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New hope for lung scarring: buloxibutid trial underway

NCT ID NCT06588686

Disease control Sponsor: Vicore Pharma AB Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 18, 2026 · Updated 5 times

Summary

This Phase 2 trial tests an oral drug called buloxibutid in 378 people with idiopathic pulmonary fibrosis (IPF), a lung-scarring disease. Over 52 weeks, researchers compare two doses of buloxibutid against a placebo to see if it can slow lung function decline. The study is double-blind, meaning neither participants nor doctors know who gets the real drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
buloxibutid
What this could lead to
If successful, buloxibutid could offer a new oral treatment option to slow lung function decline in people with idiopathic pulmonary fibrosis.
What could go wrong
This is a Phase 2 trial, so results are still early. The drug may not prove effective or safe over the long term, and side effects are possible.
Why investors are watching

Vicore Pharma Holding AB is a micro-cap company, and its subsidiary Vicore Pharma AB runs the ASPIRE trial, a Phase 2 study of the drug buloxibutid in 378 people with idiopathic pulmonary fibrosis. The trial tests two doses of the drug against a placebo over 52 weeks, with patients either taking it alone or with their current therapy. For a company this small, this single readout can determine whether its main drug candidate has a future.

If it works: If buloxibutid shows it slows the disease or improves lung function with an acceptable safety profile, Vicore could have a viable product to move into later-stage testing. That result would likely raise the company's profile and support further investment in the drug.

If it fails: Phase 2 trials in this disease often fail to show a clear benefit, and a negative or unclear result could set the program back years. A delay in enrollment or data readout would also strain a micro-cap company with limited resources.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

378 people

The number who actually took part.

Started

Dec 2024

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic pulmonary fibrosis (IPF)

Contacts and locations

Locations

  • "Sotiria" Chest Diseases Hospital of Athens

    Athens, 11527, Greece

  • Allergology- Pulmunology Outpatient Clinic Alergopneuma, Pulmonology Outpatient Clinic

    Świdnik, 21-040, Poland

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Austin Hospital

    Heidelberg, VIC 3084, Australia

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75246, United States

  • Belgrano Clinical Research Center

    Buenos Aires, C1028AAP, Argentina

  • Breathe Comprehensive Clinical Health

    Godoy Cruz, 5501, Argentina

  • CEMER Medical Center for Respiratory Diseases

    Buenos Aires, 1602, Argentina

  • CINME - Metabolic Research Center

    Buenos Aires, C1056ABI, Argentina

  • China Medical University Hospital

    Taichung, 404327, Taiwan

  • Cleveland Clinic - Cleveland, Department of Pulmonary Medicine

    Cleveland, Ohio, 44195, United States

  • Clinical Research Centre Respiratory Medicine

    Frankfurt am Main, Hesse, 60596, Germany

  • Clinical Research Specialists

    Kissimmee, Florida, 34746, United States

  • Concord Repatriation General Hospital, Department of Respiratory Medicine

    Concord, NSW 2139, Australia

  • Diex Research Trois-Riviere Inc.

    Trois-Rivières, Quebec, G9A 4P3, Canada

  • Dr. Jose Eleuterio Gonzalez Monterrey University Hospital

    Monterrey, Nuevo León, 64460, Mexico

  • El Paso Pulmonary Association

    El Paso, Texas, 79902, United States

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342, United States

  • Emphysema Foundation, Pneumology

    Mar del Plata, 7600, Argentina

  • Endeavor Health - Evanston Hospital

    Evanston, Illinois, 60201, United States

  • Erasme Hospital

    Brussels, 1070, Belgium

  • Far Eastern Memorial Hospital

    New Taipei City, 220, Taiwan

  • Flinders Medical Centre

    Adelaide, SA 5042, Australia

  • Foundation PTV - Polyclinic Tor Vergata

    Roma, 00133, Italy

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

    Athens, 11527, Greece

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

    Thessaloniki, PC 57010, Greece

  • Guy's Hospital

    London, SE1 9RT, United Kingdom

  • Hannover Medical School, Center for Internal Medicine

    Hanover, Lower Saxony, 30625, Germany

  • Hanyang University - Myongji Hospital

    Goyang-si, 10475, South Korea

  • Homerton University Hospital

    London, E9 6SR, United Kingdom

  • Hospital Penzing, Department of Respiratory and lung diseases

    Vienna, 1140, Austria

  • IMER Respiratory Medicine Institute

    Córdoba, X5003DCE, Argentina

  • Ibamedica

    Santa Fe, 3000, Argentina

  • Immenhausen Lung Hospital

    Immenhausen, Hesse, 34 376, Germany

  • InJe University Busan Paik Hospital

    Busan, 47392, South Korea

  • InJe University Haeundae Paik Hospital

    Busan, 48108, South Korea

  • InnovaCiencia

    Rosario, S2000, Argentina

  • Integral Health Medical Unit

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

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833401, Taiwan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807377, Taiwan

  • Kelowna Respiratory & Allergy Clinic

    Kelowna, British Columbia, V1W 1V3, Canada

  • Kepler University Hospital GmbH, Department of Pulmonology

    Linz, Upper Austria, 4021, Austria

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

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

    Bergamo, 24127, Italy

  • Low Country Lung and Critical Care

    North Charleston, South Carolina, 29406, United States

  • Lung Research Victoria

    Footscray, Victoria, 3011, Australia

  • MICS Medical Centre Bydgoszcz

    Bydgoszcz, 85-065, Poland

  • Medical Center Dra. De Salvo

    Buenos Aires, C1426ABP, Argentina

  • National Institute of Respiratory Diseases Ismael Cosio Villegas (INER)

    Mexico City, Mexico City, 14080, Mexico

  • National Jewish Medical and Research Center

    Denver, Colorado, 80206, United States

  • National Taiwan University Hospital

    Taipei, 100225, Taiwan

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

    Lodz, 90-153, Poland

  • Oaxaca Site Management Organization S.C - (Osmo)

    Oaxaca City, 68000, Mexico

  • Oregon Clinic, Pulmonary, Critical Care & Sleep Medicine East

    Portland, Oregon, 97220, United States

  • Oxford University Hospitals NHS Trust

    Oxford, OX3 9DU, United Kingdom

  • Paradigm Clinical Research

    San Diego, California, 92108, United States

  • Paradigm Clinical Research Centers, Inc.

    Redding, California, 96001, United States

  • Queen Elizabeth Hospital Birmingham

    Birmingham, B15 2TH, United Kingdom

  • Renown Clinical Research

    Reno, Nevada, 89502, United States

  • Research Institute of Respiratory Diseases

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Royal Brompton Hospital

    London, SW3 6NP, United Kingdom

  • Royal Devon and Exeter Hospital

    Exeter, EX2 5DW, United Kingdom

  • Royal Prince Alfred Hospital

    Sydney, NSW 2050, Australia

  • RuhrlandClinic - Lung Center

    Essen, North Rhine-Westphalia, 45122, Germany

  • Salzburg Regional Hospital, Department of Pneumology/Respiratory Medicine

    Salzburg, 5020, Austria

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • San Gerardo of Tintori IRCCS Foundation

    Monza, 20900, Italy

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Soon Chun Hyang Central Medical Center

    Bucheon-si, 14584, South Korea

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103, United States

  • St Vincent's Hospital, Sydney Ltd.

    Darlinghurst, NSW 2010, Australia

  • Summit Health - Bend

    Bend, Oregon, 97201, United States

  • Taipei Veterans General Hospital

    Taipei, 112201, Taiwan

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140, United States

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

    Bucheon-si, 14647, South Korea

  • The Prince Charles Hospital

    Brisbane, QLD 4032, Australia

  • The Queen Elizabeth Hospital

    Woodville, SA 5011, Australia

  • Townsville University Hospital

    Douglas, QLD 4814, Australia

  • Twoja Przychodnia Medical Centre of Nowa Sol

    Nowa Sól, 67-100, Poland

  • UAB Hospital, School of Medicine/Lung Health Center

    Birmingham, Alabama, 35233, United States

  • UC Davis Health System

    Sacramento, California, 95816, United States

  • UC San Diego Medical Center - Hillcrest

    San Diego, California, 92103, United States

  • UCL Mont-Godinne University Hospitals

    Yvoir, 5530, Belgium

  • University General Hospital "Attikon", 2nd Pulmonary Department

    Athens, PC 12462, Greece

  • University General Hospital of Heraklion, Pneumonology Clinic

    Heraklion, Crete, 715 00, Greece

  • University General Hospital of Ioannina

    Ioannina, 45500, Greece

  • University General Hospital of Patras

    Pátrai, 26504, Greece

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

    Ancona, 60126, Italy

  • University Hospital Center Sart-Tilman

    Liège, 4000, Belgium

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

    Turin, 10126, Italy

  • University Hospital Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • University Hospital Heidelberg, Clinic of Thoracic Medicine Heidelberg GmbH

    Heidelberg, Baden-Wurttemberg, 69126, Germany

  • University Hospital Tuebingen

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • University Hospitals Saint-Luc

    Brussels, 1200, Belgium

  • University of Florida Health (UF Health)

    Gainesville, Florida, 32610, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Utah, Health Sciences Center

    Salt Lake City, Utah, 84108, United States

  • University of Wisconsin Clinical Science Center

    Madison, Wisconsin, 53792, United States

  • VITAMED Galaj i Cichomski General Partnership

    Bydgoszcz, 85-079, Poland

  • Vistalba Health Center

    Mendoza, 5509, Argentina

  • Vivantes Hospital Neukoelln

    Berlin, 12351, Germany

  • William Beaumont Hospital - Royal Oak

    Royal Oak, Michigan, 48073, United States

  • Wythenshawe Hospital

    Manchester, M23 9LT, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.