Phase ll Study of HEC585 in Patients With IPF

Sunshine Lake Pharma

Status and phase: Enrolling; Phase 2

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: HEC585; Drug: Pirfenidone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05060822

HEC585-P-03

Details and patient eligibility

About

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

Enrollment: 270 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

270 participants in 5 patient groups, including a placebo group

HEC585 dose A

Experimental group

Description:

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

Treatment:

Drug: HEC585

HEC585 dose B

Experimental group

Description:

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

Treatment:

Drug: HEC585

HEC585 dose C

Experimental group

Description:

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

Treatment:

Drug: HEC585

pirfenidone

Active Comparator group

Description:

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

Treatment:

Drug: Pirfenidone

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo