Trial · NCT03978637
Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation
NCT03978637, Phase 1, Phase 2, Terminated, Incyte Corporation; results first posted 2025-01-29
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation. Trials, record NCT03978637. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03978637
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation
- NCT number
- NCT03978637
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Bronchiolitis Obliterans Syndrome
- Interventions
- Itacitinib
- First posted
- 2019-06-07
- Last updated
- 2025-10-20
- Other registries' IDs
- eudract:2019-004171-39
- Results first posted
- 2025-01-29
- Limitations and caveats
A business decision was made to terminate the study before the initiation of Part 2. The decision to terminate the study was unrelated to safety concerns. Results from Phase 1 of the study have been reported in this summary.
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to approximately 162 weeks | Full Analysis Set: all participants enrolled in the study who received at least 1 dose of itacitinib | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Any Grade 3 or Higher TEAE | up to approximately 162 weeks | Full Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | Baseline; Week 12 | Full Analysis Set. Only participants with available data were analyzed. | liters | MEAN |
| PRIMARY | Phase 2: FEV1 Response Rate | Baseline through Week 12 | 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: Duration of FEV1 Response | up to 34.9 months | Full Analysis Set. Only those participants with a response were analyzed. | days | MEDIAN |
| SECONDARY | Phase 2: Duration of FEV1 Response | up to 24 months | 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: Time to Progression | up to 36.4 months | Full Analysis Set | days | MEDIAN |
| SECONDARY | Phase 2: Time to Progression | up to 24 months | 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: Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score | Baseline; up to 158.4 weeks | Full Analysis Set. Only participants with available data were analyzed. | scores on a scale | MEAN |
| SECONDARY | Phase 2: Change From Baseline in the SGRQ Total Score | up to 24 months | 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. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group364
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Itacitinib 300/200 mg | 7 | Participants | ||
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Itacitinib 400/300 mg | 7 | Participants | ||
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Itacitinib 600/400 mg | 8 | Participants | ||
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Other | 1 | Participants | ||
| Number of Participants With Any Grade 3 or Higher TEAE | Itacitinib 300/200 mg | 6 | Participants | ||
| Number of Participants With Any Grade 3 or Higher TEAE | Itacitinib 400/300 mg | 7 | Participants | ||
| Number of Participants With Any Grade 3 or Higher TEAE | Itacitinib 600/400 mg | 6 | Participants | ||
| Number of Participants With Any Grade 3 or Higher TEAE | Other | 1 | Participants | ||
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | Itacitinib 300/200 mg | Baseline | 1.72 | Standard Deviation 0.962 | liters |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | Itacitinib 400/300 mg | Baseline | 1.57 | Standard Deviation 0.672 | liters |
1 to 10 of 364Source ClinicalTrials.gov
See all 364 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Itacitinib 300/200 mg | 7 | |
| Overall Study | STARTED | Itacitinib 400/300 mg | 7 | |
| Overall Study | STARTED | Itacitinib 600/400 mg | 8 | |
| Overall Study | STARTED | Other | 1 | |
| Overall Study | COMPLETED | Itacitinib 300/200 mg | 6 | |
| Overall Study | COMPLETED | Itacitinib 400/300 mg | 2 | |
| Overall Study | COMPLETED | Itacitinib 600/400 mg | 3 | |
| Overall Study | COMPLETED | Other | 1 | |
| Overall Study | NOT COMPLETED | Itacitinib 300/200 mg | 1 | |
| Overall Study | NOT COMPLETED | Itacitinib 400/300 mg | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events924
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal discomfort | Gastrointestinal disorders | Itacitinib 300/200 mg | 2 | 7 | 2 |
| other | Abdominal discomfort | Gastrointestinal disorders | Itacitinib 400/300 mg | 0 | 7 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Itacitinib 600/400 mg | 2 | 8 | 3 |
| other | Abdominal discomfort | Gastrointestinal disorders | Other | 0 | 1 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Itacitinib 300/200 mg | 1 | 7 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Itacitinib 400/300 mg | 0 | 7 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Itacitinib 600/400 mg | 0 | 8 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Other | 0 | 1 | 0 |
| other | Abdominal pain lower | Gastrointestinal disorders | Itacitinib 300/200 mg | 0 | 7 | 0 |
| other | Abdominal pain lower | Gastrointestinal disorders | Itacitinib 400/300 mg | 0 | 7 | 0 |
1 to 10 of 924Source ClinicalTrials.gov
See all 924 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Itacitinib 300/200 mg | 0 | 7 |
| Total, all-cause mortality | Itacitinib 400/300 mg | 2 | 7 |
| Total, all-cause mortality | Itacitinib 600/400 mg | 2 | 8 |
| Total, all-cause mortality | Other | 0 | 1 |
| Total, other adverse events | Itacitinib 300/200 mg | 6 | 7 |
| Total, other adverse events | Itacitinib 400/300 mg | 7 | 7 |
| Total, other adverse events | Itacitinib 600/400 mg | 7 | 8 |
| Total, other adverse events | Other | 1 | 1 |
| Total, serious adverse events | Itacitinib 300/200 mg | 6 | 7 |
| Total, serious adverse events | Itacitinib 400/300 mg | 7 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03978637
GET https://conductscience.org/api/trials/v1/NCT03978637/registered?page=2