Phase ll Study of HEC585 in Patients With IPF

Sponsor

Sunshine Lake Pharma Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05060822

Collaborator

(none)

270

Enrollment

Location

Arms

22.3

Anticipated Duration (Months)

12.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis	Drug: HEC585 Drug: Pirfenidone Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

270 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

placebo-controlled (double-blind design), active comparator-controlled (open-label design)，parallel-group

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 30, 2021

Anticipated Primary Completion Date :

Feb 10, 2023

Anticipated Study Completion Date :

May 11, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HEC585 dose A Drug: HEC585 dose A once daily, up to 24 weeks	Drug: HEC585 HEC585 Tablets，once daily
Experimental: HEC585 dose B Drug: HEC585 dose B once daily, up to 24 weeks	Drug: HEC585 HEC585 Tablets，once daily
Experimental: HEC585 dose C Drug: HEC585 dose C once daily, up to 24 weeks	Drug: HEC585 HEC585 Tablets，once daily
Active Comparator: pirfenidone Drug: pirfenidone three times a day (target dose), up to 24 weeks	Drug: Pirfenidone Pirfenidone，three times a day
Placebo Comparator: placebo Drug: placebo once daily, up to 24 weeks	Drug: Placebo Placebo，once daily

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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:

Any cytotoxic drug or immunosuppressant
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.
Moderate and strong inhibitor or strong inducer of CYP1A2.
Strong inducers or strong CYP3A4 inhibitors.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	China-Japan Friendship Hospital	Beijing	Beijing	China

Sponsors and Collaborators

Sunshine Lake Pharma Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sunshine Lake Pharma Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05060822

Other Study ID Numbers:

HEC585-P-03

First Posted:

Sep 29, 2021

Last Update Posted:

Sep 29, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis

Pirfenidone

Study Results

No Results Posted as of Sep 29, 2021