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

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

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

Treatments tested in this trial

  • HEC585 dose A
  • HEC585 dose B
  • Placebo

Treatment groups

110 Participants
are divided into 3 treatment groups

Sponsors and collaborators