Phase ll Study of HEC585 in Patients With IPF

NCT ID: NCT05060822

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2025-05-11

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HEC585 dose A

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

Group Type: EXPERIMENTAL

HEC585

Intervention Type: DRUG

HEC585 Tablets，once daily

HEC585 dose B

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

Group Type: EXPERIMENTAL

HEC585

Intervention Type: DRUG

HEC585 Tablets，once daily

HEC585 dose C

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

Group Type: EXPERIMENTAL

HEC585

Intervention Type: DRUG

HEC585 Tablets，once daily

pirfenidone

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

Group Type: ACTIVE_COMPARATOR

Pirfenidone

Intervention Type: DRUG

Pirfenidone，three times a day

placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo，once daily

Interventions

HEC585

HEC585 Tablets，once daily

Intervention Type: DRUG

Pirfenidone

Pirfenidone，three times a day

Intervention Type: DRUG

Placebo

Placebo，once daily

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunshine Lake Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

HuaPing Dai, MD

Role: CONTACT

daihuaping@ccmu.edu.cn

010-84206278

Other Identifiers

HEC585-P-03

Identifier Type: -

Identifier Source: org_study_id