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

This study is currently recruiting participants.
Verified September 2016 by Kadmon Corporation, LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT02688647
First Posted: February 23, 2016
Last Update Posted: September 26, 2016
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.
Information provided by (Responsible Party):
Kadmon Corporation, LLC
February 18, 2016
February 23, 2016
September 26, 2016
March 2016
March 2017   (Final data collection date for primary outcome measure)
  • 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 SOC. 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.

    with SOC

  • 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 SOC
Same as current
Complete list of historical versions of study NCT02688647 on ClinicalTrials.gov Archive Site
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A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Idiopathic Pulmonary Fibrosis
A Randomized, Phase 2, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
This study is being conducted to evaluate the safety, tolerability, and activity of 400 mg of KD025 once-daily (QD) compared to standard of care (SOC) in male and postmenopausal/surgically sterilized female subjects with IPF.
Thirty-six (36) male or postmenopausal/surgically sterilized female subjects with IPF who are eligible, will be randomly enrolled in a 2:1 ratio (KD025 to SOC) to one of two treatment groups. Subjects randomized to Treatment Group 1 will receive KD025 400 mg QD orally for 24 weeks. Subjects randomized to Treatment Group 2 will receive SOC (as deemed appropriate by the investigator). Subjects randomized to SOC will be treated exactly the same as subjects on KD025 and undergo all tests in similar fashion.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Idiopathic Pulmonary Fibrosis
  • Drug: KD025
    Other Name: SLx-2119
  • Drug: Standard of Care
    Treatment/Drug determined by each subject's prescribing physician
  • Experimental: KD025 Daily
    Four 100mg capsules (400 mg) KD025 once daily (QD). Subjects should take 4 capsules with their morning meal or within 5 minutes of completing a meal.
    Intervention: Drug: KD025
  • Standard of Care
    Standard of Care (SOC) which is a treatment/drug determined by each subject's prescribing physician.
    Intervention: Drug: Standard of Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
Not Provided
March 2017   (Final data collection date for primary outcome measure)

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 1 month 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 (see Appendix B)
  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
United States
 
 
NCT02688647
KD025-207
No
Not Provided
Plan to Share IPD: No
Kadmon Corporation, LLC
Kadmon Corporation, LLC
Not Provided
Not Provided
Kadmon Corporation, LLC
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP