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Trial record 1 of 1 for:    KD025-207
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A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Idiopathic Pulmonary Fibrosis

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ClinicalTrials.gov Identifier: NCT02688647
Recruitment Status : Active, not recruiting
First Posted : February 23, 2016
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Kadmon Corporation, LLC

Tracking Information
First Submitted Date  ICMJE February 18, 2016
First Posted Date  ICMJE February 23, 2016
Last Update Posted Date December 23, 2019
Actual Study Start Date  ICMJE June 2016
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 22, 2016)
  • 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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Idiopathic Pulmonary Fibrosis
Official Title  ICMJE A Randomized, Phase 2, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Pulmonary Fibrosis
Intervention  ICMJE
  • Drug: KD025
    Other Name: SLx-2119
  • Drug: Standard of Care
    Treatment/Drug determined by each subject's prescribing physician
Study Arms  ICMJE
  • 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.
    Intervention: Drug: KD025
  • Best Supportive Care
    Best Supportive Care (BSC) which is a treatment/drug determined by each subject's prescribing physician.
    Intervention: Drug: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 13, 2019)
76
Original Estimated Enrollment  ICMJE
 (submitted: February 22, 2016)
36
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02688647
Other Study ID Numbers  ICMJE KD025-207
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kadmon Corporation, LLC
Study Sponsor  ICMJE Kadmon Corporation, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kadmon Corporation, LLC
Verification Date August 2019

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