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

NCT ID: NCT03978637

Last Updated: 2025-10-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-04
• Study Completion Date: 2023-10-13

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Itacitinib 300 mg

Phase 1: Itacitinib 300 mg twice daily. There can be required dose adjustments in the protocol for concurrent CYP3A administration.

Group Type: EXPERIMENTAL

Itacitinib

Intervention Type: DRUG

Itacitinib administered orally at the specified dose.

Itacitinib 400 mg

Phase 1: Itacitinib 400 mg once daily. There can be required dose adjustments in the protocol for concurrent CYP3A administration.

Group Type: EXPERIMENTAL

Itacitinib

Intervention Type: DRUG

Itacitinib administered orally at the specified dose.

Itacitinib 600 mg

Phase 1: Itacitinib 600 mg once daily. There can be required dose adjustments in the protocol for concurrent CYP3A administration

Group Type: EXPERIMENTAL

Itacitinib

Intervention Type: DRUG

Itacitinib administered orally at the specified dose.

Itacitinib

Phase 2: Itacitinib administered orally at the recommended dose from Phase 1.

Group Type: EXPERIMENTAL

Itacitinib

Intervention Type: DRUG

Itacitinib administered orally at the specified dose.

Interventions

Itacitinib

Itacitinib administered orally at the specified dose.

Intervention Type: DRUG

Other Intervention Names

INCB039110

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin O'Hayer, MD

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

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

Countries

United States; Belgium; Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2019-004171-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

INCB 39110-214

Identifier Type: -

Identifier Source: org_study_id