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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

ConditionProgressive Fibrosing Interstitial Lung Disease (PF-ILD) / Progressive Pulmonary Fibrosis (PPF)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunshine Lake Pharma Co., Ltd.

About this trial

The main goal of this phase llb study is to compare the efficacy and safety of two doses of HEC585 tablets with placebo which is a look-alike substance that contains no active drug in patients with progressive fibrosing interstitial lung diseases. This study is divided into two stages, i.e. main study stage with 24 weeks treatment duration followed by up to 96 weeks treatment extended study stage.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Volunteer to participate and sign the ICF.

Male or female patients' age ≥ 18 years when signing the ICF.

absolute FVC (% of predicted) decline ≥ 5%.

Increased extent or severity of traction bronchiectasis and bronchiolectasis.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • HEC585 dose A

    Drug

    taking HEC585 dose A orally once daily, up to 24 weeks in main stage (if applicable); up to 96 weeks in extended stage

  • HEC585 dose B

    Drug

    taking HEC585 dose B orally once daily, up to 24 weeks in main stage; up to 96 weeks in extended stage

  • Placebo

    Drug

    taking Placebo orally once daily, up to 24 weeks in main stage

Treatment groups

110 Participants
are divided into 3 treatment groups
Group A: HEC585 tables does AExperimental treatment 1 intervention
Group B: HEC585 tables does BExperimental treatment 1 intervention
Group C: placeboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change from Baseline to Week 24 in FVC (mL) compared with placebo

change in FVC (mL), measured using Spirometer, from baseline to week 24

Time frame
24 Weeks

Secondary outcomes

1

Change from Baseline to Week 12 in FVC (mL) compared with placebo

change in FVC (mL), measured using Spirometer, from baseline to week 12

Time frame
12 Weeks
2

Proportion of subjects with the decline from baseline in FVC (% predicted) > 10%

The proportion of subjects whose %FVC decline from baseline by more than 10% in each treatment group at week 24

Time frame
24 Weeks
3

Proportion of subjects with the decline from baseline in FVC (% predicted) > 5%

The proportion of subjects whose %FVC decline from baseline by more than 5% in each treatment group at week 24

Time frame
24 Weeks
4

Changes of DLco (Hb correction)

Time frame
12 Weeks, 24 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sunshine Lake Pharma Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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