A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis

NCT07519070 | Not Yet Recruiting Phase 3

• 1 other identifier: HSK44459-301
• Study Type: interventional
• Target: 420
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the efficacy and safety of HSK44459 tablets in patients with idiopathic pulmonary fibrosis (IPF).

Conditions

IPF

Outcome Measures

Primary Outcomes (1)

• Change in FVC from baseline at Week 52

  Week 52

Secondary Outcomes (17)

• Time to first acute IPF exacerbation during the trial

  Week 52

• Time to first respiratory-related hospitalization during the trial

  Week 52

• Time to >5% relative/absolute decline in FVC% predicted from baseline during the trial

  Week 52

• Time to >10% relative/absolute decline in FVC% predicted from baseline during the trial

  Week 52

• Time to >15% absolute decline in DLCO% predicted from baseline during the trial

  Week 52

Other Outcomes (1)

• Time to first occurrence of any component of the composite endpoint during the trial: first FVC% predicted decline >10% from baseline, acute IPF exacerbation, first respiratory-related hospitalization, or death (whichever occurs first)

  Week 52

Study Arms (2)

HSK44459

EXPERIMENTAL

Drug: HSK44459

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Placebo Without IPF background therapy

Placebo

HSK44459 DRUG

HSK44459 Without IPF background therapy

HSK44459

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥40 years, regardless of gender;
• Diagnosis of IPF confirmed prior to or during screening per the 2022 ATS/ERS/JRS/ALAT guidelines (Appendix 1);
• Patients must meet one of the following criteria:
• No treatment with nintedanib or pirfenidone for at least 8 weeks prior to screening (e.g., treatment-naïve or discontinued therapy), with no plans to initiate or resume antifibrotic treatment;
• On a stable regimen of nintedanib or pirfenidone for at least 12 weeks prior to screening, without combination therapy with both drugs. \[Stable therapy is defined as maintaining a constant dosage with tolerable drug-specific adverse events\];
• Percentage predicted forced vital capacity (FVCpp) ≥45% at screening;
• Percentage predicted diffusing capacity of the lungs for carbon monoxide (DLCOpp) ≥25% and \<90% at screening \[\*hemoglobin (Hb)-adjusted\];
• Willing to participate and voluntarily sign the informed consent form.

You may not qualify if:

• Clinically significant airway obstruction during screening \[pre-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) \<0.7\];
• Other clinically significant pulmonary abnormalities per investigator judgment (exceptions: conditions requiring no treatment during the trial, e.g., asymptomatic pulmonary nodules, emphysema);
• Acute IPF exacerbation within 3 months before screening and/or during screening;
• Receiving immunomodulators (excluding oral corticosteroids) for respiratory conditions, or prednisone \>15 mg/day (or equivalent);
• History of vasculitis;
• Any suicidal behavior within 2 years before screening (actual attempt, interrupted attempt, aborted attempt, or preparatory acts/behaviors);
• Type 4 or 5 suicidal ideation per Columbia-Suicide Severity Rating Scale (C-SSRS) within 3 months before/during screening (active suicidal thoughts with method/intent but no plan, or with method/intent/plan);
• Respiratory infection requiring antibiotics or other infections requiring treatment within 4 weeks before/during screening;
• Major surgery within 3 months before screening or planned during the study (investigator-assessed; lung transplant listing excluded);
• Malignancy within 5 years before screening (except treated basal cell carcinoma, squamous cell carcinoma in situ, or cervical carcinoma in situ);
• Blood pressure ≥160/100 mmHg at screening;
• Unstable/worsening cardiovascular/cerebrovascular disease within 6 months before screening (e.g., unstable angina, myocardial infarction, heart failure, thromboembolic events including stroke/TIA);
• Aspartate transaminase (AST) or alanine transaminase (ALT) \>2.5×ULN or total bilirubin \>1.5×ULN at screening;
• Estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m² at screening;
• Gastrointestinal surgery/disease affecting pharmacokinetics (PK) (except appendectomy/hernia repair);

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Central Study Contacts

Zuojun Xu, PhD

CONTACT

+86-010-69156114; xuzj@hotmail.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 31, 2026
• First Posted: April 9, 2026
• Study Start: April 5, 2026
• Primary Completion (Estimated): April 5, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share