Learn about Research & Clinical Trials
A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
Study Purpose
This study is open to adults with idiopathic pulmonary fibrosis (IPF) who are at least 40 years old. People taking standard medicines for IPF, including antifibrotic medicines, can continue taking them throughout the study. The purpose of the study is to find out whether a medicine called BI 1015550 can slow down the worsening of lung function. Participants are in the study for about 4 months. During this time, they visit the study site about 7 times. At the beginning, they visit the study site every 2 weeks. After 1 month of treatment, they visit the study site every 4 weeks. The participants are put into 2 groups by chance. 1 group gets BI 1015550. The other group gets placebo. Placebo tablets look like BI 1015550 tablets but contain no medicine. The participants take BI 1015550 or placebo tablets twice a day. The participants have lung function tests at study visits. The results of the lung function tests are compared between the BI 1015550 group and the placebo group. The doctors also regularly check the general health of the participants.
Recruitment Criteria
|
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 40 Years and Over |
| Gender | All |
Inclusion Criteria:
1. Patients aged ≥40 years when signing the informed consent. 2. Diagnosis: 1. IPF based on 2018 ATS/ERS/JRS/ALAT Guideline as confirmed by the investigator based on chest High Resolution Computed Tomography Scan (HRCT) scan taken within 12 months of Visit 1 and if available surgical lung biopsy. and. 2. Usual interstitial pneumonia (UIP) or probable UIP HRCT pattern consistent with the clinical diagnosis of IPF, as confirmed by central review prior to Visit 2*- - if indeterminate HRCT finding IPF may be confirmed locally by (historical) biopsy.
- - not on therapy with nintedanib or pirfenidone for at least 8 weeks prior to Visit 1 (combination of nintedanib plus pirfenidone not allowed), or.
- - on stable* therapy with nintedanib or pirfenidone for at least 8 weeks prior to Visit 1 and planning to stay stable on this background therapy after randomisation.
Exclusion Criteria:
1. Relevant airways obstruction (pre-bronchodilator Forced Expiratory Volume in one second (FEV1)/Forced Vital Capacity (FVC) < 0.7) at Visit 1. 2. In the opinion of the Investigator, other clinically significant pulmonary abnormalities. 3. Acute IPF exacerbation within 4 months prior to screening and/or during the screening period (investigator-determined). 4. Lower respiratory tract infection requiring antibiotics within 4 weeks prior to Visit 1 and/or during the screening period. 5. Major surgery (major according to the investigator's assessment) performed within 3 months prior to Visit 1 or planned during the course of the trial. (Being on a transplant list is allowed). 6. Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1, except appropriately treated basal cell carcinoma of the skin, "under surveillance" prostate cancer or in situ carcinoma of uterine cervix. 7. Evidence of active infection (chronic or acute) based on clinical exam or laboratory findings at Visit 1 or at Visit 2. 8. Any suicidal behaviour in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior). 9. The patient has a confirmed infection with SARS-CoV-2 within the 4 weeks prior to Visit 1 and/or during the screening period. Further exclusion criteria apply.Trial Details
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04419506 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Boehringer Ingelheim |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
| Principal Investigator Affiliation | N/A |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Argentina, Australia, Austria, Canada, Chile, China, Czechia, Denmark, Finland, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, Ukraine, United Kingdom, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Idiopathic Pulmonary Fibrosis |
| Study Website: | View Trial Website |
Arms
Experimental: BI 1015550
Placebo Comparator: Placebo
Interventions
Drug: - BI 1015550
film-coated tablet
Drug: - Placebo
film-coated tablet
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
St. Francis Medical Institute
Clearwater, Florida, 33765
Status
Recruiting
Address
University of Florida
Gainesville, Florida, 32610
Status
Recruiting
Address
University of Kansas Medical Center
Kansas City, Kansas, 66160
Status
Recruiting
Address
Mayo Clinic, Rochester
Rochester, Minnesota, 55905
Status
Recruiting
Address
The Lung Research Center, LLC
Chesterfield, Missouri, 63017
Status
Recruiting
Address
Creighton University
Omaha, Nebraska, 68124
Status
Recruiting
Address
Southeastern Research Center
Winston-Salem, North Carolina, 27103
Status
Recruiting
Address
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Status
Recruiting
Address
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Status
Recruiting
Address
Diagnostics Research Group
San Antonio, Texas, 78229
Status
Recruiting
Address
University of Utah Health Sciences Center
Salt Lake City, Utah, 84108
International Sites
Status
Recruiting
Address
Centro de Investigaciones Metabólicas (CINME)
C.a.b.a, , C1027AAP
Status
Recruiting
Address
INSARES
Mendoza, , M5500CCG
Status
Recruiting
Address
Instituto Médico de la Fundación Estudios Clínicos
Rosario, , S2000DEJ
Status
Recruiting
Address
Royal Prince Alfred Hospital
Camperdown, Sydney, New South Wales, 2050
Status
Recruiting
Address
The Alfred Hospital
Melbourne, Victoria, 3004
Status
Recruiting
Address
LKH-Univ. Hospital Graz
Graz, , 8036
Status
Recruiting
Address
Kepler Univ. Klinikum Linz
Linz, , 4021
Status
Recruiting
Address
AKH - Medical University of Vienna
Vienna, , 1090
Status
Completed
Address
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Status
Active, not recruiting
Address
Dr. Georges-L.-Dumont University Hospital Centre
Moncton, New Brunswick, E1C 2Z3
Status
Active, not recruiting
Address
Queen's University
Kingston, Ontario, K7L 2V6
Status
Active, not recruiting
Address
Dr. Syed Anees Medicine Professional Corporation
Windsor, Ontario, N8X 1T3
Status
Active, not recruiting
Address
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 0A9
Status
Recruiting
Address
Instituto Nacional del Tórax
Providencia, Santiago De Chile, , 7500691
Status
Recruiting
Address
Centro de Investigación del Maule
Talca, , 3465586
Status
Recruiting
Address
Peking Union Medical College Hospital
Beijing, , 100032
Status
Recruiting
Address
The Second Hospital of Jilin University
Changchun, , 130041
Status
Recruiting
Address
West China Hospital
Chengdu, , 610041
Status
Recruiting
Address
Zhongshan Hospital Fudan University
Shanghai, , 200032
Status
Recruiting
Address
Shanghai Pulmonary Hospital
Shanghai, , 200433
Status
Recruiting
Address
Thomayer Hospital
Praha 4 - Krc, , 140 59
Status
Recruiting
Address
University Hospital Na Bulovce, Prague
Praha, , 180 81
Status
Recruiting
Address
Aarhus University Hospital
Aarhus N, , 8200
Status
Recruiting
Address
Herlev and Gentofte Hospital
Hellerup, , 2900
Status
Recruiting
Address
Odense University Hospital
Odense C, , 5000
Status
Recruiting
Address
HYKS Keuhkosairauksien tutkimusyksikkö
Helsinki, , 00290
Status
Recruiting
Address
KYS, Keuhkosairauksien
Kuopio, , 70210
Status
Recruiting
Address
Oulun yliopistollinen keskussairaala
Oulu, , FIN-90220
Status
Recruiting
Address
Tampere University Hospital
Tampere, , 33521
Status
Recruiting
Address
TYKS, Keuhkosairauksien klinikka, Turku
Turku, , 20520
Status
Completed
Address
Fachkrankenhaus Coswig GmbH
Coswig, , 01640
Status
Active, not recruiting
Address
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, , 45239
Status
Active, not recruiting
Address
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, , 69126
Status
Completed
Address
Lungenfachklinik Immenhausen
Immenhausen, , 34376
Status
Completed
Address
Universitätsklinikum Münster
Münster, , 48149
Status
Recruiting
Address
Athens Medical Center
Athens, , 15125
Status
Recruiting
Address
University General Hospital of Heraklion
Crete, , 71110
Status
Recruiting
Address
Univ. Gen. Hosp. of Patras
Patras, , 26504
Status
Recruiting
Address
A Pulmonology Clinic "G.Papanikolaou" Hospital Thessaloniki
Thessaloniki, , 57010
Status
Recruiting
Address
Semmelweis University
Budapest, , 1085
Status
Recruiting
Address
Ospedale Colonnello D Avanzo
Foggia, , 71100
Status
Recruiting
Address
Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli
FORLì, , 47121
Status
Recruiting
Address
Azienda Ospedaliera Universitaria di Padova
Padova, , 35128
Status
Recruiting
Address
Az. Ospedaliera Universitaria Polic.Tor Vergata
Roma, , 00133
Status
Recruiting
Address
Policlinico Gemelli
Roma, , 00168
Status
Recruiting
Address
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, , 53100
Status
Recruiting
Address
AO Città della Salute e della
Torino, , 10126
Status
Recruiting
Address
Tosei General Hospital
Aichi, Seto, , 489-8642
Status
Recruiting
Address
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, , 810-8563
Status
Recruiting
Address
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, , 236-0051
Status
Recruiting
Address
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, , 591-8555
Status
Recruiting
Address
Hamamatsu University Hospital
Shizuoka, Hamamatsu, , 431-3192
Status
Recruiting
Address
Center Hospital of the National Center for Global Health and Medicine
Tokyo, Shinjuku-ku, , 162-8655
Status
Completed
Address
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon, , 14647
Status
Completed
Address
Seoul National University Hospital
Seoul, , 03080
Status
Recruiting
Address
Asan Medical Center
Seoul, , 05505
Status
Recruiting
Address
Amsterdam UMC Locatie VUMC
Amsterdam, , 1081 HV
Status
Recruiting
Address
Zuyderland Medisch Centrum
Heerlen, , 6419 PC
Status
Recruiting
Address
St. Antonius ziekenhuis, locatie Nieuwegein
Nieuwegein, , 3435 CM
Status
Recruiting
Address
Erasmus Medisch Centrum
Rotterdam, , 3015 CE
Status
Recruiting
Address
University Clinical Center, Gdansk
Gdansk, , 80-214
Status
Recruiting
Address
Norbert Barlicki University Clinical Hospital No.1, Lodz
Lodz, , 90-141
Status
Recruiting
Address
Res.Inst.-Compl.Iss.Cardi.Dis.
Kemerovo, , 650002
Status
Recruiting
Address
Federal state budgetary scientific institution "Research Institute of occupational medicine named after academician N. F. Izmerov
Moscow, , 105275
Status
Recruiting
Address
Central Scientific Research Insitute of Tuberculosis
Moscow, , 107564
Status
Recruiting
Address
Moscow 1st State Med.Univ.n.a.I.M.Sechenov
Moscow, , 119992
Status
Recruiting
Address
Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl
Yaroslavl, , 150003
Status
Recruiting
Address
Policlínica Barcelona
Barcelona, , 08006
Status
Recruiting
Address
Hospital Clínic de Barcelona
Barcelona, , 08036
Status
Recruiting
Address
Hospital de Bellvitge
L'Hospitalet de Llobregat, , 08907
Status
Recruiting
Address
Hospital La Princesa
Madrid, , 28006
Status
Recruiting
Address
Hospital Central de Asturias
Oviedo, , 33011
Status
Recruiting
Address
Hospital Son Espases
Palma de Mallorca, , 07120
Status
Recruiting
Address
Dnyepropyetrovsk Medical Academy, Clinical Hospital No. 6
Dnyepropyetrovsk, , 49074
Status
Recruiting
Address
Instit.Phthisiology&Pulmon.na Yanovskiy,Non-Specif.Lung,Kyiv
Kyiv, , 03680
Status
Recruiting
Address
Southmead Hospital
Bristol, , BS10 5NB
Status
Recruiting
Address
Royal Brompton Hospital
London, , SW3 6NP
