Who is eligible for clinical trial NCT04598919?

Participants must meet protocol criteria for Idiopathic Pulmonary Fibrosis (IPF). Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04598919 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2024-11-12

Saracatinib in the Treatment of Idiopathic Pulmonary Fibrosis (NCT04598919)

🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: National Jewish Health

🩺 Plain-English Summary (8th-Grade Level)

Scarring of the lung, termed pulmonary fibrosis (PF), is a chronic, progressive, and usually fatal disorder. While two anti-fibrotic drugs have been approved for treating PF of unknown cause (idiopathic pulmonary fibrosis or IPF), neither drug is curative, and nearly 40% of patients stop taking the prescribed drug within a year because of side effects. The study includes the use of saracatinib, an investigational drug originally developed to treat certain types of cancers, in the treatment of IPF in a Phase 1b/2a clinical trial. The objectives of this study are to: i) evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics, and to explore the efficacy of saracatinib in IPF; ii) identify biomarkers of Src kinase activity and fibrogenesis linked to pulmonary fibrosis; and iii) explore the application of these biomarkers to assess the anti-fibrotic effect of saracatinib in IPF patients

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (24 items).

Location: National Jewish Health — Denver, Colorado

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

IPF of any duration, confirmed or diagnosed by ILD center or expert according to Fleischner Guidelines (33). Subjects with a probable or indeterminant CT scan who otherwise meet the Fleischner criteria for IPF are eligible to be included in the study after a multidisciplinary evaluation. A positive Envisia genomic classifier score (34) on a lung biopsy specimen will be considered as strong evidence for a diagnosis of IPF. Subjects with a positive invisia genomic classifier score in conjunction with a probable or indeterminant CT scan are eligible to be included in the study after a multidisciplinary evaluation.
Women or men \>40 years of age at the time of screening
FVC%\>45% of predicted value (GLI-2012)
Single breath DLCO% ≥ 30 - inclusive of predicted (without bronchodilator and uncorrected for hemoglobin GLI-2017)
FEV1/FVC\>70 (GLI-2012)
Provision of signed/dated written informed consent prior to any study-specific procedures
Females must be of nonchildbearing potential (defined as surgically sterilized \[i.e., bilateral tubal ligation, bilateral oophorectomy or complete hysterectomy\] or postmenopausal \[defined as 12 months with no menses without an alternative medical cause\] with a follicle-stimulating hormone \[FSH\] \> 25.8 IU/L) or use a highly effective method of contraception (defined as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; progestogen only hormonal contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS) for the duration of the study (from the time they sign consent) and for 3 months after the last dose of drug/matching placebo
Male subjects must be surgically sterile or using an acceptable method of contraception (defined as barrier methods in conjunction with spermicides) for the duration of the study (from the time they sign consent) and for 3 months after the last dose of drug/matching placebo to prevent pregnancy in a partner. Male subjects must not donate or bank sperm for the duration of the study (from the time they sign consent) and for 3 months after the last dose of drug/matching placebo.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Requirement for supplemental oxygen \> 4 L/min at rest to maintain saturation \> 90%
Active infection at screening or randomization
Known active or latent hepatitis B or C
Life expectancy for disease other than IPF \< 2.5 years (Investigator assessment)
Listed for lung transplantation
Taking pirfenidone or nintedanib in the last 4 weeks
Pregnancy or lactation
Known allergic reactions to components of saracatinib
Treatment with another investigational drug or other intervention within 8 weeks
Current smoker or tobacco use within 4 months
Major surgery within the past 2 months

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (4 Sites)

National Jewish Health — Denver, Colorado
Yale University School of Medicine — New Haven, Connecticut
Icahn School of Medicine at Mount Sinai — New York, New York
Baylor University Medical Center (BUMC) — Dallas, Texas

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗