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

NCT07503587 | Not Yet Recruiting Phase 3

• 1 other identifier: HSK44459-302
• Study Type: interventional
• Target: 378
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Progressive Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

HSK44459

EXPERIMENTAL

Drug: HSK44459

Interventions

HSK44459 DRUG

HSK44459 taken orally twice daily in the morning and in the evening for 52weeks.

HSK44459

Placebo DRUG

Placebo matching HSK44459 taken orally twice daily in the morning and in the evening for 52 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥18 year.
• Diagnosis of PPF other than IPF prior to screening or during the screening period.
• Patients must meet either of the following conditions:
• \. 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.
• on stable therapy with nintedanib or pirfenidone for at least 12 weeks prior to screening and during the screening period.
• 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 .

You may not qualify if:

• 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 ILD exacerbation within 3 months prior to screening and/or during the screening period.
• History of malignancy within 5 years prior to screening.
• History of vasculitis.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Central Study Contacts

Sun luyin

CONTACT

028-67258779; sunluyin@haisco.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 31, 2026
• Study Start: April 5, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share