Clinical trial NCT05060822: Phase ll Study of HEC585 in Patients With IPF
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-09-29
Enrollment: 270
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Change from Baseline to Week 24 in %FVC compared with placebo
timeFrame: 24 Weeks
Secondary outcomes:
measure: Change from Baseline to Week 24 in %FVC compared with Pirfenidone
timeFrame: 24 Weeks
measure: Change from Baseline to Week 12 in %FVC compared with placebo/ Pirfenidone
timeFrame: 12 Weeks
measure: Proportion of subjects with an absolute decline from baseline in FVC (% predicted) of > 10%
timeFrame: 24 Weeks
measure: Time to first acute IPF exacerbation
timeFrame: 24 Weeks
measure: All-cause mortality
timeFrame: 24 Weeks
measure: IPF related mortality
timeFrame: 24 Weeks
measure: Changes of 6MWT results
timeFrame: 12 Weeks, 24 Weeks
measure: Changes of SGRQ scores
timeFrame: 12 Weeks, 24 Weeks
measure: Changes of DLco (Hb correction)
timeFrame: 12 Weeks, 24 Weeks
measure: Changes of resting SpO2
timeFrame: 12 Weeks, 24 Weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
References: