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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02688647
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Kadmon Corporation, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Medical University of South Carolina, Charleston, South Carolina

Status

Recruiting

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

Site Contact

Allison Patterson

patteall@musc.edu

843-792-5168

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

Site Contact

Morgan Carnahan

kirkpatrickml@upmc.edu

412-692-2151

Pulmonix, LLC, Greensboro, North Carolina

Status

Recruiting

Address

Pulmonix, LLC

Greensboro, North Carolina, 27403

Site Contact

Jennifer Castillo

jennifer.castillo@pulmonix.com

336-323-5276

Austell, Georgia

Status

Recruiting

Address

Piedmont Healthcare Pulmonary and Critical Care Research

Austell, Georgia, 30106

Site Contact

Elizabeth Wilkins

Elizabeth.Wilkins@piedmont.org

770-944-2154

Central Florida Pulmonary Group, PA, Orlando, Florida

Status

Recruiting

Address

Central Florida Pulmonary Group, PA

Orlando, Florida, 32803

Site Contact

Kathleen Summo, MSN, RN

ksummo@cfpulmonary.com

407-841-1100 #225

Kissimmee, Florida

Status

Recruiting

Address

Pulmonary Disease Specialists, PA, d/b/a PDS Research

Kissimmee, Florida, 34741

Site Contact

Margaret Bell

mbell@pds-cfsc.com

St. Francis Medical Institute, Clearwater, Florida

Status

Recruiting

Address

St. Francis Medical Institute

Clearwater, Florida, 33765

Site Contact

Joanna Vega

jvega@stfrancismed.com

727-210-4606

Sacramento, California

Status

Recruiting

Address

UC Davis Medical Center, Division of Pulmonary/CC/SM

Sacramento, California, 95817

Site Contact

Elena Foster

eefoster@ucdavis.edu

916-734-3650

University of Arizona, Tucson, Arizona

Status

Recruiting

Address

University of Arizona

Tucson, Arizona, 85724

Site Contact

Valerie Bloss

vbloss@email.arizona.edu

520-626-8305

Pulmonary Associates, PA, Phoenix, Arizona

Status

Recruiting

Address

Pulmonary Associates, PA

Phoenix, Arizona, 85006

Site Contact

LiYi Fu

602-346-4747

Terms of Service

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