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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Incyte Corporation
Study ID
NCT03978637
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Bronchiolitis Obliterans Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Itacitinib — DRUG
    Itacitinib administered orally at the specified dose.

Study Details

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 Dates

Start date
Feb 4, 2020
Status verified
Oct 2025
Primary completion
Oct 13, 2023
Completion
Oct 13, 2023

Study Design

Enrollment
23 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Itacitinib 300 mg
    Phase 1: Itacitinib 300 mg twice daily. There can be required dose adjustments in the protocol for concurrent CYP3A administration.
  • Experimental: Itacitinib 400 mg
    Phase 1: Itacitinib 400 mg once daily. There can be required dose adjustments in the protocol for concurrent CYP3A administration.
  • Experimental: Itacitinib 600 mg
    Phase 1: Itacitinib 600 mg once daily. There can be required dose adjustments in the protocol for concurrent CYP3A administration
  • Experimental: Itacitinib
    Phase 2: Itacitinib administered orally at the recommended dose from Phase 1.

Primary Outcome Measure

Number of Participants With Any Treatment-emergent Adverse Event (TEAE) [ Time Frame: up to approximately 162 weeks ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of California, Los Angeles - David Geffen School of MedicineLos AngelesCalifornia90095-
Brigham and Women'S Faulkner Hospitals IncBostonMassachusetts02115-
Duke University Health SystemDurhamNorth Carolina27710-
Cleveland ClinicClevelandOhio44195-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
Temple University Department of Thoracic Medicine and SurgeryPhiladelphiaPennsylvania19140-
UPMCPittsburghPennsylvania15213-

Find similar trials in Los Angeles, CA

By research site
University of California, Los Angeles - David Geffen School of Medicine· Los Angeles, CABrigham and Women'S Faulkner Hospitals Inc· Boston, MADuke University Health System· Durham, NCCleveland Clinic· Cleveland, OHHospital of the University of Pennsylvania· Philadelphia, PATemple University Department of Thoracic Medicine and Surgery· Philadelphia, PA

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