We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    "KD025" and "idiopathic pulmonary fibrosis"
Previous Study | Return to List | Next Study

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
  Purpose
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.

Condition Intervention Phase
Idiopathic Pulmonary Fibrosis Drug: KD025 Drug: Standard of Care Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Kadmon Corporation, LLC:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 36
Study Start Date: March 2016
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: KD025
Other Name: SLx-2119
Standard of Care
Standard of Care (SOC) 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

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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): NCT02688647


Locations
United States, Arizona
Pulmonary Associates, PA Recruiting
Phoeniz, Arizona, United States, 85006
Contact: LiYi Fu    602-346-4747      
Principal Investigator: David Baratz, MD         
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
Contact: Maria Ambrose    520-626-8000      
Principal Investigator: Sachin Chaudhary, MD         
United States, California
UC Davis Medical Center, Division of Pulmonary/CC/SM Recruiting
Sacramento, California, United States, 95817
Contact: Elena Foster    916-734-3650    eefoster@ucdavis.edu   
United States, Florida
St. Francis Medical Institute Recruiting
Clearwater, Florida, United States, 33765
Contact: Director of Clinical Research    727-210-4606    research@stfrancismed.com   
Pulmonary Disease Specialists, PA, d/b/a PDS Research Recruiting
Kissimmee, Florida, United States, 34741
Contact: Margaret Bell       mbell@pds-cfsc.com   
Principal Investigator: Thomas O'Brien, MD         
Central Florida Pulmonary Group, PA Recruiting
Orlando, Florida, United States, 32803
Contact: Kathleen Summo, MSN, RN    407-841-1100 ext 225    ksummo@cfpulmonary.com   
Principal Investigator: Syed Mobin, MD         
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kevin Gibson, MD       gibsonkf@upmc.edu   
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Courtney Rowley    843-792-8092    rowle@musc.edu   
Principal Investigator: Timothy Whelan, MD         
United States, Utah
University of Utah Health Sciences Center Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Lisa Weaver    801-587-7855    Lisa.weaver@hsc.utah.edu   
Principal Investigator: Mary Beth Scholand, MD         
Sponsors and Collaborators
Kadmon Corporation, LLC
  More Information

Responsible Party: Kadmon Corporation, LLC
ClinicalTrials.gov Identifier: NCT02688647     History of Changes
Other Study ID Numbers: KD025-207
First Submitted: February 18, 2016
First Posted: February 23, 2016
Last Update Posted: September 26, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kadmon Corporation, LLC:
Pulmonary Fibrosis
Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial


To Top