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

  • STATUS
    Recruiting
Updated on 25 August 2021
organ transplantation
bronchiolitis obliterans
lung transplant
bronchiolitis

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).

 

Description

Details
Condition Inflammation, Organ Transplant
Clinical Study IdentifierTX233326
Last Modified on25 August 2021

Eligibility

Yes No Not Sure

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 OR Confirmed BOS Grade 1, 2, or 3 diagnosed within 2 years of screening AND 1) A ≥ 200 mL decrease in FEV1 in the previous 12 months OR 2) 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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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