Testing EGCG for treating Idiopathic Pulmonary Fibrosis

Dose Ranging Study of Oral Epigallocatechin-3-gallate (EGCG) Given Daily for 12 Weeks to Patients With Idiopathic Pulmonary Fibrosis (IPF) Evaluating Safety, PK Interactions With Standard of Care Drugs, and Biomarkers of Drug Effect

This study is testing whether a green tea compound called EGCG can safely help people with idiopathic pulmonary fibrosis when added to their current treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 40 Years to 85 Years
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Drugs / interventions: prednisone
• Locations: 7 sites (San Francisco, California and 6 other locations)
• Trial ID: NCT05195918 on ClinicalTrials.gov

What this trial studies

This multi-center, double-blind, placebo-controlled Phase I study evaluates the safety of EGCG, a compound derived from green tea, in patients with idiopathic pulmonary fibrosis (IPF). Participants will receive either EGCG or a placebo alongside their existing treatment of nintedanib or pirfenidone for 12 weeks. The study aims to assess the pharmacokinetics and biomarker responses to the drug, building on pre-clinical evidence suggesting EGCG may mitigate pulmonary fibrosis. Two different doses of EGCG will be tested to determine the most effective and safe dosage.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40-85 with a confirmed diagnosis of IPF who have been stable on nintedanib or pirfenidone for at least 12 weeks.

Not a fit: Patients who are not on stable doses of nintedanib or pirfenidone or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel treatment option for patients with idiopathic pulmonary fibrosis.

How similar studies have performed: While EGCG has shown promise in pre-clinical studies, this approach is novel in the context of treating IPF in humans.

Eligibility criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female, aged 40-85 years old.
4. Participant has IPF satisfying the 2022 ATS diagnostic criteria, confirmed by enrolling investigator at Visit 1.
5. Participant must have been on a stable dose of nintedanib twice daily or pirfenidone three times daily dose for at least 12 weeks prior to baseline (Visit 2).
6. Participant has a FVC ≥ 50% predicted using the global lung function initiative (GLI).
7. Participant has a DLCO corrected for hemoglobin ≥ 35% predicted using the GLI.
8. Women of child bearing potential (WCBP), defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if \< 55 years or 12 months if \> 55 years, must have a negative serum pregnancy test within 1 week prior to the first dose of study drug and must agree to use adequate methods of birth control throughout the study. Adequate methods of contraception include use of oral contraceptives or Depo-Provera, with an additional barrier method (diaphragm with spermicidal gel or condoms with spermicide), double-barrier methods (diaphragm with spermicidal gel and condoms with spermicide), partner vasectomy, and total abstinence.
9. Participant has a life expectancy of at least 9 months at Visit 1.
10. Ability to take oral medication and be willing to adhere to EGCG regimen.
11. Agreement to refrain from drinking green tea in excess of a cup a day or eating green tea extract for 4 weeks before baseline and during the trial.

Exclusion Criteria:

1. AST, ALT, or direct bilirubin above upper limit normal from any cause at the Screening Visit.
2. Any history of HCV or HBV infection, NASH/NAFLD, or cirrhosis.
3. Alcohol consumption greater than 7 drinks per week.
4. Participant has emphysema ≥ 50% or the extent of emphysema is greater than the extent of fibrosis as per interpretation of Site Investigator or radiologist.
5. Participant has received investigational therapy for IPF within 4 weeks before baseline (Visit 2).
6. Participant is receiving systemic corticosteroids equivalent to prednisone \> 10 mg/day or equivalent within 2 weeks of baseline visit (Visit 2).
7. Participant has any concurrent condition other than IPF that, in the Investigator's opinion, is unstable and/or would impact the likelihood of survival for the study duration or the participant's ability to complete the study as designed, or may influence any of the safety or efficacy assessments included in the study.
8. Participant has baseline resting oxygen saturation of \< 89% on room air or need for continuous oxygen use at baseline visit (Visit 2).
9. Consumption of GTE products in excess of a cup of green tea a day within one month of the baseline visit (Visit 2).
10. Participant is receiving digoxin at the time of screening (Visit 1) and for the duration of the study.
11. Active respiratory infection requiring treatment with antibiotics within 4 weeks of the baseline visit (Visit 2).
12. Likely to be listed for transplant during trial participation.

Where this trial is running

San Francisco, California and 6 other locations

• UCSF Parnassus — San Francisco, California, United States (Recruiting)
• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
• University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
• Weill Cornell Medicine — New York, New York, United States (Recruiting)
• Temple University — Philadelphia, Pennsylvania, United States (Recruiting)
• University of Virginia — Charlottesville, Virginia, United States (Not_yet_recruiting)
• University of Washington — Seattle, Washington, United States (Recruiting)

Study contacts

• Principal investigator: Harold Chapman, MD — University of California, San Francisco
• Study coordinator: Ying Wei, MD

Conditions Idiopathic Pulmonary Fibrosis; epigallocatechin-3-gallate; EGCG