NCT06764862CompletedPhase 2
Evaluating the Efficacy and Safety of of HSK44459 in People With Idiopathic Pulmonary Fibrosis
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
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 186 (actual)
- First submitted
- 6 Jan 2025
- Start date
- 17 Jan 2025
- Primary completion date
- 12 Feb 2026
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT06764862
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 186
- From 17 Jan 2025 to the primary completion date, 12 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
- Any suicidal behavior within 2 years prior to screening (i.e. actual attempts, interrupted attempts, abandoned attempts, or prepared actions or attitudes).
Other illness
- History of malignancy within 5 years prior to screening.
Other
- 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.
Who the study is looking for
- 1\. 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.
- 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:
- 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.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.