- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05139719
A Study to Explore the Therapeutic Effect of HEC585 on Delaying Forced Vital Capacity (FVC) Decline and Tolerance in Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Patients
A Phase IIb, Multi-center, Randomized, Double Blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of HEC585 Tablets in Patients With Progressive Fibrosing Interstitial Lung Disease
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: HuaPing Dai, Ph.D
- Phone Number: 010-84206271
- Email: daihuaping@ccmu.edu.cn
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Recruiting
- China-Japan Friendship Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteer to participate and sign the ICF.
- Male or female patients' age ≥ 18 years when signing the ICF.
Patients with known or unknown etiology (except IPF) and clear pulmonary fibrosis on chest CT have undergone conventional clinical treatment (assessed by the investigator, including follow-up observation) for ≥ 3 months. At least two of the following criteria occurring within 12 months before screening without alternative explanation (such as infection, heart failure, etc.):
i) Worsening respiratory symptoms like cough, shortness of breath. ii) Physiological evidence of disease progression (either of the following):
- absolute FVC (% of predicted) decline ≥ 5%.
- absolute DLco[Hb corrected] (% of predicted) decline ≥ 10%. iii) Radiological evidence of disease progression (one or more of the following):
- Increased extent or severity of traction bronchiectasis and bronchiolectasis.
- New ground-glass opacity with traction bronchiectasis.
- New fine reticulation.
- Increased extent or increased coarseness of reticular abnormality.
- New or increased honeycombing.
- Increased lobar volume loss.
- Fibrosing lung disease on HRCT, defined as reticular abnormality with traction bronchiectasis with or without honeycombing, with disease extent of >10% as confirmed by central readers.
- For patients with underlying connective tissue disease (CTD) should be in the stable status which is defined by no initiation of new therapy, treatment dose adjustment or withdrawal of therapy within 12 weeks prior to randomization.
- FEV1/FVC ≥ 0.7 before using bronchodilators.
- %FVC ≥ 45% predicted.
- Carbon Monoxide Diffusion Capacity (DLCO) corrected for Haemoglobin (Hb) ≥ 30% and ≤ 80% predicted of normal.
- Fertile female or male subjects agreed and promised to take effective contraception measures from signing the ICF till 30 days after last administration.
- Subjects are willing and able to comply with the protocol requirements and attend visits assessed by the investigator.
Exclusion Criteria:
- Diagnosis of Idiopathic Pulmonary Fibrosis (IPF).
- Lung with other clinically significant abnormalities which the investigator assess to have an effect on the results of study.
- Significant Pulmonary Arterial Hypertension (PAH), such as meeting the following: Previous clinical or echocardiographic evidence of significant right heart failure, History of right heart catheterization showing a cardiac index ≤ 2 L/min/m², or PAH requiring parenteral therapy with epoprostenol/treprostinil.
- Major extrapulmonary physiological or pathological restriction (e.g. chest wall abnormality, large pleural effusion).
- Expected to receive lung transplantation during the study.
- Expected survival time is less than 6 months.
- History of malignant tumors within 5 years (except for localized cancers such as basal cell carcinoma and carcinoma in situ of cervix).
- Thyroid dysfunction that the investigator assessed to be clinically significant and needed to be treated.
History of unstable or worsening heart disease during the 6 months prior to screening, including but not limited to the following:
- Unstable cardiac angina,
- Acute Myocardial infarction,
- Congestive heart failure (need to be treated in hospital or NYHA III/IV),
- Uncontrolled Severe Arrhythmias.
- TBIL >1.2 × ULN, AST or ALT > 1.5 × ULN.
- CLcr < 50 mL/min.
- Human immunodeficiency virus (HIV) or treponema pallidum antibody is positive.
- Uncontrolled hepatitis B virus infection or hepatitis C virus infection.
Use of any of the following medications for the treatment of Interstitial Lung Disease (ILD) or influence the effect or safety of investigational drug:
- Strong inducers or strong inhibitors of CYP3A4 within 4 weeks before randomization.
- Azathioprine (AZA), cyclosporine, MMF ( > 1.5 g/d or equivalent dose), tripterygium glycosides , hydroxychloroquine, tacrolimus, prednisone > 15mg/day or equivalent systemic glucocorticoid therapy, and the combination of OCS+AZA+NAC within 4 weeks before randomization.
- Cyclophosphamide within 8 weeks before randomization.
- Combination of ≤ 15mg/day or equivalent systemic glucocorticoid therapy with ≤ 1.5 g/d or equivalent dose MMF within 12 weeks before randomization.
- Pirfenidone or nintedanib within 1 months before screening.
- Rituximab, Adalimumab, Secukinumab, Infliximab, Tocilizumab, Certolizumab, Golimumab, Tofacitinib, Baricitinib, Etanercept, Abatacept within 6 months before randomization.
- Subjects cannot complete the PFT、6MWT,or questionnaires.
- Allergic to any component of HEC585 Tablets.
- Participated in other clinical study and received the last dose within 3 months before screening.
- Pregnant or breastfeeding.
- History of smoking (≥ 10 cigarettes/day) within 3 months before screening or are unwilling to quit smoking during the study.
- History of alcohol or drug abuse within 6 months before the screening.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HEC585 tables does A
|
taking HEC585 dose A orally once daily, up to 24 weeks in main stage (if applicable); up to 96 weeks in extended stage
|
Experimental: HEC585 tables does B
|
taking HEC585 dose B orally once daily, up to 24 weeks in main stage; up to 96 weeks in extended stage
|
Placebo Comparator: placebo
Placebo once daily up to 24 weeks in main stage; HEC585 dose A once daily up to 96 weeks in extended stage
|
taking HEC585 dose A orally once daily, up to 24 weeks in main stage (if applicable); up to 96 weeks in extended stage
taking Placebo orally once daily, up to 24 weeks in main stage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline to Week 24 in FVC (mL) compared with placebo
Time Frame: 24 Weeks
|
change in FVC (mL), measured using Spirometer, from baseline to week 24
|
24 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of 6MWT results
Time Frame: 12 Weeks, 24 Weeks
|
12 Weeks, 24 Weeks
|
|
Changes of DLco (Hb correction)
Time Frame: 12 Weeks, 24 Weeks
|
12 Weeks, 24 Weeks
|
|
Change from Baseline to Week 12 in FVC (mL) compared with placebo
Time Frame: 12 Weeks
|
change in FVC (mL), measured using Spirometer, from baseline to week 12
|
12 Weeks
|
Proportion of subjects with the decline from baseline in FVC (% predicted) > 10%
Time Frame: 24 Weeks
|
The proportion of subjects whose %FVC decline from baseline by more than 10% in each treatment group at week 24
|
24 Weeks
|
Proportion of subjects with the decline from baseline in FVC (% predicted) > 5%
Time Frame: 24 Weeks
|
The proportion of subjects whose %FVC decline from baseline by more than 5% in each treatment group at week 24
|
24 Weeks
|
Changes of St George' s Respiratory Questionnaire (SGRQ)
Time Frame: 12 Weeks, 24 Weeks
|
The higher the score, the more serious the impact on life
|
12 Weeks, 24 Weeks
|
Changes of The University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ)
Time Frame: 12 Weeks, 24 Weeks
|
Scores range from 0 to 120.
The higher the score, the more severe the difficulty in breathing
|
12 Weeks, 24 Weeks
|
Changes of Leicester coughing questionnaire scores
Time Frame: 12 Weeks, 24 Weeks
|
Scores range from 3 to 21.
The lower the score, the greater the impact of cough on quality of life
|
12 Weeks, 24 Weeks
|
Changes of HRCT
Time Frame: 24 Weeks
|
24 Weeks
|
|
Time to first acute ILD exacerbation or death
Time Frame: 24 Weeks
|
the time duration from randomization to first acute ILD exacerbation or death whichever occurs first
|
24 Weeks
|
Proportion of subjects with death caused by any reason(s)
Time Frame: 24 Weeks
|
24 Weeks
|
|
Proportion of subjects with death caused by the respiratory reason
Time Frame: 24 Weeks
|
24 Weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEC585-PF-202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Progressive Fibrosing Interstitial Lung Disease (PF-ILD) / Progressive Pulmonary Fibrosis (PPF)
-
University of AarhusAarhus University HospitalNot yet recruitingProgressive Fibrosing Interstitial Lung DiseaseDenmark
-
West Virginia UniversityNot yet recruitingProgressive Fibrosing Interstitial Lung DiseaseUnited States
-
Hospices Civils de LyonRecruitingProgressive Idiopathic Pulmonary FibrosisFrance
-
United TherapeuticsRecruitingInterstitial Lung Disease | Progressive Pulmonary FibrosisUnited States, Canada
-
University of North Carolina, Chapel HillRecruitingIdiopathic Pulmonary Fibrosis and Progressive Fibrotic Interstitial Lung DiseaseUnited States
-
Michael M. PhamTerminatedSystemic Sclerosis | Scleroderma, Systemic | Scleroderma, Diffuse | Diffuse Cutaneous Systemic Sclerosis | Interstitial Lung Disease | Scleroderma | Systemic Sclerosis, Diffuse | Diffuse Systemic Sclerosis | Pulmonary Fibrosis Interstitial | Diffuse Scleroderma | Diffuse Cutaneous Scleroderma | Progressive Systemic... and other conditionsUnited States
-
Pulmonary Fibrosis FoundationUniversity of MichiganCompletedInterstitial Lung Disease (ILD) | Idiopathic Pulmonary Fibrosis (IPF)United States
-
Heidelberg UniversityLungenfibrose e.V.CompletedIdiopathic Pulmonary Fibrosis | Fibrosing Interstitial Lung DiseasesGermany
-
Boehringer IngelheimNot yet recruitingIdiopathic Pulmonary Fibrosis | Progressive Pulmonary Fibrosis
-
Avalyn Pharma Inc.DevPro BiopharmaRecruitingProgressive Pulmonary FibrosisUnited States
Clinical Trials on HEC585 dose A
-
Sunshine Lake Pharma Co., Ltd.CompletedIdiopathic Pulmonary FibrosisChina
-
Sunshine Lake Pharma Co., Ltd.Completed
-
SeqirusDepartment of Health and Human ServicesRecruitingInfections | Virus Diseases | Respiratory Tract Infections | Influenza, Human | Infection ViralPhilippines, United States
-
Zhejiang UniversityCompletedHyperlipoproteinemia
-
AbbVieCompleted
-
Aventure ABCompletedBlood Glucose ResponseSweden
-
Ventyx Biosciences, IncTerminatedPsoriatic ArthritisUnited States, Bulgaria, Czechia, Germany, Hungary, Poland, Spain
-
National Research Council, SpainUniversidad Católica San Antonio de Murcia; The Scientific and Technological...Completed
-
Harbour BioMed (Guangzhou) Co. Ltd.RecruitingPrimary Immune Thrombocytopenic PurpuraChina
-
Lynk Pharmaceuticals Co., LtdCompletedAtopic DermatitisChina