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

NCT05139719 | Recruiting Phase 2 FDA Drug

• 1 other identifier: HEC585-PF-202
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline to Week 24 in FVC (mL) compared with placebo

  change in FVC (mL), measured using Spirometer, from baseline to week 24

  24 Weeks

Secondary Outcomes (12)

• Change from Baseline to Week 12 in FVC (mL) compared with placebo

  12 Weeks

• Proportion of subjects with the decline from baseline in FVC (% predicted) > 10%

  24 Weeks

• Proportion of subjects with the decline from baseline in FVC (% predicted) > 5%

  24 Weeks

• Changes of DLco (Hb correction)

  12 Weeks, 24 Weeks

• Changes of 6MWT results

  12 Weeks, 24 Weeks

Study Arms (3)

HEC585 tables does A

EXPERIMENTAL

Drug: HEC585 dose A

HEC585 tables does B

EXPERIMENTAL

Drug: HEC585 dose B

placebo

PLACEBO COMPARATOR

Placebo once daily up to 24 weeks in main stage; HEC585 dose A once daily up to 96 weeks in extended stage

Drug: HEC585 dose A; Drug: Placebo

Interventions

HEC585 dose A DRUG

taking HEC585 dose A orally once daily, up to 24 weeks in main stage (if applicable); up to 96 weeks in extended stage

HEC585 tables does A; placebo

HEC585 dose B DRUG

taking HEC585 dose B orally once daily, up to 24 weeks in main stage; up to 96 weeks in extended stage

HEC585 tables does B

Placebo DRUG

taking Placebo orally once daily, up to 24 weeks in main stage

placebo

Eligibility Criteria

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

You may qualify if:

• Volunteer to participate and sign the ICF.
• Male or female patients' age ≥ 18 years when signing the ICF.
• 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):
• absolute FVC (% of predicted) decline ≥ 5%.
• absolute DLco\[Hb corrected\] (% of predicted) decline ≥ 10%. iii) Radiological evidence of disease progression (one or more of the following):
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• Increased extent or severity of traction bronchiectasis and bronchiolectasis.
• New ground-glass opacity with traction bronchiectasis.
• New fine reticulation.
• Increased extent or increased coarseness of reticular abnormality.
• New or increased honeycombing.
• Increased lobar volume loss.
• Fibrosing lung disease on HRCT, defined as reticular abnormality with traction bronchiectasis with or without honeycombing, with disease extent of \>10% as confirmed by central readers.
• For patients with underlying connective tissue disease (CTD) should be in the stable status which is defined by no initiation of new therapy, treatment dose adjustment or withdrawal of therapy within 12 weeks prior to randomization.

You may not qualify if:

• Diagnosis of Idiopathic Pulmonary Fibrosis (IPF).
• Lung with other clinically significant abnormalities which the investigator assess to have an effect on the results of study.
• 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.
• Major extrapulmonary physiological or pathological restriction (e.g. chest wall abnormality, large pleural effusion).
• Expected to receive lung transplantation during the study.
• Expected survival time is less than 6 months.
• History of malignant tumors within 5 years (except for localized cancers such as basal cell carcinoma and carcinoma in situ of cervix).
• Thyroid dysfunction that the investigator assessed to be clinically significant and needed to be treated.
• History of unstable or worsening heart disease during the 6 months prior to screening, including but not limited to the following:
• Unstable cardiac angina,
• Acute Myocardial infarction,
• Congestive heart failure (need to be treated in hospital or NYHA III/IV),
• Uncontrolled Severe Arrhythmias.
• TBIL \>1.2 × ULN, AST or ALT \> 1.5 × ULN.
• CLcr \< 50 mL/min.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

RECRUITING

Central Study Contacts

HuaPing Dai, Ph.D

CONTACT

010-84206271; daihuaping@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 1, 2021
• Study Start: February 15, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)