Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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).

Official Title

An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation

Keywords

Bronchiolitis Obliterans Syndrome lung transplant JAK1 inhibitor Bronchiolitis Bronchiolitis Obliterans Syndrome Itacitinib Itacitinib 300 mg Itacitinib 400 mg Itacitinib 600 mg

Eligibility

You can join if…

Open to people ages 18 years and up

• Double lung transplantation ≥ 1 year before informed consent. Confirmed BOS progression to Grade 1, 2, or 3 diagnosed within 1 year of screening

OR

*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 CAN'T join 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.

Locations

  • University of California, Los Angeles - David Geffen School of Medicine not yet accepting patients
    Los Angeles California 90095 United States
  • Cleveland Clinic accepting new patients
    Cleveland Ohio 44195 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
ID
NCT03978637
Phase
Phase 1/2
Study Type
Interventional
Last Updated