Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF

NCT07082842 | Recruiting Phase 3 FDA Drug

• 1 other identifier: HEC585-IPF-301
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter, parallel, randomized, placebo (double-blind) and pirfenidone (open-label) controlled Phase III clinical trial to evaluate the efficacy and safety of HEC585 in patients with idiopathic pulmonary fibrosis (IPF)

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Outcome Measures

Primary Outcomes (1)

• Change in FVC from baseline at 52 weeks (mL)

  52week

Secondary Outcomes (5)

• The interval (in days) from the start of the study until the first occurrence of any of the following clinical events (whichever occurs first) within 52 weeks

  52week

• The percentage of FVC relative to the predicted value (%FVC) compared to the baseline value changes

  52week

• The percentage of DLco(Hb-correction) relative to the expected value [%DLco(Hb-correction)] and the change from the baseline value

  52week

• The total walking distance of 6MWT（six minutes walk ）test compared to the baseline value

  52week

• The change in SGRQ（St George's Respiratory Questionnaire） score compared to the baseline

  52week

Study Arms (3)

HEC585

EXPERIMENTAL

Drug: HEC585

Placebo

PLACEBO COMPARATOR

Drug: Placebo

pirfenidone

ACTIVE COMPARATOR

Drug: Pirfenidone

Interventions

HEC585 DRUG

HEC585 tablet, taken once daily

HEC585

Placebo DRUG

HEC585 Simulation Board, taken once daily

Placebo

Pirfenidone DRUG

Pirfenidone, taken three times a day

pirfenidone

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in this clinical study and sign the informed consent form before the study begins;
• When signing the informed consent form, the age should be between 40 and 80 years old (inclusive of 40 and 80), and gender is not restricted;
• Be diagnosed with IPF according to the diagnostic criteria of the IPF clinical practice guidelines jointly released by the American Thoracic Society, the European Respiratory Society, the Japanese Respiratory Society and the Latin American Thoracic Society in 2022 ; Chest high-resolution computed tomography (HRCT) examination (HRCT examination within 3 months before screening) or lung biopsy (if any) should be confirmed by central reading;
• The ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) at the screening period is ≥ 0.7;
• The percentage of FVC as a percentage of the normal predicted value at the screening period is ≥ 45%;
• The percentage of DLco (hemoglobin \[Hb\] corrected) as a percentage of the normal predicted value at the screening period is ≥ 30%;
• Female or male subjects with potential fertility agree and commit to taking effective contraceptive measures from the time of signing the informed consent form until 30 days after the last administration of the investigational drug; at the same time, avoid sperm/egg collection, sperm/egg donation;
• According to the assessment by the investigator, the subjects are willing and able to comply with the requirements of the protocol and attend the visits.

You may not qualify if:

• The researchers believe that the subjects experienced significant deterioration of IPF within the first three months of the randomization period.
• Other known causes of interstitial lung disease, such as exposure to the home or occupational environment, connective tissue diseases, drug toxicity, etc.
• Abnormalities in the lungs or chest that are clinically significant and judged by the researchers to potentially affect the trial results.
• Within one month before randomization, any active infection requiring systemic treatment (such as oral or intravenous administration) in the form of activity (including bacterial, viral, parasitic or fungal infections).
• Expected to undergo lung transplantation during the course of the study.
• Expected survival period less than 6 months.
• History of malignant tumors within the previous 5 years (excluding localized cancers such as basal cell carcinoma).
• Moderate to severe liver dysfunction (Child-Pugh classification of grade B or C).
• Within six months before screening, history of unstable or deteriorating heart disease, including but not limited to the following conditions:
• Unstable angina pectoris;
• Myocardial infarction;
• Congestive heart failure requiring hospitalization or NYHA III/IV grade;
• Uncontrolled severe arrhythmia.
• Unable to perform the 6MWT or pulmonary function test, such as if the patient is mentally unstable and unable to cooperate, etc.;
• Allergic to any component of Ifinonate Hydrochloride Tablets (except the active ingredient, the excipients include microcrystalline cellulose, pre-gelatinized starch, cross-linked povidone, povidone, dibutyl hydroxytoluene, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide) or pirfenidone tablets;

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

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

Central Study Contacts

huaping dai Doctor of Medicine(M.D.)

CONTACT

010-84206278; daihuaping@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: July 2, 2025
• First Posted: July 24, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): January 15, 2031
• Study Completion (Estimated): February 15, 2032
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)