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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BI 1015550
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Francis Medical Institute
  • University of Florida
  • University of Kansas Medical Center
  • Mayo Clinic, Rochester
  • The Lung Research Center, LLC
  • Creighton University
  • Southeastern Research Center
  • The Ohio State University Wexner Medical Center
  • Temple University Hospital
  • Diagnostics Research Group
  • University of Utah Health Sciences Center
  • Centro de Investigaciones Metabólicas (CINME)
  • The Alfred Hospital
  • LKH-Univ. Hospital Graz
  • St. Paul's Hospital
  • Dr. Georges-L.-Dumont University Hospital Centre
  • Queen's University
  • Dr. Syed Anees Medicine Professional Corporation
  • Centre Hospitalier de l'Universite de Montreal (CHUM)
  • Instituto Nacional del Tórax
  • Centro de Investigación del Maule
  • Peking Union Medical College Hospital
  • The Second Hospital of Jilin University
  • West China Hospital
  • Zhongshan Hospital Fudan University
  • Shanghai Pulmonary Hospital
  • University Thomayer's Hospital
  • University Hospital Na Bulovce, Prague
  • Aarhus University Hospital
  • Herlev and Gentofte Hospital
  • Odense University Hospital
  • HYKS Keuhkosairauksien tutkimusyksikkö
  • KYS, Keuhkosairauksien
  • Oulun yliopistollinen keskussairaala
  • Tampere University Hospital
  • TYKS
  • Fachkrankenhaus Coswig GmbH
  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
  • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
  • Lungenfachklinik Immenhausen
  • Universitätsklinikum Münster
  • Athens Medical Center
  • University General Hospital of Heraklion
  • Univ. Gen. Hosp. of Patras
  • Semmelweis University
  • Ospedale Colonnello D Avanzo
  • Azienda Ospedaliera Universitaria di Padova
  • Poli Univ A. Gemelli
  • A.O.U. Senese Policlinico Santa Maria alle Scotte
  • Tosei General Hospital
  • National Hospital Organization Kyushu Medical Center
  • Kanagawa Cardiovascular and Respiratory Center
  • National Hospital Organization Kinki-Chuo Chest Medical Center
  • Hamamatsu University Hospital
  • Center Hospital of the National Center for Global Health and Medicine
  • The Catholic University of Korea, Bucheon St.Mary's Hospital
  • Seoul National University Hospital
  • Asan Medical Center
  • Zuyderland Medisch Centrum
  • St. Antonius ziekenhuis, locatie Nieuwegein
  • Erasmus Medisch Centrum
  • University Clinical Center, Gdansk
  • Federal state budgetary scientific institution "Research Institute of occupational medicine named after academician N. F. Izmerov
  • Moscow 1st State Med.Univ.n.a.I.M.Sechenov
  • Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl
  • Policlínica Barcelona
  • Hospital Clínic de Barcelona
  • Hospital de Bellvitge
  • Hospital La Princesa
  • Hospital Central de Asturias
  • Hospital Son Espases
  • Dnyepropyetrovsk Medical Academy, Clinical Hospital No. 6
  • Instit.Phthisiology&Pulmon.na Yanovskiy,Non-Specif.Lung,Kyiv
  • Southmead Hospital
  • Royal Brompton Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Placebo, Antifibrotics at baseline

BI 1015550, Antifibrotics at baseline

Placebo, Non-antifibrotics at baseline

BI 1015550, Non-antifibrotics at baseline

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

The Change From Baseline in Forced Vital Capacity (FVC) at 12 Weeks
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

The Number of Patients With Treatment Emergent Adverse Event
The number of patients with any adverse event during the on-treatment period.

Full Information

First Posted
June 4, 2020
Last Updated
October 5, 2022
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT04419506
Brief Title
A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
Official Title
A Randomised, Double-blind, Placebo-controlled Parallel Group Study in IPF Patients Over 12 Weeks Evaluating Efficacy, Safety and Tolerability of BI 1015550 Taken Orally
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 28, 2020 (Actual)
Primary Completion Date
October 6, 2021 (Actual)
Study Completion Date
October 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo, Antifibrotics at baseline
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
BI 1015550, Antifibrotics at baseline
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo, Non-antifibrotics at baseline
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
BI 1015550, Non-antifibrotics at baseline
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
BI 1015550
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Change From Baseline in Forced Vital Capacity (FVC) at 12 Weeks
Description
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.
Time Frame
Baseline (day 1) and week 12.
Secondary Outcome Measure Information:
Title
The Number of Patients With Treatment Emergent Adverse Event
Description
The number of patients with any adverse event during the on-treatment period.
Time Frame
From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged ≥40 years when signing the informed consent. Diagnosis: 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 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 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] Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1 Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin [Hb] [Visit 1]) ≥ 25% to < 80% of predicted normal at Visit 1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. Exclusion Criteria: Relevant airways obstruction (pre-bronchodilator Forced Expiratory Volume in one second (FEV1)/Forced Vital Capacity (FVC) < 0.7) at Visit 1. In the opinion of the Investigator, other clinically significant pulmonary abnormalities. Acute IPF exacerbation within 4 months prior to screening and/or during the screening period (investigator-determined). Lower respiratory tract infection requiring antibiotics within 4 weeks prior to Visit 1 and/or during the screening period. 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). 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. Evidence of active infection (chronic or acute) based on clinical exam or laboratory findings at Visit 1 or at Visit 2. Any suicidal behaviour in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior). 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.
Facility Information:
Facility Name
St. Francis Medical Institute
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Mayo Clinic, Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
The Lung Research Center, LLC
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Southeastern Research Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Diagnostics Research Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Centro de Investigaciones Metabólicas (CINME)
City
C.a.b.a
ZIP/Postal Code
C1027AAP
Country
Argentina
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
LKH-Univ. Hospital Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Dr. Georges-L.-Dumont University Hospital Centre
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 2Z3
Country
Canada
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V6
Country
Canada
Facility Name
Dr. Syed Anees Medicine Professional Corporation
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 1T3
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Instituto Nacional del Tórax
City
Providencia, Santiago De Chile
ZIP/Postal Code
7500691
Country
Chile
Facility Name
Centro de Investigación del Maule
City
Talca
ZIP/Postal Code
3465586
Country
Chile
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
The Second Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130041
Country
China
Facility Name
West China Hospital
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
University Thomayer's Hospital
City
Praha 4 - Krc
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
University Hospital Na Bulovce, Prague
City
Praha
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Herlev and Gentofte Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Odense University Hospital
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
HYKS Keuhkosairauksien tutkimusyksikkö
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
KYS, Keuhkosairauksien
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Oulun yliopistollinen keskussairaala
City
Oulu
ZIP/Postal Code
FIN-90220
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
TYKS
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Fachkrankenhaus Coswig GmbH
City
Coswig
ZIP/Postal Code
01640
Country
Germany
Facility Name
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
City
Essen
ZIP/Postal Code
45239
Country
Germany
Facility Name
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Lungenfachklinik Immenhausen
City
Immenhausen
ZIP/Postal Code
34376
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Athens Medical Center
City
Athens
ZIP/Postal Code
15125
Country
Greece
Facility Name
University General Hospital of Heraklion
City
Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
Univ. Gen. Hosp. of Patras
City
Patras
ZIP/Postal Code
26504
Country
Greece
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Ospedale Colonnello D Avanzo
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Poli Univ A. Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
A.O.U. Senese Policlinico Santa Maria alle Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Tosei General Hospital
City
Aichi, Seto
ZIP/Postal Code
489-8642
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center
City
Fukuoka, Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Kanagawa Cardiovascular and Respiratory Center
City
Kanagawa, Yokohama
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
National Hospital Organization Kinki-Chuo Chest Medical Center
City
Osaka, Sakai
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Hamamatsu University Hospital
City
Shizuoka, Hamamatsu
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Center Hospital of the National Center for Global Health and Medicine
City
Tokyo, Shinjuku-ku
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
The Catholic University of Korea, Bucheon St.Mary's Hospital
City
Bucheon
ZIP/Postal Code
14647
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Zuyderland Medisch Centrum
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
St. Antonius ziekenhuis, locatie Nieuwegein
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
University Clinical Center, Gdansk
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Federal state budgetary scientific institution "Research Institute of occupational medicine named after academician N. F. Izmerov
City
Moscow
ZIP/Postal Code
105275
Country
Russian Federation
Facility Name
Moscow 1st State Med.Univ.n.a.I.M.Sechenov
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
Facility Name
Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Policlínica Barcelona
City
Barcelona
ZIP/Postal Code
08006
Country
Spain
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de Bellvitge
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Central de Asturias
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Son Espases
City
Palma de Mallorca
ZIP/Postal Code
07120
Country
Spain
Facility Name
Dnyepropyetrovsk Medical Academy, Clinical Hospital No. 6
City
Dnyepropyetrovsk
ZIP/Postal Code
49074
Country
Ukraine
Facility Name
Instit.Phthisiology&Pulmon.na Yanovskiy,Non-Specif.Lung,Kyiv
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Southmead Hospital
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
IPD Sharing Time Frame
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD Sharing Access Criteria
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
IPD Sharing URL
https://www.mystudywindow.com/msw/datasharing
Citations:
PubMed Identifier
35569036
Citation
Richeldi L, Azuma A, Cottin V, Hesslinger C, Stowasser S, Valenzuela C, Wijsenbeek MS, Zoz DF, Voss F, Maher TM; 1305-0013 Trial Investigators. Trial of a Preferential Phosphodiesterase 4B Inhibitor for Idiopathic Pulmonary Fibrosis. N Engl J Med. 2022 Jun 9;386(23):2178-2187. doi: 10.1056/NEJMoa2201737. Epub 2022 May 15.
Results Reference
derived
Links:
URL
http://mystudywindow.com
Description
Related Info

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

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