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Evaluating Buloxibutid for Idiopathic Pulmonary Fibrosis

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.

Phase 2 Interventional Vicore Pharma AB · NCT06588686

This study is testing a new oral medication called buloxibutid to see if it can improve lung function and overall health in people with idiopathic pulmonary fibrosis.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment270 (estimated)
Ages40 Years and up
SexAll
SponsorVicore Pharma AB Industry-sponsored
Locations96 sites (Birmingham, Alabama and 95 other locations)
Trial IDNCT06588686 on ClinicalTrials.gov

What this trial studies

This trial assesses the efficacy and safety of buloxibutid, an oral angiotensin II type 2 receptor agonist, in patients with idiopathic pulmonary fibrosis (IPF) over a 52-week period. Participants will be randomly assigned to receive either buloxibutid or a placebo, with some continuing their stable IPF therapy while others may not be on any licensed treatment. The study aims to evaluate improvements in lung function and overall health by examining the drug's effects on alveolar epithelial cells and fibrotic tissue. The trial will enroll 270 participants across multiple centers.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 and older diagnosed with IPF within the last five years, either on stable IPF therapy or not currently receiving any licensed treatment.

Not a fit: Patients who are not diagnosed with IPF or those who are currently on pirfenidone therapy will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve lung function and quality of life for patients with IPF.

How similar studies have performed: Other studies have shown promise with similar approaches targeting the AT2 receptor, but this specific treatment is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria

1. Age ≥ 40 years at the time of signing the informed consent.
2. Diagnosed with IPF within 5 years prior to visit 1, as per ATS/ERS/JRS/ALAT 2022 guidelines (Raghu et al., 2022).
3. HRCT scan within 36 months prior to visit 1 with central reading confirming either a or b, and c

   1. A pattern consistent with usual interstitial pneumonia (UIP) according to ATS/ERS/JRS/ALAT 2022 guideline (Raghu et al., 2022) UIP or probable UIP.
   2. A pattern indeterminate for UIP according to ATS/ERS/JRS/ALAT 2022 guidelines (Raghu et al., 2022) and a historical biopsy (surgical lung biopsy or transbronchial lung cryobiopsy) consistent with IPF.
   3. Extent of fibrosis \> extent of emphysema.
4. FVC ≥50% predicted at visit 1 and visit 2.
5. DLCO (corrected for hemoglobin) ≥35% predicted at visit 1.
6. Either:

   1. On a stable dose of licensed IPF therapy for at least 8 weeks prior to visit 1 and expected to remain on this background treatment after randomization. Due to the risk of DDIs, concomitant treatment with pirfenidone is not allowed in this trial.
   2. Not currently receiving treatment for IPF with a licensed therapy for any reason, including prior intolerance, non-responsiveness, ineligibility, lack of access or voluntarily decline. Any such previous treatment must have been discontinued \>8 weeks prior to visit 1.
7. Anticipated life expectancy of at least 12 months at visit 1 and not anticipated to require a lung transplant during the trial period (being on a transplant list does not exclude a participant from the trial).
8. Contraceptive use by women of childbearing potential (WOCBP) which is highly effective and consistent with local regulations regarding the methods of contraception for those participating in clinical trials.
9. Written informed consent, consistent with ICH-GCP and local laws, obtained before the initiation of any trial-related procedure.

Exclusion Criteria

Participants are excluded from the trial if any of the following criteria apply:

1. Concurrent serious medical condition that in the opinion of the investigator constitutes a risk or a contraindication for participation in the trial or that could interfere with the trial objectives, conduct or evaluation, including active or suspected malignancy or history of malignancy within 5 years prior to visit 1, except appropriately treated basal cell carcinoma of the skin, fully resected and cured squamous cell carcinoma of the skin, "under surveillance" prostate cancer or in situ carcinoma of uterine cervix.
2. Airways obstruction with a pre-bronchodilator forced expiratory volume in one second (FEV1)/FVC ratio \<0.7 at visit 1 or visit 2.
3. Lower respiratory tract infection requiring antibiotics and not fully recovered according to investigator judgement within 4 weeks prior to visit 2.
4. Confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) requiring hospitalization and not fully recovered according to investigator judgement within 4 weeks prior to visit 2.
5. Known impaired hepatic function or clinically significant liver disease (Child-Pugh B or C hepatic impairment), or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3 times upper limit of normal (ULN) or total bilirubin \>1.5 times ULN at visit 1.
6. Severe renal impairment (i.e., estimated glomerular filtration rate (eGFR) ≤35 ml/min/1.73 m2 at visit 1 according to Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula).
7. 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 visit 1, as judged by the investigator.
8. 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 visit 1.
9. Known hypersensitivity or intolerance to buloxibutid or to any other components of the test product, including excipients.
10. Pregnant or breast-feeding female participants.
11. Acute IPF exacerbation within 3 months prior to visit 1 and/or during the screening period, as defined by Collard et al., 2016:

    1. Acute worsening or development of dyspnea typically \<1 month duration.
    2. Computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia pattern (if no previous computed tomography is available, the qualifier "new" can be dropped).
    3. Deterioration not fully explained by cardiac failure or fluid overload.
12. Inability to generate spirometry data at least twice at visit 1 or visit 2 meeting the minimum standards of the ATS/ERS 2019 guideline (Graham et al., 2019).
13. Treatment with pirfenidone within 8 weeks prior to visit 1 or anticipated need for pirfenidone during participation in the trial.

More exclusion criteria may apply.

Trial website: www.aspire-ipf.com

Where this trial is running

Birmingham, Alabama and 95 other locations

+46 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Idiopathic Pulmonary FibrosisAngiotensin, IPF, angiotensin II receptor 2, buloxibutid
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.