A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)

Phase 2

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: BI 1015550; Drug: Placebo

• Registration Number: NCT04419506
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-05
• Study Start: 2020-07-28
• Primary Completion: 2021-10-06
• Study Completion: 2021-10-15
• Status Verified: 2022-10
• Results First Submitted: 2022-10-05
• Results First Submitted QC: 2022-10-05
• Last Update Submitted: 2022-10-05
• Results First Posted: 2022-11-01
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 1015550, Antifibrotics at baseline	BI 1015550	Idiopathic pulmonary fibrosis (IPF) patients on stable antifibrotic treatment with nintedanib or pirfenidone at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their stable background therapy of nintedanib or prifenidone.
Placebo, Antifibrotics at baseline	Placebo	Idiopathic pulmonary fibrosis (IPF) patients on stable antifibrotic treatment with nintedanib or pirfenidone at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their stable background therapy of nintedanib or prifenidone.
Placebo, Non-antifibrotics at baseline	Placebo	Idiopathic pulmonary fibrosis (IPF) patients not on stable antifibrotic treatment at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks.
BI 1015550, Non-antifibrotics at baseline	BI 1015550	Idiopathic pulmonary fibrosis (IPF) patients not on stable antifibrotic treatment at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks.

Primary Outcome Measures

Name	Time	Method
The Change From Baseline in Forced Vital Capacity (FVC) at 12 Weeks	Baseline (day 1) and week 12.	The change from baseline in Forced vital capacity (FVC) at 12 weeks. Data were analysed with a restricted maximum likelihood (REML)-based approach using a mixed model with repeated measures (MMRM). The analysis included the fixed, categorical effect of treatment at each visit, and the fixed, continuous effects of baseline FVC at each visit. Visit was treated as the repeated measure, with an unstructured covariance structure used to model the within-patient measurements.

Secondary Outcome Measures

Name	Time	Method
The Number of Patients With Treatment Emergent Adverse Event	From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.	The number of patients with any adverse event during the on-treatment period.

Trial Locations

Locations (75)

University Hospital Na Bulovce, Prague; 🇨🇿 Praha, Czechia

Azienda Ospedaliera Universitaria di Padova; 🇮🇹 Padova, Italy

A.O.U. Senese Policlinico Santa Maria alle Scotte; 🇮🇹 Siena, Italy

National Hospital Organization Kyushu Medical Center; 🇯🇵 Fukuoka, Fukuoka, Japan

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH; 🇩🇪 Essen, Germany

LKH-Univ. Hospital Graz; 🇦🇹 Graz, Austria

Ospedale Colonnello D Avanzo; 🇮🇹 Foggia, Italy

Athens Medical Center; 🇬🇷 Athens, Greece

Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Universitätsklinikum Münster; 🇩🇪 Münster, Germany

National Hospital Organization Kinki-Chuo Chest Medical Center; 🇯🇵 Osaka, Sakai, Japan

Instit.Phthisiology&Pulmon.na Yanovskiy,Non-Specif.Lung,Kyiv; 🇺🇦 Kyiv, Ukraine

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, China

Centro de Investigaciones Metabólicas (CINME); 🇦🇷 C.a.b.a, Argentina

The Catholic University of Korea, Bucheon St.Mary's Hospital; 🇰🇷 Bucheon, Korea, Republic of

Tosei General Hospital; 🇯🇵 Aichi, Seto, Japan

Hamamatsu University Hospital; 🇯🇵 Shizuoka, Hamamatsu, Japan

University Thomayer's Hospital; 🇨🇿 Praha 4 - Krc, Czechia

Southmead Hospital; 🇬🇧 Bristol, United Kingdom

Moscow 1st State Med.Univ.n.a.I.M.Sechenov; 🇷🇺 Moscow, Russian Federation

Poli Univ A. Gemelli; 🇮🇹 Roma, Italy

Hospital Central de Asturias; 🇪🇸 Oviedo, Spain

Center Hospital of the National Center for Global Health and Medicine; 🇯🇵 Tokyo, Shinjuku-ku, Japan

Lungenfachklinik Immenhausen; 🇩🇪 Immenhausen, Germany

Kanagawa Cardiovascular and Respiratory Center; 🇯🇵 Kanagawa, Yokohama, Japan

HYKS Keuhkosairauksien tutkimusyksikkö; 🇫🇮 Helsinki, Finland

KYS, Keuhkosairauksien; 🇫🇮 Kuopio, Finland

Oulun yliopistollinen keskussairaala; 🇫🇮 Oulu, Finland

University Clinical Center, Gdansk; 🇵🇱 Gdansk, Poland

University General Hospital of Heraklion; 🇬🇷 Crete, Greece

Hospital Son Espases; 🇪🇸 Palma de Mallorca, Spain

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Fachkrankenhaus Coswig GmbH; 🇩🇪 Coswig, Germany

Dnyepropyetrovsk Medical Academy, Clinical Hospital No. 6; 🇺🇦 Dnyepropyetrovsk, Ukraine

Hospital La Princesa; 🇪🇸 Madrid, Spain

Federal state budgetary scientific institution "Research Institute of occupational medicine named after academician N. F. Izmerov; 🇷🇺 Moscow, Russian Federation

Zuyderland Medisch Centrum; 🇳🇱 Heerlen, Netherlands

St. Antonius ziekenhuis, locatie Nieuwegein; 🇳🇱 Nieuwegein, Netherlands

Erasmus Medisch Centrum; 🇳🇱 Rotterdam, Netherlands

The Second Hospital of Jilin University; 🇨🇳 Changchun, China

West China Hospital; 🇨🇳 Chengdu, China

Zhongshan Hospital Fudan University; 🇨🇳 Shanghai, China

Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark

Herlev and Gentofte Hospital; 🇩🇰 Hellerup, Denmark

Odense University Hospital; 🇩🇰 Odense C, Denmark

Centro de Investigación del Maule; 🇨🇱 Talca, Chile

University of Florida; 🇺🇸 Gainesville, Florida, United States

Instituto Nacional del Tórax; 🇨🇱 Providencia, Santiago De Chile, Chile

Tampere University Hospital; 🇫🇮 Tampere, Finland

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

TYKS; 🇫🇮 Turku, Finland

Dr. Syed Anees Medicine Professional Corporation; 🇨🇦 Windsor, Ontario, Canada

St. Francis Medical Institute; 🇺🇸 Clearwater, Florida, United States

Mayo Clinic, Rochester; 🇺🇸 Rochester, Minnesota, United States

Diagnostics Research Group; 🇺🇸 San Antonio, Texas, United States

The Lung Research Center, LLC; 🇺🇸 Chesterfield, Missouri, United States

University of Utah Health Sciences Center; 🇺🇸 Salt Lake City, Utah, United States

Creighton University; 🇺🇸 Omaha, Nebraska, United States

Dr. Georges-L.-Dumont University Hospital Centre; 🇨🇦 Moncton, New Brunswick, Canada

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Queen's University; 🇨🇦 Kingston, Ontario, Canada

Southeastern Research Center; 🇺🇸 Winston-Salem, North Carolina, United States

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Centre Hospitalier de l'Universite de Montreal (CHUM); 🇨🇦 Montreal, Quebec, Canada

Peking Union Medical College Hospital; 🇨🇳 Beijing, China

Semmelweis University; 🇭🇺 Budapest, Hungary

Univ. Gen. Hosp. of Patras; 🇬🇷 Patras, Greece

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Spain

Policlínica Barcelona; 🇪🇸 Barcelona, Spain

Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl; 🇷🇺 Yaroslavl, Russian Federation

Royal Brompton Hospital; 🇬🇧 London, United Kingdom

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States