Acute Graft-versus-host DiseasePhase 1/2NCT03721965
Safety and Efficacy of Itacitinib in Combination With Corticosteroids for Treatment of Graft-Versus-Host Disease in Pediatric Subjects
A Phase 1/2 study testing Itacitinib and Corticosteroids in people with Acute Graft-versus-host Disease, run by Incyte Corporation at 38 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate itacitinib in combination with corticosteroids for the treatment of Grades II to IV acute graft-versus-host disease (aGVHD) in steroid-naive pediatric participants. Read more about this study
- Who is it for?
- Ages 28 days to 18 years
- Conditions the study is for
- Acute Graft-versus-host Disease
- What is being tested?
- Itacitinib and Corticosteroids
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 38 sitesin 6 countries
- Study dates
- 31 Dec 2019to 17 Feb 2020
- Phase
- Phase 1/2
- 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 28 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female participants: 12 to < 18 years old (Cohort 1), 6 to < 12 years old (Cohort 2), 2 to < 6 years old (Cohort 3), Weighing > 8 kg to < 2 years old (Cohort 4), and 28 days old to weighing ≤ 8 kg (Cohort 5).
- Undergone 1 allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor and source for hematological malignancies or disorders. Recipients of myeloablative and reduced-intensity conditioning regimens are eligible.
- Clinically suspected Grade II to IV aGVHD as per Mount Sinai Acute GVHD International Consortium (MAGIC) criteria, occurring after allo-HSCT and any GVHD prophylactic medication.
- Evidence of myeloid engraftment.
Who cannot join
- More than 1 allo-HSCT.
- Received more than 2 days of systemic corticosteroids for aGVHD before the first study drug administration.
- Presence of GVHD overlap syndrome.
- Presence of an active uncontrolled infection.
- Known HIV infection.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment or at risk for HBV reactivation.
Show all 11Show fewer
- Evidence of relapsed primary disease or have been treated for relapse after the allo-HSCT was performed.
- Any corticosteroid therapy for indications other than GVHD at doses > 1 mg/kg once daily of methylprednisolone (or equivalent) within 7 days of the first study drug administration.
- Receipt of live (including attenuated) vaccines or anticipation of need for such vaccines during the study.
- Receipt of JAK inhibitor therapy after allo-HSCT for any indication.
- Treatment with any other investigational agent, device, or procedure within 21 days (or 5 half-lives, whichever is greater) of enrollment.
Trial locations and contacts
38 sites in 6 countries.
38 sites in 6 countries
United States14 sites
Children's Hospital Colorado - Center for Cancer and Blood Disorders
Aurora, Colorado, 80045
University Hospitals Cleveland Medical Center - Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
City of Hope National Medical Center
Duarte, California, 91010
Duke University Medical Center
Durham, North Carolina, 27710
Nicklaus Children's Hospital
Miami, Florida, 33155
University of Minnesota Medical Center
Minneapolis, Minnesota, 55454
Sarah Cannon Research Institute, LLC
Nashville, Tennessee, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-6868
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Childrens Hospital of Orange County
Orange, California, 92868
Children's Hospital of Philadelphia - Center for Childhood Cancer Research
Philadelphia, Pennsylvania, 19104
Doernbecher Children's Hospital - Division of Pediatric Hematology
Portland, Oregon, 97239
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
Nemours/A.I. duPont Hospital for Children
Wilmington, Delaware, 19803
France8 sites
CHU de Grenoble
Grenoble, 38043
CHU de Grenoble
Grenoble, 38403
Robert Debre Hospital
Paris, 75019
Centre Hospitalier Universitaire de Rennes
Rennes, Cedex 2, 35203
Hopitaux Universitaires De Strasbourg
Strasbourg, Cedex, 67098
Hopitaux Universitaires De Strasbourg
Strasbourg, 67098
CHRU Nancy
Vandœuvre-lès-Nancy, 54500
CHU Nancy
Vandœuvre-lès-Nancy, 54500
United Kingdom6 sites
Birmingham Childrens Hospital
Birmingham, B4 6NH
Bristol Royal Hospital for Children
Bristol, BS2 8BJ
Leeds Teaching Hospitals NHS Trust
Leeds, LS13EX
Great Ormond Street Hospital for Children
London, WC1N 3JH
Central Manchester University Hospital - Royal Manchester Children's Hospital
Manchester, M13 9WL
Royal Marsden Hospital - Surrey
Surrey Quays, SM2 5PT
Italy5 sites
Policlinico S. Orsola-Malpighi
Bologna, 40138
Azienda Ospedaliero Unversitatia Policlinico - Vittorio Emanuele - Presido Ospedaliero G. Rodolico
Catania, 95123
Fondazione MBBM
Monza, 20900
Ospedale Pediatrico Bambino Gesu
Roma, 00165
AOU Citta della Salute e della Scienza di Torino - Ospedale Regina Margherita
Torino, 10126
Spain3 sites
Hospital Vall D Hebron
Barcelona, 08035
Hospital Clinico de Santiago de Compostela
Santiago de Compostela, 15706
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Germany2 sites
Universitaetsklinikum Aachen, AoeR
Aachen, 52074
Universitatsklinikum Jena, Klinik fur Kinder und Jugendmedizin
Jena, 07747
About this study
Official title: An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Combination With Corticosteroids for the Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Pediatric Subjects
The purpose of this study is to evaluate itacitinib in combination with corticosteroids for the treatment of Grades II to IV acute graft-versus-host disease (aGVHD) in steroid-naive pediatric participants.
- Conditions
- Acute Graft-versus-host Disease
- Being tested
- Itacitinib, Corticosteroids
- Keywords
- Acute graft-versus-host disease, GVHD, pediatric, JAK1 inhibitor, corticosteroids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItacitinibDrug
Also called INCB039110
Phase 1: Itacitinib administered orally once daily at the protocol-defined dose according to age cohort, with dose reductions or modifications based on safety assessments. Phase 2: Itacitinib administered orally once daily at the recommended dose from Phase 1.
CorticosteroidsDrug
Also called prednisone, methylprednisolone
Phase 1 and 2: Methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of disease as outlined per local treatment guidelines as background treatment.
| Study group | Role | What they receive |
|---|---|---|
| Itacitinib + Corticosteroids | Experimental | Not described Receives: Drug: Itacitinib; Drug: Corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
A TEAE was defined as an AE that began or worsened from Baseline after the first administration of study drug.
Measured: up to 45 days
Phase 1: Cmax of Itacitinib When Administered With Corticosteroids
Cmax was defined as the maximum observed plasma concentration.
Measured: Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose
Phase 1: Cmin of Itacitinib When Administered With Corticosteroids
Cmin was defined as the minimum observed plasma concentration.
Measured: Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose
Phase 1: Tmax of Itacitinib When Administered With Corticosteroids
Tmax was defined as the time to the maximum concentration.
Measured: Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose
Phase 1: AUC of Itacitinib When Administered With Corticosteroids
AUC was defined as the area under the plasma concentration-time curve.
Measured: Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose
Phase 1: Cl/F of Itacitinib When Administered With Corticosteroids
Cl/F was defined as the apparent oral dose clearance.
Measured: Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose
Phase 2: Overall Response Rate up to Day 28
Overall response rate was defined as the number of participants demonstrating a complete response (CR), a very good partial response (VGPR), or a partial response (PR).
Measured: up to Day 28
Secondary outcomes (22)
Phase 2: Number of Participants With TEAEs
A TEAE was defined as an AE that began or worsened from Baseline after the first administration of study drug.
Measured: up to 12 months
Phase 2: Cmax of Itacitinib When Administered With Corticosteroids
Cmax was defined as the maximum observed plasma concentration.
Measured: Day 7: predose; 1, 2, and 4 hours post-dose
Phase 2: Cmin of Itacitinib When Administered With Corticosteroids
Cmin was defined as the minimum observed plasma concentration.
Measured: Day 7: predose; 1, 2, and 4 hours post-dose
Phase 2: Tmax of Itacitinib When Administered With Corticosteroids
Tmax was defined as the time to the maximum concentration.
Measured: Day 7: predose; 1, 2, and 4 hours post-dose
Phase 2: AUC of Itacitinib When Administered With Corticosteroids
AUC was defined as the area under the plasma concentration-time curve.
Measured: Day 7: predose; 1, 2, and 4 hours post-dose
Phase 2: Cl/F of Itacitinib When Administered With Corticosteroids
Cl/F was defined as the apparent oral dose clearance.
Measured: Day 7: predose; 1, 2, and 4 hours post-dose
Phase 2: Overall Response Rate up to 100 Days
Overall response rate was defined as the number of participants demonstrating a CR, a VGPR, or a PR.
Measured: up to 100 days
Phase 1: Overall Response Rate
Overall response rate was defined as the number of participants demonstrating a CR, a VGPR, or a PR.
Measured: up to Day 28
Phase 2: Non Relapse Mortality
Non relapse mortality was defined as the number of participants who died due to causes other than underlying hematologic disorders relapse.
Measured: up to 24 months
Phase 2: Duration of Response
Duration of response was defined as the time of the onset of response to the loss of response.
Measured: up to approximately 12 months
Phase 2: Time to Response
Time to response was defined as the interval from treatment initiation to the first response.
Measured: up to approximately 12 months
Phase 2: Relapse Rate of Malignant and Nonmalignant Disorders
Relapse rate was defined as the number of participants whose underlying disease relapsed.
Measured: up to approximately 12 months
Phase 2: Malignant and Nonmalignant Disorders Relapse-related Mortality Rate
Mortality rate was defined as the number of participants whose underlying hematologic disorder relapsed and had a fatal outcome.
Measured: up to approximately 12 months
Phase 2: Failure-free Survival
Failure-free survival was defined as the number of participants who were still alive, had not relapsed, had not required additional therapy for acute graft-versus-host disease (aGVHD), and had not demonstrated signs or symptoms of chronic GVHD.
Measured: up to 6 months
Phase 2: Overall Survival
Overall survival was defined as the interval from study enrollment to death due to any cause.
Measured: up to approximately 12 months
Phase 2: Incidence Rate of Secondary Graft Failure
Analysis was to be conducted to assess the number of participants experiencing secondary graft failure.
Measured: up to approximately 12 months
Phase 2: Average Corticosteroid Use
The average number of participants who discontinued corticosteroids was to be assessed.
Measured: up to 180 days
Phase 2: Cumulative Corticosteroid Dose
The number of participants with various cumulative corticosteroid doses was assessed.
Measured: up to 180 days
Phase 2: Number of Participants Who Discontinued Corticosteroids
The number of participants who discontinued corticosteroids was assessed.
Measured: up to 100 days
Phase 2: Number of Participants Who Discontinued Immunosuppressive Medication
The number of participants who discontinued immunosuppressive medication was assessed.
Measured: up to 100 days
Phase 2: Number of Participants With aGVHD Flares
The number of participants who experienced aGVHD flares requiring treatment was assessed.
Measured: up to 100 Days
Phase 2: Number of Participants With Chronic Graft-versus-host Disease (cGVHD)
The number of participants with a diagnosis of any cGVHD, including mild, moderate, severe, was assessed.
Measured: up to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start31 Dec 2019
- Primary completion17 Feb 2020
- Study completion17 Feb 2020
Why it stopped: The study was terminated due to insufficient efficacy in a separate phase III study
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 Acute Graft-versus-host DiseaseStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rodica Morariu-Zamfir, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721965
- Sponsor's protocol ID
- INCB 39110-120
- Other IDs
- 2018-002253-30, 2018
- Status last verified
- Oct 2025
- First submitted
- 25 Oct 2018
- Last updated
- 4 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Combination With Corticosteroids for the Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Pediatric Subjects
- ClinicalTrials.gov ID
- NCT03721965
- Acronym / sponsor ID
- INCB 39110-120
- Conditions
- Acute Graft-versus-host Disease
- Keywords
- Acute graft-versus-host disease, GVHD, pediatric, JAK1 inhibitor, corticosteroids
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to insufficient efficacy in a separate phase III study
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2019 (actual)
- Primary completion
- 17 Feb 2020 (actual)
- Study completion
- 17 Feb 2020 (actual)
- First posted
- 26 Oct 2018 (actual)
- Results
- Posted 21 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate itacitinib in combination with corticosteroids for the treatment of Grades II to IV acute graft-versus-host disease (aGVHD) in steroid-naive pediatric participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Itacitinib + Corticosteroids | Experimental | Drug: Itacitinib, Drug: Corticosteroids |
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male and female participants: 12 to < 18 years old (Cohort 1), 6 to < 12 years old (Cohort 2), 2 to < 6 years old (Cohort 3), Weighing > 8 kg to < 2 years old (Cohort 4), and 28 days old to weighing ≤ 8 kg (Cohort 5).
- Undergone 1 allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor and source for hematological malignancies or disorders. Recipients of myeloablative and reduced-intensity conditioning regimens are eligible.
- Clinically suspected Grade II to IV aGVHD as per Mount Sinai Acute GVHD International Consortium (MAGIC) criteria, occurring after allo-HSCT and any GVHD prophylactic medication.
- Evidence of myeloid engraftment.
Key exclusion criteria (11 listed)
- More than 1 allo-HSCT.
- Received more than 2 days of systemic corticosteroids for aGVHD before the first study drug administration.
- Presence of GVHD overlap syndrome.
- Presence of an active uncontrolled infection.
- Known HIV infection.
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 |
|---|---|---|
| ItacitinibAlso: INCB039110Phase 1: Itacitinib administered orally once daily at the protocol-defined dose according to age cohort, with dose reductions or modifications based on safety assessments. Phase 2: Itacitinib administered orally once daily at the recommended dose from Phase 1. | Drug | Itacitinib + Corticosteroids |
| CorticosteroidsAlso: prednisone, methylprednisolonePhase 1 and 2: Methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of disease as outlined per local treatment guidelines as background treatment. | Drug | Itacitinib + Corticosteroids |
Primary outcome
Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: up to 45 days
A TEAE was defined as an AE that began or worsened from Baseline after the first administration of study drug.
Phase 1: Cmax of Itacitinib When Administered With Corticosteroids
Time frame: Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose
Cmax was defined as the maximum observed plasma concentration.
Phase 1: Cmin of Itacitinib When Administered With Corticosteroids
Time frame: Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose
Cmin was defined as the minimum observed plasma concentration.
Phase 1: Tmax of Itacitinib When Administered With Corticosteroids
Time frame: Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose
Tmax was defined as the time to the maximum concentration.
Phase 1: AUC of Itacitinib When Administered With Corticosteroids
Time frame: Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose
AUC was defined as the area under the plasma concentration-time curve.
Phase 1: Cl/F of Itacitinib When Administered With Corticosteroids
Time frame: Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose
Cl/F was defined as the apparent oral dose clearance.
Phase 2: Overall Response Rate up to Day 28
Time frame: up to Day 28
Overall response rate was defined as the number of participants demonstrating a complete response (CR), a very good partial response (VGPR), or a partial response (PR).
22 secondary outcomes
Phase 2: Number of Participants With TEAEs
Time frame: up to 12 months
Phase 2: Cmax of Itacitinib When Administered With Corticosteroids
Time frame: Day 7: predose; 1, 2, and 4 hours post-dose
Phase 2: Cmin of Itacitinib When Administered With Corticosteroids
Time frame: Day 7: predose; 1, 2, and 4 hours post-dose
Phase 2: Tmax of Itacitinib When Administered With Corticosteroids
Time frame: Day 7: predose; 1, 2, and 4 hours post-dose
Phase 2: AUC of Itacitinib When Administered With Corticosteroids
Time frame: Day 7: predose; 1, 2, and 4 hours post-dose
Phase 2: Cl/F of Itacitinib When Administered With Corticosteroids
Time frame: Day 7: predose; 1, 2, and 4 hours post-dose
Phase 2: Overall Response Rate up to 100 Days
Time frame: up to 100 days
Phase 1: Overall Response Rate
Time frame: up to Day 28
Phase 2: Non Relapse Mortality
Time frame: up to 24 months
Phase 2: Duration of Response
Time frame: up to approximately 12 months
Phase 2: Time to Response
Time frame: up to approximately 12 months
Phase 2: Relapse Rate of Malignant and Nonmalignant Disorders
Time frame: up to approximately 12 months
Phase 2: Malignant and Nonmalignant Disorders Relapse-related Mortality Rate
Time frame: up to approximately 12 months
Phase 2: Failure-free Survival
Time frame: up to 6 months
Phase 2: Overall Survival
Time frame: up to approximately 12 months
Phase 2: Incidence Rate of Secondary Graft Failure
Time frame: up to approximately 12 months
Phase 2: Average Corticosteroid Use
Time frame: up to 180 days
Phase 2: Cumulative Corticosteroid Dose
Time frame: up to 180 days
Phase 2: Number of Participants Who Discontinued Corticosteroids
Time frame: up to 100 days
Phase 2: Number of Participants Who Discontinued Immunosuppressive Medication
Time frame: up to 100 days
Phase 2: Number of Participants With aGVHD Flares
Time frame: up to 100 Days
Phase 2: Number of Participants With Chronic Graft-versus-host Disease (cGVHD)
Time frame: up to 365 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Rodica Morariu-Zamfir, MD study director
Incyte Corporation
38 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Itacitinib and Corticosteroids in people with Acute Graft-versus-host Disease, run by Incyte Corporation at 38 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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, France, United Kingdom, Italy, Spain 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 21 Feb 2023). 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?
Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: up to 45 days). The study lists 7 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 4 Nov 2025.