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

Purpose

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.

Conditions

  • Idiopathic Pulmonary Fibrosis
  • Progressive Pulmonary Fibrosis

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  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. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial 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

Exclusion Criteria

  1. Any disease that may put the patient at risk when participating in this trial at investigator's discretion. 2. Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1: - any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour) - 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) 3. Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore >14 at Visit 1. 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. 5. Patient will undergo lung transplantation, with an assigned date of surgery. 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 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 8. Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial. Further exclusion criteria apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BI 1015550 treatment group
  • Drug: BI 1015550
    BI 1015550
    Other names:
    • Nerandomilast

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

University of Southern California
Los Angeles, California 90033
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Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Cedars-Sinai Medical Center
Los Angeles, California 90048
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Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

University of California Los Angeles
Los Angeles, California 90095
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Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

University of California Davis
Sacramento, California 95817
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Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

National Jewish Health
Denver, Colorado 80206
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Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Yale University School of Medicine
New Haven, Connecticut 06510
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Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Christiana Hospital
Newark, Delaware 19713
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Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Georgetown University
Washington, District of Columbia 20007
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Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

St. Francis Medical Institute
Clearwater, Florida 33765
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Boehringer Ingelheim
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unitedstates@bitrialsupport.com

University of Florida
Gainesville, Florida 32610
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Boehringer Ingelheim
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unitedstates@bitrialsupport.com

Clinical Research Specialists LLC
Kissimmee, Florida 34746
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Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida 33470
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Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
Atlanta, Georgia 30309
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Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Northshore University Health System
Evanston, Illinois 60201
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Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

University of Kansas Medical Center
Kansas City, Kansas 66160
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Boehringer Ingelheim
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Tulane Medical Center
New Orleans, Louisiana 70112
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Johns Hopkins Hospital
Baltimore, Maryland 21224
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Massachusetts General Hospital
Boston, Massachusetts 02114
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Brigham and Women's Hospital
Boston, Massachusetts 02115
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Boehringer Ingelheim
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unitedstates@bitrialsupport.com

St. Elizabeth's Medical Center
Boston, Massachusetts 02135
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Boehringer Ingelheim
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Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
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Boehringer Ingelheim
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University of Michigan Health System
Ann Arbor, Michigan 48109
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Boehringer Ingelheim
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Corewell Health William Beaumont University Hospital
Royal Oak, Michigan 48073
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Boehringer Ingelheim
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unitedstates@bitrialsupport.com

University of Minnesota
Minneapolis, Minnesota 55455
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Boehringer Ingelheim
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unitedstates@bitrialsupport.com

Mayo Clinic, Rochester
Rochester, Minnesota 55905
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Boehringer Ingelheim
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The Lung Research Center, LLC
Chesterfield, Missouri 63017
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Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Creighton University
Omaha, Nebraska 68124
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University of Nebraska Medical Center
Omaha, Nebraska 68198
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Renown Regional Medical Center
Reno, Nevada 89502
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Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
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Northern Westchester Hospital
Mount Kisco, New York 10549
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Columbia University Medical Center-New York Presbyterian Hospital
New York, New York 10032
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NewYork-Presbyterian/Weill Cornell Medical Center
New York, New York 10065
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Duke University Medical Center
Durham, North Carolina 27710
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Boehringer Ingelheim
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Southeastern Research Center-Winston Salem-69289
Winston-Salem, North Carolina 27103
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Cleveland Clinic
Cleveland, Ohio 44195
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Boehringer Ingelheim
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The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
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Boehringer Ingelheim
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unitedstates@bitrialsupport.com

The Oregon Clinic
Portland, Oregon 97220
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Boehringer Ingelheim
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University of Pennsylvania
Philadelphia, Pennsylvania 19104
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Temple University Hospital
Philadelphia, Pennsylvania 19140
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Boehringer Ingelheim
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Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
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Boehringer Ingelheim
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Infinity Medical Research, Inc.
East Providence, Rhode Island 02914
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Boehringer Ingelheim
833-602-2368
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Lowcountry Lung and Critical Care
Charleston, South Carolina 29406
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Boehringer Ingelheim
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Clinical Trials Center of Middle Tennessee, LLC
Franklin, Tennessee 37067
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Boehringer Ingelheim
833-602-2368
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Vanderbilt University Medical Center
Nashville, Tennessee 37204
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Boehringer Ingelheim
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unitedstates@bitrialsupport.com

Baylor University Medical Center
Dallas, Texas 75246
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Boehringer Ingelheim
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UT Health San Antonio
San Antonio, Texas 78229
Contact:
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

University of Utah Health Sciences Center
Salt Lake City, Utah 84108
Contact:
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Inova Fairfax Hospital
Falls Church, Virginia 22042
Contact:
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Virginia Mason Medical Center
Seattle, Washington 98101
Contact:
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

University of Wisconsin
Madison, Wisconsin 53792
Contact:
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

More Details

NCT ID
NCT06238622
Status
Recruiting
Sponsor
Boehringer Ingelheim

Study Contact

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