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.

Status: Recruiting
Location: See all (112) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• Age ≥ 40 years at the time of signing the informed consent.

• Diagnosed with IPF within 5 years prior to visit 1, as per ATS/ERS/JRS/ALAT 2022 guidelines (Raghu et al., 2022).

• 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 and visit 2.

• DLCO (corrected for hemoglobin) ≥35% 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.

• Written informed consent, consistent with ICH-GCP and local laws, obtained before the initiation of any trial-related procedure.

Locations
United States
Alabama
UAB Hospital, School of Medicine/Lung Health Center
RECRUITING
Birmingham
California
Keck Medicine of University of Southern California
RECRUITING
Los Angeles
Paradigm Clinical Research Centers, Inc.
RECRUITING
Redding
UC Davis Health System
NOT_YET_RECRUITING
Sacramento
Paradigm Clinical Research
RECRUITING
San Diego
UC San Diego Medical Center - Hillcrest
NOT_YET_RECRUITING
San Diego
Colorado
National Jewish Medical and Research Center
RECRUITING
Denver
Florida
University of Florida Health (UF Health)
RECRUITING
Gainesville
Clinical Research Specialists
RECRUITING
Kissimmee
Georgia
Emory Saint Joseph's Hospital
RECRUITING
Atlanta
Illinois
Endeavor Health - Evanston Hospital
RECRUITING
Evanston
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Massachusetts
Massachusetts General Hospital, Pulmonary & Critical Care Medicine
NOT_YET_RECRUITING
Boston
Michigan
William Beaumont Hospital - Royal Oak
NOT_YET_RECRUITING
Royal Oak
North Carolina
Southeastern Research Center
RECRUITING
Winston-salem
New Mexico
University of New Mexico, Health Sciences Center
NOT_YET_RECRUITING
Albuquerque
Nevada
Renown Regional Medical Center
NOT_YET_RECRUITING
Reno
New York
Stony Brook University
NOT_YET_RECRUITING
Stony Brook
Ohio
Cleveland Clinic - Cleveland, Department of Pulmonary Medicine
NOT_YET_RECRUITING
Cleveland
Oklahoma
University of Oklahoma Health Sciences Center
NOT_YET_RECRUITING
Oklahoma City
Oregon
Summit Health - Bend
NOT_YET_RECRUITING
Bend
Oregon Clinic, Pulmonary, Critical Care & Sleep Medicine East
RECRUITING
Portland
Pennsylvania
Temple University Hospital
RECRUITING
Philadelphia
South Carolina
Low Country Lung and Critical Care
RECRUITING
North Charleston
Texas
Baylor Scott & White Research Institute
RECRUITING
Dallas
El Paso Pulmonary Association
NOT_YET_RECRUITING
El Paso
Utah
University of Utah, Health Sciences Center
RECRUITING
Salt Lake City
Wisconsin
University of Wisconsin Clinical Science Center
NOT_YET_RECRUITING
Madison
Other Locations
Argentina
CEMER Medical Center for Respiratory Diseases
RECRUITING
Buenos Aires
CINME - Metabolic Research Center
NOT_YET_RECRUITING
Buenos Aires
Medical Center Dra. De Salvo
NOT_YET_RECRUITING
Buenos Aires
IMER Respiratory Medicine Institute
RECRUITING
Córdoba
Breathe Comprehensive Clinical Health
RECRUITING
Godoy Cruz
Emphysema Foundation, Pneumology
RECRUITING
Mar Del Plata
Vistalba Health Center
RECRUITING
Mendoza
InnovaCiencia
NOT_YET_RECRUITING
Rosario
Research Institute of Respiratory Diseases
RECRUITING
San Miguel De Tucumán
Ibamedica
NOT_YET_RECRUITING
Santa Fe
Australia
Flinders Medical Centre
RECRUITING
Adelaide
The Prince Charles Hospital
RECRUITING
Brisbane
Concord Repatriation General Hospital, Department of Respiratory Medicine
RECRUITING
Concord
St Vincent's Hospital, Sydney Ltd.
RECRUITING
Darlinghurst
Townsville University Hospital
RECRUITING
Douglas
Lung Research Victoria
RECRUITING
Footscray
Austin Hospital
RECRUITING
Heidelberg
Royal Prince Alfred Hospital
RECRUITING
Sydney
The Queen Elizabeth Hospital
RECRUITING
Woodville
Austria
Kepler University Hospital GmbH, Department of Pulmonology
RECRUITING
Linz
Salzburg Regional Hospital, Department of Pneumology/Respiratory Medicine
RECRUITING
Salzburg
Hospital Penzing, Department of Respiratory and lung diseases
RECRUITING
Vienna
Belgium
Erasme Hospital
RECRUITING
Brussels
University Hospitals Saint-Luc
RECRUITING
Brussels
University Hospital Center Sart-Tilman
NOT_YET_RECRUITING
Liège
UCL Mont-Godinne University Hospitals
RECRUITING
Yvoir
Canada
Kelowna Respiratory & Allergy Clinic
NOT_YET_RECRUITING
Kelowna
Laval Hospital
NOT_YET_RECRUITING
Laval
Pierre-Le Gardeur
NOT_YET_RECRUITING
Terrebonne
Diex Research Trois-Riviere Inc.
RECRUITING
Trois-rivières
Germany
Vivantes Hospital Neukoelln
RECRUITING
Berlin
RuhrlandClinic - Lung Center
RECRUITING
Essen
University Hospital Freiburg
RECRUITING
Freiburg Im Breisgau
Hannover Medical School, Center for Internal Medicine
RECRUITING
Hanover
University Hospital Heidelberg, Clinic of Thoracic Medicine Heidelberg GmbH
RECRUITING
Heidelberg
Immenhausen Lung Hospital
RECRUITING
Immenhausen
University Hospital Tuebingen
RECRUITING
Tübingen
Greece
General Hospital of Chest Diseases Sotiria 5th Pulmonology Department
RECRUITING
Athens
Sotiria Chest Diseases Hospital of Athens
RECRUITING
Athens
University General Hospital Attikon, 2nd Pulmonary Department
RECRUITING
Athens
University General Hospital of Heraklion, Pneumonology Clinic
RECRUITING
Heraklion
University General Hospital of Ioannina
RECRUITING
Ioannina
University General Hospital of Patras
RECRUITING
Pátrai
General Hospital of Thessaloniki G. Papanikolaou, University Department of Pulmonology
RECRUITING
Thessaloniki
Italy
University Hospital - Ospedali Riuniti Umberto I - GM Lancisi - G Salesi of Ancona
RECRUITING
Ancona
Local Healthcare Company Papa Giovanni XXIII (ASST Papa Giovanni XXIII)
RECRUITING
Bergamo
IRCCS Policlinic Hospital San Martino
NOT_YET_RECRUITING
Genoa
San Gerardo of Tintori IRCCS Foundation
RECRUITING
Monza
Foundation PTV - Polyclinic Tor Vergata
RECRUITING
Roma
University Hospital City of Health and Science of Turin - Hospital Molinette
RECRUITING
Turin
Mexico
National Institute of Respiratory Diseases Ismael Cosio Villegas (INER)
NOT_YET_RECRUITING
Mexico City
Dr. Jose Eleuterio Gonzalez Monterrey University Hospital
RECRUITING
Monterrey
Oaxaca Site Management Organization S.C - (Osmo)
RECRUITING
Oaxaca City
Integral Health Medical Unit
RECRUITING
San Nicolás De Los Garza
Poland
MICS Medical Centre Bydgoszcz
RECRUITING
Bydgoszcz
VITAMED Galaj i Cichomski General Partnership
RECRUITING
Bydgoszcz
Norbert Barlicki University Clinical Hospital in Lodz Departament of Pneumology and Allergy
NOT_YET_RECRUITING
Lodz
Twoja Przychodnia Medical Centre of Nowa Sol
RECRUITING
Nowa Sól
Allergology- Pulmunology Outpatient Clinic Alergopneuma, Pulmonology Outpatient Clinic
RECRUITING
Świdnik
Republic of Korea
Soon Chun Hyang Central Medical Center
RECRUITING
Bucheon-si
The Catholic University Of Korea Bucheon St. Mary's Hospital
RECRUITING
Bucheon-si
InJe University Busan Paik Hospital
NOT_YET_RECRUITING
Busan
InJe University Haeundae Paik Hospital
RECRUITING
Busan
Hanyang University - Myongji Hospital
RECRUITING
Goyang-si
Asan Medical Center
RECRUITING
Seoul
Korea University Anam Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Soon Chun Hyang University Hospital Seoul
RECRUITING
Seoul
Taiwan
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Far Eastern Memorial Hospital
ACTIVE_NOT_RECRUITING
New Taipei City
China Medical University Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan City
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
United Kingdom
Queen Elizabeth Hospital Birmingham
RECRUITING
Birmingham
Royal Devon and Exeter Hospital
RECRUITING
Exeter
Guy's Hospital
RECRUITING
London
Homerton University Hospital
NOT_YET_RECRUITING
London
Royal Brompton Hospital
RECRUITING
London
Wythenshawe Hospital
RECRUITING
Manchester
Oxford University Hospitals NHS Trust
RECRUITING
Oxford
Contact Information
Primary
Thomas Eskildsen, MSc. Pharm.
info@aspire-ipf.com
+ 46 317880560
Backup
Bernt Van Den Blink, MD
info@aspire-ipf.com
+ 46 317880560
Time Frame
Start Date: 2024-12-09
Estimated Completion Date: 2027-03
Participants
Target number of participants: 270
Treatments
Experimental: Buloxibutid 100 mg BID
For 52 weeks.
Experimental: Buloxibutid 50 mg BID
For 52 weeks.
Placebo_comparator: Placebo BID
For 52 weeks.
Sponsors
Collaborators: Population Services International
Leads: Vicore Pharma AB

This content was sourced from clinicaltrials.gov

Similar Clinical Trials