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A Trial to Evaluate Efficacy and Safety of Buloxibutid in People with Idiopathic Pulmonary Fibrosis.
270 patients around the world
Available in Argentina, United States, Mexico
Buloxibutid is an oral angiotensin II type 2 (AT2) receptor agonist and has been shown to
improve lung function in IPF over 36 weeks.
Buloxibutid agonizes the AT2 receptor on alveolar epithelial type 2 cells (AEC2s), which
are believed to play a central role in the disease. Buloxibutid has been demonstrated
preclinically to improve AEC2 viability, alveolar integrity via surfactant secretion and
epithelial repair via replenishment of gas exchange alveolar epithelial type 1 cells
(AEC1s). This leads to decreasing downstream profibrotic signaling, enhancing resolution
of existing fibrotic tissue via upregulation of collagenase matrix metalloproteinases,
and addressing vascular disfunction associated with the disease.
The trial will include participants who are on stable licensed IPF therapy or who are
currently not treated with a licensed IPF therapy. The latter group will include
participants intolerant or not responsive to licensed IPF therapies, participants
ineligible to receive these therapies, and participants who have voluntarily declined to
receive a licensed IPF therapy after being fully informed of the potential benefits and
risks of such therapy. Due to the potential risk of drug-drug interactions (DDIs),
concomitant treatment with pirfenidone is not allowed in this trial. Participants who are
not on antifibrotic therapy at study start may initiate such treatment during the study.
The trial is planned to enroll 270 participants, 90 participants on oral buloxibutid 100
mg BID, 90 participants on oral buloxibutid 50 mg BID, and 90 participants on oral
placebo BID for 52 weeks. The treatment will be blinded and treatment allocation will be
randomized.
The primary measurement will be based on spirometry, measuring the forced vital capacity
(FVC).
The trial consists of 3 consecutive periods: a screening period of up to 6 weeks, a
52-week treatment period, and a follow-up period of 2-4 weeks after the 52-week visit.
The study procedures have been planned with focus on optimizing patient convenience while
allowing a safe conduct and strict scientific rigor.
Trial website: www.aspire-ipf.com
Vicore Pharma AB
8Research sites
270Patients around the world
This study is for people with
Pulmonary fibrosis
Idiopathic pulmonary fibrosis
Requirements for the patient
From 40 Years
All Gender
Medical requirements
- Age ≥ 40 years at the time of signing the informed consent.Diagnosed with IPF within 5 years prior to visit 1, as per ATS/ERS/JRS/ALAT 2022 guidelines.HRCT scan within 36 months prior to visit 1 with central reading confirming either a pattern consistent with usual interstitial pneumonia (UIP) according to ATS/ERS/JRS/ALAT 2022 guideline or a pattern indeterminate for UIP according to ATS/ERS/JRS/ALAT 2022 guidelines and a historical biopsy consistent with IPF or extent of fibrosis > extent of emphysema.A pattern consistent with usual interstitial pneumonia (UIP) according to ATS/ERS/JRS/ALAT 2022 guideline.A pattern indeterminate for UIP according to ATS/ERS/JRS/ALAT 2022 guidelines and a historical biopsy consistent with IPF.Extent of fibrosis > extent of emphysema.FVC ≥50% predicted at visit 1 and visit 2.DLCO (corrected for hemoglobin) ≥35% predicted at visit 1.Either 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 or 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.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.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.Anticipated life expectancy of at least 12 months at visit 1 and not anticipated to require a lung transplant during the trial period.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.Written informed consent, consistent with ICH-GCP and local laws, obtained before the initiation of any trial-related procedure.
- 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.Airways obstruction with a pre-bronchodilator forced expiratory volume in one second (FEV1)/FVC ratio <0.7 at visit 1 or visit 2.Lower respiratory tract infection requiring antibiotics and not fully recovered according to investigator judgement within 4 weeks prior to visit 2.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.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.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).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.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.Known hypersensitivity or intolerance to buloxibutid or to any other components of the test product, including excipients.Pregnant or breast-feeding female participants.Acute IPF exacerbation within 3 months prior to visit 1 and/or during the screening period, as defined by Collard et al., 2016:Acute worsening or development of dyspnea typically <1 month duration.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).Deterioration not fully explained by cardiac failure or fluid overload.Inability to generate spirometry data at least twice at visit 1 or visit 2 meeting the minimum standards of the ATS/ERS 2019 guideline.Treatment with pirfenidone within 8 weeks prior to visit 1 or anticipated need for pirfenidone during participation in the trial.
Sites
Polo de Salud Vistalba
Respira Salud
Instituto de Medicina Respiratoria IMER - Córdoba
CEMER Centro Médico de Enfermedades Respiratorias - Vicente Lopez
Unidad Medica para la Salud Integral (UMSI)
Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
Hospital Universitario Dr. José Eleuterio González
Oaxaca Site Management Organization S.C.
StudyASPIRE
SponsorVicore Pharma AB
Conditions
Idiopathic pulmonary fibrosis
Requirements
From 40 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06588686
