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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
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: 75
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/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:     Incyte Corporation Call Center (US)
Address: 
Telephone: 1.855.463.3463
Email: medinfo@incyte.com
Affiliation: 
Name:     Kevin O'Hayer, MD
Address: 
Telephone:
Email:
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

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.

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 1: Change from baseline in forced expiratory volume in 1 second (FEV1) [Time Frame: Week 12]
Phase 1: Number of treatment-emergent adverse events [Time Frame: Week 12]
Phase 2: Change from baseline in FEV1 response rate [Time Frame: Week 12]
Secondary Outcome(s)
Phase 1 and 2: AUC0-t 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 QOL-SF-12 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: Cl/F of itacitinib [Time Frame: Up to Week 4]
Phase 1 and 2: Cmax 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: Duration of FEV1 response [Time Frame: Up to approximately 24 months]
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 2: Overall Survival [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
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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