Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF Patients

NCT05195918 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 22-35979
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 7

Brief Summary

The primary purpose of this multi-center, double-blind, placebo-controlled, dose-ranging Phase I study is to assess the safety of a purified from green tea, EGCG, in patients with idiopathic pulmonary fibrosis (IPF) as a potential novel treatment for pulmonary fibrosis.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis; epigallocatechin-3-gallate; EGCG

Outcome Measures

Primary Outcomes (24)

• Participants with treatment-emergent adverse event (TEAE)

  The number of participants with at least 1 treatment-emergent adverse event

  Up to 12 weeks

• The number of treatment-emergent adverse events (TEAE)

  The number of treatment-emergent adverse events

  Up to 12 weeks

• Participants with grade 3 or 4 treatment-emergent adverse events (TEAE)

  The number of participants with at least 1 grade 3 or 4 treatment-emergent adverse events

  Up to 12 weeks

• The number of grade 3 or 4 treatment-emergent adverse events (TEAE)

  The number of grade 3 or 4 treatment-emergent adverse events

  Up to 12 weeks

• Participants with serious adverse event (SAE)

  The number of participants with at least 1 serious adverse event

  Up to 12 weeks

• The number of serious adverse event (SAE)

  The number of serious adverse events

  Up to 12 weeks

• Participants with discontinued study treatment due to adverse events (AE)

  The number of participants who discontinued study treatment due to adverse events

  Up to 12 weeks

• Participants with discontinued study treatment due to serious adverse events (SAE)

  The number of participants who discontinued study treatment due to serious adverse events

  Up to 12 weeks

• Participants died due to adverse events (AE) on study treatment

  The number of participants who died due to adverse events on study treatment

  Up to 12 weeks

• Participants died due to adverse events (AE) within 4 weeks of discontinuation

  The number of participants who died due to adverse events within 4 weeks of discontinuation from study treatment

  Up to 12 weeks

• Participants with adverse event (AE) by causality

  The number of participants with at least 1 adverse event by causality (reasonable possibility/no reasonable possibility)

  Up to 12 weeks

• Adverse events (AE) by causality

  The number of adverse events by causality (reasonable possibility/no reasonable possibility)

  Up to 12 weeks

• Change in individual laboratory parameters

  Absolute and relative change in individual laboratory parameters from baseline at day 84

  Up to 12 weeks

• Change in forced vital capacity (FVC)

  Absolute and relative change in forced vital capacity from baseline at day 84

  Up to 12 weeks

• Change in forced vital capacity (FVC) % predicted

  Absolute and relative change in forced vital capacity % predicted from baseline at day 84

  Up to 12 weeks

• Change in diffusing capacity for carbon monoxide (DLCO)

  Absolute and relative change in diffusing capacity for carbon monoxide uncorrected for hemoglobin from baseline at day 84

  Up to 12 weeks

• Change in total score for the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire

  Absolute change in total score for the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire from baseline at day 84

  Up to 12 weeks

• Participants with an absolute change in K-BILD of 5 points or more in either direction

  The number of participants with an absolute change in K-BILD from baseline to day 84 of 5 points or more in either direction

  Up to 12 weeks

• Change in total score for the Leicester Cough Questionnaire (LCQ)

  Absolute change in total score for the Leicester Cough Questionnaire (LCQ) from baseline at day 84

  Up to 12 weeks

• Participants with an absolute change of at least 1.5 points for the LCQ

  The number of participants with an absolute change from baseline to day 84 of 1.5 points or more in either direction for the LCQ

  Up to 12 weeks

• Participants with a peak level change for nintedanib or pirfenidone over 50% from screening to baseline (day 1)

  The number of participants with a change from screening to baseline (day 1) in peak levels for nintedanib or pirfenidone of 50% or more in either direction

  Day 1

• Participants with a peak level change for nintedanib or pirfenidone over 50% from baseline to day 14

  The number of participants with a change from baseline to day 14 in peak levels for nintedanib or pirfenidone of 50% or more in either direction

  Day 14

• Participants with a trough level change for nintedanib or pirfenidone over 50% from baseline to day 14

  The number of participants with a change from baseline to day 14 in trough levels for nintedanib or pirfenidone of 50% or more in either direction

  Day 14

• Participants with peak (cmax) levels for EGCG < 250 nM at day 14

  The number of participants with peak (cmax) levels for EGCG \< 250 nM at day 14

  Day 14

Secondary Outcomes (6)

• Change of serum biomarker COMP at day 14

  Day 14

• Change of serum biomarker COMP at day 84

  Day 84

• Change of serum biomarker Periostin at day 14

  Day 14

• Change of serum biomarker Periostin at day 84

  Day 84

• Change of serum biomarker pro-MMP1 at day 14

  Day 14

Study Arms (6)

EGCG 300 mg with Nintedanib

ACTIVE COMPARATOR

Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided Nintedanib for 12 weeks.

Combination Product: EGCG 300 mg + Nintedanib

EGCG 300 mg with Pirfenidone

ACTIVE COMPARATOR

Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided Pirfenidone for 12 weeks.

Combination Product: EGCG 300 mg + Pirfenidone

Placebo for EGCG 300 mg

PLACEBO COMPARATOR

Patients enrolled in this group will be given oral capsule Placebo daily for 12 weeks with doctor provided Nintedanib or Pirfenidone. The number of placebo capsules will be equal to that of 300 mg EGCG.

Combination Product: Placebo 2 capsules + Nintedanib or Pirfenidone

EGCG 600 mg with Nintedanib

ACTIVE COMPARATOR

Patients enrolled in this group will be given oral capsule EGCG 600 mg daily with doctor provided Nintedanib for 12 weeks.

Combination Product: EGCG 600 mg + Nintedanib

EGCG 600 mg with Pirfenidone

ACTIVE COMPARATOR

Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided Pirfenidone for 12 weeks.

Combination Product: EGCG 600 mg + Pirfenidone

Placebo for EGCG 600 mg

PLACEBO COMPARATOR

Patients enrolled in this group will be given oral capsule Placebo daily for 12 weeks with doctor provided Nintedanib or Pirfenidone. The number of placebo capsules will be equal to that of 600 mg EGCG.

Combination Product: Placebo 4 capsules + Nintedanib or Pirfenidone

Interventions

Placebo 4 capsules + Nintedanib or Pirfenidone COMBINATION_PRODUCT

Dietary Supplement: Placebo Placebo (4 capsules) taken orally daily for 12 weeks. Drug: Nintedanib Drug: Pirfenidone

Also known as: Placebo + Ofev or Esbriet

Placebo for EGCG 600 mg

EGCG 300 mg + Pirfenidone COMBINATION_PRODUCT

Dietary Supplement: EGCG Capsules with Teavigo EGCG (at least 94% purity). 300 mg EGCG (2 capsules) taken orally daily for 12 weeks. Drug: Pirfenidone

Also known as: epigallocatechin-3-gallate + Esbriet

EGCG 300 mg with Pirfenidone

EGCG 600 mg + Nintedanib COMBINATION_PRODUCT

Dietary Supplement: EGCG Capsules with Teavigo EGCG (at least 94% purity). 600 mg EGCG (2 capsules) taken orally daily for 12 weeks. Drug: Nintedanib

Also known as: epigallocatechin-3-gallate + Ofev

EGCG 600 mg with Nintedanib

EGCG 600 mg + Pirfenidone COMBINATION_PRODUCT

Dietary Supplement: EGCG Capsules with Teavigo EGCG (at least 94% purity). 600 mg EGCG (2 capsules) taken orally daily for 12 weeks. Drug: Pirfenidone

Also known as: epigallocatechin-3-gallate + Esbriet

EGCG 600 mg with Pirfenidone

EGCG 300 mg + Nintedanib COMBINATION_PRODUCT

Dietary Supplement: EGCG Capsules with Teavigo EGCG (at least 94% purity). 300 mg EGCG (2 capsules) taken orally daily for 12 weeks. Drug: Nintedanib

Also known as: epigallocatechin-3-gallate + Ofev

EGCG 300 mg with Nintedanib

Placebo 2 capsules + Nintedanib or Pirfenidone COMBINATION_PRODUCT

Dietary Supplement: Placebo Placebo (2 capsules) taken orally daily for 12 weeks. Drug: Nintedanib Drug: Pirfenidone

Also known as: Placebo + Ofev or Esbriet

Placebo for EGCG 300 mg

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, aged 40-85 years old.
• Participant has IPF satisfying the 2022 ATS diagnostic criteria, confirmed by enrolling investigator at Visit 1.
• 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).
• Participant has a FVC ≥ 50% predicted using the global lung function initiative (GLI).
• Participant has a DLCO corrected for hemoglobin ≥ 35% predicted using the GLI.
• 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.
• Participant has a life expectancy of at least 9 months at Visit 1.
• Ability to take oral medication and be willing to adhere to EGCG regimen.
• 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.

You may not qualify if:

• AST, ALT, or direct bilirubin above upper limit normal from any cause at the Screening Visit.
• Any history of HCV or HBV infection, NASH/NAFLD, or cirrhosis.
• Alcohol consumption greater than 7 drinks per week.
• Participant has emphysema ≥ 50% or the extent of emphysema is greater than the extent of fibrosis as per interpretation of Site Investigator or radiologist.
• Participant has received investigational therapy for IPF within 4 weeks before baseline (Visit 2).
• Participant is receiving systemic corticosteroids equivalent to prednisone \> 10 mg/day or equivalent within 2 weeks of baseline visit (Visit 2).
• 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.
• Participant has baseline resting oxygen saturation of \< 89% on room air or need for continuous oxygen use at baseline visit (Visit 2).
• Consumption of GTE products in excess of a cup of green tea a day within one month of the baseline visit (Visit 2).
• Participant is receiving digoxin at the time of screening (Visit 1) and for the duration of the study.
• Active respiratory infection requiring treatment with antibiotics within 4 weeks of the baseline visit (Visit 2).
• Likely to be listed for transplant during trial participation.

Sponsors & Collaborators

• University of Michigan: collaborator
• Cornell University: collaborator
• Hal Chapman: lead
• Massachusetts General Hospital: collaborator
• Temple University: collaborator
• University of Washington: collaborator
• University of Virginia: collaborator

Study Sites (7)

UCSF Parnassus

San Francisco, California, 94143, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

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• Wei Y, Dong W, Jackson J, Ho TC, Le Saux CJ, Brumwell A, Li X, Klesney-Tait J, Cohen ML, Wolters PJ, Chapman HA. Blocking LOXL2 and TGFbeta1 signalling induces collagen I turnover in precision-cut lung slices derived from patients with idiopathic pulmonary fibrosis. Thorax. 2021 Jul;76(7):729-732. doi: 10.1136/thoraxjnl-2020-215745. Epub 2021 Jan 20.

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MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

epigallocatechin gallate; nintedanib; pirfenidone

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Harold Chapman, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Fernando J Martinez, MD

  Cornell University

  PRINCIPAL INVESTIGATOR

• Sydney Montesi

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants will be on one of the standard of care drugs (nintedanib or pirfenidone) and blindly given EGCG or placebo.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: There will be two stages in this multi-center, double-blind, placebo-controlled, dose-ranging Phase I study. Participants will first be randomized to one of the four groups to receive 300 mg EGCG or placebo with one of the standard of care drugs (nintedanib or pirfenidone) for 12 weeks and 4 weeks follow-up. Once all 25 subjects at stage one have completed the study, a staged safety analysis will occur prior to opening stage two study with a higher group dose of 600 mg EGCG.

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: January 19, 2022
• Study Start: August 24, 2023
• Primary Completion: March 19, 2026
• Study Completion: March 19, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)