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RECRUITING

NCT06588686

PHASE2

A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.

Sponsor: Vicore Pharma AB

View on ClinicalTrials.gov

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

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.

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2024-12-09

Completion Date

2027-06

Last Updated

2026-03-10

Healthy Volunteers

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Interventions

DRUG

Buloxibutid

DRUG

Placebo

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

Locations (117)

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

Research Institute of Respiratory Diseases

San Miguel de Tucumán, Tucumán Province, Argentina

CEMER Medical Center for Respiratory Diseases

Buenos Aires, Argentina

Belgrano Clinical Research Center

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

InnovaCiencia

Rosario, 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

Clinical Research Centre Respiratory Medicine

Frankfurt am Main, Hesse, 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, 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

Clinical Research Directory

A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (117)