Phase ll Study of HEC585 in Patients With IPF

A Phase II, Multi-center, Randomized, Placebo-controlled (Double-blind Design), Active Comparator-controlled (Open-label Design), Parallel-group, Dose-finding Study, to Evaluate the Efficacy and Safety of HEC585 Tablets in Patients With IPF

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

Study Overview

• Status: Active, not recruiting
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: HEC585; Drug: Placebo; Drug: Pirfenidone

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• Family or personal history of QT prolongation syndrome;
• Any condition that, in the opinion of the investigator, would compromise the safety or compliance of the subject, or prevent the subject from completing the study.
• TBil > 1.5 × ULN or AST or ALT > 2 × ULN;
• CLcr < 50 mL/min;
• Human immunodeficiency virus (HIV) antibody is positive;
• Uncontrolled hepatitis B virus infection or hepatitis C virus infection;
• QTcF > 480 ms.

• Subjects have received any of the following treatments within 28 days before randomization:

  1. Any cytotoxic drug or immunosuppressant
  2. Therapeutic drugs for IPF, including but not limited to pirfenidone, nintedanib, prednisone at > 15 mg/d or other glucocorticoids of the equivalent dose, N-acetylcysteine at > 600 mg/d.
  3. Moderate and strong inhibitor or strong inducer of CYP1A2.
  4. Strong inducers or strong CYP3A4 inhibitors.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: pirfenidone; Drug: pirfenidone three times a day (target dose), up to 24 weeks	Drug: Pirfenidone; Pirfenidone，three times a day
Experimental: HEC585 dose A; Drug: HEC585 dose A once daily, up to 24 weeks-120 weeks	Drug: HEC585; HEC585 Tablets，once daily
Experimental: HEC585 dose B; Drug: HEC585 dose B once daily, up to 24 weeks-120 weeks	Drug: HEC585; HEC585 Tablets，once daily
Experimental: HEC585 dose C; Drug: HEC585 dose C once daily, up to 24 weeks-120 weeks	Drug: HEC585; HEC585 Tablets，once daily
Placebo Comparator: placebo; Drug: placebo once daily, up to 24 weeks-120 weeks	Drug: Placebo; Placebo，once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline to Week 24 in %FVC compared with Pirfenidone	change in %FVC, measured using Spirometer, from baseline to week 24	24 Weeks
Change from Baseline to Week 12 in %FVC compared with placebo/ Pirfenidone	change in %FVC, measured using Spirometer, from baseline to week 12	12 Weeks
Proportion of subjects with an absolute decline from baseline in FVC (% predicted) of > 10%	The proportion of subjects whose %FVC decline from baseline by more than 10% in each treatment group at W24	24 Weeks
Time to first acute IPF exacerbation		24 Weeks
All-cause mortality		24 Weeks
IPF related mortality		24 Weeks
Changes of 6MWT results		12 Weeks, 24 Weeks
Changes of SGRQ scores		12 Weeks, 24 Weeks
Changes of DLco (Hb correction)		12 Weeks, 24 Weeks
Changes of resting SpO2		12 Weeks, 24 Weeks

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Actual): July 16, 2025
• Study Completion (Estimated): December 11, 2026

Study Registration Dates

• First Submitted: September 18, 2021
• First Submitted That Met QC Criteria: September 18, 2021
• First Posted (Actual): September 29, 2021

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; pirfenidone
• Other Study ID Numbers: HEC585-P-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No