RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Quick Facts

Study Start:2024-12
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06588686

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Thomas Eskildsen, MSc. pharm.
CONTACT
+46 317880560
info@vicorepharma.com
Cecilia Ganslandt, MD
CONTACT
+46 317880560
info@vicorepharma.com

Study Locations (Sites)

UAB Hospital
Birmingham, Alabama, 35294
United States
Paradigm Clinical Research
La Mesa, California, 92942
United States
Keck Medicine of University of Southern California
Los Angeles, California, 90033
United States
Paradigm Clinical Research Centers, Inc.
Redding, California, 96001
United States
UC Davis Health System
Sacramento, California, 95816
United States
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103
United States
National Jewish Medical and Research Center
Denver, Colorado, 80206
United States
University of Florida Health (UF Health)
Gainesville, Florida, 32610
United States
Clinical Research Specialists
Kissimmee, Florida, 34746
United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
United States
Northshore University Health System Research Institute
Evanston, Illinois, 60201
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073
United States
Stony Brook University
Stony Brook, New York, 91942
United States
Southeastern Research Center
Winston-Salem, North Carolina, 27103
United States
Cleveland Clinic - Cleveland, Department of Pulmonary Medicine
Cleveland, Ohio, 44106
United States
Oregon Clinic, Pulmonary, Critical Care & Sleep Medicine East
Portland, Oregon, 96001
United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140
United States
Low Country Lung and Critical Care
North Charleston, South Carolina, 29406
United States
Baylor Research Institute d/b/a Baylor Scott & White Research Institute
Dallas, Texas, 75204
United States
University of Utah, Health Sciences Center
Salt Lake City, Utah, 84112
United States
University of Wisconsin Clinical Science Center
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Vicore Pharma AB

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12
Study Completion Date2027-03

Study Record Updates

Study Start Date2024-12
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • Angiotensin, IPF, angiotensin II receptor 2, buloxibutid

Additional Relevant MeSH Terms

  • Idiopathic Pulmonary Fibrosis (IPF)