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

Idiopathic Pulmonary Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04419506
• Other study ID #: 1305-0013
• Secondary ID: 2019-004167-45
• Status: Completed
• Phase: Phase 2
• Start date: July 28, 2020
• Est. completion date: October 15, 2021

Study information

• Verified date: October 2022
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: October 15, 2021
• Est. primary completion date: October 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• BI 1015550
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.
• Placebo
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.

Locations

Country	Name	City	State
Argentina	Centro de Investigaciones Metabólicas (CINME)	C.a.b.a
Australia	The Alfred Hospital	Melbourne	Victoria
Austria	LKH-Univ. Hospital Graz	Graz
Canada	Queen's University	Kingston	Ontario
Canada	Dr. Georges-L.-Dumont University Hospital Centre	Moncton	New Brunswick
Canada	Centre Hospitalier de l'Universite de Montreal (CHUM)	Montreal	Quebec
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Dr. Syed Anees Medicine Professional Corporation	Windsor	Ontario
Chile	Instituto Nacional del Tórax	Providencia, Santiago De Chile
Chile	Centro de Investigación del Maule	Talca
China	Peking Union Medical College Hospital	Beijing
China	The Second Hospital of Jilin University	Changchun
China	West China Hospital	Chengdu
China	Shanghai Pulmonary Hospital	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai
Czechia	University Hospital Na Bulovce, Prague	Praha
Czechia	University Thomayer's Hospital	Praha 4 - Krc
Denmark	Aarhus University Hospital	Aarhus N
Denmark	Herlev and Gentofte Hospital	Hellerup
Denmark	Odense University Hospital	Odense C
Finland	HYKS Keuhkosairauksien tutkimusyksikkö	Helsinki
Finland	KYS, Keuhkosairauksien	Kuopio
Finland	Oulun yliopistollinen keskussairaala	Oulu
Finland	Tampere University Hospital	Tampere
Finland	TYKS	Turku
Germany	Fachkrankenhaus Coswig GmbH	Coswig
Germany	Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH	Essen
Germany	Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg	Heidelberg
Germany	Lungenfachklinik Immenhausen	Immenhausen
Germany	Universitätsklinikum Münster	Münster
Greece	Athens Medical Center	Athens
Greece	University General Hospital of Heraklion	Crete
Greece	Univ. Gen. Hosp. of Patras	Patras
Hungary	Semmelweis University	Budapest
Italy	Ospedale Colonnello D Avanzo	Foggia
Italy	Azienda Ospedaliera Universitaria di Padova	Padova
Italy	Poli Univ A. Gemelli	Roma
Italy	A.O.U. Senese Policlinico Santa Maria alle Scotte	Siena
Japan	Tosei General Hospital	Aichi, Seto
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka, Fukuoka
Japan	Kanagawa Cardiovascular and Respiratory Center	Kanagawa, Yokohama
Japan	National Hospital Organization Kinki-Chuo Chest Medical Center	Osaka, Sakai
Japan	Hamamatsu University Hospital	Shizuoka, Hamamatsu
Japan	Center Hospital of the National Center for Global Health and Medicine	Tokyo, Shinjuku-ku
Korea, Republic of	The Catholic University of Korea, Bucheon St.Mary's Hospital	Bucheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Netherlands	Zuyderland Medisch Centrum	Heerlen
Netherlands	St. Antonius ziekenhuis, locatie Nieuwegein	Nieuwegein
Netherlands	Erasmus Medisch Centrum	Rotterdam
Poland	University Clinical Center, Gdansk	Gdansk
Russian Federation	Federal state budgetary scientific institution "Research Institute of occupational medicine named after academician N. F. Izmerov	Moscow
Russian Federation	Moscow 1st State Med.Univ.n.a.I.M.Sechenov	Moscow
Russian Federation	Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl	Yaroslavl
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Policlínica Barcelona	Barcelona
Spain	Hospital de Bellvitge	L'Hospitalet de Llobregat
Spain	Hospital La Princesa	Madrid
Spain	Hospital Central de Asturias	Oviedo
Spain	Hospital Son Espases	Palma de Mallorca
Ukraine	Dnyepropyetrovsk Medical Academy, Clinical Hospital No. 6	Dnyepropyetrovsk
Ukraine	Instit.Phthisiology&Pulmon.na Yanovskiy,Non-Specif.Lung,Kyiv	Kyiv
United Kingdom	Southmead Hospital	Bristol
United Kingdom	Royal Brompton Hospital	London
United States	The Lung Research Center, LLC	Chesterfield	Missouri
United States	St. Francis Medical Institute	Clearwater	Florida
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	University of Florida	Gainesville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Creighton University	Omaha	Nebraska
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Mayo Clinic, Rochester	Rochester	Minnesota
United States	University of Utah Health Sciences Center	Salt Lake City	Utah
United States	Diagnostics Research Group	San Antonio	Texas
United States	Southeastern Research Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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.	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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