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

• Status: Active, not recruiting
• Trial end date: 2024-01-09
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

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.