> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-trial-to-evaluate-efficacy-and-safety-of-buloxibutid-in-8242d8e6-1eb0-4402-84a0-ed9db8324a63 > Record changed: 2026-10-13 # A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis. NCT06588686 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) Participants 378 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) Lead sponsor Vicore Pharma AB Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) Start date 2024-12-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) Number of sites 104 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) ## Title and summary **Summary** The ASPIRE trial is a 52 week randomized, double-blind, placebo-controlled, parallel-group, multicenter trial in which the efficacy, safety, and pharmacokinetics of orally administered buloxibutid, either on top of stable IPF therapy or as monotherapy, are assessed in participants with IPF. Trial website: www.aspire-ipf.com Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) **Acronym** ASPIRE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) **Short title** A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) **Official title** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) ## Dates **Completion date** 2027-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) **First posted** 2024-09-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) **Registry last updated** 2026-08-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) **Primary completion date** 2027-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) **Start date** 2024-12-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) ## Size and sites **Actual participants** 378 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) **Participants** 378 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) **Number of sites** 104 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) **Lead sponsor** Vicore Pharma AB Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) ## Identifiers **Registry ID** NCT06588686 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) **ClinicalTrials.gov ID** NCT06588686 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) ## Outcomes ### Primary outcomes 1. To evaluate the efficacy of buloxibutid compared to placebo in participants with IPF as assessed by FVC Timeframe: week 52 • Absolute change from baseline in FVC (mL) at week 52 ### Secondary outcomes 1. To further evaluate the effects of buloxibutid on disease progression, respiratory-related hospitalization or death compared to placebo in participants with IPF Timeframe: week 52 • A composite of the proportion of patients with an absolute FVC percent predicted (FVCpp) decrease from baseline of ≥10%; a respiratory-related hospitalization, or death, up to week 52 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 40 Years **Healthy volunteers** No ### Inclusion criteria 1. Age ≥ 40 years at the time of signing the informed consent. 2. Diagnosed with IPF within 7 years prior to visit 1, as per applicable ATS/ERS/JRS/ALAT guidelines at the time of diagnosis. 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. 5. DLCO (corrected for hemoglobin) ≥30% 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. For UK and countries within the EU: Male participants, if heterosexually active with a female partner of childbearing potential, or a pregnant or breastfeeding partner, must agree to use barrier contraception (male condom) and abstain from sperm donation for the duration of the treatment period and for at least 2 weeks after the last dose of the trial drug. 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. 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. Patients with implantable cardiovascular devices (e.g. pacemaker) affecting the QT interval time may be enrolled in the trial based upon investigator judgement, following cardiologist consultation if deemed necessary, and only after discussion with the medical monitor. 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 a spirometry test at visit 1 meeting the 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) ## Sites - UAB Hospital, School of Medicine/Lung Health CenterBirmingham, United States - Paradigm Clinical Research Centers, Inc.Redding, United States - UC Davis Health SystemSacramento, United States - UC San Diego Medical Center - HillcrestSan Diego, United States - Paradigm Clinical ResearchSan Diego, United States - National Jewish Medical and Research CenterDenver, United States - University of Florida Health (UF Health)Gainesville, United States - Clinical Research SpecialistsKissimmee, United States - Emory Saint Joseph's HospitalAtlanta, United States - Endeavor Health - Evanston HospitalEvanston, United States - University of Kansas Medical CenterKansas City, United States - William Beaumont Hospital - Royal OakRoyal Oak, United States - Renown Clinical ResearchReno, United States - Southeastern Research CenterWinston-Salem, United States - Cleveland Clinic - Cleveland, Department of Pulmonary MedicineCleveland, United States - Summit Health - BendBend, United States - Oregon Clinic, Pulmonary, Critical Care & Sleep Medicine EastPortland, United States - Temple University HospitalPhiladelphia, United States - Low Country Lung and Critical CareNorth Charleston, United States - Baylor Scott & White Research InstituteDallas, United States - El Paso Pulmonary AssociationEl Paso, United States - University of Utah, Health Sciences CenterSalt Lake City, United States - University of Wisconsin Clinical Science CenterMadison, United States - Research Institute of Respiratory DiseasesSan Miguel de Tucumán, Argentina - CEMER Medical Center for Respiratory DiseasesBuenos Aires, Argentina And 79 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) ## References - Related resource (aspire-ipf.com) Source: [aspire-ipf.com](http://aspire-ipf.com/) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06588686) ## Related records ### Drugs (1) - [Buloxibutid](https://trialight.com/data/asset/buloxibutid-159891e9-bf22-46f4-8684-d6908d9b646b.md) ### Collaborators (1) - Population Services International ### Lead sponsors (1) - [Vicore Pharma AB](https://trialight.com/data/company/vicore-pharma-ab-63db7c61-68cc-4f52-9886-4f8991b05d76.md) ### Conditions (1) - [Idiopathic pulmonary fibrosis](https://trialight.com/data/condition/idiopathic-pulmonary-fibrosis-9d400b0a-ada5-55c8-96c1-87bddcdf6913.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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