NCT07503587Not yet recruitingPhase 3
Evaluating the Efficacy and Safety of of HSK44459 in People With Progressive Pulmonary Fibrosis
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
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 378 (estimated)
- First submitted
- 25 Mar 2026
- Start date
- 5 Apr 2026
- Primary completion date
- 30 Dec 2028
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT07503587
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 378
- From 5 Apr 2026 to the primary completion date, 30 Dec 2028
- No sites listed in no 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 ILD exacerbation within 3 months prior to screening and/or during the screening period.
Other illness
- History of malignancy within 5 years prior to screening.
- History of vasculitis.
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
- 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:
- 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 .
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.