Phase ll Study of HEC585 in Patients With IPF

Phase 2

Recruiting

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: HEC585; Drug: Placebo; Drug: Pirfenidone

• Registration Number: NCT05060822
• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-30
• Study First Submitted: 2021-09-18
• Study First Submitted QC: 2021-09-18
• Study First Posted: 2021-09-29
• Status Verified: 2023-04
• Last Update Submitted: 2023-08-14
• Last Update Posted: 2023-08-18
• Primary Completion: 2024-05-10
• Study Completion: 2025-05-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HEC585 dose A	HEC585	Drug: HEC585 dose A once daily, up to 24 weeks-120 weeks
placebo	Placebo	Drug: placebo once daily, up to 24 weeks-120 weeks
HEC585 dose C	HEC585	Drug: HEC585 dose C once daily, up to 24 weeks-120 weeks
pirfenidone	Pirfenidone	Drug: pirfenidone three times a day (target dose), up to 24 weeks
HEC585 dose B	HEC585	Drug: HEC585 dose B once daily, up to 24 weeks-120 weeks

Primary Outcome Measures

Name	Time	Method
Change from Baseline to Week 24 in %FVC compared with placebo	24 Weeks	change in %FVC, measured using Spirometer, from baseline to week 24

Secondary Outcome Measures

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

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China