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Idiopathic Pulmonary Fibrosis (IPF)Phase 2ASPIRENCT06588686

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

A Phase 2 study testing Buloxibutid in people with Idiopathic Pulmonary Fibrosis (IPF), run by Vicore Pharma AB at 104 sites in 14 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis (IPF)
What is being tested?
Buloxibutid
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
378 participants
Where
104 sitesin 14 countries
Study dates
9 Dec 2024to Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 15Show fewer
  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.
  • Inability to generate a spirometry test at visit 1 meeting the standards of the ATS/ERS 2019 guideline (Graham et al., 2019).
  • 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

Trial locations and contacts

104 sites in 14 countries.

104 sites in 14 countries

United States23 sites

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • Summit Health - Bend

    Bend, Oregon, 97201

  • UAB Hospital, School of Medicine/Lung Health Center

    Birmingham, Alabama, 35233

  • Cleveland Clinic - Cleveland, Department of Pulmonary Medicine

    Cleveland, Ohio, 44195

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75246

  • National Jewish Medical and Research Center

    Denver, Colorado, 80206

  • El Paso Pulmonary Association

    El Paso, Texas, 79902

  • Endeavor Health - Evanston Hospital

    Evanston, Illinois, 60201

  • University of Florida Health (UF Health)

    Gainesville, Florida, 32610

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Clinical Research Specialists

    Kissimmee, Florida, 34746

  • University of Wisconsin Clinical Science Center

    Madison, Wisconsin, 53792

  • Low Country Lung and Critical Care

    North Charleston, South Carolina, 29406

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

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

    Portland, Oregon, 97220

  • Paradigm Clinical Research Centers, Inc.

    Redding, California, 96001

  • Renown Clinical Research

    Reno, Nevada, 89502

  • William Beaumont Hospital - Royal Oak

    Royal Oak, Michigan, 48073

  • UC Davis Health System

    Sacramento, California, 95816

  • University of Utah, Health Sciences Center

    Salt Lake City, Utah, 84108

  • UC San Diego Medical Center - Hillcrest

    San Diego, California, 92103

  • Paradigm Clinical Research

    San Diego, California, 92108

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103

Other trials in United States

Argentina11 sites

  • CEMER Medical Center for Respiratory Diseases

    Buenos Aires, 1602

  • Belgrano Clinical Research Center

    Buenos Aires, C1028AAP

  • CINME - Metabolic Research Center

    Buenos Aires, C1056ABI

  • Medical Center Dra. De Salvo

    Buenos Aires, C1426ABP

  • IMER Respiratory Medicine Institute

    Córdoba, X5003DCE

  • Breathe Comprehensive Clinical Health

    Godoy Cruz, 5501

  • Emphysema Foundation, Pneumology

    Mar del Plata, 7600

  • Vistalba Health Center

    Mendoza, 5509

  • InnovaCiencia

    Rosario, Rosario, S2000

  • Research Institute of Respiratory Diseases

    San Miguel de Tucumán, Tucumán Province, 4000

  • Ibamedica

    Santa Fe, 3000

Other trials in Argentina

South Korea10 sites

  • Soon Chun Hyang Central Medical Center

    Bucheon-si, 14584

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

    Bucheon-si, 14647

  • InJe University Busan Paik Hospital

    Busan, 47392

  • InJe University Haeundae Paik Hospital

    Busan, 48108

  • Hanyang University - Myongji Hospital

    Goyang-si, 10475

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Australia9 sites

  • Flinders Medical Centre

    Adelaide, SA 5042

  • The Prince Charles Hospital

    Brisbane, QLD 4032

  • Concord Repatriation General Hospital, Department of Respiratory Medicine

    Concord, NSW 2139

  • St Vincent's Hospital, Sydney Ltd.

    Darlinghurst, NSW 2010

  • Townsville University Hospital

    Douglas, QLD 4814

  • Lung Research Victoria

    Footscray, Victoria, 3011

  • Austin Hospital

    Heidelberg, VIC 3084

  • Royal Prince Alfred Hospital

    Sydney, NSW 2050

  • The Queen Elizabeth Hospital

    Woodville, SA 5011

Other trials in Australia

Germany8 sites

  • Vivantes Hospital Neukoelln

    Berlin, 12351

  • RuhrlandClinic - Lung Center

    Essen, North Rhine-Westphalia, 45122

  • Clinical Research Centre Respiratory Medicine

    Frankfurt am Main, Hesse, 60596

  • University Hospital Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Hannover Medical School, Center for Internal Medicine

    Hanover, Lower Saxony, 30625

  • University Hospital Heidelberg, Clinic of Thoracic Medicine Heidelberg GmbH

    Heidelberg, Baden-Wurttemberg, 69126

  • Immenhausen Lung Hospital

    Immenhausen, Hesse, 34 376

  • University Hospital Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Greece7 sites

  • "Sotiria" Chest Diseases Hospital of Athens

    Athens, 11527

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

    Athens, 11527

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

    Athens, PC 12462

  • University General Hospital of Heraklion, Pneumonology Clinic

    Heraklion, Crete, 715 00

  • University General Hospital of Ioannina

    Ioannina, 45500

  • University General Hospital of Patras

    Pátrai, 26504

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

    Thessaloniki, PC 57010

Other trials in Greece

United Kingdom7 sites

  • Queen Elizabeth Hospital Birmingham

    Birmingham, B15 2TH

  • Royal Devon and Exeter Hospital

    Exeter, EX2 5DW

  • Homerton University Hospital

    London, E9 6SR

  • Guy's Hospital

    London, SE1 9RT

  • Royal Brompton Hospital

    London, SW3 6NP

  • Wythenshawe Hospital

    Manchester, M23 9LT

  • Oxford University Hospitals NHS Trust

    Oxford, OX3 9DU

Other trials in United Kingdom

Taiwan6 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807377

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833401

  • Far Eastern Memorial Hospital

    New Taipei City, 220

  • China Medical University Hospital

    Taichung, 404327

  • National Taiwan University Hospital

    Taipei, 100225

  • Taipei Veterans General Hospital

    Taipei, 112201

Other trials in Taiwan

Italy5 sites

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

    Ancona, 60126

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

    Bergamo, 24127

  • San Gerardo of Tintori IRCCS Foundation

    Monza, 20900

  • Foundation PTV - Polyclinic Tor Vergata

    Roma, 00133

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

    Turin, 10126

Other trials in Italy

Poland5 sites

  • MICS Medical Centre Bydgoszcz

    Bydgoszcz, 85-065

  • VITAMED Galaj i Cichomski General Partnership

    Bydgoszcz, 85-079

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

    Lodz, 90-153

  • Twoja Przychodnia Medical Centre of Nowa Sol

    Nowa Sól, 67-100

  • Allergology- Pulmunology Outpatient Clinic Alergopneuma, Pulmonology Outpatient Clinic

    Świdnik, 21-040

Other trials in Poland

Belgium4 sites

  • Erasme Hospital

    Brussels, 1070

  • University Hospitals Saint-Luc

    Brussels, 1200

  • University Hospital Center Sart-Tilman

    Liège, 4000

  • UCL Mont-Godinne University Hospitals

    Yvoir, 5530

Other trials in Belgium

Mexico4 sites

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

    Mexico City, Mexico City, 14080

  • Dr. Jose Eleuterio Gonzalez Monterrey University Hospital

    Monterrey, Nuevo León, 64460

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

    Oaxaca City, Oaxaca, 68000

  • Integral Health Medical Unit

    San Nicolás de los Garza, Nuevo León, 66465

Other trials in Mexico

Austria3 sites

  • Kepler University Hospital GmbH, Department of Pulmonology

    Linz, Upper Austria, 4021

  • Salzburg Regional Hospital, Department of Pneumology/Respiratory Medicine

    Salzburg, 5020

  • Hospital Penzing, Department of Respiratory and lung diseases

    Vienna, 1140

Other trials in Austria

Canada2 sites

  • Kelowna Respiratory & Allergy Clinic

    Kelowna, British Columbia, V1W 1V3

  • Diex Research Trois-Riviere Inc.

    Trois-Rivières, Quebec, G9A 4P3

Other trials in Canada

About this study

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.

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

Read the 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 360 participants, 120 participants on oral buloxibutid 100 mg BID, 120 participants on oral buloxibutid 50 mg BID, and 120 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

Being tested
Buloxibutid, Placebo
Keywords
Angiotensin, IPF, angiotensin II receptor 2, buloxibutid
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BuloxibutidDrug

    Also called C21

    Buloxibutid

  • PlaceboDrug

    Placebo

Study groups in NCT06588686
Study groupRoleWhat they receive
Buloxibutid 100 mg BIDExperimentalFor 52 weeks.
Receives: Drug: Buloxibutid
Buloxibutid 50 mg BIDExperimentalFor 52 weeks.
Receives: Drug: Buloxibutid
Placebo BIDPlacebo comparatorFor 52 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: week 52

Secondary outcomes (1)

  1. To further evaluate the effects of buloxibutid on disease progression, respiratory-related hospitalization or death compared to placebo in participants with IPF

    • 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

    Measured: week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start9 Dec 2024
  3. Primary completionMay 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
378 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06588686
Sponsor's protocol ID
VP-C21-011
Acronym
ASPIRE
Status last verified
Oct 2026
First submitted
6 Sep 2024
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Buloxibutid in people with Idiopathic Pulmonary Fibrosis (IPF), run by Vicore Pharma AB at 104 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in United States, Argentina, South Korea, Australia, Germany and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the efficacy of buloxibutid compared to placebo in participants with IPF as assessed by FVC (time frame: week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06588686.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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