Idiopathic Pulmonary Fibrosis (IPF)Phase 1IPFNCT02874989
Targeting Pro-Inflammatory Cells in Idiopathic Pulmonary Fibrosis: a Human Trial
A Phase 1 study testing Dasatinib + Quercetin in people with Idiopathic Pulmonary Fibrosis (IPF), run by Wake Forest University Health Sciences at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- Dasatinib + Quercetin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Dec 2016to 3 Jun 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas Health Science Center
San Antonio, Texas, 78245
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: Targeted Removal of Pro-Inflammatory Cells: An Open Label Human Pilot Study in Idiopathic Pulmonary Fibrosis
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.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- Dasatinib + Quercetin, Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dasatinib + QuercetinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib + Quercetin | Experimental | Not described Receives: Drug: Dasatinib + Quercetin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of pro-inflammatory expressing cells
A skin biopsy will be obtained at baseline and the percentage of pro-inflammatory expressing cells will be recorded
Measured: baseline
Percentage of pro-inflammatory expressing cells
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
Measured: 4 weeks post baseline visit biopsy/ 5 days post last dose study drug
Blood Pressure
Measured: screening 1 week pre baseline visit
Blood Pressure
Measured: baseline visit
Blood Pressure
Measured: 4 weeks post baseline
Weight
Measured: screening 1 week pre baseline visit
Weight
Measured: baseline visit
Weight
Measured: 4 weeks post baseline
Heart Rate
Measured: screening 1 week pre baseline visit
Heart Rate
Measured: baseline visit
Heart Rate
Measured: 4 weeks post baseline
CBC (complete blood count)
Measured: screening 1 week pre baseline visit
CBC (complete blood count)
Measured: 4 weeks post baseline
Lipid Panel
Measured: screening 1 week pre baseline visit
Lipid Panel
Measured: 4 weeks post baseline
HbA1c (glycated hemoglobin)
Measured: screening 1 week pre baseline visit
HbA1c (glycated hemoglobin)
Measured: 4 weeks post baseline
CMP (comprehensive metabolic panel)
Measured: screening 1 week pre baseline visit
CMP (comprehensive metabolic panel)
Measured: 4 weeks post baseline
Plasma hsCRP (high-sensitivity C-reactive protein)
Measured: screening 1 week pre baseline visit
Plasma hsCRP (high-sensitivity C-reactive protein)
Measured: 4 weeks post baseline
Plasma IL-6 (inflammatory biomarker)
Measured: baseline
Plasma IL-6 (inflammatory biomarker)
Measured: 4 weeks post baseline
Plasma IL-6R (inflammatory biomarker)
Measured: baseline
Plasma IL-6R (inflammatory biomarker)
Measured: 4 weeks post baseline
Plasma PASP biomarkers (inflammatory biomarkers)
Measured: baseline
Plasma PASP biomarkers (inflammatory biomarkers)
Measured: 4 weeks post baseline
p16INK4a biomarker (inflammatory biomarker)
Measured: baseline
p16INK4a biomarker (inflammatory biomarker)
Measured: 4 weeks post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study start16 Dec 2016
- Primary completion3 Jun 2019
- Study completion3 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Kritchevsky, PhD, Principal investigator, Wake Forest Univerisity Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874989
- Sponsor's protocol ID
- IRB00037000
- Acronym
- IPF
- Status last verified
- Dec 2019
- First submitted
- 17 Aug 2016
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Justice JN, Nambiar AM, Tchkonia T, LeBrasseur NK, Pascual R, Hashmi SK, Prata L, Masternak MM, Kritchevsky SB, Musi N, Kirkland JL. Senolytics in idiopathic pulmonary fibrosis: Results from a first-in-human, open-label, pilot study. EBioMedicine. 2019 Feb;40:554-563. doi: 10.1016/j.ebiom.2018.12.052. Epub 2019 Jan 5.
PubMed 30616998
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Removal of Pro-Inflammatory Cells: An Open Label Human Pilot Study in Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT02874989
- Acronym / sponsor ID
- IPF / IRB00037000
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Mayo Clinic, The University of Texas Health Science Center at San Antonio
- Study start
- 16 Dec 2016 (actual)
- Primary completion
- 3 Jun 2019 (actual)
- Study completion
- 3 Jun 2019 (actual)
- First posted
- 22 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dasatinib + Quercetin | Experimental | Drug: Dasatinib + Quercetin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dasatinib + Quercetin | Drug | Dasatinib + Quercetin |
| Placebo | Drug | Placebo |
Primary outcome
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
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
Blood Pressure
Time frame: screening 1 week pre baseline visit
Blood Pressure
Time frame: baseline visit
Blood Pressure
Time frame: 4 weeks post baseline
Weight
Time frame: screening 1 week pre baseline visit
Weight
Time frame: baseline visit
Weight
Time frame: 4 weeks post baseline
Heart Rate
Time frame: screening 1 week pre baseline visit
Heart Rate
Time frame: baseline visit
Heart Rate
Time frame: 4 weeks post baseline
CBC (complete blood count)
Time frame: screening 1 week pre baseline visit
CBC (complete blood count)
Time frame: 4 weeks post baseline
Lipid Panel
Time frame: screening 1 week pre baseline visit
Lipid Panel
Time frame: 4 weeks post baseline
HbA1c (glycated hemoglobin)
Time frame: screening 1 week pre baseline visit
HbA1c (glycated hemoglobin)
Time frame: 4 weeks post baseline
CMP (comprehensive metabolic panel)
Time frame: screening 1 week pre baseline visit
CMP (comprehensive metabolic panel)
Time frame: 4 weeks post baseline
Plasma hsCRP (high-sensitivity C-reactive protein)
Time frame: screening 1 week pre baseline visit
Plasma hsCRP (high-sensitivity C-reactive protein)
Time frame: 4 weeks post baseline
Plasma IL-6 (inflammatory biomarker)
Time frame: baseline
Plasma IL-6 (inflammatory biomarker)
Time frame: 4 weeks post baseline
Plasma IL-6R (inflammatory biomarker)
Time frame: baseline
Plasma IL-6R (inflammatory biomarker)
Time frame: 4 weeks post baseline
Plasma PASP biomarkers (inflammatory biomarkers)
Time frame: baseline
Plasma PASP biomarkers (inflammatory biomarkers)
Time frame: 4 weeks post baseline
p16INK4a biomarker (inflammatory biomarker)
Time frame: baseline
p16INK4a biomarker (inflammatory biomarker)
Time frame: 4 weeks post baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Derived from this study: PubMed 30616998Justice JN, Nambiar AM, Tchkonia T, LeBrasseur NK, Pascual R, Hashmi SK, Prata L, Masternak MM, Kritchevsky SB, Musi N, Kirkland JL. Senolytics in idiopathic pulmonary fibrosis: Results from a first-in-human, open-label, pilot study. EBioMedicine. 2019 Feb;40:554-563. doi: 10.1016/j.ebiom.2018.12.052. Epub 2019 Jan 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Kritchevsky, PhD principal investigator
Wake Forest Univerisity Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dasatinib + Quercetin in people with Idiopathic Pulmonary Fibrosis (IPF), run by Wake Forest University Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of pro-inflammatory expressing cells (time frame: baseline). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02874989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.