A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Interventions
- Drug: Placebo
- Registration Number
- NCT06588686
- Lead Sponsor
- Vicore Pharma AB
- Brief 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
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 270
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Buloxibutid 100 mg BID Buloxibutid For 52 weeks. Buloxibutid 50 mg BID Buloxibutid For 52 weeks. Placebo BID Placebo For 52 weeks.
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of buloxibutid compared to placebo in participants with IPF as assessed by FVC week 52 • Absolute change from baseline in FVC (mL) at week 52
- Secondary Outcome Measures
Name Time Method To further evaluate the effects of buloxibutid on disease progression, respiratory-related hospitalization or death compared to placebo in participants with IPF 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (106)
Integral Health Medical Unit
🇲🇽San Nicolás De Los Garza, Mexico
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Queen Elizabeth Hospital Birmingham
🇬🇧Birmingham, 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
UAB Hospital, School of Medicine/Lung Health Center
🇺🇸Birmingham, Alabama, United States
Paradigm Clinical Research
🇺🇸La Mesa, California, 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
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
William Beaumont Hospital - Royal Oak
🇺🇸Royal Oak, Michigan, 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
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
Baylor Scott & White Research Institute
🇺🇸Dallas, 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
IMER Respiratory Medicine Institute
🇦🇷Córdoba, Cordoba, Argentina
Research Institute of Respiratory Diseases
🇦🇷San Miguel De Tucumán, Tucuman, Argentina
CEMER Medical Center for Respiratory Diseases
🇦🇷Buenos Aires, Argentina
Breathe Comprehensive Clinical Health
🇦🇷Godoy Cruz, Argentina
Emphysema Foundation, Pneumology
🇦🇷Mar Del Plata, Argentina
Vistalba Health Center
🇦🇷Mendoza, Argentina
Flinders Medical Centre
🇦🇺Adelaide, Australia
Concord Repatriation General Hospital, Department of Respiratory Medicine
🇦🇺Concord, Australia
St Vincent's Hospital, Sydney Ltd.
🇦🇺Darlinghurst, 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, 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, Canada
Laval Hospital
🇨🇦Laval, Canada
Pierre-Le Gardeur
🇨🇦Québec, Canada
Diex Research Trois-Riviere Inc.
🇨🇦Trois-Rivieres, Canada
Vivantes Hospital Neukoelln
🇩🇪Berlin, Germany
RuhrlandClinic - Lung Center
🇩🇪Essen, Germany
University Hospital Freiburg
🇩🇪Freiburg, Germany
Hannover Medical School, Center for Internal Medicine
🇩🇪Hannover, Germany
University Hospital Heidelberg, Clinic of Thoracic Medicine Heidelberg GmbH
🇩🇪Heidelberg, Germany
Immenhausen Lung Hospital
🇩🇪Immenhausen, Germany
University Hospital Tuebingen
🇩🇪Tuebingen, Germany
"Sotiria" Chest Diseases Hospital of Athens - Site 2
🇬🇷Athens, Greece
General Hospital of Chest Diseases "Sotiria" 5th Pulmonology Department - Site 1
🇬🇷Athens, Greece
University General Hospital "Attikon", 2nd Pulmonary Department
🇬🇷Athens, Greece
University General Hospital of Heraklion, Pneumonology Clinic
🇬🇷Heraklion, Greece
University General Hospital of Ioannina
🇬🇷Ioánnina, Greece
University General Hospital of Patras
🇬🇷Patras, Greece
General Hospital of Thessaloniki
🇬🇷Thessaloníki, Greece
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
University Polyclinic Hospital of Modena
🇮🇹Modena, 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
Soon Chun Hyang Central Medical Center
🇰🇷Bucheon, Korea, Republic of
The Catholic University Of Korea Bucheon St. Mary's Hospital
🇰🇷Bucheon, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
InJe University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Hanyang University - Myongji Hospital
🇰🇷Goyang-si, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Soon Chun Hyang University Hospital Seoul
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
National Institute of Respiratory Diseases Ismael Cosio Villegas (INER)
🇲🇽Mexico City, Mexico
Dr. Jose Eleuterio Gonzalez Monterrey University Hospital
🇲🇽Monterrey, Mexico
Oaxaca Site Management Organization S.C - (Osmo)
🇲🇽Oaxaca, Mexico
Integral Health Medical Unit
🇲🇽San Nicolás De Los Garza, Mexico
MICS Medical Centre Bydgoszcz
🇵🇱Bydgoszcz, Poland
VITAMED Galaj i Cichomski General Partnership
🇵🇱Bydgoszcz, Poland
Twoja Przychodnia Medical Centre of Nowa Sol
🇵🇱Nowa Sól, Poland
Allergology- Pulmunology Outpatient Clinic Alergopneuma, Pulmonology Outpatient Clinic
🇵🇱Świdnik, Poland
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, 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
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