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
More Inclusion & Exclusion Criteria

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.
3. Stable for at least 8 weeks prior to Visit 1. Patients have to be either :
  • - 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.
[*stable therapy is defined as the individually and general tolerated regimen of either pirfenidone or nintedanib] 4. Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1. 5. Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin [Hb] [Visit 1]) ≥ 25% to < 80% of predicted normal at Visit 1. 6. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

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 Australia, Austria, Canada, Chile, China, Czechia, Denmark, Finland, Germany, Italy, Japan, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Study Website: View Trial Website
Arms & Interventions

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.

St. Francis Medical Institute, Clearwater, Florida

Status

Recruiting

Address

St. Francis Medical Institute

Clearwater, Florida, 33765

Site Contact

Francis Averill

faverill@stfrancismed.com

+001 (727) 210-4606

University of Florida, Gainesville, Florida

Status

Recruiting

Address

University of Florida

Gainesville, Florida, 32610

University of Kansas Medical Center, Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center

Kansas City, Kansas, 66160

Site Contact

Mark Hamblin

mhamblin@kumc.edu

+001 (913) 588-5273

Mayo Clinic, Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic, Rochester

Rochester, Minnesota, 55905

Site Contact

Teng Moua

Moua.teng@mayo.edu

+001 (507) 266-2497

The Lung Research Center, LLC, Chesterfield, Missouri

Status

Recruiting

Address

The Lung Research Center, LLC

Chesterfield, Missouri, 63017

Creighton University, Omaha, Nebraska

Status

Recruiting

Address

Creighton University

Omaha, Nebraska, 68124

Site Contact

Lee Morrow

lmorrow@creighton.edu

+001 (402) 449-4486

Southeastern Research Center, Winston-Salem, North Carolina

Status

Recruiting

Address

Southeastern Research Center

Winston-Salem, North Carolina, 27103

Site Contact

Barry Sigal

bsigal@salemchest.com

+001 (336) 659-8414

Columbus, Ohio

Status

Recruiting

Address

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210

Site Contact

Nitin Bhatt

nitin.bhatt@osumc.edu

+001 (614) 293-4925

Diagnostics Research Group, San Antonio, Texas

Status

Recruiting

Address

Diagnostics Research Group

San Antonio, Texas, 78229

Site Contact

Charles Andrews

dr.andrews@dxrg.com

+001 (210) 692-7157

International Sites

Royal Prince Alfred Hospital, Camperdown, Sydney, New South Wales, Australia

Status

Recruiting

Address

Royal Prince Alfred Hospital

Camperdown, Sydney, New South Wales, 2050

Site Contact

Tamera Corte

Tamera.Corte@health.nsw.gov.au

612 9515 6120

The Alfred Hospital, Melbourne, Victoria, Australia

Status

Recruiting

Address

The Alfred Hospital

Melbourne, Victoria, 3004

Site Contact

Ian Glaspole

i.glaspole@alfred.org.au

61 3 9076 6963

LKH-Univ. Hospital Graz, Graz, Austria

Status

Recruiting

Address

LKH-Univ. Hospital Graz

Graz, , 8036

Site Contact

Horst Olschewski

horst.olschewski@medunigraz.at

00433163852183

Moncton, New Brunswick, Canada

Status

Recruiting

Address

Dr. Georges-L.-Dumont University Hospital Centre

Moncton, New Brunswick, E1C 2Z3

Site Contact

Marcel Mallet

Marcel.Mallet@vitalitenb.ca

506-869-2030

Queen's University, Kingston, Ontario, Canada

Status

Recruiting

Address

Queen's University

Kingston, Ontario, K7L 2V6

Site Contact

Onofre Moran Mendoza

morano@queensu.ca

613-549-1459

Windsor, Ontario, Canada

Status

Recruiting

Address

Dr. Syed Anees Medicine Professional Corporation

Windsor, Ontario, N8X 1T3

Site Contact

Syed Anees

saneesmd@yahoo.com

519-252-4448

Montreal, Quebec, Canada

Status

Recruiting

Address

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, H2X 0A9

Site Contact

Helene Manganas

helene.manganas.chum@ssss.gouv.qc.ca

613-562-5800

Centro de Investigación del Maule, Talca, Chile

Status

Recruiting

Address

Centro de Investigación del Maule

Talca, , 3465586

Site Contact

Absalon Silva Orellana

rafaelsilvao@gmail.com

+56 71 261 5989

Peking Union Medical College Hospital, Beijing, China

Status

Recruiting

Address

Peking Union Medical College Hospital

Beijing, , 100032

Site Contact

Zuojun Xu

Xuzj@hotmail.com

86-10-65295033

The Second Hospital of Jilin University, Changchun, China

Status

Recruiting

Address

The Second Hospital of Jilin University

Changchun, , 130041

Site Contact

Jie Zhang

doctorzhangj20@126.com

+86 13504326312

West China Hospital, Chengdu, China

Status

Recruiting

Address

West China Hospital

Chengdu, , 610041

Site Contact

Fuqiang Wen

SCHX_1305_0013@163.com

+86 18980601258

Zhongshan Hospital Fudan University, Shanghai, China

Status

Recruiting

Address

Zhongshan Hospital Fudan University

Shanghai, , 200032

Thomayer Hospital, Praha 4 - Krc, Czechia

Status

Recruiting

Address

Thomayer Hospital

Praha 4 - Krc, , 140 59

Aarhus University Hospital, Aarhus N, Denmark

Status

Recruiting

Address

Aarhus University Hospital

Aarhus N, , 8200

Site Contact

Elisabeth Bendstrup

karbends@rm.dk

+45 78462201

Herlev and Gentofte Hospital, Hellerup, Denmark

Status

Recruiting

Address

Herlev and Gentofte Hospital

Hellerup, , 2900

Odense University Hospital, Odense C, Denmark

Status

Recruiting

Address

Odense University Hospital

Odense C, , 5000

Site Contact

Ingrid Titlestad

ingrid.titlestad@rsyd.dk

+4565412740

HYKS Keuhkosairauksien tutkimusyksikkö, Helsinki, Finland

Status

Recruiting

Address

HYKS Keuhkosairauksien tutkimusyksikkö

Helsinki, , 00290

Site Contact

Marjukka Myllärniemi

marjukka.myllarniemi@hus.fi

+35 894711

KYS, Keuhkosairauksien, Kuopio, Finland

Status

Recruiting

Address

KYS, Keuhkosairauksien

Kuopio, , 70210

Site Contact

Minna Purokivi

minna.purokivi@kuh.fi

358447174795

Oulun yliopistollinen keskussairaala, Oulu, Finland

Status

Recruiting

Address

Oulun yliopistollinen keskussairaala

Oulu, , FIN-90220

Site Contact

Riitta Kaarteenaho

riitta.kaarteenaho@oulu.fi

+358 8 3152011

Tampere University Hospital, Tampere, Finland

Status

Recruiting

Address

Tampere University Hospital

Tampere, , 33521

Site Contact

Ismo Strander

Ismo.Strander@pshp.fi

358 50 5503 491

TYKS, Keuhkosairauksien klinikka, Turku, Turku, Finland

Status

Recruiting

Address

TYKS, Keuhkosairauksien klinikka, Turku

Turku, , 20520

Site Contact

Maritta Kilpeläinen

maritta.kilpelainen@tyks.fi

35823134739

Fachkrankenhaus Coswig GmbH, Coswig, Germany

Status

Recruiting

Address

Fachkrankenhaus Coswig GmbH

Coswig, , 01640

Klinik Donaustauf, Donaustauf, Germany

Status

Recruiting

Address

Klinik Donaustauf

Donaustauf, , 93093

Site Contact

Stefan Blaas

stefan.blaas@ukr.de

+49 (9403) 80747

Essen, Germany

Status

Recruiting

Address

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, , 45239

Heidelberg, Germany

Status

Recruiting

Address

Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

Heidelberg, , 69126

Site Contact

Michael Kreuter

kreuter@uni-heidelberg.de

+49 (6221) 3961201

Lungenfachklinik Immenhausen, Immenhausen, Germany

Status

Recruiting

Address

Lungenfachklinik Immenhausen

Immenhausen, , 34376

Universitätsklinikum Münster, Münster, Germany

Status

Recruiting

Address

Universitätsklinikum Münster

Münster, , 48149

Site Contact

Rainer Wiewrodt

rainer.wiewrodt@ukmuenster.de

+49 (251) 8344803

Ospedale Colonnello D Avanzo, Foggia, Italy

Status

Recruiting

Address

Ospedale Colonnello D Avanzo

Foggia, , 71100

Site Contact

Donato Lacedonia

donato.lacedonia@unifg.it

+39 (328) 1264221

FORLì, Italy

Status

Recruiting

Address

Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli

FORLì, , 47121

Site Contact

Claudia Ravaglia

claudiaravaglia79@gmail.com

+39 (0543) 735828

Padova, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria di Padova

Padova, , 35128

Site Contact

Elisabetta Balestro

Elisabetta.balestro@aopd.veneto.it

+39 (049) 8213721

Policlinico Gemelli, Roma, Italy

Status

Recruiting

Address

Policlinico Gemelli

Roma, , 00168

Siena, Italy

Status

Recruiting

Address

A.O.U. Senese Policlinico Santa Maria alle Scotte

Siena, , 53100

Site Contact

Elena Bargagli

bargagli2@gmail.com

+39 (0577) 586710

Fukuoka, Fukuoka, Japan

Status

Recruiting

Address

National Hospital Organization Kyushu Medical Center

Fukuoka, Fukuoka, , 810-8563

Kanagawa, Yokohama, Japan

Status

Recruiting

Address

Kanagawa Cardiovascular and Respiratory Center

Kanagawa, Yokohama, , 236-0051

Site Contact

Hideya Kitamura

kitamura@kanagawa-junko.jp

045-701-9581

Osaka, Sakai, Japan

Status

Recruiting

Address

National Hospital Organization Kinki-Chuo Chest Medical Center

Osaka, Sakai, , 591-8555

Site Contact

Yoshikazu Inoue

giichiyi@me.com

+81 72 2523021

Hamamatsu University Hospital, Shizuoka, Hamamatsu, Japan

Status

Recruiting

Address

Hamamatsu University Hospital

Shizuoka, Hamamatsu, , 431-3192

Site Contact

Yutaro Nakamura

nakayuta@hama-med.ac.jp

+81 53 4352111

Tokyo, Shinjuku-ku, Japan

Status

Recruiting

Address

Center Hospital of the National Center for Global Health and Medicine

Tokyo, Shinjuku-ku, , 162-8655

Site Contact

Shinyu Izumi

shinyu67@hotmail.co.jp

+81 3 32027181

Bucheon, Korea, Republic of

Status

Recruiting

Address

The Catholic University of Korea, Bucheon St.Mary's Hospital

Bucheon, , 14647

Site Contact

Yong-Hyun Kim

kyh30med@catholic.ac.kr

82 10 6654 9704

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital

Seoul, , 03080

Site Contact

Sun Mi Choi

sunmich81@gmail.com

82 2 2072 4915

Asan Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Asan Medical Center

Seoul, , 05505

Site Contact

Jin Woo Song

jwsong@amc.seoul.kr

82 2 3010 3993

Amsterdam UMC Locatie VUMC, Amsterdam, Netherlands

Status

Recruiting

Address

Amsterdam UMC Locatie VUMC

Amsterdam, , 1081 HV

Site Contact

Esther J. Nossent

e.nossent@Amsterdamumc.nl

+31(0)20-4443432

Zuyderland Medisch Centrum, Heerlen, Netherlands

Status

Recruiting

Address

Zuyderland Medisch Centrum

Heerlen, , 6419 PC

Site Contact

R.L.M. Mostard

r.mostard@zuyderland.nl

+31(0) 45 57666 66

Nieuwegein, Netherlands

Status

Recruiting

Address

St. Antonius ziekenhuis, locatie Nieuwegein

Nieuwegein, , 3435 CM

Site Contact

Marcel Veltkamp

m.veltkamp@antoniusziekenhuis.nl

+31 883201572

Erasmus Medisch Centrum, Rotterdam, Netherlands

Status

Recruiting

Address

Erasmus Medisch Centrum

Rotterdam, , 3015 CE

Site Contact

Marlies Wijsenbeek-Lourens

m.wijsenbeek-lourens@erasmusmc.nl

+31(0)10-7030323

Lodz, Poland

Status

Recruiting

Address

Norbert Barlicki University Clinical Hospital No.1, Lodz

Lodz, , 90-141

Res.Inst.-Compl.Iss.Cardi.Dis., Kemerovo, Russian Federation

Status

Recruiting

Address

Res.Inst.-Compl.Iss.Cardi.Dis.

Kemerovo, , 650002

Site Contact

Evgeny Bazdyrev

edb624@mail.ru

+7 3842 34 19 02

Yaroslavl, Russian Federation

Status

Recruiting

Address

Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl

Yaroslavl, , 150003

Site Contact

Vladimir Yakusevich

yakusevich@yandex.ru

+7-4852 73 25 87

Policlínica Barcelona, Barcelona, Spain

Status

Recruiting

Address

Policlínica Barcelona

Barcelona, , 08006

Site Contact

Juan Roldán Sánchez

juan.roldan@giromedinstitute.com

+34627942876

Hospital Clínic de Barcelona, Barcelona, Spain

Status

Recruiting

Address

Hospital Clínic de Barcelona

Barcelona, , 08036

Site Contact

Jacobo Sellares

SELLARES@clinic.cat

+34932275400

Hospital La Princesa, Madrid, Spain

Status

Recruiting

Address

Hospital La Princesa

Madrid, , 28006

Site Contact

Claudia Valenzuela

claudiavale@hotmail.com

+34915202277

Hospital Central de Asturias, Oviedo, Spain

Status

Recruiting

Address

Hospital Central de Asturias

Oviedo, , 33011

Site Contact

Miguel Arias

miguelariasguillen@gmail.com

+34985108000

Hospital Son Espases, Palma de Mallorca, Spain

Status

Recruiting

Address

Hospital Son Espases

Palma de Mallorca, , 07120

Site Contact

Jaume Sauleda

jaume.sauleda@ssib.es

+34871206718

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