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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03978637
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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).

Condition or disease Intervention/treatment Phase
Bronchiolitis Obliterans Syndrome Drug: Itacitinib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Phase 1 Itacitinib administered orally followed by phase 2; Itacitinib administered orally at the recommended dose from Phase 1.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 9, 2019
Estimated Primary Completion Date : December 9, 2020
Estimated Study Completion Date : September 16, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Itacitinib 200 mg
Phase 1: Itacitinib 200 mg once daily.
Drug: Itacitinib
Itacitinib administered orally at the specified dose.
Other Name: INCB039110

Experimental: Itacitinib 400 mg
Phase 1: Itacitinib 400 mg once daily.
Drug: Itacitinib
Itacitinib administered orally at the specified dose.
Other Name: INCB039110

Experimental: Itacitinib
Phase 2: Itacitinib administered orally at the recommended dose from Phase 1.
Drug: Itacitinib
Itacitinib administered orally at the specified dose.
Other Name: INCB039110




Primary Outcome Measures :
  1. Phase 1: Number of treatment-emergent adverse events [ Time Frame: Week 12 ]
    Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug until 30 days after the last dose of study drug.

  2. Phase 1: Change from baseline in forced expiratory volume in 1 second (FEV1) [ Time Frame: Week 12 ]
  3. Phase 2: Change from baseline in FEV1 response rate [ Time Frame: Week 12 ]
    Defined as the proportion of participants demonstrating a ≥ 10% absolute increase in FEV1 compared to baseline.


Secondary Outcome Measures :
  1. Phase 1 and 2: Duration of FEV1 response [ Time Frame: Up to approximately 24 months ]
    Defined as the time of the onset of response (≥ 10% absolute increase in FEV1 compared to baseline) to BOS progression or loss of clinical benefit as determined by the investigator.

  2. Phase 1 and 2: Time to progression [ Time Frame: Up to approximately 24 months ]
    Defined as the interval between the start of treatment and BOS progression (≥ 10% absolute decrease in FEV1 compared to baseline).

  3. Phase 1 and 2: Change from baseline in SGRQ total score [ Time Frame: Up to approximately 24 months ]
    St. Georges Respiratory Questionnaire, a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airway disease.

  4. Phase 1 and 2: Change from baseline in QOL-SF-12 questionnaire [ Time Frame: Up to approximately 24 months ]
    A 12-item subset of the SF-36 v2 scale that will capture changes in health status during the course of treatment.

  5. Phase 1 and 2: Categorical summary or change from baseline in EQ-5D-3L questionnaire [ Time Frame: Up to approximately 24 months ]
    A descriptive classification consisting of 5 dimensions of health: mobility, self-care, usual activities, anxiety/depression, and pain/discomfort.

  6. Phase 1 and 2: Cmax of itacitinib [ Time Frame: Up to Week 4 ]
    Maximum observed concentration.

  7. Phase 1 and 2: Cmin of itacitinib [ Time Frame: Up to Week 4 ]
    Minimum observed plasma or serum concentration over the dose interval.

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

  9. Phase 1 and 2: AUC0-t of itacitinib [ Time Frame: Up to Week 4 ]
    Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.

  10. Phase 1 and 2: Cl/F of itacitinib [ Time Frame: Up to Week 4 ]
    Apparent oral dose clearance.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03978637


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 globalmedinfo@incyte.com

Locations
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United States, California
University of California, Los Angeles Not yet recruiting
Los Angeles, California, United States, 90095
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital Pulmonary Division, Clinic 3 Not yet recruiting
Boston, Massachusetts, United States, 02115
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Temple University Department of Thoracic Medicine and Surgery Not yet recruiting
Philadelphia, Pennsylvania, United States, 19140
University of Pittsburgh Medical Center Falk Medical Building (Comprehensive Lung Center) Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Belgium
Universitaire Ziekenhuis Leuven-Gasthuisberg Not yet recruiting
Leuven, Belgium, 3000
Canada
University Health Network Toronto General Hospital Not yet recruiting
Toronto, Canada, M5G 2N2
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Kevin O'Hayer, MD Incyte Corporation

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03978637    
Other Study ID Numbers: INCB 39110-214
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Bronchiolitis obliterans syndrome
lung transplant
JAK1 inhibitor
Additional relevant MeSH terms:
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Bronchiolitis
Bronchiolitis Obliterans
Syndrome
Disease
Pathologic Processes
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections