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

• Register: ClinicalTrials.gov
• Last refreshed on: 20 November 2023
• Main ID: NCT03978637
• Date of registration: 05/06/2019
• Prospective Registration: Yes
• Primary sponsor: Incyte Corporation
• Public title: Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation
• Scientific 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
• Date of first enrolment: February 4, 2020
• Target sample size: 23
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT03978637
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Belgium, Canada, United States

Contacts

• Name: Kevin O'Hayer, MD
• Affiliation: Incyte Corporation

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Bronchiolitis Obliterans Syndrome

Intervention(s)

Drug: Itacitinib

Primary Outcome(s)

Phase 2: Change from baseline in FEV1 response rate [Time Frame: Week 12]

Phase 1: Number of treatment-emergent adverse events [Time Frame: Up to approximately 24 months]

Phase 1: Change from baseline in forced expiratory volume in 1 second (FEV1) [Time Frame: Week 12]

Secondary Outcome(s)

Phase 1 and 2: Change from baseline in QOL-SF-12 questionnaire [Time Frame: Up to approximately 24 months]

Phase 1 and 2: Cl/F of itacitinib [Time Frame: Up to Week 4]

Phase 1 and 2: Cmax of itacitinib [Time Frame: Up to Week 4]

Phase 2: Overall Survival [Time Frame: Up to approximately 24 months]

Phase 1 and 2: AUC0-t of itacitinib [Time Frame: Up to Week 4]

Phase 1 and 2: Cmin of itacitinib [Time Frame: Up to Week 4]

Phase 1 and 2: Time to progression [Time Frame: Up to approximately 24 months]

Phase 1 and 2: Tmax of itacitinib [Time Frame: Up to Week 4]

Phase 1 and 2: Categorical summary or change from baseline in EQ-5D-3L questionnaire [Time Frame: Up to approximately 24 months]

Phase 1 and 2: Change from baseline in SGRQ total score [Time Frame: Up to approximately 24 months]

Phase 1 and 2: Duration of FEV1 response [Time Frame: Up to approximately 24 months]

Secondary ID(s)

INCB 39110-214

Source(s) of Monetary Support

Please refer to primary and secondary sponsors