Phase ll Study of HEC585 in Patients With IPF

NCT05060822 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: HEC585-P-03
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase ll Study to evaluate the efficacy and safety of various doses of HEC585 Tablets in patients with idiopathic pulmonary fibrosis

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Change from Baseline to Week 24 in %FVC compared with placebo

  change in %FVC, measured using Spirometer, from baseline to week 24

  24 Weeks

Secondary Outcomes (10)

• Change from Baseline to Week 24 in %FVC compared with Pirfenidone

  24 Weeks

• Change from Baseline to Week 12 in %FVC compared with placebo/ Pirfenidone

  12 Weeks

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

  24 Weeks

• Time to first acute IPF exacerbation

  24 Weeks

• All-cause mortality

  24 Weeks

Study Arms (5)

HEC585 dose A

EXPERIMENTAL

Drug: HEC585 dose A once daily, up to 24 weeks-120 weeks

Drug: HEC585

HEC585 dose B

EXPERIMENTAL

Drug: HEC585 dose B once daily, up to 24 weeks-120 weeks

Drug: HEC585

HEC585 dose C

EXPERIMENTAL

Drug: HEC585 dose C once daily, up to 24 weeks-120 weeks

Drug: HEC585

pirfenidone

ACTIVE COMPARATOR

Drug: pirfenidone three times a day (target dose), up to 24 weeks

Drug: Pirfenidone

placebo

PLACEBO COMPARATOR

Drug: placebo once daily, up to 24 weeks-120 weeks

Drug: Placebo

Interventions

HEC585 DRUG

HEC585 Tablets，once daily

HEC585 dose A; HEC585 dose B; HEC585 dose C

Pirfenidone DRUG

Pirfenidone，three times a day

pirfenidone

Placebo DRUG

Placebo，once daily

placebo

Eligibility Criteria

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

You may qualify if:

• Volunteer to participate in this clinical study and sign the ICF before the study begins;
• Aged 40-80 (including 40 and 80) ;
• Female or male subjects with child-bearing potential who agree and promise to take effective contraceptive measures;
• Diagnosed with IPF according to the Official ATS/ERS/JRS/ALAT Clinical Practice Guideline for IPF Diagnosis (2018);
• FEV1/FVC ≥ 0.7;
• FVC ≥ 45% predicted;
• DLCO corrected for Haemoglobin (Hb) ≥ 30% predicted of normal;
• In the opinion of the Investigator, subjects are willing and able to comply with the protocol requirements and attend the visit.

You may not qualify if:

• In the opinion of the Investigator, subjects underwent significant deterioration in IPF within one month before randomization;
• Interstitial lung disease caused by other known causes;
• Any bacterial, viral, parasitic or fungal infection that needs to be treated at screening;
• Expected to receive lung transplantation during the study;
• Expected survival is less than 6 months;
• History of tumors within 5 years before screening (except for localized cancers such as basal cell carcinoma);
• Moderate to severe hepatic insufficiency (Child-Pugh grade B or C, see Appendix 4);
• History of unstable or worsening heart disease within 6 months before screening;
• Cannot perform 6MWT or PFT;
• Allergic to any component of HEC585 Tablets or pirfenidone tablets;
• Participated in other clinical study and received the last dose within 3 months before screening;
• Pregnant or breastfeeding;
• History of smoking within 3 months before screening or are unwilling to quit smoking during the study;
• Subjects often drink alcohol within 6 months before the screening (drink more than 21 units of alcohol a week), or refuse to reduce alcohol intake during the study;
• History of drug abuse within 6 months before the screening;

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: placebo-controlled (double-blind design), active comparator-controlled (open-label design)，parallel-group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2021
• First Posted: September 29, 2021
• Study Start: June 30, 2021
• Primary Completion: July 16, 2025
• Study Completion (Estimated): December 11, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)