RECRUITING

A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast

Talk to us

Conditions

Idiopathic Pulmonary FibrosisProgressive Pulmonary Fibrosis

Quick Navigation

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

This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550. The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die. Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study. Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.

Official Title

An Open-label Extension Trial of the Long-term Safety and Efficacy of BI 1015550 Taken Orally in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) (FIBRONEER™-ON)

Quick Facts

Study Start:2024-09-24
Study Completion:2027-05-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06238622

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients who completed treatment in the parent trials (1305-0014, 1305-0023, or 1305-0035) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption)
  2. 2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
  3. 3. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. WOCBP taking oral contraceptives (OCs) also have to ensure the use of one barrier method during sexual intercourse with their partner, e.g., condom to account for the risk of potentially reduced efficacy of the OCs in the event of severe vomiting and diarrhoea. For France, fertile males must be ready and able to use acceptable methods of birth control
  1. 1. Any disease that may put the patient at risk when participating in this trial at investigator's discretion.
  2. 2. Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1:
  3. * any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)
  4. * any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)
  5. 3. Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore \>14 at Visit 1.
  6. 4. An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit 1.
  7. 5. Patient will undergo lung transplantation, with an assigned date of surgery.
  8. 6. Patients with a Body Mass index (BMI) \<18.5 kg/m² that experienced an additional, unexplained and clinically significant (\>10%) weight loss during the parent trial
  9. 7. At Visit 1, patients with ongoing Adverse Event of Special Interest (AESI), except for latent tuberculosis (suspected vasculitis, Drug Induced Liver Injury (DILI), severe infections) that led to temporary treatment interruption in the parent trial
  10. 8. Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial.

Contacts and Locations

Study Contact

Boehringer Ingelheim
CONTACT
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
University of Arizona
Tucson, Arizona, 85724
United States
University of Southern California
Los Angeles, California, 90033
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
University of California Los Angeles
Los Angeles, California, 90095
United States
University of California Davis
Sacramento, California, 95817
United States
National Jewish Health
Denver, Colorado, 80206
United States
Yale University School of Medicine
New Haven, Connecticut, 06510
United States
Christiana Hospital
Newark, Delaware, 19713
United States
Georgetown University
Washington, District of Columbia, 20007
United States
St. Francis Medical Institute
Clearwater, Florida, 33765
United States
University of Florida
Gainesville, Florida, 32610
United States
Clinical Research Specialists LLC
Kissimmee, Florida, 34746
United States
Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida, 33470
United States
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
Atlanta, Georgia, 30309
United States
The Emory Clinic
Atlanta, Georgia, 30322
United States
Northshore University Health System
Evanston, Illinois, 60201
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Tulane Medical Center
New Orleans, Louisiana, 70112
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21224
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
University of Michigan Health System
Ann Arbor, Michigan, 48109
United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Mayo Clinic, Rochester
Rochester, Minnesota, 55905
United States
The Lung Research Center, LLC
Chesterfield, Missouri, 63017
United States
Creighton University
Omaha, Nebraska, 68124
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Renown Regional Medical Center
Reno, Nevada, 89502
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Northern Westchester Hospital
Mount Kisco, New York, 10549
United States
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, 10032
United States
NewYork-Presbyterian/Weill Cornell Medical Center
New York, New York, 10065
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Southeastern Research Center-Winston Salem-69289
Winston-Salem, North Carolina, 27103
United States
University of Cincinnati
Cincinnati, Ohio, 45267
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States
The Oregon Clinic
Portland, Oregon, 97220
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
Infinity Medical Research, Inc.
East Providence, Rhode Island, 02914
United States
Lowcountry Lung and Critical Care
Charleston, South Carolina, 29406
United States
Clinical Trials Center of Middle Tennessee, LLC
Franklin, Tennessee, 37067
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37204
United States
Baylor University Medical Center
Dallas, Texas, 75246
United States
UT Health San Antonio
San Antonio, Texas, 78229
United States
Intermountain Medical Center-Murray-69497
Murray, Utah, 84107
United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84108
United States
University of Vermont
Burlington, Vermont, 05401
United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042
United States
Virginia Mason Medical Center
Seattle, Washington, 98101
United States
University of Wisconsin
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Boehringer Ingelheim

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 Date2024-09-24
Study Completion Date2027-05-05

Study Record Updates

Study Start Date2024-09-24
Study Completion Date2027-05-05

Terms related to this study

Additional Relevant MeSH Terms

  • Idiopathic Pulmonary Fibrosis
  • Progressive Pulmonary Fibrosis