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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004167-45 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo, Antifibrotics at baseline | Placebo Comparator | 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. |
|
| BI 1015550, Antifibrotics at baseline | Experimental | 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, Non-antifibrotics at baseline | Placebo Comparator | 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 | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1015550 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (day 1) and week 12. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Patients With Treatment Emergent Adverse Event | The number of patients with any adverse event during the on-treatment period. | From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days. |
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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*
Stable for at least 8 weeks prior to Visit 1. Patients have to be either :
[*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:
Further exclusion criteria apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Francis Medical Institute | Clearwater | Florida | 33765 | United States | ||
| University of Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35569036 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
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.
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'.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This was a trial with a randomised, placebo-controlled, double-blind, parallel-group design over 12 weeks, including a screening period of up to 44 days, a 12-week treatment period, and a 1-week follow-up period in patients with idiopathic pulmonary fibrosis (IPF) stratified by baseline antifibrotic treatment (Non-AF stratum: patients not on antifibrotic treatment at baseline; AF stratum: stable antifibrotic treatment with nintedanib or pirfenidone at baseline).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo - Antifibrotics at Baseline | Idiopathic pulmonary fibrosis (IPF) patients on 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 background therapy of nintedanib or prifenidone. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 9, 2020 | Jul 19, 2022 |
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|
| Placebo | Drug | 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. |
|
| Gainesville |
| Florida |
| 32610 |
| United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Mayo Clinic, Rochester | Rochester | Minnesota | 55905 | United States |
| The Lung Research Center, LLC | Chesterfield | Missouri | 63017 | United States |
| Creighton University | Omaha | Nebraska | 68124 | United States |
| Southeastern Research Center | Winston-Salem | North Carolina | 27103 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Diagnostics Research Group | San Antonio | Texas | 78229 | United States |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84108 | United States |
| Centro de Investigaciones Metabólicas (CINME) | C.a.b.a | C1027AAP | Argentina |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| LKH-Univ. Hospital Graz | Graz | 8036 | Austria |
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Dr. Georges-L.-Dumont University Hospital Centre | Moncton | New Brunswick | E1C 2Z3 | Canada |
| Queen's University | Kingston | Ontario | K7L 2V6 | Canada |
| Dr. Syed Anees Medicine Professional Corporation | Windsor | Ontario | N8X 1T3 | Canada |
| Centre Hospitalier de l'Universite de Montreal (CHUM) | Montreal | Quebec | H2X 0A9 | Canada |
| Instituto Nacional del Tórax | Providencia, Santiago de Chile | 7500691 | Chile |
| Centro de Investigación del Maule | Talca | 3465586 | Chile |
| Peking Union Medical College Hospital | Beijing | 100032 | China |
| The Second Hospital of Jilin University | Changchun | 130041 | China |
| West China Hospital | Chengdu | 610041 | China |
| Zhongshan Hospital Fudan University | Shanghai | 200032 | China |
| Shanghai Pulmonary Hospital | Shanghai | 200433 | China |
| University Hospital Na Bulovce, Prague | Prague | 180 81 | Czechia |
| University Thomayer's Hospital | Praha 4 - Krc | 140 59 | Czechia |
| Aarhus University Hospital | Aarhus N | 8200 | Denmark |
| Herlev and Gentofte Hospital | Hellerup | 2900 | Denmark |
| Odense University Hospital | Odense C | 5000 | Denmark |
| HYKS Keuhkosairauksien tutkimusyksikkö | Helsinki | 00290 | Finland |
| KYS, Keuhkosairauksien | Kuopio | 70210 | Finland |
| Oulun yliopistollinen keskussairaala | Oulu | FIN-90220 | Finland |
| Tampere University Hospital | Tampere | 33521 | Finland |
| TYKS | Turku | 20520 | Finland |
| Fachkrankenhaus Coswig GmbH | Coswig | 01640 | Germany |
| Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH | Essen | 45239 | Germany |
| Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg | Heidelberg | 69126 | Germany |
| Lungenfachklinik Immenhausen | Immenhausen | 34376 | Germany |
| Universitätsklinikum Münster | Münster | 48149 | Germany |
| Athens Medical Center | Athens | 15125 | Greece |
| University General Hospital of Heraklion | Crete | 71110 | Greece |
| Univ. Gen. Hosp. of Patras | Pátrai | 26504 | Greece |
| Semmelweis University | Budapest | 1085 | Hungary |
| Ospedale Colonnello D Avanzo | Foggia | 71100 | Italy |
| Azienda Ospedaliera Universitaria di Padova | Padova | 35128 | Italy |
| Poli Univ A. Gemelli | Roma | 00168 | Italy |
| A.O.U. Senese Policlinico Santa Maria alle Scotte | Siena | 53100 | Italy |
| Tosei General Hospital | Aichi, Seto | 489-8642 | Japan |
| National Hospital Organization Kyushu Medical Center | Fukuoka, Fukuoka | 810-8563 | Japan |
| Kanagawa Cardiovascular and Respiratory Center | Kanagawa, Yokohama | 236-0051 | Japan |
| National Hospital Organization Kinki-Chuo Chest Medical Center | Osaka, Sakai | 591-8555 | Japan |
| Hamamatsu University Hospital | Shizuoka, Hamamatsu | 431-3192 | Japan |
| Center Hospital of the National Center for Global Health and Medicine | Tokyo, Shinjuku-ku | 162-8655 | Japan |
| Zuyderland Medisch Centrum | Heerlen | 6419 PC | Netherlands |
| St. Antonius ziekenhuis, locatie Nieuwegein | Nieuwegein | 3435 CM | Netherlands |
| Erasmus Medisch Centrum | Rotterdam | 3015 CE | Netherlands |
| University Clinical Center, Gdansk | Gdansk | 80-214 | Poland |
| Federal state budgetary scientific institution "Research Institute of occupational medicine named after academician N. F. Izmerov | Moscow | 105275 | Russia |
| Moscow 1st State Med.Univ.n.a.I.M.Sechenov | Moscow | 119992 | Russia |
| Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl | Yaroslavl | 150003 | Russia |
| The Catholic University of Korea, Bucheon St.Mary's Hospital | Bucheon-si | 14647 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Policlínica Barcelona | Barcelona | 08006 | Spain |
| Hospital Clínic de Barcelona | Barcelona | 08036 | Spain |
| Hospital de Bellvitge | L'Hospitalet de Llobregat | 08907 | Spain |
| Hospital La Princesa | Madrid | 28006 | Spain |
| Hospital Central de Asturias | Oviedo | 33011 | Spain |
| Hospital Son Espases | Palma de Mallorca | 07120 | Spain |
| Dnyepropyetrovsk Medical Academy, Clinical Hospital No. 6 | Dnyepropyetrovsk | 49074 | Ukraine |
| Instit.Phthisiology&Pulmon.na Yanovskiy,Non-Specif.Lung,Kyiv | Kyiv | 03680 | Ukraine |
| Southmead Hospital | Bristol | BS10 5NB | United Kingdom |
| Royal Brompton Hospital | London | SW3 6NP | United Kingdom |
| FG001 | BI 1015550 - Antifibrotics at Baseline | Idiopathic pulmonary fibrosis (IPF) patients on 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 background therapy of nintedanib or prifenidone. |
| FG002 | Placebo - Non-antifibrotics at Baseline | Idiopathic pulmonary fibrosis (IPF) patients not on 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. Patients were not expected to start antifibrotic treatment during the 12 weeks of placebo treatment. |
| FG003 | BI 1015550 - Non-antifibrotics at Baseline | Idiopathic pulmonary fibrosis (IPF) patients not on 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. Patients were not expected to start antifibrotic treatment during the 12 weeks of BI 1015550 treatment. |
| COMPLETED | Completion of trial medication |
|
| NOT COMPLETED |
|
|
Treated Set (TS): all patients who received at least one dose of trial drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo - Antifibrotics at Baseline | Idiopathic pulmonary fibrosis (IPF) patients on 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 background therapy of nintedanib or prifenidone. |
| BG001 | BI 1015550 - Antifibrotics at Baseline | Idiopathic pulmonary fibrosis (IPF) patients on 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 background therapy of nintedanib or prifenidone. |
| BG002 | Placebo - Non-antifibrotics at Baseline | Idiopathic pulmonary fibrosis (IPF) patients not on 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. Patients were not expected to start antifibrotic treatment during the 12 weeks of placebo treatment. |
| BG003 | BI 1015550 - Non-antifibrotics at Baseline | Idiopathic pulmonary fibrosis (IPF) patients not on 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. Patients were not expected to start antifibrotic treatment during the 12 weeks of BI 1015550 treatment. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Forced vital capacity (FVC) | Forced vital capacity (FVC) at baseline. FVC is the total amount of air exhaled during a Forced expiratory volume (FEV) test. | Treated Set (TS): all patients who received at least one dose of trial drug. | Mean | Standard Deviation | Milliliter |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set (FAS): all patients who received at least one dose of trial drug and who had a baseline and at least one post-baseline measurement available for Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1) or Diffusion Capacity of the Lung for Carbon Monoxide (DLCO). | Posted | Mean | 95% Confidence Interval | Milliliter | Baseline (day 1) and week 12. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Number of Patients With Treatment Emergent Adverse Event | The number of patients with any adverse event during the on-treatment period. | Treated Set (TS): all patients who received at least one dose of trial drug. | Posted | Count of Participants | Participants | From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days. |
|
From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo - Antifibrotics at Baseline | Idiopathic pulmonary fibrosis (IPF) patients on 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 background therapy of nintedanib or prifenidone. | 0 | 25 | 0 | 25 | 10 | 25 |
| EG001 | BI 1015550 - Antifibrotics at Baseline | Idiopathic pulmonary fibrosis (IPF) patients on 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 background therapy of nintedanib or prifenidone. | 1 | 49 | 3 | 49 | 24 | 49 |
| EG002 | Placebo - Non-antifibrotics at Baseline | Idiopathic pulmonary fibrosis (IPF) patients not on 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. Patients were not expected to start antifibrotic treatment during the 12 weeks of placebo treatment. | 0 | 25 | 5 | 25 | 5 | 25 |
| EG003 | BI 1015550 - Non-antifibrotics at Baseline | Idiopathic pulmonary fibrosis (IPF) patients not on 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. Patients were not expected to start antifibrotic treatment during the 12 weeks of BI 1015550 treatment. | 1 | 48 | 3 | 48 | 18 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Diabetic metabolic decompensation | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Peripheral nerve paresis | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 8, 2021 | Jul 19, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000727475 | BI 1015550 |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Adjusted means in the placebo group were combined with the meta-analytic predictive priors derived based on the clinical trials in the nintedanib clinical development program in IPF. In order to evaluate the treatment effects, the posterior distribution for the treatment difference of BI 1015550 versus placebo with respect to the primary endpoint was used. The median of the posterior distribution for the treatment difference (and 95% credible intervals) was calculated. | Posterior difference | 62.4 | 2-Sided | 95 | 6.3 | 125.5 | Difference calculated as BI 1015550 - Placebo | Other |
| Placebo - Non-antifibrotics at Baseline |
Idiopathic pulmonary fibrosis (IPF) patients not on 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. Patients were not expected to start antifibrotic treatment during the 12 weeks of placebo treatment. |
| OG003 | BI 1015550 - Non-antifibrotics at Baseline | Idiopathic pulmonary fibrosis (IPF) patients not on 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. Patients were not expected to start antifibrotic treatment during the 12 weeks of BI 1015550 treatment. |
|
|