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

NCT04419506 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 1305-00132019-004167-45
• Study Type: interventional
• Target: 147
• Locations: 21 countries
• Sites: 74

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (4)

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.

Drug: Placebo

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.

Drug: BI 1015550

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.

Drug: Placebo

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.

Drug: BI 1015550

Interventions

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.

BI 1015550, Antifibrotics at baseline; BI 1015550, Non-antifibrotics at baseline

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.

Placebo, Antifibrotics at baseline; Placebo, Non-antifibrotics at baseline

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (75)

St. Francis Medical Institute

Clearwater, Florida, 33765, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Mayo Clinic, Rochester

Rochester, Minnesota, 55905, United States

Location

The Lung Research Center, LLC

Chesterfield, Missouri, 63017, United States

Location

Creighton University

Omaha, Nebraska, 68124, United States

Location

Southeastern Research Center

Winston-Salem, North Carolina, 27103, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Diagnostics Research Group

San Antonio, Texas, 78229, United States

Location

University of Utah Health Sciences Center

Salt Lake City, Utah, 84108, United States

Location

Centro de Investigaciones Metabólicas (CINME)

C.a.b.a, C1027AAP, Argentina

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

LKH-Univ. Hospital Graz

Graz, 8036, Austria

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Dr. Georges-L.-Dumont University Hospital Centre

Moncton, New Brunswick, E1C 2Z3, Canada

Location

Queen's University

Kingston, Ontario, K7L 2V6, Canada

Location

Dr. Syed Anees Medicine Professional Corporation

Windsor, Ontario, N8X 1T3, Canada

Location

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, H2X 0A9, Canada

Location

Instituto Nacional del Tórax

Providencia, Santiago de Chile, 7500691, Chile

Location

Centro de Investigación del Maule

Talca, 3465586, Chile

Location

Peking Union Medical College Hospital

Beijing, 100032, China

Location

The Second Hospital of Jilin University

Changchun, 130041, China

Location

West China Hospital

Chengdu, 610041, China

Location

Zhongshan Hospital Fudan University

Shanghai, 200032, China

Location

Shanghai Pulmonary Hospital

Shanghai, 200433, China

Location

University Hospital Na Bulovce, Prague

Prague, 180 81, Czechia

Location

University Thomayer's Hospital

Praha 4 - Krc, 140 59, Czechia

Location

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Herlev and Gentofte Hospital

Hellerup, 2900, Denmark

Location

Odense University Hospital

Odense C, 5000, Denmark

Location

HYKS Keuhkosairauksien tutkimusyksikkö

Helsinki, 00290, Finland

Location

KYS, Keuhkosairauksien

Kuopio, 70210, Finland

Location

Oulun yliopistollinen keskussairaala

Oulu, FIN-90220, Finland

Location

Tampere University Hospital

Tampere, 33521, Finland

Location

TYKS

Turku, 20520, Finland

Location

Fachkrankenhaus Coswig GmbH

Coswig, 01640, Germany

Location

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, 45239, Germany

Location

Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

Heidelberg, 69126, Germany

Location

Lungenfachklinik Immenhausen

Immenhausen, 34376, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Athens Medical Center

Athens, 15125, Greece

Location

University General Hospital of Heraklion

Crete, 71110, Greece

Location

Univ. Gen. Hosp. of Patras

Pátrai, 26504, Greece

Location

Semmelweis University

Budapest, 1085, Hungary

Location

Ospedale Colonnello D Avanzo

Foggia, 71100, Italy

Location

Azienda Ospedaliera Universitaria di Padova

Padua, 35128, Italy

Location

Poli Univ A. Gemelli

Roma, 00168, Italy

Location

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

Siena, 53100, Italy

Location

Tosei General Hospital

Aichi, Seto, 489-8642, Japan

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, Fukuoka, 810-8563, Japan

Location

Kanagawa Cardiovascular and Respiratory Center

Kanagawa, Yokohama, 236-0051, Japan

Location

National Hospital Organization Kinki-Chuo Chest Medical Center

Osaka, Sakai, 591-8555, Japan

Location

Hamamatsu University Hospital

Shizuoka, Hamamatsu, 431-3192, Japan

Location

Center Hospital of the National Center for Global Health and Medicine

Tokyo, Shinjuku-ku, 162-8655, Japan

Location

Zuyderland Medisch Centrum

Heerlen, 6419 PC, Netherlands

Location

St. Antonius ziekenhuis, locatie Nieuwegein

Nieuwegein, 3435 CM, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, 3015 CE, Netherlands

Location

University Clinical Center, Gdansk

Gdansk, 80-214, Poland

Location

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

Moscow, 105275, Russia

Location

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

Moscow, 119992, Russia

Location

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

Yaroslavl, 150003, Russia

Location

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

Bucheon-si, 14647, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Policlínica Barcelona

Barcelona, 08006, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital de Bellvitge

L'Hospitalet de Llobregat, 08907, Spain

Location

Hospital La Princesa

Madrid, 28006, Spain

Location

Hospital Central de Asturias

Oviedo, 33011, Spain

Location

Hospital Son Espases

Palma de Mallorca, 07120, Spain

Location

Dnyepropyetrovsk Medical Academy, Clinical Hospital No. 6

Dnyepropyetrovsk, 49074, Ukraine

Location

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

Kyiv, 03680, Ukraine

Location

Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35569036 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

BI 1015550

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 5, 2020
• Study Start: July 28, 2020
• Primary Completion: October 6, 2021
• Study Completion: October 15, 2021
• Last Updated: November 1, 2022
• Results First Posted: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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'.

Locations

AU (1); GR (3); PL (1); US (11); KR (3); CZ (2); IT (4); HU (1); DK (3); CA (5); CL (2); JP (6); NL (3); CN (5); AR (1); RU (3); ES (6); FI (5); UA (2); GB (2); DE (5)