Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation

Stopped early · Phase 1/Phase 2

Conditions studied: Bronchiolitis Obliterans Syndrome

In brief

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).

Key facts

Study ID

NCT03978637

Run by

Incyte Corporation

People needed

23

Starts

2020-02-04

Expected to finish

2023-10-13

Last updated by the study team

2025-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California, Los Angeles - David Geffen School of Medicine — Los Angeles, California, United States
• Brigham and Women'S Faulkner Hospitals Inc — Boston, Massachusetts, United States
• Duke University Health System — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Temple University Department of Thoracic Medicine and Surgery — Philadelphia, Pennsylvania, United States
• UPMC — Pittsburgh, Pennsylvania, United States
• Universitaire Ziekenhuis Leuven - Gasthuisberg — Leuven, Belgium
• University Health Network Toronto General Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.