Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation
Bronchiolitis Obliterans Syndrome
About this trial
This is an interventional treatment trial for Bronchiolitis Obliterans Syndrome focused on measuring Bronchiolitis obliterans syndrome, lung transplant, JAK1 inhibitor
Eligibility Criteria
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.
Sites / Locations
- University of California, Los Angeles - David Geffen School of Medicine
- Brigham and Women'S Faulkner Hospitals Inc
- Duke University Health System
- Cleveland Clinic
- Hospital of the University of Pennsylvania
- Temple University Department of Thoracic Medicine and Surgery
- UPMC
- Universitaire Ziekenhuis Leuven - Gasthuisberg
- University Health Network Toronto General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Itacitinib 300 mg
Itacitinib 400 mg
Itacitinib 600 mg
Itacitinib
Phase 1: Itacitinib 300 mg twice daily. There can be required dose adjustments in the protocol for concurrent CYP3A administration.
Phase 1: Itacitinib 400 mg once daily. There can be required dose adjustments in the protocol for concurrent CYP3A administration.
Phase 1: Itacitinib 600 mg once daily. There can be required dose adjustments in the protocol for concurrent CYP3A administration
Phase 2: Itacitinib administered orally at the recommended dose from Phase 1.