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Clinical Trial to Investigate the Safety and Tolerability of EP395 in Patients With COPD | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Clinical Trial to Investigate the Safety and Tolerability of EP395 in Patients With COPD

A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety and Tolerability of EP395 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT05572333•EpiEndo Pharmaceuticals

View on ClinicalTrials.gov

Summary

The aim of this clinical trial is to investigate the safety and tolerability of oral, once-daily EP395 administration in COPD patients for 12 weeks.

Detailed Description

This is a randomised, double-blind, placebo-controlled, multicentre study to assess the safety and tolerability of EP395 in COPD patients. In this study, EP395 will be administered to COPD patients for the first time. Patients will receive either EP395 or placebo as oral capsules once-daily for 12 weeks. Safety and tolerability will be assessed, as well as effect on lung function, lung inflammation and systemic inflammation. Patients' symptoms and quality of life will be assessed with questionnaires. In a sub-set of patients, bronchoscopies will be conducted, to investigate exploratory biomarkers in bronchial brushings and bronchoalveolar lavage.

Eligibility

Age

45 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Willing and able to understand the information on the nature, the scope, and the relevance of the study, and to provide voluntary, written informed consent to participate in the study before any study-related procedures
•2. Men and women, aged ≥45 years
•3. Women of childbearing potential must:
•1. have a negative pregnancy test (blood) at Screening and (urine) Day 1
•2. agree to use, and be able to comply with, highly effective measures of contraceptive control (failure rate less than 1% per year when used consistently and correctly) without interruption, during study participation and until 90 days after the last investigational product (IP) intake.
•3. agree to abstain from breast feeding during the study participation and for 90 days after the last IP intake.
•4. Men must agree to use a condom during sexual intercourse with women of childbearing potential during treatment and for 90 days after the last IP intake and should not donate sperm during this time
•5. Diagnosed with COPD for at least 2 years with FEV1/forced vital capacity (FVC) ratio \<0.70 and FEV1 \<70% (post bronchodilator) at Screening
•6. Receiving at least one maintenance inhaled therapy (ie, long acting beta-agonist \[LABA\], long acting muscarinic antagonist \[LAMA\], LABA/LAMA, LABA/inhaled corticosteroid \[ICS\], LAMA/ICS, or LABA/LAMA/ICS) for at least 3 months before Screening
•7. Able to tolerate the sputum induction procedure and to produce an adequate (volume and sufficient quality for cell count) sputum sample
+3 more criteria

Exclusion Criteria

•1. History or presence of any clinically relevant medical condition including laboratory test abnormality or planned surgery that in the investigator's opinion could affect the patient's safety or interfere with the objectives of the study
•2. Exacerbation of COPD in the 3 months before Screening
•3. Change in medication for COPD in the 3 months before Screening
•4. Lung function at Screening that in the investigator's opinion would indicate not safe to perform sputum induction or bronchoscopy (bronchoscopy applicable only in a subset of patients)
•5. History of or active tuberculosis
•6. Malignancy within the past 5 years, except removed basal cell carcinoma and resected benign colonic polyps
•7. Clinically significant abnormality on 12-lead ECG including prolonged corrected QT interval by Fredericia (QTcF) (\>450 msec in men or \>470 msec in women; based on triplicate) at Screening and Day 1 pre-dose
•8. Absolute estimated glomerular filtration rate (\[eGFR cystatin C + eGFR creatinine\]/2) \<60mL/min according to Lund-Malmö equation at Screening
•9. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1.5 x upper limit of normal at Screening
•10. Use (including prescription, over-the-counter, herbal or dietary) of cytochrome P450 (CYP) inducers within 28 days before first dosing, or strong or moderate inhibitors of CYP3A4 (including dietary eg, grapefruit juice) or P-glycoprotein (Pgp) inhibitors or oral narrow therapeutic index (TI) Pgp substrates (eg, digoxin) within 14 days before first dosing (substrates, inhibitors, and inducers are listed in https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers)
+17 more criteria

Locations (6)

IKF Pneumologie GmbH & Co. KG

Frankfurt, Germany

Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

Großhansdorf, Germany

IKF Pneumologie GmbH & Co. KG Institut für klinische Forschung Pneumologie

Mainz, Germany

Bradford Royal Infirmary, Clinical Research Facility

Bradford, United Kingdom

Medicines Evaluation Unit Ltd. (MEU)

Manchester, United Kingdom

Southampton University Faculty of Medicine

Southampton, United Kingdom

Key Dates

Start Date

November 22, 2022

Primary Completion Date

November 24, 2023

Completion Date

November 24, 2023

Last Updated

November 29, 2023

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary DiseaseCOPD

Interventions

EP395

DRUG

Placebo

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 29, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Trial to Investigate the Safety and Tolerability of EP395 in Patients With COPD

Inclusion Criteria

Exclusion Criteria

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