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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004171-39 | EudraCT Number |
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Business Decision
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Itacitinib 300 mg | Experimental | Phase 1: Itacitinib 300 mg twice daily. There can be required dose adjustments in the protocol for concurrent CYP3A administration. |
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| Itacitinib 400 mg | Experimental | Phase 1: Itacitinib 400 mg once daily. There can be required dose adjustments in the protocol for concurrent CYP3A administration. |
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| Itacitinib 600 mg | Experimental | Phase 1: Itacitinib 600 mg once daily. There can be required dose adjustments in the protocol for concurrent CYP3A administration |
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| Itacitinib | Experimental | Phase 2: Itacitinib administered orally at the recommended dose from Phase 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itacitinib | Drug | Itacitinib administered orally at the specified dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 34.9 months |
| Phase 2: Duration of FEV1 Response |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin O'Hayer, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles - David Geffen School of Medicine | Los Angeles | California | 90095 | United States | ||
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This study was conducted at 7 study centers in the United States, Canada, and Belgium. The site in Canada had a screen failure but did not recruit any participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Itacitinib 300/200 mg | Participants not taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 300 milligrams (mg) twice daily (BID). Participants taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 200 mg BID. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in forced expiratory volume in 1 second (FEV1), confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 30, 2021 | Oct 10, 2024 |
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Phase 1 Itacitinib administered orally followed by phase 2; Itacitinib administered orally at the recommended dose from Phase 1.
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| Baseline through Week 12 |
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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | up to 24 months |
| Phase 1: Cmax of Itacitanib | Cmax was defined as the maximum observed concentration of itacitanib. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | up to 24 months |
| Brigham and Women'S Faulkner Hospitals Inc |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Duke University Health System | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Temple University Department of Thoracic Medicine and Surgery | Philadelphia | Pennsylvania | 19140 | United States |
| UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| Universitaire Ziekenhuis Leuven - Gasthuisberg | Leuven | 03000 | Belgium |
| University Health Network Toronto General Hospital | Toronto | Ontario | M5G 2N2 | Canada |
| FG001 | Itacitinib 400/300 mg | Participants not taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 400 mg once daily (QD). Participants taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 300 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| FG002 | Itacitinib 600/400 mg | Participants not taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 600 mg QD. Participants taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 400 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| FG003 | Other | Participants received a starting dose of itacitinib 200 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Itacitinib 300/200 mg | Participants not taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 300 milligrams (mg) twice daily (BID). Participants taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 200 mg BID. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in forced expiratory volume in 1 second (FEV1), confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| BG001 | Itacitinib 400/300 mg | Participants not taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 400 mg once daily (QD). Participants taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 300 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| BG002 | Itacitinib 600/400 mg | Participants not taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 600 mg QD. Participants taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 400 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| BG003 | Other | Participants received a starting dose of itacitinib 200 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | 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. | Full Analysis Set: all participants enrolled in the study who received at least 1 dose of itacitinib | Posted | Count of Participants | Participants | up to approximately 162 weeks |
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| Primary | 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. | Full Analysis Set | Posted | Count of Participants | Participants | up to approximately 162 weeks |
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| Primary | 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. | Full Analysis Set. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | liters | Baseline; Week 12 |
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| Primary | 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. | A business decision was made to terminate the study before the initiation of Part 2. The decision to terminate the study was unrelated to safety concerns. | Posted | Baseline through Week 12 |
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| Secondary | 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. | Full Analysis Set. Only those participants with a response were analyzed. | Posted | Median | 95% Confidence Interval | days | up to 34.9 months |
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| Secondary | 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. | A business decision was made to terminate the study before the initiation of Part 2. The decision to terminate the study was unrelated to safety concerns. | Posted | up to 24 months |
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| Secondary | 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. | Full Analysis Set | Posted | Median | 95% Confidence Interval | days | up to 36.4 months |
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| Secondary | 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. | A business decision was made to terminate the study before the initiation of Part 2. The decision to terminate the study was unrelated to safety concerns. | Posted | up to 24 months |
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| Secondary | 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. | Full Analysis Set. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline; up to 158.4 weeks |
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| Secondary | 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. | A business decision was made to terminate the study before the initiation of Part 2. The decision to terminate the study was unrelated to safety concerns. | Posted | up to 24 months |
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| Secondary | 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. | Full Analysis Set. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline; up to 158.4 weeks |
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| Secondary | 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. | A business decision was made to terminate the study before the initiation of Part 2. The decision to terminate the study was unrelated to safety concerns. | Posted | up to 24 months |
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| Secondary | 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. | Full Analysis Set. Only participants with available data were analyzed. | Posted | Count of Participants | Participants | Baseline; up to 158.4 weeks |
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| Secondary | 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. | A business decision was made to terminate the study before the initiation of Part 2. The decision to terminate the study was unrelated to safety concerns. | Posted | up to 24 months |
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| Secondary | Phase 1: Cmax of Itacitanib | Cmax was defined as the maximum observed concentration of itacitanib. | Pharmacokinetic (PK)-Evaluable Population: all enrolled participants who received at least 1 dose of itacitinib and provided at least 1 post-dose PK sample. Data were analyzed by dose rather than by treatment arm because approximately one-third of the participants had a dose adjustment (dose reduction) during the course of the study. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomoles per liter (nmol/L) | pre-dose and 1, 2, and 5 hours post-dose on Day 1 (Baseline) and at Week 4 |
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| Secondary | Phase 2: Cmax of Itacitanib | Cmax was defined as the maximum observed concentration of itacitanib. | A business decision was made to terminate the study before the initiation of Part 2. The decision to terminate the study was unrelated to safety concerns. | Posted | pre-dose and 1, 2, and 5 hours post-dose at Week 4 |
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| Secondary | 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. | PK-Evaluable Population. Data were analyzed by dose rather than by treatment arm because approximately one-third of the participants had a dose adjustment (dose reduction) during the course of the study. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours x nmol/L | pre-dose and 1, 2, and 5 hours post-dose on Day 1 (Baseline) and at Week 4 |
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| Secondary | 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. | A business decision was made to terminate the study before the initiation of Part 2. The decision to terminate the study was unrelated to safety concerns. | Posted | pre-dose and 1, 2, and 5 hours post-dose at Week 4 |
|
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| Secondary | Phase 1: Tmax of Itacitanib | tmax was defined as the time to the maximum observed concentration of itacitanib. | PK-Evaluable Population. Data were analyzed by dose rather than by treatment arm because approximately one-third of the participants had a dose adjustment (dose reduction) during the course of the study. | Posted | Median | Full Range | hours | pre-dose and 1, 2, and 5 hours post-dose on Day 1 (Baseline) and at Week 4 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: Tmax of Itacitanib | tmax was defined as the time to the maximum observed concentration of itacitanib. | A business decision was made to terminate the study before the initiation of Part 2. The decision to terminate the study was unrelated to safety concerns. | Posted | pre-dose and 1, 2, and 5 hours post-dose at Week 4 |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Phase 1: Ctau of Itacitanib | Ctau was defined as the observed itacitanib concentration at the end of the dosing interval. | PK-Evaluable Population. Data were analyzed by dose rather than by treatment arm because approximately one-third of the participants had a dose adjustment (dose reduction) during the course of the study. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | pre-dose and 1, 2, and 5 hours post-dose on Day 1 (Baseline) and at Week 4 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: Ctau of Itacitanib | Ctau was defined as the observed itacitanib concentration at the end of the dosing interval. | A business decision was made to terminate the study before the initiation of Part 2. The decision to terminate the study was unrelated to safety concerns. | Posted | pre-dose and 1, 2, and 5 hours post-dose at Week 4 |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | A business decision was made to terminate the study before the initiation of Part 2. The decision to terminate the study was unrelated to safety concerns. | Posted | up to 24 months |
|
|
from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 3.67 years)
Adverse events had been reported for members of the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of itacitinib.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Itacitinib 300/200 mg | Participants not taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 300 milligrams (mg) twice daily (BID). Participants taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 200 mg BID. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in forced expiratory volume in 1 second (FEV1), confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. | 0 | 7 | 6 | 7 | 6 | 7 |
| EG001 | Itacitinib 400/300 mg | Participants not taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 400 mg once daily (QD). Participants taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 300 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. | 2 | 7 | 7 | 7 | 7 | 7 |
| EG002 | Itacitinib 600/400 mg | Participants not taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 600 mg QD. Participants taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 400 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. | 2 | 8 | 6 | 8 | 7 | 8 |
| EG003 | Other | Participants received a starting dose of itacitinib 200 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. | 0 | 1 | 1 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acidosis hyperchloraemic | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac death | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cryptococcus test positive | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Donor specific antibody present | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| End stage renal disease | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Herpes simplex pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Large intestine infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Metastatic squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Myelodysplastic syndrome with single lineage dysplasia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Q fever | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Spinal synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Transplant rejection | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anaemia macrocytic | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac flutter | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Colorectal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Congenital dyskeratosis | Congenital, familial and genetic disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Defaecation urgency | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Disseminated superficial actinic porokeratosis | Congenital, familial and genetic disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 26.1 | Systematic Assessment |
| |
| End stage renal disease | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Enlarged uvula | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Feeling jittery | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Genital herpes | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| HCoV-OC43 infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Herpes simplex reactivation | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Human polyomavirus infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Immunisation reaction | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Immunosuppressant drug level increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Lower respiratory tract infection bacterial | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Morganella infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myelocyte count increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ocular hypertension | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Polyp | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Prostatic specific antigen increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rectal ulcer | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory tract infection bacterial | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Retinal vein occlusion | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Scrotal pain | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Scrotal swelling | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tinea infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Tongue disorder | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Transplant rejection | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Vasomotor rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
A business decision was made to terminate the study before the initiation of Part 2. The decision to terminate the study was unrelated to safety concerns. Results from Phase 1 of the study have been reported in this summary.
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Incyte Corporation | 1-855-463-3463 | medinfo@incyte.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 26, 2024 | Oct 10, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718170 | itacitinib |
| C000603457 | INCB039110 |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Black/African-American |
|
| Not Hispanic or Latino |
|
| Unknown |
|
| OG001 | Itacitinib 400/300 mg | Participants not taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 400 mg once daily (QD). Participants taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 300 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| OG002 | Itacitinib 600/400 mg | Participants not taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 600 mg QD. Participants taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 400 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| OG003 | Other | Participants received a starting dose of itacitinib 200 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
|
|
| OG002 | Itacitinib 600/400 mg | Participants not taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 600 mg QD. Participants taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 400 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| OG003 | Other | Participants received a starting dose of itacitinib 200 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
|
|
| OG002 | Itacitinib 600/400 mg | Participants not taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 600 mg QD. Participants taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 400 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| OG003 | Other | Participants received a starting dose of itacitinib 200 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
|
|
| OG002 | Itacitinib 600/400 mg | Participants not taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 600 mg QD. Participants taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 400 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| OG003 | Other | Participants received a starting dose of itacitinib 200 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
|
|
| OG001 | Itacitinib 400/300 mg | Participants not taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 400 mg once daily (QD). Participants taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 300 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| OG002 | Itacitinib 600/400 mg | Participants not taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 600 mg QD. Participants taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 400 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| OG003 | Other | Participants received a starting dose of itacitinib 200 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
|
|
| OG001 | Itacitinib 400/300 mg | Participants not taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 400 mg once daily (QD). Participants taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 300 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| OG002 | Itacitinib 600/400 mg | Participants not taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 600 mg QD. Participants taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 400 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| OG003 | Other | Participants received a starting dose of itacitinib 200 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
| Itacitinib 400/300 mg |
Participants not taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 400 mg once daily (QD). Participants taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 300 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| OG002 | Itacitinib 600/400 mg | Participants not taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 600 mg QD. Participants taking a concomitant strong CYP3A inhibitor received a starting dose of itacitinib 400 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| OG003 | Other | Participants received a starting dose of itacitinib 200 mg QD. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in FEV1, confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
|
|
| OG002 | Itacitinib 300 mg BID | Participants received itacitinib 300 mg BID during the course of the study. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in forced expiratory volume in 1 second (FEV1), confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| OG003 | Itacitinib 400 mg QD | Participants received itacitinib 400 mg QD during the course of the study. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in forced expiratory volume in 1 second (FEV1), confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| OG004 | Itacitininb 600 mg QD | Participants received itacitinib 600 mg QD during the course of the study. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in forced expiratory volume in 1 second (FEV1), confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
|
|
| OG002 | Itacitinib 300 mg BID | Participants received itacitinib 300 mg BID during the course of the study. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in forced expiratory volume in 1 second (FEV1), confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| OG003 | Itacitinib 400 mg QD | Participants received itacitinib 400 mg QD during the course of the study. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in forced expiratory volume in 1 second (FEV1), confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| OG004 | Itacitininb 600 mg QD | Participants received itacitinib 600 mg QD during the course of the study. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in forced expiratory volume in 1 second (FEV1), confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
|
|
| OG002 | Itacitinib 300 mg BID | Participants received itacitinib 300 mg BID during the course of the study. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in forced expiratory volume in 1 second (FEV1), confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| OG003 | Itacitinib 400 mg QD | Participants received itacitinib 400 mg QD during the course of the study. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in forced expiratory volume in 1 second (FEV1), confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| OG004 | Itacitininb 600 mg QD | Participants received itacitinib 600 mg QD during the course of the study. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in forced expiratory volume in 1 second (FEV1), confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
|
|
| OG002 | Itacitinib 300 mg BID | Participants received itacitinib 300 mg BID during the course of the study. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in forced expiratory volume in 1 second (FEV1), confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| OG003 | Itacitinib 400 mg QD | Participants received itacitinib 400 mg QD during the course of the study. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in forced expiratory volume in 1 second (FEV1), confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
| OG004 | Itacitininb 600 mg QD | Participants received itacitinib 600 mg QD during the course of the study. Participants may have had dose reductions or modifications during the course of treatment based on adverse events, clinical evaluation, changes to concomitant medications, and laboratory assessments. Itacitinib treatment was continued until progression of bronchiolitis obliterans syndrome (defined as a ≥10% absolute decrease from Baseline in forced expiratory volume in 1 second (FEV1), confirmed by 2 consecutive spirometric assessments ≥3 weeks apart), unacceptable toxicity, loss of clinical benefit, or withdrawal of consent. |
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