Evaluating the Efficacy and Safety of of HSK44459 in People With Idiopathic Pulmonary Fibrosis (IPF)

A Randomised, Double-blind, Placebo-controlled Parallel Group Phase II Clinical Study Evaluating the Efficacy and Safety of HSK44459 Tablets in Subjects With Idiopathic Pulmonary Fibrosis

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: HSK44459 dose 1; Drug: HSK44459 dose 2; Drug: Placebo; Drug: HSK44459 dose 3

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100000
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

1. 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.
2. 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% of predicted normal at screening period.

4. Patients have to be either:

1. 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.
2. on stable therapy with nintedanib or pirfenidone for at least 8 weeks prior to screening and during the screening period.

Exclusion Criteria:

1. Clinically significant airways obstruction (Forced Expiratory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) < 0.7) at screening.
2. In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
3. Acute IPF exacerbation within 4 months prior to screening and/or during the screening period (investigator-determined).
4. Lower respiratory tract infection requiring antibiotics within 2 weeks prior to screening and/or during the screening period.
5. 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).
6. History of malignancy within 5 years prior to screening.
7. Any suicidal behavior within 2 years prior to screening (i.e. actual attempts, interrupted attempts, abandoned attempts, or prepared actions or attitudes).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo matching HSK44459 taken orally twice daily in the morning and in the evening for 12 weeks.
Experimental: HSK44459-dose 1	Drug: HSK44459 dose 1; HSK44459 taken orally twice daily in the morning and in the evening for 12 weeks.
Experimental: HSK44459-dose 2	Drug: HSK44459 dose 2; HSK44459 taken orally twice daily in the morning and in the evening for 12 weeks.
Experimental: HSK44459-dose 3	Drug: HSK44459 dose 3; HSK44459 taken orally twice daily in the morning and in the evening for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change from baseline in forced vital capacity (FVC) at week 12	FVC is a standard pulmonary function test used to quantify respiratory muscle weakness	day 1 and week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change from baseline in FVC at week 12	FVC is a standard pulmonary function test used to quantify respiratory muscle weakness	day 1 and week 12
The change from baseline in percentage predicted forced vital capacity ( ppFVC) at week 12	FVC is a standard pulmonary function test used to quantify respiratory muscle weakness	day 1 and week 12

Collaborators and Investigators

• Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2025
• Primary Completion (Actual): February 12, 2026
• Study Completion (Actual): March 4, 2026

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): January 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: HSK44459-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No