NCT07909655Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial Evaluating the Treatment of Idiopathic Pulmonary Fibrosis Patients With HB0056
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
This trial is a 58 week randomized, double-blind, placebo-controlled, parallel-group, multicenter trial in which the efficacy, safety, and pharmacokinetics of HB0056, either on top of stable IPF therapy or as monotherapy, are assessed in participants with IPF.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 27 Oct 2026
- Start date
- Nov 2026
- Primary completion date
- Jan 2028
- Lead sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT07909655
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 75
- From Nov 2026 to the primary completion date, Jan 2028
- 2 sites 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 exacerbation of Idiopathic Pulmonary Fibrosis (IPF) within 3 months prior to screening and/or during the screening period (investigator-determined).
- Received experimental treatment for IPF within the first 4 weeks of randomization;
- Individuals who have received treatment with Namistat or other PDE4 inhibitors within the first 8 weeks of randomization or plan to receive treatment with Namistat or other Phosphodiesterase-4(PDE4) inhibitors during the study period;
- Have participated in any clinical trials of investigational drugs within 28 days prior to screening or within 5 half lives of the drug (whichever is longer);
- Acute respiratory or systemic bacterial, viral, or fungal infections requiring treatment within 4 weeks prior to Visit 1 and/or during the screening period.
Other
- Those who have used prednisone\>15mg/day or equivalent dose within the first 2 weeks of randomization and require maintenance;
Who the study is looking for
- Age 40 to 80, inclusive, at the time of screening
- IPF diagnosed within 5 years prior to screening，and whose HRCT during the screening period meets the diagnostic guidelines for idiopathic pulmonary fibrosis jointly released by the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Association (ALAT) in 2022
- HRCT diagnosis UIP type/possible UIP type (standard HRCT confirmed by central review in recent 3 months) with or without pathological UIP type/possible UIP type (pathology refers to frozen lung biopsy or surgical/thoracoscopic lung biopsy)；
- FVCpp ≥ 45% during screening period and the first day;
- The percent of predicted DLCO value (corrected by Hb value) at screening is ≥ 30%;
- pre-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ≥ 0.7
- Before randomization, pirfenidone or nidanib with stable dose ≥ 8 weeks can continue to maintain treatment with stable dose during the study period; Or at least 8 weeks before randomization, pirfenidone or nidanib was not used；
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xiangya Third Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Fudan University Affiliated Zhongshan Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.