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A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Idiopathic Pulmonary Fibrosis

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. Read our disclaimer for details. Identifier: NCT02688647
Recruitment Status : Active, not recruiting
First Posted : February 23, 2016
Last Update Posted : December 23, 2019
Information provided by (Responsible Party):
Kadmon Corporation, LLC

Brief Summary:
This study is being conducted to evaluate the safety, tolerability, and activity of 400 mg of KD025 once-daily (QD) compared to Best Supportive Care(BSC) in male and postmenopausal/surgically sterilized female subjects with IPF.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: KD025 Drug: Standard of Care Phase 2

Detailed Description:
Approximately 81 subjects with IPF will be randomly enrolled in a 2:1 ratio (KD025 to BSC) to one of two treatment groups. Subjects randomized to Treatment Group 1 will receive KD025 400 mg QD orally for 24 weeks, with the option for continuation as long as there is no safety signal and clinical progress continues. Subjects randomized to Treatment Group 2 will receive BSC (as deemed appropriate by the investigator). Subjects randomized to BSC will undergo the same procedures and assessments as subjects on KD025.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Phase 2, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Actual Study Start Date : June 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: KD025 Daily
Two 200mg tablets (400 mg) KD025 once daily (QD). Subjects should take 2 Tablets with their morning meal or within 5 minutes of completing a meal.
Drug: KD025
Other Name: SLx-2119

Best Supportive Care
Best Supportive Care (BSC) which is a treatment/drug determined by each subject's prescribing physician.
Drug: Standard of Care
Treatment/Drug determined by each subject's prescribing physician

Primary Outcome Measures :
  1. Change in Forced Vital Capacity (FVC) in baseline to 24 weeks [ Time Frame: 24 weeks ]
    To evaluate the change in FVC from baseline to 24 weeks after dosing with KD025 400 mg QD in subjects with IPF compared with Best Supportive Care (BSC). The change in FVC from baseline to 24 weeks will be evaluated through the pulmonary function test being conducted at baseline, end of week 12, end of week 24, end of week 36 and end of week 48.

  2. Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 24 weeks ]
    To evaluate the safety and tolerability of KD025 400 mg QD when administered for 24 weeks to subjects with IPF compared to Best Supportive Care.

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

Inclusion Criteria:

  • Adult male and postmenopausal/surgically sterilized female subjects at least 18 years of age (if female, is surgically sterilized [ie, total hysterectomy, or bilateral salpingo-oophorectomy]).
  • Able to provide written informed consent before the performance of any study specific procedures.
  • IPF diagnosis within 5 years before study entry, proven according to the American Thoracic Society/European Respiratory Society consensus conference criteria, with surgical lung biopsy. In the absence of a surgical lung biopsy, HRCT must be consistent with usual interstitial pneumonitis.
  • Resting state SpO2 ≥ 88% with or without supplemental oxygen, FVC % ≥ 50% normal predicted value, and DLCO ≥ 30% normal predicted value at baseline.
  • Men with partners of childbearing potential must be willing to use 2 medically acceptable methods of contraception during the trial and for 3 months after the last dose of study drug. Effective birth control includes (a) intrauterine device (IUD) plus 1 barrier method; (b) stable doses of hormonal contraception for at least 3 months (eg, oral, injectable, implant, transdermal) plus 1 barrier method; (c) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm); or (d) vasectomy.
  • Have adequate bone marrow function:

    1. ANC > 1500/mm3
    2. Hemoglobin > 9.0 g/L
    3. Platelets > 100,000/mm3
  • Willing to complete all study measurements and assessments in compliance with the protocol
  • Has either received pirfenidone and/or nintedanib or has been offered both treatments (with last dose administered at least 1 month before the expected start of study drug dosing). If either or both pirfenidone and nintedanib treatment has not been given, then documentation that the patient was offered both treatments must be documented.

Exclusion Criteria:

  • Interstitial lung disease caused by conditions other than IPF
  • Severe concomitant illness limiting life expectancy (< 1 year)
  • Diffusing capacity of the lung for carbon monoxide (DLCO) < 30% predicted
  • Residual volume ≥ 120% predicted
  • Obstructive lung disease: FEV1/ FVC ratio < 0.70
  • Documented sustained improvement of the subject's IPF condition up to 12 months before study entry with or without IPF-specific therapy
  • Pulmonary or upper respiratory tract infection within 4 weeks before study entry
  • Acute or chronic impairment (other than dyspnea) limiting the ability to comply with study requirements (eg, pulmonary function tests)
  • Chronic heart failure with New York Heart Association class III/IV or known left ventricular ejection fraction < 25%
  • Moderate to severe hepatic impairment (ie, Child-Pugh Class B or C)
  • Estimated creatinine clearance < 30 mL/min
  • Aspartate aminotransferase (AST) and/or ALT > 2.0 × upper limit of normal (ULN)
  • Hemoglobin < 75% of the lower limit of normal
  • Systolic blood pressure < 100 mmHg
  • Men whose partner is pregnant or breastfeeding
  • Current drug or alcohol dependence
  • Chronic treatment with the following drugs (within 4 weeks of study entry and during the study)

    1. Immunosuppressive or cytotoxic drugs including cyclophosphamide and azathioprine
    2. Antifibrotic drugs including pirfenidone, nintedanib, D penicillamine, colchicine, tumor necrosis factor α blockers, imatinib and interferon-γ
    3. Chronic use of N-acetylcysteine prescribed for IPF (> 600 mg/day)
    4. Oral anticoagulants prescribed for IPF
  • Treatment with endothelin receptor antagonists within 4 weeks before study entry
  • Systemic treatment within 4 weeks before study entry with cyclosporine A or tacrolimus, everolimus, or sirolimus (calcineurin or mammalian target of rapamycin inhibitors)
  • Previous exposure to KD025 or known allergy/sensitivity to KD025 or any other ROCK2 inhibitor
  • Planned treatment, or treatment with another investigational drug within 4 weeks before study entry
  • Subject is taking a medication that has the potential for QTc prolongation (see Appendix A)
  • Subject is taking a drug that is a sensitive substrate of CYP enzymes
  • Subject is taking an inhibitor or inducer of CYP3A4
  • Subject has consumed an herbal medication (eg, St. John's Wort) or grapefruit/grapefruit juice within 14 days prior to the Week 1, Day 1 visit

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 identifier (NCT number): NCT02688647

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United States, Arizona
Pulmonary Associates, PA
Phoenix, Arizona, United States, 85006
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
UC Davis Medical Center, Division of Pulmonary/CC/SM
Sacramento, California, United States, 95817
United States, Florida
St. Francis Medical Institute
Clearwater, Florida, United States, 33765
Pulmonary Disease Specialists, PA, d/b/a PDS Research
Kissimmee, Florida, United States, 34741
Central Florida Pulmonary Group, PA
Orlando, Florida, United States, 32803
United States, Georgia
Piedmont Healthcare Pulmonary and Critical Care Research
Austell, Georgia, United States, 30106
United States, North Carolina
Pulmonix, LLC
Greensboro, North Carolina, United States, 27403
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Kadmon Corporation, LLC
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Responsible Party: Kadmon Corporation, LLC Identifier: NCT02688647    
Other Study ID Numbers: KD025-207
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kadmon Corporation, LLC:
Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial