 12 years of age at the time of informed consent.
- Participant has experienced between 2 and 10 VOCs within the 12 months prior to the Screening Visit as determined by documented medical history. A prior VOC is defined as an acute episode of pain which:
- Participants receiving erythropoiesis-stimulating agents (ESA, e.g., erythropoietin [EPO]) must be on a stable dose for at least 90 days prior to the Screening Visit and expected to continue with the stabilized regimen throughout the course of the study.
Key exclusion criteria (4 listed)
- Participant is receiving regularly scheduled red blood cell (RBC) transfusion therapy (also termed chronic, prophylactic, or preventative transfusion).
- Participant is taking or has received crizanlizumab (ADAKVEO®) within 90 days prior to the Screening Visit
- Participant weighs > 133 kg (292 lbs.).
- Other protocol-defined Inclusion/Exclusion may apply.
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 |
|---|---|---|
| InclacumabInclacumab will be supplied in single use 10 mL vials at a concentration of 50 mg/mL. One vial contains 500 mg of inclacumab. This is a liquid concentrate for IV infusion. | Drug | inclacumab, 30 mg/kg |
| PlaceboPlacebo will be supplied in single use 10 mL vials containing the same ingredients without the active drug. Placebo will be prepared as a liquid concentrate for IV infusion and administered in the same manner as active study drug | Drug | placebo |
Primary outcome
Rate of Vaso-occlusive Crises (VOCs) [Adjudicated] Through Week 48
Time frame: Randomization (Day 1) up to Week 48
A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral nonsteroidal anti-inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics. The rate of VOC was defined as number of VOC events per 48 weeks and presented in this outcome measure.
6 secondary outcomes
Time to First VOC Through Week 48
Time frame: Randomization (Day 1) up to Week 48
Time to Second VOC Through Week 48
Time frame: Randomization (Day 1) up to Week 48
Percentage of Participants With no VOCs Through Week 48
Time frame: Randomization (Day 1) up to Week 48
Rate of VOCs Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication [Adjudicated] Through Week 48
Time frame: Randomization (Day 1) up to Week 48
Rate of Inpatient Hospitalization Days for a VOC Through Week 48
Time frame: Randomization (Day 1) up to Week 48
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Day 1 up to Week 60 (12 week of follow-up post Week 48)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
58 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inclacumab in people with Sickle Cell Disease and Vaso-occlusive Pain Episode in Sickle Cell Disease, run by Pfizer at 58 sites in 12 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 9 inclusion and 4 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 2 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 58 sites in United States, Brazil, Nigeria, Kenya, Turkey (Türkiye) and 7 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Vaso-occlusive Crises (VOCs) [Adjudicated] Through Week 48 (time frame: Randomization (Day 1) up to Week 48). 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 2 Dec 2025.