About the study
Disease target: Idiopathic Pulmonary Fibrosis (IPF)
Recruitment target: 270 participants (90 in each study arm)
Duration: The trial consists of 3 consecutive periods:
- Screening period of up to 6 weeks,
- 52-week treatment period,
- Follow-up period of 2-4 weeks
Study Locations
NSW
- St Vincent’s Hospital
- Royal Prince Alfred Hospital
- Concord Repatriation Hospital
VIC
- Austin Health
SA
- Flinders Medical Centre
- Queen Elizabeth Hospital
What is involved?
This is a study is being conducted to see if Buloxibutid is safe and effective for improving lung function and treating idiopathic pulmonary fibrosis (IPF).
This study will compare Buloxibutid to a placebo (a non-active treatment) to determine how well it works.
Investigational medicinal product, comparator and randomisation
- Buloxibutid is a drug that works by activating a specific receptor in the lungs called the AT2 receptor. This receptor is found in certain lung cells that help keep the lungs healthy and repair damage. In simpler terms, Buloxibutid helps the lungs repair themselves and stay healthy by targeting these important cells.
- Buloxibutid is taken orally, two times per day.
- The clinical study will have three groups: Buloxibutid dose A (50mg) / Buloxibutid dose B (100 mg) / matching placebo, randomized 1:1:1.
Can I participate?
Inclusion Criteria
- Age ≥ 40 years
- Diagnosed with IPF within 5 years
- HRCT scan within 36 months confirming either a or b, and c:
a. A pattern consistent with usual interstitial pneumonia (UIP)
b. A pattern indeterminate for UIP and a historical biopsy consistent with IPF.
c. Extent of fibrosis > extent of emphysema. - FVC ≥50%
- DLCO (corrected for hemoglobin) ≥35%
- Either:
a. On a stable dose of IPF therapy for at least 8 weeks. Due to the risk of DDIs, concomitant treatment with pirfenidone is not allowed in this trial.
b. Not currently receiving treatment for IPF with a licensed therapy for any reason. Any previous treatment must have been discontinued >8 weeks prior.
7. Anticipated life expectancy of at least 12 months and not anticipated to require a lung transplant during the trial period
8. Contraceptive use by women of childbearing potential
Exclusion Criteria
- Concurrent serious medical condition, including active or suspected malignancy or history of malignancy within 5 years.
- Airways obstruction with a pre-bronchodilator forced expiratory volume in one second (FEV1)/FVC ratio <0.7 at V1 or V2.
- Lower respiratory tract infection requiring antibiotics within 4 weeks prior to V2.
- Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) requiring hospitalization within 4 weeks prior to V2.
- Known impaired hepatic function or clinically significant liver disease.
- Severe renal disease.
- Prolonged QTcF (QT interval with Fridericia’s correction) (>450 ms), AV-block II or III, uncontrolled arrhythmia, or other clinically significant abnormality in the resting ECG at V1.
- Heart failure NYHA Class IV, acutely decompensated right heart failure, PH with syncopal episode, confirmed myocardial infarction, unstable angina or uncontrolled hypertension, within 6 months prior to V1.
- Known hypersensitivity or intolerance to buloxibutid
- Pregnant or breast-feeding female participants.
- Acute IPF exacerbation within 3 months
- Inability to generate spirometry data.
- Treatment with pirfenidone within 8 weeks prior or anticipated need for pirfenidone during participation in the trial.
- Treatment with the contraindicated medications listed within 2 weeks prior.
- Current or previous participation in any other clinical trial within 4 weeks.
- Previous participation in a clinical trial with buloxibutid and received at least one dose of buloxibutid.
- ASPIRE Study Trial Summary ASPIRE-Study-Trial-Summary.pdf
Further information or how to take part
If you would like to take part or have any questions about this research study, please complete our Patient Trial Enquiry Form or email enquiries@pactnetwork.com.au.
This study is sponsored by Vicore Pharma AB
Clinicaltrials.gov ID: NCT06588686