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

NCT06588686 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: VP-C21-011
• Study Type: interventional
• Target: 378
• Locations: 13 countries
• Sites: 108

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

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Keywords

Angiotensin, IPF, angiotensin II receptor 2, buloxibutid

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of buloxibutid compared to placebo in participants with IPF as assessed by FVC

  • Absolute change from baseline in FVC (mL) at week 52

  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

  week 52

Study Arms (3)

Buloxibutid 100 mg BID

EXPERIMENTAL

For 52 weeks.

Drug: Buloxibutid

Buloxibutid 50 mg BID

EXPERIMENTAL

For 52 weeks.

Drug: Buloxibutid

Placebo BID

PLACEBO COMPARATOR

For 52 weeks.

Drug: Placebo

Interventions

Buloxibutid DRUG

Buloxibutid

Also known as: C21

Buloxibutid 100 mg BID; Buloxibutid 50 mg BID

Placebo DRUG

Placebo

Placebo BID

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 40 years at the time of signing the informed consent.
• Diagnosed with IPF within 7 years prior to visit 1, as per applicable ATS/ERS/JRS/ALAT guidelines at the time of diagnosis.
• HRCT scan within 36 months prior to visit 1 with central reading confirming either a or b, and c
• A pattern consistent with usual interstitial pneumonia (UIP) according to ATS/ERS/JRS/ALAT 2022 guideline (Raghu et al., 2022) UIP or probable UIP.
• 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.
• Extent of fibrosis \> extent of emphysema.
• FVC ≥50% predicted at visit 1.
• DLCO (corrected for hemoglobin) ≥30% 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. Due to the risk of DDIs, concomitant treatment with pirfenidone is not allowed in this trial.
• 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 (being on a transplant list does not exclude a participant from the trial).
• 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.
• Written informed consent, consistent with ICH-GCP and local laws, obtained before the initiation of any trial-related procedure.

You may not qualify if:

• Participants are excluded from the trial if any of the following criteria apply:
• 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.
• Airways obstruction with a pre-bronchodilator forced expiratory volume in one second (FEV1)/FVC ratio \<0.7 at visit 1.
• 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. 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.
• 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.

Sponsors & Collaborators

• Vicore Pharma AB: lead
• Population Services International: collaborator

Study Sites (111)

UAB Hospital, School of Medicine/Lung Health Center

Birmingham, Alabama, 35233, United States

Location

Keck Medicine of University of Southern California

Los Angeles, California, 90033, United States

Location

Paradigm Clinical Research Centers, Inc.

Redding, California, 96001, United States

Location

UC Davis Health System

Sacramento, California, 95816, United States

Location

UC San Diego Medical Center - Hillcrest

San Diego, California, 92103, United States

Location

Paradigm Clinical Research

San Diego, California, 92108, United States

Location

National Jewish Medical and Research Center

Denver, Colorado, 80206, United States

Location

University of Florida Health (UF Health)

Gainesville, Florida, 32610, United States

Location

Clinical Research Specialists

Kissimmee, Florida, 34746, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Endeavor Health - Evanston Hospital

Evanston, Illinois, 60201, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Massachusetts General Hospital, Pulmonary & Critical Care Medicine

Boston, Massachusetts, 02114, United States

Location

William Beaumont Hospital - Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Renown Clinical Research

Reno, Nevada, 89502, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Southeastern Research Center

Winston-Salem, North Carolina, 27103, United States

Location

Cleveland Clinic - Cleveland, Department of Pulmonary Medicine

Cleveland, Ohio, 44195, United States

Location

Summit Health - Bend

Bend, Oregon, 97201, United States

Location

Oregon Clinic, Pulmonary, Critical Care & Sleep Medicine East

Portland, Oregon, 97220, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Low Country Lung and Critical Care

North Charleston, South Carolina, 29406, United States

Location

StatCare - Bearden

Knoxville, Tennessee, 37919, United States

Location

Baylor Scott & White Research Institute

Dallas, Texas, 75246, United States

Location

El Paso Pulmonary Association

El Paso, Texas, 79902, United States

Location

University of Utah, Health Sciences Center

Salt Lake City, Utah, 84108, United States

Location

University of Wisconsin Clinical Science Center

Madison, Wisconsin, 53792, United States

Location

Research Institute of Respiratory Diseases

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

CEMER Medical Center for Respiratory Diseases

Buenos Aires, 1602, Argentina

Location

Belgrano Clinical Research Center

Buenos Aires, C1028AAP, Argentina

Location

CINME - Metabolic Research Center

Buenos Aires, C1056ABI, Argentina

Location

Medical Center Dra. De Salvo

Buenos Aires, C1426ABP, Argentina

Location

IMER Respiratory Medicine Institute

Córdoba, X5003DCE, Argentina

Location

Breathe Comprehensive Clinical Health

Godoy Cruz, 5501, Argentina

Location

Emphysema Foundation, Pneumology

Mar del Plata, 7600, Argentina

Location

Vistalba Health Center

Mendoza, 5509, Argentina

Location

InnovaCiencia

Rosario, S2000, Argentina

Location

Ibamedica

Santa Fe, 3000, Argentina

Location

Lung Research Victoria

Footscray, Victoria, 3011, Australia

Location

Flinders Medical Centre

Adelaide, SA 5042, Australia

Location

The Prince Charles Hospital

Brisbane, QLD 4032, Australia

Location

Concord Repatriation General Hospital, Department of Respiratory Medicine

Concord, NSW 2139, Australia

Location

St Vincent's Hospital, Sydney Ltd.

Darlinghurst, NSW 2010, Australia

Location

Townsville University Hospital

Douglas, QLD 4814, Australia

Location

Austin Hospital

Heidelberg, VIC 3084, Australia

Location

Royal Prince Alfred Hospital

Sydney, NSW 2050, Australia

Location

The Queen Elizabeth Hospital

Woodville, SA 5011, Australia

Location

Kepler University Hospital GmbH, Department of Pulmonology

Linz, Upper Austria, 4021, Austria

Location

Salzburg Regional Hospital, Department of Pneumology/Respiratory Medicine

Salzburg, 5020, Austria

Location

Hospital Penzing, Department of Respiratory and lung diseases

Vienna, 1140, Austria

Location

Erasme Hospital

Brussels, 1070, Belgium

Location

University Hospitals Saint-Luc

Brussels, 1200, Belgium

Location

University Hospital Center Sart-Tilman

Liège, 4000, Belgium

Location

UCL Mont-Godinne University Hospitals

Yvoir, 5530, Belgium

Location

Kelowna Respiratory & Allergy Clinic

Kelowna, British Columbia, V1W 1V3, Canada

Location

Diex Research Trois-Riviere Inc.

Trois-Rivières, Quebec, G9A 4P3, Canada

Location

University Hospital Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

University Hospital Heidelberg, Clinic of Thoracic Medicine Heidelberg GmbH

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Clinical Research Centre Respiratory Medicine

Frankfurt am Main, Hesse, 60596, Germany

Location

Immenhausen Lung Hospital

Immenhausen, Hesse, 34 376, Germany

Location

Hannover Medical School, Center for Internal Medicine

Hanover, Lower Saxony, 30625, Germany

Location

RuhrlandClinic - Lung Center

Essen, North Rhine-Westphalia, 45122, Germany

Location

Vivantes Hospital Neukoelln

Berlin, 12351, Germany

Location

University General Hospital of Heraklion, Pneumonology Clinic

Heraklion, Crete, 715 00, Greece

Location

"Sotiria" Chest Diseases Hospital of Athens

Athens, 11527, Greece

Location

General Hospital of Chest Diseases "Sotiria" 5th Pulmonology Department

Athens, 11527, Greece

Location

University General Hospital "Attikon", 2nd Pulmonary Department

Athens, PC 12462, Greece

Location

University General Hospital of Ioannina

Ioannina, 45500, Greece

Location

University General Hospital of Patras

Pátrai, 26504, Greece

Location

General Hospital of Thessaloniki "G. Papanikolaou", University Department of Pulmonology

Thessaloniki, PC 57010, Greece

Location

IRCCS Policlinic Hospital San Martino

Genoa, Liguria, 16132, Italy

Location

University Hospital - Ospedali Riuniti Umberto I - GM Lancisi - G Salesi of Ancona

Ancona, 60126, Italy

Location

Local Healthcare Company Papa Giovanni XXIII (ASST Papa Giovanni XXIII)

Bergamo, 24127, Italy

Location

San Gerardo of Tintori IRCCS Foundation

Monza, 20900, Italy

Location

Foundation PTV - Polyclinic Tor Vergata

Roma, 00133, Italy

Location

University Hospital City of Health and Science of Turin - Hospital Molinette

Turin, 10126, Italy

Location

National Institute of Respiratory Diseases Ismael Cosio Villegas (INER)

Mexico City, Mexico City, 14080, Mexico

Location

Dr. Jose Eleuterio Gonzalez Monterrey University Hospital

Monterrey, Nuevo León, 64460, Mexico

Location

Integral Health Medical Unit

San Nicolás de los Garza, Nuevo León, 66465, Mexico

Location

Oaxaca Site Management Organization S.C - (Osmo)

Oaxaca City, 68000, Mexico

Location

MICS Medical Centre Bydgoszcz

Bydgoszcz, 85-065, Poland

Location

VITAMED Galaj i Cichomski General Partnership

Bydgoszcz, 85-079, Poland

Location

Norbert Barlicki University Clinical Hospital in Lodz Departament of Pneumology and Allergy

Lodz, 90-153, Poland

Location

Twoja Przychodnia Medical Centre of Nowa Sol

Nowa Sól, 67-100, Poland

Location

Allergology- Pulmunology Outpatient Clinic Alergopneuma, Pulmonology Outpatient Clinic

Świdnik, 21-040, Poland

Location

Soon Chun Hyang Central Medical Center

Bucheon-si, 14584, South Korea

Location

The Catholic University Of Korea Bucheon St. Mary's Hospital

Bucheon-si, 14647, South Korea

Location

InJe University Busan Paik Hospital

Busan, 47392, South Korea

Location

InJe University Haeundae Paik Hospital

Busan, 48108, South Korea

Location

Hanyang University - Myongji Hospital

Goyang-si, 10475, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Soon Chun Hyang University Hospital Seoul

Seoul, 04401, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807377, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833401, Taiwan

Location

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

China Medical University Hospital

Taichung, 404327, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704302, Taiwan

Location

National Taiwan University Hospital

Taipei, 100225, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112201, Taiwan

Location

Queen Elizabeth Hospital Birmingham

Birmingham, B15 2TH, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, EX2 5DW, United Kingdom

Location

Homerton University Hospital

London, E9 6SR, United Kingdom

Location

Guy's Hospital

London, SE1 9RT, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

Wythenshawe Hospital

Manchester, M23 9LT, United Kingdom

Location

Oxford University Hospitals NHS Trust

Oxford, OX3 9DU, United Kingdom

Location

Related Links

• Trial webpage

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

compound 21

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: December 9, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

GB (7); IT (6); PL (5); KR (11); AR (11); GR (7); AU (9); BE (4); US (27); DE (8); ME (4); TW (7); CA (2)