Phase ll Study of HEC585 in Patients With IPF

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05060822
• Other study ID #: HEC585-P-03
• Status: Recruiting
• Phase: Phase 2
• Start date: June 30, 2021
• Est. completion date: May 11, 2025

Study information

• Verified date: April 2023
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: HuaPing Dai, MD
• Phone: 010-84206278
• Email: daihuaping[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: May 11, 2025
• Est. primary completion date: May 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• HEC585
HEC585 Tablets,once daily
• Pirfenidone
Pirfenidone,three times a day
• Placebo
Placebo,once daily

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline to Week 24 in %FVC compared with Pirfenidone	change in %FVC, measured using Spirometer, from baseline to week 24	24 Weeks
Secondary	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
Secondary	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
Secondary	Time to first acute IPF exacerbation		24 Weeks
Secondary	All-cause mortality		24 Weeks
Secondary	IPF related mortality		24 Weeks
Secondary	Changes of 6MWT results		12 Weeks, 24 Weeks
Secondary	Changes of SGRQ scores		12 Weeks, 24 Weeks
Secondary	Changes of DLco (Hb correction)		12 Weeks, 24 Weeks
Secondary	Changes of resting SpO2		12 Weeks, 24 Weeks