Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation
NCT03978637 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2025-10-20
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).
Conditions
- Bronchiolitis Obliterans Syndrome
Interventions
- DRUG
-
Itacitinib
Itacitinib administered orally at the specified dose.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Kevin O'Hayer, MD · Incyte Corporation
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-02-04
- Primary Completion
- 2023-10-13
- Completion
- 2023-10-13
- FDA Drug
- Yes
Countries
- United States
- Belgium
- Canada
Study Locations
More Related Trials
-
A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy
NCT04071366 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Safety and Efficacy of Infliximab (Remicade) in Patients With COPD
NCT00056264 ·Status: COMPLETED ·Phase: PHASE3
-
Effectiveness of Etanercept for Idiopathic Pneumonia Syndrome Following Stem Cell Transplantation (BMT CTN 0403)
NCT00421174 ·Status: COMPLETED ·Phase: PHASE3
-
A Long-term Safety Study of Infliximab in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD).
NCT00380796 ·Status: COMPLETED
-
Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant
NCT00141726 ·Status: COMPLETED ·Phase: PHASE2
-
Safety of Itacitinib in Combination With Corticosteroids for Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects
NCT03497273 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of Efficacy and Safety of Rituximab With Mycophenolate Mofetil in Patients With Interstitial Lung Diseases
NCT02990286 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Interstitial Lung Disease (ILD) Associated With Systemic Sclerosis (SSc) and Other Connective Tissue Diseases (CTD) (BLISSconneCTD-OLE)
NCT06716606 ·Status: RECRUITING ·Phase: PHASE3
-
Safety and Efficacy of Itacitinib in Combination With Corticosteroids for Treatment of Graft-Versus-Host Disease in Pediatric Subjects
NCT03721965 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Itacitinib (INCB039110) and Extracorporeal Photopheresis (ECP) for First-Line Treatment in Chronic GVHD
NCT04446182 ·Status: TERMINATED ·Phase: PHASE2
-
A Study of Itacitinib in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Participants With Myelofibrosis
NCT03144687 ·Status: COMPLETED ·Phase: PHASE2
-
Ruxolitinib in Treating Patients With Hypereosinophilic Syndrome or Primary Eosinophilic Disorders
NCT03801434 ·Status: RECRUITING ·Phase: PHASE2
-
To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213)
NCT04629508 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute GVHD
NCT02614612 ·Status: COMPLETED ·Phase: PHASE1
-
B Cell Induction in Pediatric Lung Transplantation
NCT02266888 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Clinical Activity of Itolizumab in aGVHD
NCT05823675 ·Status: UNKNOWN ·Phase: PHASE1
-
A Study of Itacitinib for the Treatment of Chronic Graft Versus Host Disease (cGVHD)
NCT04200365 ·Status: TERMINATED ·Phase: PHASE2
-
Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors
NCT05660421 ·Status: WITHDRAWN ·Phase: PHASE2
-
Study of the ITK Inhibitor Soquelitinib to Reduce Lymphoproliferation and Improve Cytopenias in Autoimmune Lymphoproliferative Syndrome (ALPS)-FAS Patients
NCT06730126 ·Status: RECRUITING ·Phase: PHASE2
-
Treatment of Non Severe Hemophagocytosis Lymphohistiocytosis With ITACITINIB
NCT05063110 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis
NCT02466243 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis
NCT05084963 ·Status: COMPLETED ·Phase: PHASE2
-
Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease
NCT02195869 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis
NCT05314517 ·Status: TERMINATED ·Phase: PHASE2
-
A Study of the Safety and Tolerability of INCB050465 in Pemphigus Vulgaris
NCT03780166 ·Status: WITHDRAWN ·Phase: PHASE2