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

NCT06764862 | Completed Phase 2

• 1 other identifier: HSK44459-201
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Relative change from baseline in FVC at week 12

  day 1 and week 12

• The change from baseline in percentage predicted forced vital capacity ( ppFVC) at week 12

  day 1 and week 12

Study Arms (4)

HSK44459-dose 1

EXPERIMENTAL

Drug: HSK44459 dose 1

HSK44459-dose 2

EXPERIMENTAL

Drug: HSK44459 dose 2

HSK44459-dose 3

EXPERIMENTAL

Drug: HSK44459 dose 3

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HSK44459 dose 3 DRUG

HSK44459 taken orally twice daily in the morning and in the evening for 12 weeks.

HSK44459-dose 3

HSK44459 dose 1 DRUG

HSK44459 taken orally twice daily in the morning and in the evening for 12 weeks.

HSK44459-dose 1

HSK44459 dose 2 DRUG

HSK44459 taken orally twice daily in the morning and in the evening for 12 weeks.

HSK44459-dose 2

Placebo DRUG

Placebo matching HSK44459 taken orally twice daily in the morning and in the evening for 12 weeks.

Placebo

Eligibility Criteria

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

You may qualify if:

• \. 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.
• \. 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.
• \. 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 for at least 8 weeks prior to screening and during the 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 IPF exacerbation within 4 months prior to screening and/or during the screening period (investigator-determined).
• Lower respiratory tract infection requiring antibiotics within 2 weeks prior to screening and/or during the screening period.
• 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).
• History of malignancy within 5 years prior to screening.
• Any suicidal behavior within 2 years prior to screening (i.e. actual attempts, interrupted attempts, abandoned attempts, or prepared actions or attitudes).

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: January 6, 2025
• First Posted: January 9, 2025
• Study Start: January 17, 2025
• Primary Completion: February 12, 2026
• Study Completion: March 4, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

CN (1)