A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.
NCT ID: NCT06588686
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
360 participants
INTERVENTIONAL
2024-12-09
2027-03-31
Brief Summary
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Trial website: www.aspire-ipf.com
Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Buloxibutid 100 mg BID
For 52 weeks.
Buloxibutid
Buloxibutid
Buloxibutid 50 mg BID
For 52 weeks.
Buloxibutid
Buloxibutid
Placebo BID
For 52 weeks.
Placebo
Placebo
Interventions
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Buloxibutid
Buloxibutid
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
Trial website: www.aspire-ipf.com
40 Years
ALL
No
Sponsors
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Population Services International
OTHER
Vicore Pharma AB
INDUSTRY
Responsible Party
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Locations
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UAB Hospital, School of Medicine/Lung Health Center
Birmingham, Alabama, United States
Keck Medicine of University of Southern California
Los Angeles, California, United States
Paradigm Clinical Research Centers, Inc.
Redding, California, United States
UC Davis Health System
Sacramento, California, United States
UC San Diego Medical Center - Hillcrest
San Diego, California, United States
Paradigm Clinical Research
San Diego, California, United States
National Jewish Medical and Research Center
Denver, Colorado, United States
University of Florida Health (UF Health)
Gainesville, Florida, United States
Clinical Research Specialists
Kissimmee, Florida, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Endeavor Health - Evanston Hospital
Evanston, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Massachusetts General Hospital, Pulmonary & Critical Care Medicine
Boston, Massachusetts, United States
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States
Renown Clinical Research
Reno, Nevada, United States
University of New Mexico, Health Sciences Center
Albuquerque, New Mexico, United States
Stony Brook University
Stony Brook, New York, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
Cleveland Clinic - Cleveland, Department of Pulmonary Medicine
Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Summit Health - Bend
Bend, Oregon, United States
Oregon Clinic, Pulmonary, Critical Care & Sleep Medicine East
Portland, Oregon, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Low Country Lung and Critical Care
North Charleston, South Carolina, United States
StatCare - Bearden
Knoxville, Tennessee, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
El Paso Pulmonary Association
El Paso, Texas, United States
University of Utah, Health Sciences Center
Salt Lake City, Utah, United States
University of Wisconsin Clinical Science Center
Madison, Wisconsin, United States
InnovaCiencia
Rosario, Rosario, Argentina
Research Institute of Respiratory Diseases
San Miguel de Tucumán, Tucumán Province, Argentina
CEMER Medical Center for Respiratory Diseases
Buenos Aires, , Argentina
CINME - Metabolic Research Center
Buenos Aires, , Argentina
Medical Center Dra. De Salvo
Buenos Aires, , Argentina
IMER Respiratory Medicine Institute
Córdoba, , Argentina
Breathe Comprehensive Clinical Health
Godoy Cruz, , Argentina
Emphysema Foundation, Pneumology
Mar del Plata, , Argentina
Vistalba Health Center
Mendoza, , Argentina
Ibamedica
Santa Fe, , Argentina
Lung Research Victoria
Footscray, Victoria, Australia
Flinders Medical Centre
Adelaide, , Australia
The Prince Charles Hospital
Brisbane, , Australia
Concord Repatriation General Hospital, Department of Respiratory Medicine
Concord, , Australia
St Vincent's Hospital, Sydney Ltd.
Darlinghurst, , Australia
Townsville University Hospital
Douglas, , Australia
Austin Hospital
Heidelberg, , Australia
Royal Prince Alfred Hospital
Sydney, , Australia
The Queen Elizabeth Hospital
Woodville, , Australia
Kepler University Hospital GmbH, Department of Pulmonology
Linz, Upper Austria, Austria
Salzburg Regional Hospital, Department of Pneumology/Respiratory Medicine
Salzburg, , Austria
Hospital Penzing, Department of Respiratory and lung diseases
Vienna, , Austria
Erasme Hospital
Brussels, , Belgium
University Hospitals Saint-Luc
Brussels, , Belgium
University Hospital Center Sart-Tilman
Liège, , Belgium
UCL Mont-Godinne University Hospitals
Yvoir, , Belgium
Kelowna Respiratory & Allergy Clinic
Kelowna, British Columbia, Canada
Laval Hospital
Laval, Quebec, Canada
Pierre-Le Gardeur
Terrebonne, Quebec, Canada
Diex Research Trois-Riviere Inc.
Trois-Rivières, Quebec, Canada
University Hospital Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
University Hospital Heidelberg, Clinic of Thoracic Medicine Heidelberg GmbH
Heidelberg, Baden-Wurttemberg, Germany
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Immenhausen Lung Hospital
Immenhausen, Hesse, Germany
Hannover Medical School, Center for Internal Medicine
Hanover, Lower Saxony, Germany
RuhrlandClinic - Lung Center
Essen, North Rhine-Westphalia, Germany
Vivantes Hospital Neukoelln
Berlin, , Germany
University General Hospital of Heraklion, Pneumonology Clinic
Heraklion, Crete, Greece
"Sotiria" Chest Diseases Hospital of Athens
Athens, , Greece
"Sotiria" Chest Diseases Hospital of Athens
Athens, , Greece
General Hospital of Chest Diseases "Sotiria" 5th Pulmonology Department
Athens, , Greece
University General Hospital "Attikon", 2nd Pulmonary Department
Athens, , Greece
University General Hospital of Ioannina
Ioannina, , Greece
University General Hospital of Larissa
Larissa, , Greece
University General Hospital of Patras
Pátrai, , Greece
General Hospital of Thessaloniki "G. Papanikolaou", University Department of Pulmonology
Thessaloniki, , Greece
IRCCS Policlinic Hospital San Martino
Genoa, Liguria, Italy
University Hospital - Ospedali Riuniti Umberto I - GM Lancisi - G Salesi of Ancona
Ancona, , Italy
Local Healthcare Company Papa Giovanni XXIII (ASST Papa Giovanni XXIII)
Bergamo, , Italy
San Gerardo of Tintori IRCCS Foundation
Monza, , Italy
Foundation PTV - Polyclinic Tor Vergata
Roma, , Italy
University Hospital City of Health and Science of Turin - Hospital Molinette
Turin, , Italy
National Institute of Respiratory Diseases Ismael Cosio Villegas (INER)
Mexico City, Mexico City, Mexico
Dr. Jose Eleuterio Gonzalez Monterrey University Hospital
Monterrey, Nuevo León, Mexico
Integral Health Medical Unit
San Nicolás de los Garza, Nuevo León, Mexico
Oaxaca Site Management Organization S.C - (Osmo)
Oaxaca City, Oaxaca, Mexico
MICS Medical Centre Bydgoszcz
Bydgoszcz, , Poland
VITAMED Galaj i Cichomski General Partnership
Bydgoszcz, , Poland
Norbert Barlicki University Clinical Hospital in Lodz Departament of Pneumology and Allergy
Lodz, , Poland
Twoja Przychodnia Medical Centre of Nowa Sol
Nowa Sól, , Poland
Allergology- Pulmunology Outpatient Clinic Alergopneuma, Pulmonology Outpatient Clinic
Świdnik, , Poland
Soon Chun Hyang Central Medical Center
Bucheon-si, , South Korea
The Catholic University Of Korea Bucheon St. Mary's Hospital
Bucheon-si, , South Korea
InJe University Busan Paik Hospital
Busan, , South Korea
InJe University Haeundae Paik Hospital
Busan, , South Korea
Hanyang University - Myongji Hospital
Goyang-si, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Soon Chun Hyang University Hospital Seoul
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Queen Elizabeth Hospital Birmingham
Birmingham, , United Kingdom
Royal Devon and Exeter Hospital
Exeter, , United Kingdom
Homerton University Hospital
London, , United Kingdom
Guy's Hospital
London, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
Oxford University Hospitals NHS Trust
Oxford, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Tejaswini Kulkarni, MD
Role: primary
Brittany Harrison
Role: backup
Kathy Sanchez
Role: primary
Lynn Fukushima
Role: backup
Sarah Sandberg, Regional Director
Role: primary
Emily Crews, Asst. Site Manager
Role: backup
Sarah Natera
Role: primary
Meigan Wu
Role: backup
Nicolle Mendez
Role: primary
Jisha Joshua
Role: backup
Daniel Jones, MD
Role: primary
Cheryl Bolovits
Role: backup
Kaitlin Fier
Role: primary
Rosie Kizza
Role: primary
Christopher Harden, MD
Role: backup
Kenney Alvarado
Role: primary
Ria Gripaldo, MD
Role: primary
Shashi Bellam, MD
Role: primary
Janell Reichuber, Nurse
Role: primary
Facilities Department
Role: primary
Alpa Desai, MD
Role: primary
Lauren Miller
Role: primary
Karen McCutcheon
Role: backup
Brian Southern
Role: primary
Tiana Powell
Role: backup
Meg Day, CCRP
Role: primary
Johanna Donnelly, CRC
Role: backup
Role: primary
Courtney H. Arnold, RPSGT, CCRC
Role: primary
Becky Hicks, RT
Role: backup
Felicia Padilla
Role: primary
Brianna Kamran
Role: backup
Stefan Lakonios
Role: primary
Irina Eikenberry
Role: backup
Yuliya Henes
Role: primary
Sydney Thompson
Role: backup
Ana Maria Stok, MD
Role: primary
Miguel Bergna, MD
Role: primary
Alexis Cazaux, MD
Role: primary
Victor Hugo Cambursano
Role: backup
Alejandro Chirino, MD
Role: primary
Vanesa Bonetto, SC
Role: backup
Louis Wehbe, MD
Role: primary
Cristian Fazio, MD
Role: primary
Ian Glaspole, MD
Role: primary
Midhu Johny
Role: backup
Huw Davies, MD
Role: primary
Harmeet Kaur Madhay, Clinical Research Manager
Role: backup
John Mackintosh, MD
Role: primary
Sheral Prasad, Bachelor of nursing
Role: backup
Mayrose Chan, Nurse
Role: primary
Sofia Yao, Nurse
Role: backup
Lisa Singleton, Nurse
Role: primary
Rebecca Wong, Nurse
Role: backup
Helen Whitford, MD
Role: primary
Katri Malinen
Role: backup
Nicole Goh, MD
Role: primary
Tamera Corte, MD
Role: primary
Thomas Altree, MD
Role: primary
David Lang, MD
Role: primary
Role: backup
Jan Boor
Role: primary
Michael Studnicka, MD
Role: backup
Marie-Kathrin Breyer, MD
Role: primary
Alice Petschnig, SC
Role: backup
Benjamin Bondue, MD
Role: primary
Antoine Froidure, MD
Role: primary
Julien Guiot, MD
Role: primary
Caroline Dahlqvist, MD
Role: primary
Douglass Rolf, MD
Role: primary
Madeline Ludwig, Lead Study Coordinator
Role: backup
Patrice Gauthier, MD
Role: primary
Bjoern Frye, MD
Role: primary
Daiana Stolz, MD
Role: backup
Felix Herth, MD
Role: primary
Markus Polke
Role: backup
Maren Viehrig, MD
Role: primary
Katrin Schwedler, Study Coordinator
Role: primary
Sophie Grummes, Nurse
Role: backup
Theresa Graalmann, MD
Role: primary
Christina Kilicaslan, Coordinator
Role: primary
Nadine Rami
Role: backup
Sven Glaeser, MD
Role: primary
Katerina Antoniou, Professor
Role: primary
Lykourgos Kolilekas, MD
Role: primary
Ioannis Tomos, MD
Role: primary
Efrosyni Manali, MD
Role: primary
Konstantinos Kostikas, MD
Role: primary
Argyrios Tzouvelekis, MD
Role: primary
Aikaterini Manika, MD
Role: primary
Martina Bonifazi, MD
Role: primary
Fabiano Di Marco, MD
Role: primary
Fabrizio Luppi, MD
Role: primary
Gabriella Marsoni, MD
Role: backup
Elena Pistocchini, MD
Role: primary
Francesco Cavalli, MD
Role: backup
Rocco Francesco Rinaldo, MD
Role: primary
Andrea Estrada Garrido
Role: primary
Brenda Flores
Role: backup
Leopoldo Fernandez
Role: primary
Andrea Rodriguez
Role: backup
Adalia Carolina Longoria Jimenez
Role: primary
Alma Delia Carreon Segoviano
Role: backup
Lic. Vianney García Medina
Role: primary
Erika Aguedha Arias Sánchez
Role: backup
Agnieszka Jarzemska, MD
Role: primary
Iwona Patyk, MD
Role: primary
Katarzyna Płończak
Role: primary
Natalia Izydorczyk
Role: backup
Barbara Mackiewicz, MD
Role: primary
Sung-Woo Park, MD
Role: primary
Yong Hyun Kim, MD
Role: primary
Sookhee Moon
Role: backup
Hyun-Kyung Lee, MD
Role: primary
Jae Ha Lee, MD
Role: primary
Wonil Choi, MD
Role: primary
Mija Kim, MD
Role: primary
Jimyung Park, MD
Role: primary
Moo Suk Park, MD
Role: primary
Hee Young Yoon, MD
Role: primary
Jin Woo Song, MD
Role: primary
Man Pyo Chung, MD
Role: primary
Chau-Chyun Sheu
Role: primary
Yuan-Chen Hung
Role: backup
Kuo-Tung Huang, MD
Role: primary
Yi-Chun Shih
Role: backup
Chia-Hsiang Li, MD
Role: primary
Liang-Wen Hang
Role: backup
Tang-Hsiu Huang, MD
Role: primary
Jui-Fang Su
Role: backup
Ping-Hung Kuo, MD
Role: primary
Hsin-Mei Yu
Role: backup
Wei-Chih Chen
Role: primary
Yi-Ting Li
Role: backup
Emma Bruce, Study Coordinator
Role: primary
Pilar Rivera Ortega, MD
Role: primary
Katherine Myall, MD
Role: primary
Philip Molyneaux, MD
Role: primary
Conal Hayton, MBChB, PhD
Role: primary
Peter Saunders, MD
Role: primary
Related Links
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Trial webpage
Other Identifiers
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VP-C21-011
Identifier Type: -
Identifier Source: org_study_id