Bronchiolitis Obliterans Syndrome
Conditions
Keywords
Bronchiolitis obliterans syndrome, lung transplant, JAK1 inhibitor
Brief 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).
Interventions
DRUGItacitinib
Itacitinib administered orally at the specified dose.
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase 1 Itacitinib administered orally followed by phase 2; Itacitinib administered orally at the recommended dose from Phase 1.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score | Baseline; up to 158.4 weeks | 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. |
| Phase 2: Change From Baseline in the SGRQ Total Score | up to 24 months | 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. |
| Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline; up to 158.4 weeks | 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. |
| Phase 2: Change From Baseline in QOL-SF-12 Questionnaire Scores | up to 24 months | 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. |
| Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Baseline; up to 158.4 weeks | 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. |
| Phase 2: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | up to 24 months | 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. |
| Phase 1: Cmax of Itacitanib | pre-dose and 1, 2, and 5 hours post-dose on Day 1 (Baseline) and at Week 4 | Cmax was defined as the maximum observed concentration of itacitanib. |
| Phase 1: Duration of FEV1 Response | up to 34.9 months | 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. |
| Phase 1: AUC0-24h of Itacitanib | pre-dose and 1, 2, and 5 hours post-dose on Day 1 (Baseline) and at Week 4 | AUC0-24h was defined as the area under the plasma concentration-time curve over the last 24-hour dosing interval. |
| Phase 2: AUC0-24h of Itacitanib | pre-dose and 1, 2, and 5 hours post-dose at Week 4 | AUC0-24h was defined as the area under the plasma concentration-time curve over the last 24-hour dosing interval. |
| Phase 1: Tmax of Itacitanib | pre-dose and 1, 2, and 5 hours post-dose on Day 1 (Baseline) and at Week 4 | tmax was defined as the time to the maximum observed concentration of itacitanib. |
| Phase 2: Tmax of Itacitanib | pre-dose and 1, 2, and 5 hours post-dose at Week 4 | tmax was defined as the time to the maximum observed concentration of itacitanib. |
| Phase 1: Ctau of Itacitanib | pre-dose and 1, 2, and 5 hours post-dose on Day 1 (Baseline) and at Week 4 | Ctau was defined as the observed itacitanib concentration at the end of the dosing interval. |
| Phase 2: Ctau of Itacitanib | pre-dose and 1, 2, and 5 hours post-dose at Week 4 | Ctau was defined as the observed itacitanib concentration at the end of the dosing interval. |
| Phase 2: Time to Retransplantation or Death | up to 24 months | 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. |
| Phase 2: Cmax of Itacitanib | pre-dose and 1, 2, and 5 hours post-dose at Week 4 | Cmax was defined as the maximum observed concentration of itacitanib. |
| Phase 2: Duration of FEV1 Response | up to 24 months | 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. |
| Phase 1: Time to Progression | up to 36.4 months | 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. |
| Phase 2: Time to Progression | up to 24 months | 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. |
Countries
Belgium, Canada, United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| 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. | 7 |
| 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. | 8 |
| 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. | 1 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 2 | 2 | 0 |
| Overall Study | Transitioned to Itacitinib Rollover Trial | 1 | 3 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Itacitinib 300/200 mg | Itacitinib 400/300 mg | Itacitinib 600/400 mg | Other | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 2 Participants | 0 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 6 Participants | 1 Participants | 17 Participants |
| Race/Ethnicity, Customized Black/African-American | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 6 Participants | 7 Participants | 7 Participants | 1 Participants | 21 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White/Caucasian | 6 Participants | 6 Participants | 7 Participants | 1 Participants | 20 Participants |
| Sex/Gender, Customized Female | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 6 Participants |
| Sex/Gender, Customized Male | 5 Participants | 5 Participants | 7 Participants | 0 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 2 / 7 | 2 / 8 | 0 / 1 |
| other Total, other adverse events | 6 / 7 | 7 / 7 | 7 / 8 | 1 / 1 |
| serious Total, serious adverse events | 6 / 7 | 7 / 7 | 6 / 8 | 1 / 1 |
Outcome results
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.
Time frame: Baseline; Week 12
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Itacitinib 300/200 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | Change from Baseline | 0.09 liters | Standard Deviation 0.168 |
| Itacitinib 300/200 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | Baseline | 1.72 liters | Standard Deviation 0.962 |
| Itacitinib 400/300 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | Baseline | 1.57 liters | Standard Deviation 0.672 |
| Itacitinib 400/300 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | Change from Baseline | 0.04 liters | Standard Deviation 0.114 |
| Itacitinib 600/400 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | Change from Baseline | 0.22 liters | Standard Deviation 0.571 |
| Itacitinib 600/400 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | Baseline | 1.59 liters | Standard Deviation 0.511 |
| Other | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | Baseline | 1.34 liters | — |
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.
Time frame: up to approximately 162 weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Itacitinib 300/200 mg | Number of Participants With Any Grade 3 or Higher TEAE | 6 Participants |
| Itacitinib 400/300 mg | Number of Participants With Any Grade 3 or Higher TEAE | 7 Participants |
| Itacitinib 600/400 mg | Number of Participants With Any Grade 3 or Higher TEAE | 6 Participants |
| Other | Number of Participants With Any Grade 3 or Higher TEAE | 1 Participants |
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.
Time frame: up to approximately 162 weeks
Population: Full Analysis Set: all participants enrolled in the study who received at least 1 dose of itacitinib
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Itacitinib 300/200 mg | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 7 Participants |
| Itacitinib 400/300 mg | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 7 Participants |
| Itacitinib 600/400 mg | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 8 Participants |
| Other | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 1 Participants |
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.
Time frame: Baseline through Week 12
Population: 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.
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.
Time frame: pre-dose and 1, 2, and 5 hours post-dose on Day 1 (Baseline) and at Week 4
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Itacitinib 300/200 mg | Phase 1: AUC0-24h of Itacitanib | 2590 hours x nmol/L | — |
| Itacitinib 400/300 mg | Phase 1: AUC0-24h of Itacitanib | 33100 hours x nmol/L | — |
| Itacitinib 600/400 mg | Phase 1: AUC0-24h of Itacitanib | 26800 hours x nmol/L | Geometric Coefficient of Variation 62 |
| Other | Phase 1: AUC0-24h of Itacitanib | 11900 hours x nmol/L | Geometric Coefficient of Variation 68.6 |
| Itacitininb 600 mg QD | Phase 1: AUC0-24h of Itacitanib | 14300 hours x nmol/L | Geometric Coefficient of Variation 77.2 |
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.
Time frame: Baseline; up to 158.4 weeks
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Did Work/Activities Less Carefully | 1.00 scores on a scale | — |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Did Work/Activities Less Carefully | 0.20 scores on a scale | Standard Deviation 1.095 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Accomplished Less than Liked because of Physical Health | 0.20 scores on a scale | Standard Deviation 1.095 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Felt Downhearted/Depressed | -0.20 scores on a scale | Standard Deviation 0.447 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Did Work/Activities Less Carefully | 4.14 scores on a scale | Standard Deviation 0.9 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Accomplished Less than Liked because of Emotional Problems | 1.00 scores on a scale | — |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Accomplished Less than Liked because of Physical Health | -1.00 scores on a scale | — |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Moderate Activities | 1.50 scores on a scale | Standard Deviation 0.837 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Accomplished Less than Liked because of Emotional Problems | 0.20 scores on a scale | Standard Deviation 1.095 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Limited in Work/Other Activities | 2.14 scores on a scale | Standard Deviation 0.9 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Change from Baseline (CFB) at Week 12, assessment of health | -0.28 scores on a scale | Standard Deviation 0.626 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Accomplished Less than Liked because of Emotional Problems | 4.14 scores on a scale | Standard Deviation 0.9 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Limited in Work/Other Activities | -1.00 scores on a scale | — |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Limited in Work/Other Activities | -0.20 scores on a scale | Standard Deviation 0.447 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Felt Downhearted/Depressed | 4.43 scores on a scale | Standard Deviation 0.787 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Had a Lot of Energy | 0.00 scores on a scale | — |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Moderate Activities | 0.20 scores on a scale | Standard Deviation 0.447 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Interference with Social Activity | 1.00 scores on a scale | — |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Had a Lot of Energy | 0.00 scores on a scale | Standard Deviation 0.707 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Had a Lot of Energy | 2.29 scores on a scale | Standard Deviation 1.113 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Interference with Social Activity | 4.43 scores on a scale | Standard Deviation 0.787 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Felt Calm/Peaceful | 0.00 scores on a scale | — |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Climbing Several Flights of Stairs | 1.33 scores on a scale | Standard Deviation 0.816 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Felt Downhearted/Depressed | 1.00 scores on a scale | — |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Felt Calm/Peaceful | -0.20 scores on a scale | Standard Deviation 1.643 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Felt Calm/Peaceful | 3.86 scores on a scale | Standard Deviation 0.378 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Climbing Several Flights of Stairs | 0.20 scores on a scale | Standard Deviation 0.837 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at end of treatment (EOT), assessment of health | 0.00 scores on a scale | — |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Pain Interfered with Normal Work | -1.00 scores on a scale | — |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Pain Interfered with Normal Work | 0.00 scores on a scale | Standard Deviation 0.707 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Interference with Social Activity | -0.20 scores on a scale | Standard Deviation 0.447 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Pain Interfered with Normal Work | 4.29 scores on a scale | Standard Deviation 1.254 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Accomplished Less than Liked because of Physical Health | 2.14 scores on a scale | Standard Deviation 0.9 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, assessment of health | 2.60 scores on a scale | Standard Deviation 0.748 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Felt Downhearted/Depressed | 0.43 scores on a scale | Standard Deviation 0.787 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, assessment of health | 2.80 scores on a scale | Standard Deviation 0.748 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Change from Baseline (CFB) at Week 12, assessment of health | 0.14 scores on a scale | Standard Deviation 0.378 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at end of treatment (EOT), assessment of health | -0.70 scores on a scale | Standard Deviation 0.99 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Moderate Activities | 2.00 scores on a scale | Standard Deviation 0.577 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Moderate Activities | 0.00 scores on a scale | Standard Deviation 0.577 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Moderate Activities | -0.50 scores on a scale | Standard Deviation 0.707 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Climbing Several Flights of Stairs | 1.86 scores on a scale | Standard Deviation 0.69 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Climbing Several Flights of Stairs | 0.00 scores on a scale | Standard Deviation 0.577 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week EOT, Climbing Several Flights of Stairs | -1.00 scores on a scale | Standard Deviation 0 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Accomplished Less than Liked because of Physical Health | 3.14 scores on a scale | Standard Deviation 1.345 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Accomplished Less than Liked because of Physical Health | 0.14 scores on a scale | Standard Deviation 1.773 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Accomplished Less than Liked because of Physical Health | -0.50 scores on a scale | Standard Deviation 3.536 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Limited in Work/Other Activities | 2.86 scores on a scale | Standard Deviation 0.9 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Limited in Work/Other Activities | 0.43 scores on a scale | Standard Deviation 0.787 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Limited in Work/Other Activities | 0.50 scores on a scale | Standard Deviation 0.707 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Accomplished Less than Liked because of Emotional Problems | 3.57 scores on a scale | Standard Deviation 0.976 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Accomplished Less than Liked because of Emotional Problems | 0.00 scores on a scale | Standard Deviation 1.291 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Accomplished Less than Liked because of Emotional Problems | -2.00 scores on a scale | Standard Deviation 1.414 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Did Work/Activities Less Carefully | 3.71 scores on a scale | Standard Deviation 0.756 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Did Work/Activities Less Carefully | -0.29 scores on a scale | Standard Deviation 1.38 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Did Work/Activities Less Carefully | -2.00 scores on a scale | Standard Deviation 0 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Pain Interfered with Normal Work | 4.00 scores on a scale | Standard Deviation 0.816 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Pain Interfered with Normal Work | 0.14 scores on a scale | Standard Deviation 1.215 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Pain Interfered with Normal Work | 0.00 scores on a scale | Standard Deviation 0 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Felt Calm/Peaceful | 3.14 scores on a scale | Standard Deviation 0.69 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Felt Calm/Peaceful | 0.29 scores on a scale | Standard Deviation 1.113 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Felt Calm/Peaceful | -1.00 scores on a scale | Standard Deviation 1.414 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Had a Lot of Energy | 2.71 scores on a scale | Standard Deviation 0.756 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Had a Lot of Energy | 0.43 scores on a scale | Standard Deviation 1.512 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Had a Lot of Energy | -1.00 scores on a scale | Standard Deviation 0 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Felt Downhearted/Depressed | 3.14 scores on a scale | Standard Deviation 0.69 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Felt Downhearted/Depressed | -0.50 scores on a scale | Standard Deviation 0.707 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Interference with Social Activity | 4.14 scores on a scale | Standard Deviation 0.9 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Interference with Social Activity | -0.29 scores on a scale | Standard Deviation 1.38 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Interference with Social Activity | -1.00 scores on a scale | Standard Deviation 1.414 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Felt Downhearted/Depressed | -0.80 scores on a scale | Standard Deviation 1.304 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Did Work/Activities Less Carefully | -0.80 scores on a scale | Standard Deviation 1.095 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Accomplished Less than Liked because of Physical Health | 2.63 scores on a scale | Standard Deviation 1.302 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Pain Interfered with Normal Work | 4.00 scores on a scale | Standard Deviation 1.309 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Pain Interfered with Normal Work | -0.20 scores on a scale | Standard Deviation 1.095 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Climbing Several Flights of Stairs | 0.00 scores on a scale | Standard Deviation 0 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Change from Baseline (CFB) at Week 12, assessment of health | -0.20 scores on a scale | Standard Deviation 0.447 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Felt Calm/Peaceful | 3.50 scores on a scale | Standard Deviation 1.195 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Climbing Several Flights of Stairs | 1.38 scores on a scale | Standard Deviation 0.518 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, assessment of health | 2.53 scores on a scale | Standard Deviation 1.1 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Felt Calm/Peaceful | -0.20 scores on a scale | Standard Deviation 1.095 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Interference with Social Activity | 2.75 scores on a scale | Standard Deviation 1.581 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Had a Lot of Energy | 2.25 scores on a scale | Standard Deviation 0.886 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Moderate Activities | 0.20 scores on a scale | Standard Deviation 0.447 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Had a Lot of Energy | -0.60 scores on a scale | Standard Deviation 1.14 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Moderate Activities | 1.50 scores on a scale | Standard Deviation 0.756 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Limited in Work/Other Activities | -0.40 scores on a scale | Standard Deviation 1.14 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Interference with Social Activity | 0.00 scores on a scale | Standard Deviation 1.581 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Limited in Work/Other Activities | 2.50 scores on a scale | Standard Deviation 1.309 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Felt Downhearted/Depressed | 4.75 scores on a scale | Standard Deviation 0.463 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Accomplished Less than Liked because of Emotional Problems | 4.13 scores on a scale | Standard Deviation 1.246 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Accomplished Less than Liked because of Emotional Problems | -0.20 scores on a scale | Standard Deviation 1.483 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Accomplished Less than Liked because of Physical Health | -0.80 scores on a scale | Standard Deviation 0.837 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at end of treatment (EOT), assessment of health | 0.00 scores on a scale | — |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Did Work/Activities Less Carefully | 4.25 scores on a scale | Standard Deviation 1.035 |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Moderate Activities | 0.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Accomplished Less than Liked because of Physical Health | 4.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Felt Calm/Peaceful | 0.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Moderate Activities | 1.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Interference with Social Activity | 5.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Accomplished Less than Liked because of Emotional Problems | 5.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Had a Lot of Energy | 4.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Accomplished Less than Liked because of Physical Health | 1.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, assessment of health | 3.40 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Felt Downhearted/Depressed | 5.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Had a Lot of Energy | 0.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Moderate Activities | 2.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Interference with Social Activity | 0.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Did Work/Activities Less Carefully | 0.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Had a Lot of Energy | 1.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Felt Downhearted/Depressed | 0.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Did Work/Activities Less Carefully | 0.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week EOT, Climbing Several Flights of Stairs | 0.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Change from Baseline (CFB) at Week 12, assessment of health | 0.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Did Work/Activities Less Carefully | 5.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Pain Interfered with Normal Work | 5.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Climbing Several Flights of Stairs | 0.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Interference with Social Activity | 0.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Accomplished Less than Liked because of Emotional Problems | 0.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Pain Interfered with Normal Work | 0.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Limited in Work/Other Activities | 0.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Felt Downhearted/Depressed | 0.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Pain Interfered with Normal Work | 0.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Climbing Several Flights of Stairs | 2.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Limited in Work/Other Activities | 4.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Accomplished Less than Liked because of Physical Health | 1.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | Baseline, Felt Calm/Peaceful | 5.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Limited in Work/Other Activities | 0.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at end of treatment (EOT), assessment of health | 0.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at EOT, Accomplished Less than Liked because of Emotional Problems | 0.00 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the Quality of Life-Short Form-12 (QOL-SF-12) Questionnaire Scores | CFB at Week 12, Felt Calm/Peaceful | 0.00 scores on a scale | — |
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.
Time frame: Baseline; up to 158.4 weeks
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score | Baseline | 51.21 scores on a scale | Standard Deviation 16.74 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score | Change from Baseline at Week 12 | -5.70 scores on a scale | Standard Deviation 8.792 |
| Itacitinib 300/200 mg | Phase 1: Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score | Change from Baseline at End of Treatment | 13.17 scores on a scale | — |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score | Change from Baseline at Week 12 | -4.55 scores on a scale | Standard Deviation 7.627 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score | Baseline | 38.79 scores on a scale | Standard Deviation 15.165 |
| Itacitinib 400/300 mg | Phase 1: Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score | Change from Baseline at End of Treatment | 6.82 scores on a scale | Standard Deviation 3.416 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score | Change from Baseline at Week 12 | 0.87 scores on a scale | Standard Deviation 15.895 |
| Itacitinib 600/400 mg | Phase 1: Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score | Baseline | 52.94 scores on a scale | Standard Deviation 20.961 |
| Other | Phase 1: Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score | Change from Baseline at Week 12 | -1.84 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score | Change from Baseline at End of Treatment | -2.34 scores on a scale | — |
| Other | Phase 1: Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score | Baseline | 19.86 scores on a scale | — |
Secondary
Phase 1: Cmax of Itacitanib
Cmax was defined as the maximum observed concentration of itacitanib.
Time frame: pre-dose and 1, 2, and 5 hours post-dose on Day 1 (Baseline) and at Week 4
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Itacitinib 300/200 mg | Phase 1: Cmax of Itacitanib | 370 nanomoles per liter (nmol/L) | — |
| Itacitinib 400/300 mg | Phase 1: Cmax of Itacitanib | 2820 nanomoles per liter (nmol/L) | — |
| Itacitinib 600/400 mg | Phase 1: Cmax of Itacitanib | 1820 nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 33.9 |
| Other | Phase 1: Cmax of Itacitanib | 2050 nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 53 |
| Itacitininb 600 mg QD | Phase 1: Cmax of Itacitanib | 2410 nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 61.7 |
Secondary
Phase 1: Ctau of Itacitanib
Ctau was defined as the observed itacitanib concentration at the end of the dosing interval.
Time frame: pre-dose and 1, 2, and 5 hours post-dose on Day 1 (Baseline) and at Week 4
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Itacitinib 300/200 mg | Phase 1: Ctau of Itacitanib | 9.34 nmol/L | — |
| Itacitinib 400/300 mg | Phase 1: Ctau of Itacitanib | 403 nmol/L | — |
| Itacitinib 600/400 mg | Phase 1: Ctau of Itacitanib | 510 nmol/L | Geometric Coefficient of Variation 130 |
| Other | Phase 1: Ctau of Itacitanib | 16.5 nmol/L | Geometric Coefficient of Variation 675 |
| Itacitininb 600 mg QD | Phase 1: Ctau of Itacitanib | 43.4 nmol/L | Geometric Coefficient of Variation 92.7 |
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.
Time frame: up to 34.9 months
Population: Full Analysis Set. Only those participants with a response were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Itacitinib 300/200 mg | Phase 1: Duration of FEV1 Response | NA days |
| Itacitinib 400/300 mg | Phase 1: Duration of FEV1 Response | 491.5 days |
| Itacitinib 600/400 mg | Phase 1: Duration of FEV1 Response | NA days |
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.
Time frame: Baseline; up to 158.4 weeks
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, unable to wash or dress self at BL | 0 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, no pain/discomfort at EOT | 0 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, no problems walking about at EOT | 0 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, not anxious/depressed at Week 12 | 4 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, no problems at Week 12 | 4 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, extreme pain/discomfort at Week 12 | 0 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, confined to bed at Week 12 | 0 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, extreme pain/discomfort at BL | 1 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, some problems at Week 12 | 0 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, unable to perform usual activities at EOT | 0 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, no problems walking about at BL | 1 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, extremely anxious/depressed at BL | 0 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, unable to wash or dress self at Week 12 | 1 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, some problems walking about at EOT | 0 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, no pain/discomfort at Week 12 | 2 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, no problems at EOT | 0 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, no problems at EOT | 0 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, unable to perform usual activities at Week 12 | 1 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, moderately anxious/depressed at EOT | 0 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, moderately anxious/depressed at BL | 1 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, some problems at EOT | 0 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, extremely anxious/depressed at Week 12 | 0 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, no problems walking about at Week 12 | 3 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, confined to bed at EOT | 0 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, unable to wash or dress self at EOT | 0 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, not anxious/depressed at EOT | 0 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, extremely anxious/depressed at EOT | 0 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, not anxious/depressed at BL | 6 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, no problems at BL | 2 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, no pain/discomfort at BL | 3 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, no problems at BL | 4 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, some problems walking about at BL | 6 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, some problems at BL | 4 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, some problems at EOT | 0 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, moderately anxious/depressed at Week 12 | 1 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, extreme pain/discomfort at EOT | 0 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, unable to perform usual activities at BL | 1 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, some problems at BL | 3 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, some problems walking about at Week 12 | 2 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, moderate pain/discomfort at Week 12 | 3 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, no problems at Week 12 | 1 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, confined to bed at BL | 0 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, moderate pain/discomfort at EOT | 0 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, some problems at Week 12 | 3 Participants |
| Itacitinib 300/200 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, moderate pain/discomfort at BL | 3 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, some problems at Week 12 | 3 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, no pain/discomfort at EOT | 0 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, unable to perform usual activities at Week 12 | 1 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, no problems at EOT | 0 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, extreme pain/discomfort at Week 12 | 0 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, some problems at EOT | 1 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, unable to perform usual activities at EOT | 0 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, no problems walking about at EOT | 0 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, moderate pain/discomfort at Week 12 | 4 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, no pain/discomfort at BL | 1 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, some problems walking about at BL | 5 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, moderate pain/discomfort at BL | 6 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, extremely anxious/depressed at Week 12 | 0 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, no pain/discomfort at Week 12 | 2 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, extreme pain/discomfort at BL | 0 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, some problems walking about at EOT | 1 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, no problems walking about at BL | 2 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, confined to bed at EOT | 0 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, moderately anxious/depressed at Week 12 | 4 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, no problems at BL | 5 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, moderately anxious/depressed at EOT | 1 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, some problems at BL | 2 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, not anxious/depressed at Week 12 | 2 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, unable to wash or dress self at BL | 0 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, confined to bed at BL | 0 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, no problems at Week 12 | 4 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, extremely anxious/depressed at BL | 0 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, some problems at Week 12 | 2 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, unable to wash or dress self at Week 12 | 0 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, confined to bed at Week 12 | 0 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, moderately anxious/depressed at BL | 5 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, no problems at EOT | 0 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, some problems at EOT | 1 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, not anxious/depressed at BL | 2 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, unable to wash or dress self at EOT | 0 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, no problems walking about at Week 12 | 2 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, no problems at BL | 3 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, extremely anxious/depressed at EOT | 0 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, extreme pain/discomfort at EOT | 0 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, some problems at BL | 4 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, not anxious/depressed at EOT | 0 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, unable to perform usual activities at BL | 0 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, moderate pain/discomfort at EOT | 1 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, some problems walking about at Week 12 | 4 Participants |
| Itacitinib 400/300 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, no problems at Week 12 | 2 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, some problems walking about at Week 12 | 2 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, no problems walking about at BL | 4 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, some problems walking about at BL | 4 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, confined to bed at BL | 0 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, no problems walking about at Week 12 | 3 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, confined to bed at Week 12 | 0 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, no problems walking about at EOT | 0 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, some problems walking about at EOT | 0 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, confined to bed at EOT | 0 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, no problems at BL | 6 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, some problems at BL | 2 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, unable to wash or dress self at BL | 0 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, no problems at Week 12 | 4 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, some problems at Week 12 | 1 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, unable to wash or dress self at Week 12 | 0 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, no problems at EOT | 0 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, some problems at EOT | 0 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, unable to wash or dress self at EOT | 0 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, no problems at BL | 2 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, some problems at BL | 5 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, unable to perform usual activities at BL | 1 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, no problems at Week 12 | 1 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, some problems at Week 12 | 3 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, unable to perform usual activities at Week 12 | 1 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, no problems at EOT | 0 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, some problems at EOT | 0 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, unable to perform usual activities at EOT | 0 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, no pain/discomfort at BL | 4 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, moderate pain/discomfort at BL | 4 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, extreme pain/discomfort at BL | 0 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, no pain/discomfort at Week 12 | 2 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, moderate pain/discomfort at Week 12 | 3 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, extreme pain/discomfort at Week 12 | 0 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, no pain/discomfort at EOT | 0 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, moderate pain/discomfort at EOT | 0 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, extreme pain/discomfort at EOT | 0 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, not anxious/depressed at BL | 6 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, moderately anxious/depressed at BL | 1 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, extremely anxious/depressed at BL | 1 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, not anxious/depressed at Week 12 | 4 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, moderately anxious/depressed at Week 12 | 1 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, extremely anxious/depressed at Week 12 | 0 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, not anxious/depressed at EOT | 0 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, moderately anxious/depressed at EOT | 0 Participants |
| Itacitinib 600/400 mg | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, extremely anxious/depressed at EOT | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, no pain/discomfort at EOT | 1 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, no problems at Week 12 | 1 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, unable to perform usual activities at BL | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, no problems walking about at Week 12 | 1 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, moderate pain/discomfort at EOT | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, some problems at BL | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, no problems at BL | 1 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, no problems walking about at BL | 1 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, extreme pain/discomfort at EOT | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, unable to wash or dress self at EOT | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, some problems at EOT | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, not anxious/depressed at EOT | 1 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, not anxious/depressed at BL | 1 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, no problems at EOT | 1 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, unable to wash or dress self at Week 12 | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, confined to bed at BL | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, moderately anxious/depressed at BL | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, some problems at Week 12 | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, no problems at Week 12 | 1 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, some problems walking about at BL | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, extremely anxious/depressed at BL | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, unable to wash or dress self at BL | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, some problems at BL | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, extremely anxious/depressed at EOT | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, not anxious/depressed at Week 12 | 1 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Self-care, no problems at BL | 1 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, confined to bed at EOT | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, moderately anxious/depressed at EOT | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, moderately anxious/depressed at Week 12 | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, some problems walking about at EOT | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, extreme pain/discomfort at BL | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, moderate pain/discomfort at BL | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, no problems walking about at EOT | 1 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, no pain/discomfort at Week 12 | 1 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, no pain/discomfort at BL | 1 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, unable to perform usual activities at EOT | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, some problems walking about at Week 12 | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, moderate pain/discomfort at Week 12 | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, some problems at EOT | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, no problems at EOT | 1 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Anxiety/depression, extremely anxious/depressed at Week 12 | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Pain/discomfort, extreme pain/discomfort at Week 12 | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, unable to perform usual activities at Week 12 | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Usual activities, some problems at Week 12 | 0 Participants |
| Other | Phase 1: Number of Participants With the Indicated Responses on the EQ-5D-3L Questionnaire Regarding Their Health State | Mobility, confined to bed at Week 12 | 0 Participants |
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.
Time frame: up to 36.4 months
Population: Full Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Itacitinib 300/200 mg | Phase 1: Time to Progression | 516.0 days |
| Itacitinib 400/300 mg | Phase 1: Time to Progression | 485.0 days |
| Itacitinib 600/400 mg | Phase 1: Time to Progression | NA days |
| Other | Phase 1: Time to Progression | NA days |
Secondary
Phase 1: Tmax of Itacitanib
tmax was defined as the time to the maximum observed concentration of itacitanib.
Time frame: pre-dose and 1, 2, and 5 hours post-dose on Day 1 (Baseline) and at Week 4
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Itacitinib 300/200 mg | Phase 1: Tmax of Itacitanib | 2.15 hours |
| Itacitinib 400/300 mg | Phase 1: Tmax of Itacitanib | 4.63 hours |
| Itacitinib 600/400 mg | Phase 1: Tmax of Itacitanib | 3.2 hours |
| Other | Phase 1: Tmax of Itacitanib | 2.0 hours |
| Itacitininb 600 mg QD | Phase 1: Tmax of Itacitanib | 1.9 hours |
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.
Time frame: pre-dose and 1, 2, and 5 hours post-dose at Week 4
Population: 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.
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.
Time frame: up to 24 months
Population: 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.
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.
Time frame: up to 24 months
Population: 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.
Secondary
Phase 2: Cmax of Itacitanib
Cmax was defined as the maximum observed concentration of itacitanib.
Time frame: pre-dose and 1, 2, and 5 hours post-dose at Week 4
Population: 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.
Secondary
Phase 2: Ctau of Itacitanib
Ctau was defined as the observed itacitanib concentration at the end of the dosing interval.
Time frame: pre-dose and 1, 2, and 5 hours post-dose at Week 4
Population: 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.
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.
Time frame: up to 24 months
Population: 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.
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.
Time frame: up to 24 months
Population: 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.
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.
Time frame: up to 24 months
Population: 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.
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.
Time frame: up to 24 months
Population: 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.
Secondary
Phase 2: Tmax of Itacitanib
tmax was defined as the time to the maximum observed concentration of itacitanib.
Time frame: pre-dose and 1, 2, and 5 hours post-dose at Week 4
Population: 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.