Clinical Trials List
Protocol NumberVP-C21-011
Active
2024-09-16 - 2027-09-24
Others
Recruiting7
ICD-10J84.10
Pulmonary fibrosis, unspecified
ICD-10J84.112
Idiopathic pulmonary fibrosis
ICD-10J84.114
Acute interstitial pneumonitis
ICD-10J98.19
Other pulmonary collapse
ICD-9516.3
Idiopathic fibrosing alveolitis
A randomized, double-blind, placebo-controlled, parallel-group, multicenter trial evaluating the efficacy and safety of 2 doses of buloxibutid over 52 weeks in people with idiopathic pulmonary fibrosis. (ASPIRE)
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Trial Applicant
TAIWAN PSI HEALTH DEVELOPMENT COMPANY LIMITED
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Sponsor
TAIWAN PSI HEALTH DEVELOPMENT COMPANY LTD.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Shuo-Chueh Chen Division of Thoracic Medicine
- Wen-Chien Cheng Division of Thoracic Medicine
- Yu-Chao Lin Division of Thoracic Medicine
- Liang-wen Hang Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chian-Wei Chen Division of Thoracic Medicine
- Chin-Wei Kuo Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 黃俊凱 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- D.W. Peng Division of Thoracic Medicine
- Kang-Cheng Su Division of Thoracic Medicine
- 沈曉津 Division of Thoracic Medicine
- Hsin-Kuo Ko Division of Thoracic Medicine
- 潘聖衛 Division of Thoracic Medicine
- 游偉光 Division of Thoracic Medicine
- KUANG-YAO YANG Division of Thoracic Medicine
- 余文光 Division of Thoracic Medicine
- 林芳綺 Division of Thoracic Medicine
- Jia-Yih Feng Division of Thoracic Medicine
- 蕭逸函 Division of Thoracic Medicine
- 孫傳硯 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chau-Chyun Sheu
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
• Absolute change from baseline in Forced Vital Capacity (FVC, mL) at Week 52
Objectives
Evaluate the efficacy of buloxibutid versus placebo in participants with idiopathic pulmonary fibrosis (IPF) using FVC as the assessment measure.
Test Drug
Buloxibutid
Active Ingredient
Buloxibutid
Dosage Form
capsule
Dosage
50mg
Endpoints
• Absolute change from baseline in Forced Vital Capacity (FVC, mL) at Week 52
Inclution Criteria
Age ≥ 40 years at the time of signing the informed consent form.
Diagnosed with idiopathic pulmonary fibrosis (IPF) within 7 years prior to Visit 1 (V1) according to applicable diagnostic guidelines at the time of diagnosis.
High-resolution computed tomography (HRCT) performed within 36 months prior to V1, confirmed by central review as meeting both of the following:
a. A pattern consistent with usual interstitial pneumonia (UIP) or probable UIP as defined by the 2022 ATS/ERS/JRS/ALAT Clinical Practice Guideline (Raghu et al., 2022).
b. An indeterminate for UIP pattern per the 2022 ATS/ERS/JRS/ALAT guideline with prior lung biopsy (surgical lung biopsy or transbronchial lung cryobiopsy) consistent with IPF.
c. Extent of fibrosis greater than the extent of emphysema.
If prior scans cannot be centrally reviewed, an on-study HRCT performed before Visit 2 (V2) may be used for central review. See Section 8.2.2 of the protocol for HRCT scan requirements.
Forced Vital Capacity (FVC) ≥ 50% of predicted value at V1.
Diffusing capacity for carbon monoxide (DLCO), hemoglobin-corrected, ≥ 30% of predicted value at V1.
One of the following:
a. Receiving an approved IPF therapy at a stable dose for ≥ 8 weeks prior to V1, and expected to continue background treatment after randomization. Use of pirfenidone is not permitted in this trial due to potential drug–drug interaction (DDI) risks.
b. Not currently treated with any approved IPF therapy for any reason, including prior intolerance, lack of response, ineligibility, unavailability, or voluntary refusal. Any prior IPF therapy must have been discontinued > 8 weeks before V1.
Life expectancy of at least 12 months at V1, and not expected to require lung transplantation during the study (participants already listed for transplant are not excluded).
Women of childbearing potential (WOCBP) must use a highly effective method of contraception consistent with local regulatory requirements for clinical trial participants.
For the United Kingdom and EU countries: Male participants with female partners of childbearing potential, or with pregnant or breastfeeding partners, must agree to use barrier contraception (condoms) and refrain from sperm donation during treatment and for at least 2 weeks after the last dose of the study drug.
Written informed consent must be obtained prior to any study-related procedure, in accordance with ICH-GCP and local regulatory requirements.
Diagnosed with idiopathic pulmonary fibrosis (IPF) within 7 years prior to Visit 1 (V1) according to applicable diagnostic guidelines at the time of diagnosis.
High-resolution computed tomography (HRCT) performed within 36 months prior to V1, confirmed by central review as meeting both of the following:
a. A pattern consistent with usual interstitial pneumonia (UIP) or probable UIP as defined by the 2022 ATS/ERS/JRS/ALAT Clinical Practice Guideline (Raghu et al., 2022).
b. An indeterminate for UIP pattern per the 2022 ATS/ERS/JRS/ALAT guideline with prior lung biopsy (surgical lung biopsy or transbronchial lung cryobiopsy) consistent with IPF.
c. Extent of fibrosis greater than the extent of emphysema.
If prior scans cannot be centrally reviewed, an on-study HRCT performed before Visit 2 (V2) may be used for central review. See Section 8.2.2 of the protocol for HRCT scan requirements.
Forced Vital Capacity (FVC) ≥ 50% of predicted value at V1.
Diffusing capacity for carbon monoxide (DLCO), hemoglobin-corrected, ≥ 30% of predicted value at V1.
One of the following:
a. Receiving an approved IPF therapy at a stable dose for ≥ 8 weeks prior to V1, and expected to continue background treatment after randomization. Use of pirfenidone is not permitted in this trial due to potential drug–drug interaction (DDI) risks.
b. Not currently treated with any approved IPF therapy for any reason, including prior intolerance, lack of response, ineligibility, unavailability, or voluntary refusal. Any prior IPF therapy must have been discontinued > 8 weeks before V1.
Life expectancy of at least 12 months at V1, and not expected to require lung transplantation during the study (participants already listed for transplant are not excluded).
Women of childbearing potential (WOCBP) must use a highly effective method of contraception consistent with local regulatory requirements for clinical trial participants.
For the United Kingdom and EU countries: Male participants with female partners of childbearing potential, or with pregnant or breastfeeding partners, must agree to use barrier contraception (condoms) and refrain from sperm donation during treatment and for at least 2 weeks after the last dose of the study drug.
Written informed consent must be obtained prior to any study-related procedure, in accordance with ICH-GCP and local regulatory requirements.
Exclusion Criteria
Medical Conditions
Presence of a serious concurrent medical condition that, in the opinion of the investigator, constitutes a risk or contraindication for study participation or may interfere with the study objectives, conduct, or evaluation, including active or suspected malignancy, or a history of malignancy within 5 years prior to Visit 1 (V1), except for adequately treated basal cell carcinoma of the skin, completely excised and cured squamous cell carcinoma of the skin, prostate cancer under active surveillance, or carcinoma in situ of the cervix.
Airway obstruction with a pre-bronchodilator FEV₁/FVC ratio < 0.7 at V1.
Lower respiratory tract infection requiring antibiotic therapy and not fully recovered within 4 weeks prior to Visit 2 (V2), as determined by the investigator.
Confirmed SARS-CoV-2 infection (COVID-19) requiring hospitalization and not fully recovered within 4 weeks prior to V2, as determined by the investigator.
Known hepatic impairment or clinically significant liver disease (Child-Pugh Class B or C), or AST or ALT > 3× the upper limit of normal (ULN), or total bilirubin > 1.5× ULN at V1. One retest is permitted.
Severe renal impairment, defined as estimated glomerular filtration rate (eGFR) ≤ 35 mL/min/1.73 m² at V1, calculated using the CKD-EPI formula. One retest is permitted.
At V1, prolonged QTcF (> 450 ms), second- or third-degree atrioventricular (AV) block, uncontrolled arrhythmia, or other clinically significant abnormalities on resting ECG, as determined by the investigator. Participants with implanted cardiovascular devices that may affect QT interval (e.g., pacemaker) may be enrolled at the investigator’s discretion after consultation with a cardiologist and discussion with the medical monitor.
Any of the following events within 6 months prior to V1: New York Heart Association (NYHA) Class IV heart failure, acute decompensated right heart failure, syncope due to pulmonary hypertension, confirmed myocardial infarction, unstable angina, or uncontrolled hypertension.
Known hypersensitivity or intolerance to buloxibutid or any of its excipients.
Pregnant or breastfeeding women.
Acute exacerbation of IPF within 3 months prior to V1 and/or during screening, as defined by Collard et al., 2016:
a. Unexplained worsening or development of dyspnea, typically lasting < 1 month.
b. New bilateral ground-glass opacities and/or consolidation superimposed on a background pattern consistent with UIP on HRCT (the term “new” may be omitted if prior imaging is unavailable).
c. Deterioration not fully explained by cardiac failure or fluid overload.
Unable to generate acceptable pulmonary function data meeting the minimum standards of the 2019 ATS/ERS guidelines (Graham et al., 2019) at V1.
Prior / Concomitant Treatments
13. Treatment with pirfenidone (a CYP1A2 substrate) within 8 weeks prior to V1, or anticipated need for pirfenidone during the study.
14. Treatment within 2 weeks prior to V2, or anticipated use during the study, of any of the following:
a. Narrow therapeutic index drugs that are sensitive or moderately sensitive substrates of CYP1A2 (e.g., theophylline, tizanidine), CYP2C9 (e.g., warfarin, tolbutamide, gliclazide, glibenclamide, acenocoumarol, phenprocoumon, phenytoin, siponimod), CYP2C19 (e.g., mephenytoin, valproic acid, escitalopram), or CYP2C8 (e.g., paclitaxel).
b. Fluvastatin or pitavastatin.
c. Any immunosuppressive therapy, except for:
• Inhaled, intranasal, or topical corticosteroids (allowed if on a stable dose).
• Corticosteroids used for the treatment of acute exacerbations.
• Stable daily dose ≤ 15 mg prednisolone (or equivalent).
Prior / Concomitant Clinical Trial Experience
15. Current or prior participation in another clinical trial in which the participant received an investigational medicinal product (IMP) within 4 weeks prior to V1 or within 5 half-lives of the IMP, whichever is longer.
16. Prior participation in a buloxibutid clinical trial and receipt of at least one dose of buloxibutid.
Diagnostic Evaluation
17. Clinically significant laboratory abnormalities at V1, as determined by the investigator, indicating potential risk if enrolled. One retest is permitted.
Other Criteria
18. Unable to refrain from smoking (including e-cigarettes or cannabis) during on-site study visits prior to completion of study procedures.
19. Institutionalized by judicial or administrative order (e.g., incarcerated or under compulsory care), if applicable by national law.
20. Participants deemed unlikely by the investigator to comply with study procedures, restrictions, or requirements.
21. Resting oxygen saturation < 89% while receiving up to 4 L/min supplemental oxygen at sea level or up to 6 L/min at high altitude (≥ 5,000 ft / 1,524 m) during screening.
Presence of a serious concurrent medical condition that, in the opinion of the investigator, constitutes a risk or contraindication for study participation or may interfere with the study objectives, conduct, or evaluation, including active or suspected malignancy, or a history of malignancy within 5 years prior to Visit 1 (V1), except for adequately treated basal cell carcinoma of the skin, completely excised and cured squamous cell carcinoma of the skin, prostate cancer under active surveillance, or carcinoma in situ of the cervix.
Airway obstruction with a pre-bronchodilator FEV₁/FVC ratio < 0.7 at V1.
Lower respiratory tract infection requiring antibiotic therapy and not fully recovered within 4 weeks prior to Visit 2 (V2), as determined by the investigator.
Confirmed SARS-CoV-2 infection (COVID-19) requiring hospitalization and not fully recovered within 4 weeks prior to V2, as determined by the investigator.
Known hepatic impairment or clinically significant liver disease (Child-Pugh Class B or C), or AST or ALT > 3× the upper limit of normal (ULN), or total bilirubin > 1.5× ULN at V1. One retest is permitted.
Severe renal impairment, defined as estimated glomerular filtration rate (eGFR) ≤ 35 mL/min/1.73 m² at V1, calculated using the CKD-EPI formula. One retest is permitted.
At V1, prolonged QTcF (> 450 ms), second- or third-degree atrioventricular (AV) block, uncontrolled arrhythmia, or other clinically significant abnormalities on resting ECG, as determined by the investigator. Participants with implanted cardiovascular devices that may affect QT interval (e.g., pacemaker) may be enrolled at the investigator’s discretion after consultation with a cardiologist and discussion with the medical monitor.
Any of the following events within 6 months prior to V1: New York Heart Association (NYHA) Class IV heart failure, acute decompensated right heart failure, syncope due to pulmonary hypertension, confirmed myocardial infarction, unstable angina, or uncontrolled hypertension.
Known hypersensitivity or intolerance to buloxibutid or any of its excipients.
Pregnant or breastfeeding women.
Acute exacerbation of IPF within 3 months prior to V1 and/or during screening, as defined by Collard et al., 2016:
a. Unexplained worsening or development of dyspnea, typically lasting < 1 month.
b. New bilateral ground-glass opacities and/or consolidation superimposed on a background pattern consistent with UIP on HRCT (the term “new” may be omitted if prior imaging is unavailable).
c. Deterioration not fully explained by cardiac failure or fluid overload.
Unable to generate acceptable pulmonary function data meeting the minimum standards of the 2019 ATS/ERS guidelines (Graham et al., 2019) at V1.
Prior / Concomitant Treatments
13. Treatment with pirfenidone (a CYP1A2 substrate) within 8 weeks prior to V1, or anticipated need for pirfenidone during the study.
14. Treatment within 2 weeks prior to V2, or anticipated use during the study, of any of the following:
a. Narrow therapeutic index drugs that are sensitive or moderately sensitive substrates of CYP1A2 (e.g., theophylline, tizanidine), CYP2C9 (e.g., warfarin, tolbutamide, gliclazide, glibenclamide, acenocoumarol, phenprocoumon, phenytoin, siponimod), CYP2C19 (e.g., mephenytoin, valproic acid, escitalopram), or CYP2C8 (e.g., paclitaxel).
b. Fluvastatin or pitavastatin.
c. Any immunosuppressive therapy, except for:
• Inhaled, intranasal, or topical corticosteroids (allowed if on a stable dose).
• Corticosteroids used for the treatment of acute exacerbations.
• Stable daily dose ≤ 15 mg prednisolone (or equivalent).
Prior / Concomitant Clinical Trial Experience
15. Current or prior participation in another clinical trial in which the participant received an investigational medicinal product (IMP) within 4 weeks prior to V1 or within 5 half-lives of the IMP, whichever is longer.
16. Prior participation in a buloxibutid clinical trial and receipt of at least one dose of buloxibutid.
Diagnostic Evaluation
17. Clinically significant laboratory abnormalities at V1, as determined by the investigator, indicating potential risk if enrolled. One retest is permitted.
Other Criteria
18. Unable to refrain from smoking (including e-cigarettes or cannabis) during on-site study visits prior to completion of study procedures.
19. Institutionalized by judicial or administrative order (e.g., incarcerated or under compulsory care), if applicable by national law.
20. Participants deemed unlikely by the investigator to comply with study procedures, restrictions, or requirements.
21. Resting oxygen saturation < 89% while receiving up to 4 L/min supplemental oxygen at sea level or up to 6 L/min at high altitude (≥ 5,000 ft / 1,524 m) during screening.
The Estimated Number of Participants
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Taiwan
23 participants
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Global
270 participants
