Evaluating the Efficacy and Safety of of HSK44459 in People With Progressive Pulmonary Fibrosis (PPF)

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

This study is open to adults with PPF . The main objective is to evaluate of the efficacy and the secondary objective is to evaluate the safety and pharmacokinetic.

Study Overview

• Status: Not yet recruiting
• Conditions: Progressive Pulmonary Fibrosis
• Intervention / Treatment: Drug: Placebo; Drug: HSK44459

• Study Type: Interventional
• Enrollment (Estimated): 378
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sun luyin; Phone Number: 028-67258779; Email: sunluyin@haisco.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Adults aged ≥18 year.
2. Diagnosis of PPF other than IPF prior to screening or during the screening period.
3. Patients must meet either of the following conditions:

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 antiibrotic therapy.

2.on stable therapy with nintedanib or pirfenidone for at least 12 weeks prior to screening and during the screening period.

4.Percentage Predicted Forced Vital Capacity (ppFVC) ≥45% at screening period. 5.Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin [Hb]) ≥ 25% and <90% of predicted normal at 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 ILD exacerbation within 3 months prior to screening and/or during the screening period.
4. History of malignancy within 5 years prior to screening.
5. History of vasculitis.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

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 52 weeks
Experimental: HSK44459	Drug: HSK44459; HSK44459 taken orally twice daily in the morning and in the evening for 52weeks.

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 52	FVC is a standard pulmonary function test used to quantify respiratory muscle weakness	day 1 and week 52

Collaborators and Investigators

• Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 5, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HSK44459-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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