Starting soon
Phase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Condition(s) studied
Idiopathic Pulmonary Fibrosis (IPF)
Investigational drug(s) / intervention(s)
HB0056: subjects be given HB0056 high dose
HB0056: subjects be given HB0056 low dose
Placebo: subjects be given placebo during the first 24 weeks
Study summary
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.
Eligibility
Key Inclusion Criteria:
* 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;
Key Exclusion Criteria:
* 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;
* Those who have used prednisone\>15mg/day or equivalent dose within the first 2 weeks of randomization and require maintenance;
* 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.
Primary outcome measure(s)
- Change from Baseline in FVC% (Percent of Predicted FVC value) to week 24 — 24 weeks
Trial sites (2)
| Facility | City | Region | Status |
| Xiangya Third Hospital of Central South University |
Changsha |
Hunan |
|
| Fudan University Affiliated Zhongshan Hospital |
Shanghai |
China |
|
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