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

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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).

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I/II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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.

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Study Stats
Protocol No.
19-001104
Category
Pulmonary Disease
Principal Investigator
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03978637
For detailed technical eligibility, visit ClinicalTrials.gov.