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

NCT ID: NCT04419506

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-28
• Study Completion Date: 2021-10-15

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.

Conditions

Idiopathic Pulmonary Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo, Antifibrotics at baseline

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

BI 1015550, Antifibrotics at baseline

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.

Group Type: EXPERIMENTAL

BI 1015550

Intervention Type: 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.

Placebo, Non-antifibrotics at baseline

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

BI 1015550, Non-antifibrotics at baseline

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.

Group Type: EXPERIMENTAL

BI 1015550

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St. Francis Medical Institute

Clearwater, Florida, United States

University of Florida

Gainesville, Florida, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Mayo Clinic, Rochester

Rochester, Minnesota, United States

The Lung Research Center, LLC

Chesterfield, Missouri, United States

Creighton University

Omaha, Nebraska, United States

Southeastern Research Center

Winston-Salem, North Carolina, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Diagnostics Research Group

San Antonio, Texas, United States

University of Utah Health Sciences Center

Salt Lake City, Utah, United States

Centro de Investigaciones Metabólicas (CINME)

C.a.b.a, , Argentina

The Alfred Hospital

Melbourne, Victoria, Australia

LKH-Univ. Hospital Graz

Graz, , Austria

St. Paul's Hospital

Vancouver, British Columbia, Canada

Dr. Georges-L.-Dumont University Hospital Centre

Moncton, New Brunswick, Canada

Queen's University

Kingston, Ontario, Canada

Dr. Syed Anees Medicine Professional Corporation

Windsor, Ontario, Canada

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

Instituto Nacional del Tórax

Providencia, Santiago de Chile, , Chile

Centro de Investigación del Maule

Talca, , Chile

Peking Union Medical College Hospital

Beijing, , China

The Second Hospital of Jilin University

Changchun, , China

West China Hospital

Chengdu, , China

Zhongshan Hospital Fudan University

Shanghai, , China

Shanghai Pulmonary Hospital

Shanghai, , China

University Hospital Na Bulovce, Prague

Prague, , Czechia

University Thomayer's Hospital

Praha 4 - Krc, , Czechia

Aarhus University Hospital

Aarhus N, , Denmark

Herlev and Gentofte Hospital

Hellerup, , Denmark

Odense University Hospital

Odense C, , Denmark

HYKS Keuhkosairauksien tutkimusyksikkö

Helsinki, , Finland

KYS, Keuhkosairauksien

Kuopio, , Finland

Oulun yliopistollinen keskussairaala

Oulu, , Finland

Tampere University Hospital

Tampere, , Finland

TYKS

Turku, , Finland

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, , Germany

Athens Medical Center

Athens, , Greece

University General Hospital of Heraklion

Crete, , Greece

Univ. Gen. Hosp. of Patras

Pátrai, , Greece

Semmelweis University

Budapest, , Hungary

Ospedale Colonnello D Avanzo

Foggia, , Italy

Azienda Ospedaliera Universitaria di Padova

Padua, , Italy

Poli Univ A. Gemelli

Roma, , Italy

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

Siena, , Italy

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, , Japan

Zuyderland Medisch Centrum

Heerlen, , Netherlands

St. Antonius ziekenhuis, locatie Nieuwegein

Nieuwegein, , Netherlands

Erasmus Medisch Centrum

Rotterdam, , Netherlands

University Clinical Center, Gdansk

Gdansk, , Poland

Federal state budgetary scientific institution "Research Institute of occupational medicine named after academician N. F. Izmerov

Moscow, , Russia

Moscow 1st State Med.Univ.n.a.I.M.Sechenov

Moscow, , Russia

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

Yaroslavl, , Russia

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

Bucheon-si, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Policlínica Barcelona

Barcelona, , Spain

Hospital Clínic de 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, , Spain

Dnyepropyetrovsk Medical Academy, Clinical Hospital No. 6

Dnyepropyetrovsk, , Ukraine

Instit.Phthisiology&Pulmon.na Yanovskiy,Non-Specif.Lung,Kyiv

Kyiv, , Ukraine

Southmead Hospital

Bristol, , United Kingdom

Royal Brompton Hospital

London, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Canada; Chile; China; Czechia; Denmark; Finland; Germany; Greece; Hungary; Italy; Japan; Netherlands; Poland; Russia; South Korea; Spain; Ukraine; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 35569036 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://mystudywindow.com

Related Info

Other Identifiers

2019-004167-45

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1305-0013

Identifier Type: -

Identifier Source: org_study_id