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A Study to Explore the Therapeutic Effect of HEC585 on Delaying Forced Vital Capacity (FVC) Decline and Tolerance in Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Patients | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Study to Explore the Therapeutic Effect of HEC585 on Delaying Forced Vital Capacity (FVC) Decline and Tolerance in Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Patients

A Phase IIb, Multi-center, Randomized, Double Blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of HEC585 Tablets in Patients With Progressive Fibrosing Interstitial Lung Disease

NCT05139719•Sunshine Lake Pharma Co., Ltd.

View on ClinicalTrials.gov

Summary

The main goal of this phase llb study is to compare the efficacy and safety of two doses of HEC585 tablets with placebo which is a look-alike substance that contains no active drug in patients with progressive fibrosing interstitial lung diseases. This study is divided into two stages, i.e. main study stage with 24 weeks treatment duration followed by up to 96 weeks treatment extended study stage.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Volunteer to participate and sign the ICF.
•2. Male or female patients' age ≥ 18 years when signing the ICF.
•3. Patients with known or unknown etiology (except IPF) and clear pulmonary fibrosis on chest CT have undergone conventional clinical treatment (assessed by the investigator, including follow-up observation) for ≥ 3 months. At least two of the following criteria occurring within 12 months before screening without alternative explanation (such as infection, heart failure, etc.):
•i) Worsening respiratory symptoms like cough, shortness of breath. ii) Physiological evidence of disease progression (either of the following):
•1. absolute FVC (% of predicted) decline ≥ 5%.
•2. absolute DLco\[Hb corrected\] (% of predicted) decline ≥ 10%. iii) Radiological evidence of disease progression (one or more of the following):
•
•1. Increased extent or severity of traction bronchiectasis and bronchiolectasis.
•2. New ground-glass opacity with traction bronchiectasis.
•3. New fine reticulation.
+10 more criteria

Exclusion Criteria

•1. Diagnosis of Idiopathic Pulmonary Fibrosis (IPF).
•2. Lung with other clinically significant abnormalities which the investigator assess to have an effect on the results of study.
•3. Significant Pulmonary Arterial Hypertension (PAH), such as meeting the following: Previous clinical or echocardiographic evidence of significant right heart failure, History of right heart catheterization showing a cardiac index ≤ 2 L/min/m², or PAH requiring parenteral therapy with epoprostenol/treprostinil.
•4. Major extrapulmonary physiological or pathological restriction (e.g. chest wall abnormality, large pleural effusion).
•5. Expected to receive lung transplantation during the study.
•6. Expected survival time is less than 6 months.
•7. History of malignant tumors within 5 years (except for localized cancers such as basal cell carcinoma and carcinoma in situ of cervix).
•8. Thyroid dysfunction that the investigator assessed to be clinically significant and needed to be treated.
•9. History of unstable or worsening heart disease during the 6 months prior to screening, including but not limited to the following:
•1. Unstable cardiac angina,
+21 more criteria

Locations (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

February 15, 2023

Primary Completion Date

December 1, 2024

Completion Date

December 1, 2026

Last Updated

July 5, 2023

Enrollment

110

ESTIMATED participants

Conditions

Progressive Fibrosing Interstitial Lung Disease (PF-ILD) / Progressive Pulmonary Fibrosis (PPF)

Interventions

HEC585 dose A

DRUG

HEC585 dose B

DRUG

Placebo

DRUG

Contacts

HuaPing Dai, Ph.D

CONTACT

010-84206271 daihuaping@ccmu.edu.cn