Evaluating the Efficacy and Safety of of HSK50042 in People With Idiopathic Pulmonary Fibrosis

Official title

A Randomised, Double-blind, Placebo-controlled Parallel Group Phase II Clinical Study Evaluating the Efficacy and Safety of HSK50042 in Subjects With Idiopathic Pulmonary Fibrosis

Overview

This study is open to adults with idiopathic pulmonary fibrosis who are at least 40 years old. The main objective is to evaluate of the efficacy and the secondary objective is to evaluate the safety and pharmacokinetic.

Interventions

• Drug HSK50042 dose 1
  HSK50042 taken orally once daily in the morning for 26 weeks.
• Drug HSK50042 dose 2
  HSK50042 taken orally once daily in the morning for 26 weeks.
• Drug HSK50042 dose 3
  HSK50042 taken orally once daily in the morning for 26 weeks.
• Drug Placebo
  Placebo matching HSK50042 taken orally once daily in the morning for 26 weeks.

Primary outcome measures

• The change from baseline in forced vital capacity (FVC) at week 12 [Time frame: week 12]

Secondary outcome measures (2)

• The change from baseline in forced vital capacity (FVC) at week 26 [Time frame: week 26]
• The change from baseline in percentage predicted forced vital capacity ( ppFVC) at week 12/26 [Time frame: week12/26]

Eligibility criteria

Inclusion criteria

1\. Diagnosed with Idiopathic Pulmonary Fibrosis (IPF) prior to screening, patients must meet both of the following criteria:

• IPF based on 2022 ATS/ERS/JRS/ALAT Guideline as confirmed by the investigator based on chest HRCT scan taken before or during screening period and if available surgical lung biopsy.
• Usual interstitial pneumonia (UIP) or probable UIP HRCT pattern consistent with the clinical diagnosis of IPF, as confirmed by the investigator prior to screening. if indeterminate HRCT finding IPF may be confirmed locally by (historical) biopsy.

2\. Percentage Predicted Forced Vital Capacity (ppFVC) ≥45% at screening period. 3. Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin \[Hb\]) ≥ 25% and<90% of predicted normal at screening period.

4\. Patients have to be either:

• not on therapy with nintedanib or pirfenidone for at least 8 weeks prior to screening and during the screening period, and not planning to start or restart anti fibrotic therapy.
• on stable therapy with nintedanib or pirfenidone or nerandomilast for at least 12 weeks prior to screening and during the screening period.

Exclusion criteria

• Clinically significant airways obstruction (Forced Expiratory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) < 0.7) at screening.
• In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
• Acute IPF exacerbation within 3 months prior to screening and/or during the screening period (investigator-determined).
• History of persistent or active micturition/defecation syncope, known prior history of syncope, or concomitant other diseases increasing the risk of syncope (e.g., symptomatic bradycardia, second- or third-degree atrioventricular block, symptomatic valvular heart disease, etc.).
• Major surgery (major according to the investigator's assessment) performed within 3 months prior to screening or planned during the course of the trial. (Being on a transplant list is allowed).
• Uncontrolled hypertension at screening or prior to randomization/investigational product administration (defined as refractory hypertension as assessed by the investigator, systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg); or hypotension (seated systolic blood pressure <100 mmHg or diastolic blood pressure <60 mmHg).
• Administration of systemic corticosteroids equivalent to >15 mg prednisone per day within 4 weeks prior to screening and/or during the screening period.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07728721 · HSK50042-201

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗