Bronchiolitis Obliterans SyndromePhase 1/2NCT03978637
Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation
A Phase 1/2 study testing Itacitinib in people with Bronchiolitis Obliterans Syndrome, run by Incyte Corporation at 9 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of itacitinib in participants with post-lung transplant bronchiolitis obliterans syndrome (BOS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiolitis Obliterans Syndrome
- What is being tested?
- Itacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 4 Feb 2020to 13 Oct 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Double lung transplantation ≥ 1 year before informed consent. Confirmed BOS progression to Grade 1, 2, or 3 diagnosed within 1 year of screening
- Confirmed BOS progression to Grade 1, 2, or 3 diagnosed within 2 years of screening AND:
- A ≥ 200 mL decrease in FEV1 in the previous 12 months
- OR
- A ≥ 50 mL decrease in FEV1 in the last 2 measurements.
- Willingness to avoid pregnancy or fathering children.
Who cannot join
- History of a single lung transplant
- FEV1 decline attributable to cause(s) other than BOS.
- Participants who have had any significant change (eg, addition of new agents) in an immunosuppressive regimen in the 4 weeks before screening.
- Untreated and/or symptomatic gastroesophageal reflux disease.
- Significant infectious comorbidities including invasive fungal disease, B. Cepacia, non TB mycobacteria, or TB.
- Receipt of JAK inhibitor therapy after lung transplant for any indication. Treatment with a JAK inhibitor before lung transplant is permitted.
Show all 12Show fewer
- Laboratory values at screening outside the protocol-defined ranges.
- Active HBV or HCV infection that requires treatment, or at risk for HBV reactivation (ie, positive HBsAg).
- Known HIV infection.
- History of active malignancy within 3 years of screening.
- Women who are pregnant or breastfeeding.
- Treatment with an investigational agent, procedure, or device within 30 days of enrollment, or within 5 half-lives of the investigational product, whichever is longer.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United States7 sites
Brigham and Women'S Faulkner Hospitals Inc
Boston, Massachusetts, 02115
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University Health System
Durham, North Carolina, 27710
University of California, Los Angeles - David Geffen School of Medicine
Los Angeles, California, 90095
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Temple University Department of Thoracic Medicine and Surgery
Philadelphia, Pennsylvania, 19140
UPMC
Pittsburgh, Pennsylvania, 15213
Canada1 site
University Health Network Toronto General Hospital
Toronto, Ontario, M5G 2N2
About this study
Official title: An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of itacitinib in participants with post-lung transplant bronchiolitis obliterans syndrome (BOS).
- Conditions
- Bronchiolitis Obliterans Syndrome
- Being tested
- Itacitinib
- Keywords
- Bronchiolitis obliterans syndrome, lung transplant, JAK1 inhibitor
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItacitinibDrug
Also called INCB039110
Itacitinib administered orally at the specified dose.
| Study group | Role | What they receive |
|---|---|---|
| Itacitinib 300 mg | Experimental | Phase 1: Itacitinib 300 mg twice daily. There can be required dose adjustments in the protocol for concurrent CYP3A administration. Receives: Drug: Itacitinib |
| Itacitinib 400 mg | Experimental | Phase 1: Itacitinib 400 mg once daily. There can be required dose adjustments in the protocol for concurrent CYP3A administration. Receives: Drug: Itacitinib |
| Itacitinib 600 mg | Experimental | Phase 1: Itacitinib 600 mg once daily. There can be required dose adjustments in the protocol for concurrent CYP3A administration Receives: Drug: Itacitinib |
| Itacitinib | Experimental | Phase 2: Itacitinib administered orally at the recommended dose from Phase 1. Receives: Drug: Itacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as either an AE reported for the first time or the worsening of a pre-existing condition after the first dose of itacitinib until 30 days after the last dose of itacitinib.
Measured: up to approximately 162 weeks
Number of Participants With Any Grade 3 or Higher TEAE
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was defined as either an AE reported for the first time or the worsening of a pre-existing condition after the first dose of itacitinib until 30 days after the last dose of itacitinib. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events v5.0. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Measured: up to approximately 162 weeks
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12
FEV1 was defined as the volume of air exhaled in 1 second. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; Week 12
Phase 2: FEV1 Response Rate
FEV1 response rate was defined as the percentage of participants demonstrating a ≥10% absolute increase in FEV1 compared with Baseline, confirmed by 2 consecutive spirometric assessments ≥1 week apart.
Measured: Baseline through Week 12
Secondary outcomes (19)
Phase 1: Duration of FEV1 Response
Duration of FEV1 response was defined as the interval between the onset of response and the earliest of bronchiolitis obliterans syndrome (BOS) progression, loss of clinical benefit as determined by the investigator, or death.
Measured: up to 34.9 months
Phase 2: Duration of FEV1 Response
Duration of FEV1 response was defined as the interval between the onset of response and the earliest of bronchiolitis obliterans syndrome progression, loss of clinical benefit as determined by the investigator, or death.
Measured: up to 24 months
Phase 1: Time to Progression
Time to progression was defined as defined as the interval between the start of treatment and bronchiolitis obliterans syndrome progression (≥10% absolute decrease in FEV1 compared to baseline), or death.
Measured: up to 36.4 months
Phase 2: Time to Progression
Time to progression was defined as defined as the interval between the start of treatment and bronchiolitis obliterans syndrome progression (≥10% absolute decrease in FEV1 compared to baseline), or death.
Measured: up to 24 months
Phase 1: Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score
The SGRQ is a disease-specific instrument designed to measure the impact on overall health, daily life, and perceived well-being in participants with obstructive airway disease. It consists of 50 items covering 3 domains: symptoms (8 items), activity (16 items), and impacts (26 items). A component score is calculated for each of the 3 domains. One total score is calculated if none of the component scores is missing. All scales (both domain and total) have a score ranging between 0 and 100, with higher scores indicating a worse quality of life. Change from (CFB) Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; up to 158.4 weeks
Phase 2: Change From Baseline in the SGRQ Total Score
The SGRQ is a disease-specific instrument designed to measure the impact on overall health, daily life, and perceived well-being in participants with obstructive airway disease. It consists of 50 items covering 3 domains: symptoms (8 items), activity (16 items), and impacts (26 items). A component score is calculated for each of the 3 domains. One total score is calculated if none of the component scores is missing. All scales (both domain and total) have a score ranging between 0 and 100, with higher scores indicating a worse quality of life. Change from Baseline was to be calculated as the post-Baseline value minus the Baseline value.
Measured: up to 24 months
Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores
The QOL-SF-12 v2 is a 12-item subset of the QOL-SF-36 v2 scale that assesses 8 health concepts related to limitations in physical activities, social activities (SA), bodily pain, general mental and physical health, and vitality. Participants answered each question by selecting pre-specified choices. Score ranges are specified for each item; higher scores indicate better health. Assessment of health score: poor (1) to excellent (5). Moderate activities and climbing stairs score: limited a lot (1) to not limited at all (3). Accomplished less because of physical health (PH) or emotional problems (EP)/limited in work/did work less carefully score: all of the time (1) to none of the time (5). Pain interfered with work score: extremely (1) to not at all (5). Felt calm/peaceful, had a lot of energy, felt depressed, PH or EP interfered with SA score: none of the time (1) to all of the time (6). Change from Baseline (BL) was calculated as the post-BL value minus the BL value.
Measured: Baseline; up to 158.4 weeks
Phase 2: Change From Baseline in QOL-SF-12 Questionnaire Scores
The QOL-SF-12 v2 is a 12-item subset of the QOL-SF-36 v2 scale that assesses 8 health concepts related to limitations in physical activities, social activities (SA), bodily pain, general mental and physical health, and vitality. Participants answered each question by selecting pre-specified choices. Score ranges are specified for each item; higher scores indicate better health. Assessment of health score: poor (1) to excellent (5). Moderate activities and climbing stairs score: limited a lot (1) to not limited at all (3). Accomplished less because of physical health (PH) or emotional problems (EP)/limited in work/did work less carefully score: all of the time (1) to none of the time (5). Pain interfered with work score: extremely (1) to not at all (5). Felt calm/peaceful, had a lot of energy, felt depressed, PH or EP interfered with SA score: none of the time (1) to all of the time (6). Change from Baseline (BL) was to be calculated as the post-BL value minus the BL value.
Measured: up to 24 months
Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State
The EQ-5D-3L essentially consists of 2 components: the EQ-5D descriptive scale and the EQ-VAS. The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, anxiety/depression, and pain/discomfort. Each dimension has 3 levels: no problems, some problems, and extreme problems. At each specific visit (starting on Day 1), the participant was asked to indicate their health state. BL=Baseline; EOT=end of treatment.
Measured: Baseline; up to 158.4 weeks
Phase 2: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State
The EQ-5D-3L essentially consists of 2 components: the EQ-5D descriptive scale and the EQ-VAS. The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, anxiety/depression, and pain/discomfort. Each dimension has 3 levels: no problems, some problems, and extreme problems. At each specific visit (starting on Day 1), the participant was asked to indicate their health state.
Measured: up to 24 months
Phase 1: Cmax of Itacitanib
Cmax was defined as the maximum observed concentration of itacitanib.
Measured: pre-dose and 1, 2, and 5 hours post-dose on Day 1 (Baseline) and at Week 4
Phase 2: Cmax of Itacitanib
Cmax was defined as the maximum observed concentration of itacitanib.
Measured: pre-dose and 1, 2, and 5 hours post-dose at Week 4
Phase 1: AUC0-24h of Itacitanib
AUC0-24h was defined as the area under the plasma concentration-time curve over the last 24-hour dosing interval.
Measured: pre-dose and 1, 2, and 5 hours post-dose on Day 1 (Baseline) and at Week 4
Phase 2: AUC0-24h of Itacitanib
AUC0-24h was defined as the area under the plasma concentration-time curve over the last 24-hour dosing interval.
Measured: pre-dose and 1, 2, and 5 hours post-dose at Week 4
Phase 1: Tmax of Itacitanib
tmax was defined as the time to the maximum observed concentration of itacitanib.
Measured: pre-dose and 1, 2, and 5 hours post-dose on Day 1 (Baseline) and at Week 4
Phase 2: Tmax of Itacitanib
tmax was defined as the time to the maximum observed concentration of itacitanib.
Measured: pre-dose and 1, 2, and 5 hours post-dose at Week 4
Phase 1: Ctau of Itacitanib
Ctau was defined as the observed itacitanib concentration at the end of the dosing interval.
Measured: pre-dose and 1, 2, and 5 hours post-dose on Day 1 (Baseline) and at Week 4
Phase 2: Ctau of Itacitanib
Ctau was defined as the observed itacitanib concentration at the end of the dosing interval.
Measured: pre-dose and 1, 2, and 5 hours post-dose at Week 4
Phase 2: Time to Retransplantation or Death
Time to retransplantation or death was defined as the interval between the start of treatment and the date of retransplantation or death due to any cause.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start4 Feb 2020
- Primary completion13 Oct 2023
- Study completion13 Oct 2023
Why it stopped: Business Decision
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 Bronchiolitis Obliterans SyndromeStudies 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
- Randomised
- Intervention model
- Sequential
- Model description
- Phase 1 Itacitinib administered orally followed by phase 2; Itacitinib administered orally at the recommended dose from Phase 1.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin O'Hayer, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978637
- Sponsor's protocol ID
- INCB 39110-214
- Other IDs
- 2019-004171-39, 2019
- Status last verified
- Oct 2025
- First submitted
- 5 Jun 2019
- Last updated
- 20 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 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 Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation
- ClinicalTrials.gov ID
- NCT03978637
- Acronym / sponsor ID
- INCB 39110-214
- Conditions
- Bronchiolitis Obliterans Syndrome
- Keywords
- Bronchiolitis obliterans syndrome, lung transplant, JAK1 inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Posted 29 Jan 2025
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 the safety, efficacy, pharmacokinetics, and pharmacodynamics of itacitinib in participants with post-lung transplant bronchiolitis obliterans syndrome (BOS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Phase 1 Itacitinib administered orally followed by phase 2; Itacitinib administered orally at the recommended dose from Phase 1.
| Arm | Type | Receives |
|---|---|---|
| Itacitinib 300 mg | Experimental | Drug: ItacitinibPhase 1: Itacitinib 300 mg twice daily. There can be required dose adjustments in the protocol for concurrent CYP3A administration. |
| Itacitinib 400 mg | Experimental | Drug: ItacitinibPhase 1: Itacitinib 400 mg once daily. There can be required dose adjustments in the protocol for concurrent CYP3A administration. |
| Itacitinib 600 mg | Experimental | Drug: ItacitinibPhase 1: Itacitinib 600 mg once daily. There can be required dose adjustments in the protocol for concurrent CYP3A administration |
| Itacitinib | Experimental | Drug: ItacitinibPhase 2: Itacitinib administered orally at the recommended dose from Phase 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Double lung transplantation ≥ 1 year before informed consent. Confirmed BOS progression to Grade 1, 2, or 3 diagnosed within 1 year of screening
- A ≥ 200 mL decrease in FEV1 in the previous 12 months
- OR
- A ≥ 50 mL decrease in FEV1 in the last 2 measurements.
- Willingness to avoid pregnancy or fathering children.
Key exclusion criteria (12 listed)
- History of a single lung transplant
- FEV1 decline attributable to cause(s) other than BOS.
- Participants who have had any significant change (eg, addition of new agents) in an immunosuppressive regimen in the 4 weeks before screening.
- Untreated and/or symptomatic gastroesophageal reflux disease.
- Significant infectious comorbidities including invasive fungal disease, B. Cepacia, non TB mycobacteria, or TB.
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: INCB039110Itacitinib administered orally at the specified dose. | Drug | Itacitinib, Itacitinib 300 mg, Itacitinib 400 mg, Itacitinib 600 mg |
Primary outcome
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time frame: up to approximately 162 weeks
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as either an AE reported for the first time or the worsening of a pre-existing condition after the first dose of itacitinib until 30 days after the last dose of itacitinib.
Number of Participants With Any Grade 3 or Higher TEAE
Time frame: up to approximately 162 weeks
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was defined as either an AE reported for the first time or the worsening of a pre-existing condition after the first dose of itacitinib until 30 days after the last dose of itacitinib. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events v5.0. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12
Time frame: Baseline; Week 12
FEV1 was defined as the volume of air exhaled in 1 second. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Phase 2: FEV1 Response Rate
Time frame: Baseline through Week 12
FEV1 response rate was defined as the percentage of participants demonstrating a ≥10% absolute increase in FEV1 compared with Baseline, confirmed by 2 consecutive spirometric assessments ≥1 week apart.
19 secondary outcomes
Phase 1: Duration of FEV1 Response
Time frame: up to 34.9 months
Phase 2: Duration of FEV1 Response
Time frame: up to 24 months
Phase 1: Time to Progression
Time frame: up to 36.4 months
Phase 2: Time to Progression
Time frame: up to 24 months
Phase 1: Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score
Time frame: Baseline; up to 158.4 weeks
Phase 2: Change From Baseline in the SGRQ Total Score
Time frame: up to 24 months
Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores
Time frame: Baseline; up to 158.4 weeks
Phase 2: Change From Baseline in QOL-SF-12 Questionnaire Scores
Time frame: up to 24 months
Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State
Time frame: Baseline; up to 158.4 weeks
Phase 2: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State
Time frame: up to 24 months
Phase 1: Cmax of Itacitanib
Time frame: pre-dose and 1, 2, and 5 hours post-dose on Day 1 (Baseline) and at Week 4
Phase 2: Cmax of Itacitanib
Time frame: pre-dose and 1, 2, and 5 hours post-dose at Week 4
Phase 1: AUC0-24h of Itacitanib
Time frame: pre-dose and 1, 2, and 5 hours post-dose on Day 1 (Baseline) and at Week 4
Phase 2: AUC0-24h of Itacitanib
Time frame: pre-dose and 1, 2, and 5 hours post-dose at Week 4
Phase 1: Tmax of Itacitanib
Time frame: pre-dose and 1, 2, and 5 hours post-dose on Day 1 (Baseline) and at Week 4
Phase 2: Tmax of Itacitanib
Time frame: pre-dose and 1, 2, and 5 hours post-dose at Week 4
Phase 1: Ctau of Itacitanib
Time frame: pre-dose and 1, 2, and 5 hours post-dose on Day 1 (Baseline) and at Week 4
Phase 2: Ctau of Itacitanib
Time frame: pre-dose and 1, 2, and 5 hours post-dose at Week 4
Phase 2: Time to Retransplantation or Death
Time frame: up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 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.
Kevin O'Hayer, MD study director
Incyte Corporation
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Itacitinib in people with Bronchiolitis Obliterans Syndrome, run by Incyte Corporation at 9 sites in 3 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 6 inclusion and 12 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 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Belgium, Canada. 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 29 Jan 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?
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) (time frame: up to approximately 162 weeks). The study lists 4 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 20 Oct 2025.