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Completed

NCT Number: NCT02874989

Targeting Pro-Inflammatory Cells in Idiopathic Pulmonary Fibrosis: a Human Trial

The study team hypothesizes that intermittent (3 doses administered over 3 consecutive days in 3 consecutive weeks) oral administration of combination Dasatinib (100 mg/d) + Quercetin (1250 mg/d) will be safe and well tolerated in patients with IPF. Treatment with D+Q will result in reduced abundance of pro-inflammatory cells within subjects over baseline. Finally, the reduction in biomarkers of cellular pro-inflammatory state will be related to no change in functional and patient reported outcomes.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Wake Forest Baptist Health, Winston-Salem, North Carolina, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men between ages 50 and above, at the time of signing the informed consent.
  • Post-menopausal women ages 50 and above, at the time of signing the informed consent. Note: Postmenopausal is defined as 12 months of spontaneous amenorrhea determined by self-report.
  • A clinical diagnosis of IPF and characteristic chest HRCT scan (determined by panel of pulmonary radiologists) OR biopsy showing usual interstitial pneumonia (UIP).
  • Body Mass Index (BMI) within the range 19 - 39.9 kg/ m2 (inclusive), where BMI = (weight in kg) / (height in meters)2 .
  • Subjects participating in an exercise program must be willing to maintain their current activity level for the duration of the study period.
  • Patients on stable therapy with nintedanib (Ofev) or pirfenidone (Esbriet) over the past 3 months.ORPatients not taking nintedanib (Ofev) or pirfenidone (Esbriet) may be enrolled if they have previously not tolerated one of those medications or if those medications have not yet been prescribed or used by the patient.
  • Giving signed informed consent.
  • No plans to travel over the next 6 weeks.

Exclusion criteria

  • More than two moderate/severe IPF exacerbations within the past year Exacerbation is defined as worsening of two or more of the following major symptoms: dyspnea, sputum volume, sputum purulence OR worsening of any one major symptom together with at least one of the following additional symptoms: sore throat, colds (nasal discharge and/or nasal congestion), fever > 37.5 ° C without any explained cause, increased cough, increase wheeze.

A moderate exacerbation is defined as an event that is associated with a new prescription for antibiotics and/or oral steroids. A severe exacerbation is defined as an event that is associated with hospitalization or emergency room visit.

  • Any moderate/severe IPF exacerbation within the past 4 weeks.
  • History of a lung transplant.
  • Use of anti-arrhythmic medications known to cause QTc prolongation.
  • Pulmonary hypertension or cor pulmonale confirmed by echocardiography or heart catheterization.
  • Myocardial infarction, angina, hospitalization for cardiac aetiology, stroke or transient ischemic attack in the past 6 months.
  • Chronic heart failure.
  • Neurologic, musculoskeletal, or other condition that in the opinion of the study physician limits subject's ability to complete study physical assessments.
  • Uncontrolled diabetes (HbA1c > 8% and fasting glucose >200 mg/dL or the current use of insulin).
  • Subjects with values outside the specified ranges for the following Key Clinical Laboratory Tests must be excluded from the study:

Renal function: Glomerular Filtration Rate (GFR) <30 (mL/min/1.73 m2) using formulae provided in the Study Reference Manual (SRM). Note: Subjects receiving dialysis are excluded from this study.

ALT >2xULN and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • QTcB or QTcF > 450 msec or QTc > 480 msec in subjects with Bundle Branch Block based on a single ECG.
  • Subjects with a history of malignancy that is not in complete remission for at least 2 years or 1 year for non-melanoma skin carcinoma.
  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to participation in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • History of drug or alcohol abuse within 5 years prior to randomization.
  • Use of Coumadin or other anti-platelet or anti-coagulant medication. The use of aspirin is permitted.
  • Current use of quinolone antibiotics.
  • Low CBC.
  • Cognitive Impairment (MoCA score less than 21)
  • Other medical or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention

Treatment and study plan

Dasatinib + Quercetin

Drug

Placebo

Drug

Primary outcomes

  1. Percentage of pro-inflammatory expressing cells

    Time frame: baseline

    A skin biopsy will be obtained at baseline and the percentage of pro-inflammatory expressing cells will be recorded

  2. Percentage of pro-inflammatory expressing cells

    Time frame: 4 weeks post baseline visit biopsy/ 5 days post last dose study drug

    A skin biopsy will be obtained at 4 weeks post baseline/5 days after the last dose of study medication and the percentage of pro-inflammatory expressing cells will be recorded

  3. Blood Pressure

    Time frame: screening 1 week pre baseline visit

  4. Blood Pressure

    Time frame: baseline visit

  5. Blood Pressure

    Time frame: 4 weeks post baseline

  6. Weight

    Time frame: screening 1 week pre baseline visit

  7. Weight

    Time frame: baseline visit

  8. Weight

    Time frame: 4 weeks post baseline

  9. Heart Rate

    Time frame: screening 1 week pre baseline visit

  10. Heart Rate

    Time frame: baseline visit

  11. Heart Rate

    Time frame: 4 weeks post baseline

  12. CBC (complete blood count)

    Time frame: screening 1 week pre baseline visit

  13. CBC (complete blood count)

    Time frame: 4 weeks post baseline

  14. Lipid Panel

    Time frame: screening 1 week pre baseline visit

  15. Lipid Panel

    Time frame: 4 weeks post baseline

  16. HbA1c (glycated hemoglobin)

    Time frame: screening 1 week pre baseline visit

  17. HbA1c (glycated hemoglobin)

    Time frame: 4 weeks post baseline

  18. CMP (comprehensive metabolic panel)

    Time frame: screening 1 week pre baseline visit

  19. CMP (comprehensive metabolic panel)

    Time frame: 4 weeks post baseline

  20. Plasma hsCRP (high-sensitivity C-reactive protein)

    Time frame: screening 1 week pre baseline visit

  21. Plasma hsCRP (high-sensitivity C-reactive protein)

    Time frame: 4 weeks post baseline

  22. Plasma IL-6 (inflammatory biomarker)

    Time frame: baseline

  23. Plasma IL-6 (inflammatory biomarker)

    Time frame: 4 weeks post baseline

  24. Plasma IL-6R (inflammatory biomarker)

    Time frame: baseline

  25. Plasma IL-6R (inflammatory biomarker)

    Time frame: 4 weeks post baseline

  26. Plasma PASP biomarkers (inflammatory biomarkers)

    Time frame: baseline

  27. Plasma PASP biomarkers (inflammatory biomarkers)

    Time frame: 4 weeks post baseline

  28. p16INK4a biomarker (inflammatory biomarker)

    Time frame: baseline

  29. p16INK4a biomarker (inflammatory biomarker)

    Time frame: 4 weeks post baseline

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Mayo Clinic
  • The University of Texas Health Science Center at San Antonio

Registry information

Official study title

Targeted Removal of Pro-Inflammatory Cells: An Open Label Human Pilot Study in Idiopathic Pulmonary Fibrosis

Acronym: IPF

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 22, 2016
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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