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Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients II

NCT ID: NCT01335477

Last Updated: 2016-07-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

551 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-10-31

Brief Summary

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Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate.

In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with high dose of BIBF 1120 compared to placebo.

Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data.

Respiratory function is globally accepted for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in IPF patients.

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Detailed Description

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Conditions

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Pulmonary Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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placebo

patient receives capsules identical to those containing active drug

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo matching BIBF 1120 BID

BIBF 1120

patient receives capsules containing BIBF 1120 twice a day

Group Type EXPERIMENTAL

BIBF 1120

Intervention Type DRUG

BIBF 1120 BID (twice daily)

Interventions

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placebo

placebo matching BIBF 1120 BID

Intervention Type DRUG

BIBF 1120

BIBF 1120 BID (twice daily)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age \>= 40 years;
2. IPF diagnosed, according to most recent American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic Association (ALAT) IPF guideline for diagnosis and management, within 5 years;
3. Combination of High Resolution Computerized Tomography (HRCT) pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF
4. Dlco (corrected for Hb): 30%-79% predicted of normal; 5.FVC\>= 50% predicted of normal

Exclusion Criteria

1. Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) \> 1.5 x Upper Limit of Normal (ULN)
2. Bilirubin \> 1.5 x ULN;
3. Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC \< 0.7);
4. Patient likely to have lung transplantation during study (being on transplantation list is acceptable for participation);
5. Myocardial infarction within 6 months;
6. Unstable angina within 1 month;
7. Bleeding risk (genetic predisposition; fibrinolysis or full-dose therapeutic anticoagulation or high dose antiplatelet therapy; history of hemorrhagic CNS event within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or ulcers or major injury or surgery within 3 months);
8. Thrombotic risk (inherited predisposition; history of thrombotic event (including stroke and transient ischemic attacks) within 12 months;
9. International normalised ratio (INR) \> 2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by \> 50% of institutional ULN);
10. N-ACetyl Cystein, prednisone \> 15mg/day or equivalent received within 2 weeks of visit 1;
11. Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of visit 1;
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1199.34.10078 Boehringer Ingelheim Investigational Site

Scottsdale, Arizona, United States

Site Status

1199.34.10086 Boehringer Ingelheim Investigational Site

San Francisco, California, United States

Site Status

1199.34.10093 Boehringer Ingelheim Investigational Site

Santa Barbara, California, United States

Site Status

1199.34.10077 Boehringer Ingelheim Investigational Site

Stanford, California, United States

Site Status

1199.34.10083 Boehringer Ingelheim Investigational Site

Torrance, California, United States

Site Status

1199.34.10080 Boehringer Ingelheim Investigational Site

Stamford, Connecticut, United States

Site Status

1199.34.10087 Boehringer Ingelheim Investigational Site

South Miami, Florida, United States

Site Status

1199.34.10100 Boehringer Ingelheim Investigational Site

Austell, Georgia, United States

Site Status

1199.34.10075 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

1199.34.10069 Boehringer Ingelheim Investigational Site

Olathe, Kansas, United States

Site Status

1199.34.10090 Boehringer Ingelheim Investigational Site

Lexington, Kentucky, United States

Site Status

1199.34.10079 Boehringer Ingelheim Investigational Site

Rochester, Minnesota, United States

Site Status

1199.34.10067 Boehringer Ingelheim Investigational Site

Chesterfield, Missouri, United States

Site Status

1199.34.10066 Boehringer Ingelheim Investigational Site

Lebanon, New Hampshire, United States

Site Status

1199.34.10085 Boehringer Ingelheim Investigational Site

Albany, New York, United States

Site Status

1199.34.10092 Boehringer Ingelheim Investigational Site

Jamaica, New York, United States

Site Status

1199.34.10074 Boehringer Ingelheim Investigational Site

Durham, North Carolina, United States

Site Status

1199.34.10088 Boehringer Ingelheim Investigational Site

Toledo, Ohio, United States

Site Status

1199.34.10070 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Site Status

1199.34.10064 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

1199.34.10089 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

1199.34.10082 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Site Status

1199.34.10095 Boehringer Ingelheim Investigational Site

Longview, Texas, United States

Site Status

1199.34.10060 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

1199.34.10084 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Site Status

1199.34.10101 Boehringer Ingelheim Investigational Site

Colchester, Vermont, United States

Site Status

1199.34.10073 Boehringer Ingelheim Investigational Site

Madison, Wisconsin, United States

Site Status

1199.34.02001 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Site Status

1199.34.02003 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

Site Status

1199.34.02002 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Site Status

1199.34.56001 Boehringer Ingelheim Investigational Site

Santiago, , Chile

Site Status

1199.34.86056 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1199.34.86052 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1199.34.86054 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1199.34.86055 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1199.34.86058 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1199.34.86051 Boehringer Ingelheim Investigational Site

Shenyang, , China

Site Status

1199.34.86053 Boehringer Ingelheim Investigational Site

Shenyang, , China

Site Status

1199.34.86057 Boehringer Ingelheim Investigational Site

Yinchuan, , China

Site Status

1199.34.35801 Boehringer Ingelheim Investigational Site

Helsinki, , Finland

Site Status

1199.34.33004 Boehringer Ingelheim Investigational Site

Dijon, , France

Site Status

1199.34.33003 Boehringer Ingelheim Investigational Site

Lille, , France

Site Status

1199.34.33005 Boehringer Ingelheim Investigational Site

Lyon, , France

Site Status

1199.34.33007 Boehringer Ingelheim Investigational Site

Marseille, , France

Site Status

1199.34.33002 Boehringer Ingelheim Investigational Site

Montpellier, , France

Site Status

1199.34.33006 Boehringer Ingelheim Investigational Site

Toulouse, , France

Site Status

1199.34.49003 Boehringer Ingelheim Investigational Site

Bad Berka, , Germany

Site Status

1199.34.49002 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1199.34.49010 Boehringer Ingelheim Investigational Site

Buch, , Germany

Site Status

1199.34.49011 Boehringer Ingelheim Investigational Site

Cologne, , Germany

Site Status

1199.34.49005 Boehringer Ingelheim Investigational Site

Coswig, , Germany

Site Status

1199.34.49001 Boehringer Ingelheim Investigational Site

Essen, , Germany

Site Status

1199.34.49007 Boehringer Ingelheim Investigational Site

Greifswald, , Germany

Site Status

1199.34.49009 Boehringer Ingelheim Investigational Site

Immenhausen, , Germany

Site Status

1199.34.49006 Boehringer Ingelheim Investigational Site

München, , Germany

Site Status

1199.34.49004 Boehringer Ingelheim Investigational Site

Münster, , Germany

Site Status

1199.34.30005 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1199.34.30001 Boehringer Ingelheim Investigational Site

Heraklion, , Greece

Site Status

1199.34.30004 Boehringer Ingelheim Investigational Site

Larissa, , Greece

Site Status

1199.34.30002 Boehringer Ingelheim Investigational Site

Maroussi, Athens, , Greece

Site Status

1199.34.30003 Boehringer Ingelheim Investigational Site

Nikaia, , Greece

Site Status

1199.34.91051 Boehringer Ingelheim Investigational Site

Ahmedabad, , India

Site Status

1199.34.91053 Boehringer Ingelheim Investigational Site

Banglore, , India

Site Status

1199.34.91056 Boehringer Ingelheim Investigational Site

Jaipur, , India

Site Status

1199.34.91054 Boehringer Ingelheim Investigational Site

Pune, , India

Site Status

1199.34.91055 Boehringer Ingelheim Investigational Site

Pune, , India

Site Status

1199.34.81059 Boehringer Ingelheim Investigational Site

Himeji, Hyogo, , Japan

Site Status

1199.34.81063 Boehringer Ingelheim Investigational Site

Kawasaki, Kanagawa, , Japan

Site Status

1199.34.81060 Boehringer Ingelheim Investigational Site

Kobe, Hyogo, , Japan

Site Status

1199.34.81051 Boehringer Ingelheim Investigational Site

Minato-ku, Tokyo, , Japan

Site Status

1199.34.81054 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

Site Status

1199.34.81055 Boehringer Ingelheim Investigational Site

Ogaki, Gifu, , Japan

Site Status

1199.34.81058 Boehringer Ingelheim Investigational Site

Osaka-Sayama, Osaka, , Japan

Site Status

1199.34.81057 Boehringer Ingelheim Investigational Site

Sakai, Osaka, , Japan

Site Status

1199.34.81053 Boehringer Ingelheim Investigational Site

Seto, Aichi, , Japan

Site Status

1199.34.81052 Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, , Japan

Site Status

1199.34.81056 Boehringer Ingelheim Investigational Site

Tenri, Nara, , Japan

Site Status

1199.34.81062 Boehringer Ingelheim Investigational Site

Tokushima, Tokushima, , Japan

Site Status

1199.34.81061 Boehringer Ingelheim Investigational Site

Yonago, Tottori, , Japan

Site Status

1199.34.52001 Boehringer Ingelheim Investigational Site

Mexico City, , Mexico

Site Status

1199.34.31002 Boehringer Ingelheim Investigational Site

Amsterdam, , Netherlands

Site Status

1199.34.31001 Boehringer Ingelheim Investigational Site

Nieuwegein, , Netherlands

Site Status

1199.34.31003 Boehringer Ingelheim Investigational Site

Rotterdam, , Netherlands

Site Status

1199.34.35107 Boehringer Ingelheim Investigational Site

Amadora, , Portugal

Site Status

1199.34.35105 Boehringer Ingelheim Investigational Site

Coimbra, , Portugal

Site Status

1199.34.35102 Boehringer Ingelheim Investigational Site

Lisbon, , Portugal

Site Status

1199.34.35103 Boehringer Ingelheim Investigational Site

Lisbon, , Portugal

Site Status

1199.34.35101 Boehringer Ingelheim Investigational Site

Porto, , Portugal

Site Status

1199.34.35106 Boehringer Ingelheim Investigational Site

Vila Nova de Gaia, , Portugal

Site Status

1199.34.07001 Boehringer Ingelheim Investigational Site

Kazan', , Russia

Site Status

1199.34.07003 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1199.34.82002 Boehringer Ingelheim Investigational Site

Bucheon-si, , South Korea

Site Status

1199.34.82004 Boehringer Ingelheim Investigational Site

Incheon, , South Korea

Site Status

1199.34.82001 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1199.34.82003 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1199.34.82006 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1199.34.82007 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1199.34.34001 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1199.34.34003 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1199.34.34004 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1199.34.34005 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat, , Spain

Site Status

1199.34.34009 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1199.34.34008 Boehringer Ingelheim Investigational Site

Seville, , Spain

Site Status

1199.34.90003 Boehringer Ingelheim Investigational Site

Ankara, , Turkey (Türkiye)

Site Status

1199.34.90001 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

1199.34.90005 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

1199.34.90002 Boehringer Ingelheim Investigational Site

Izmir, , Turkey (Türkiye)

Site Status

1199.34.90004 Boehringer Ingelheim Investigational Site

Izmir, , Turkey (Türkiye)

Site Status

Countries

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United States Canada Chile China Finland France Germany Greece India Japan Mexico Netherlands Portugal Russia South Korea Spain Turkey (Türkiye)

References

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Glaspole I, Bonella F, Bargagli E, Glassberg MK, Caro F, Stansen W, Quaresma M, Orsatti L, Bendstrup E. Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities. Respir Res. 2021 Apr 26;22(1):125. doi: 10.1186/s12931-021-01695-y.

Reference Type DERIVED
PMID: 33902584 (View on PubMed)

Jouneau S, Crestani B, Thibault R, Lederlin M, Vernhet L, Valenzuela C, Wijsenbeek M, Kreuter M, Stansen W, Quaresma M, Cottin V. Analysis of body mass index, weight loss and progression of idiopathic pulmonary fibrosis. Respir Res. 2020 Nov 25;21(1):312. doi: 10.1186/s12931-020-01528-4.

Reference Type DERIVED
PMID: 33239000 (View on PubMed)

Brown KK, Martinez FJ, Walsh SLF, Thannickal VJ, Prasse A, Schlenker-Herceg R, Goeldner RG, Clerisme-Beaty E, Tetzlaff K, Cottin V, Wells AU. The natural history of progressive fibrosing interstitial lung diseases. Eur Respir J. 2020 Jun 25;55(6):2000085. doi: 10.1183/13993003.00085-2020. Print 2020 Jun.

Reference Type DERIVED
PMID: 32217654 (View on PubMed)

Richeldi L, Kolb M, Jouneau S, Wuyts WA, Schinzel B, Stowasser S, Quaresma M, Raghu G. Efficacy and safety of nintedanib in patients with advanced idiopathic pulmonary fibrosis. BMC Pulm Med. 2020 Jan 8;20(1):3. doi: 10.1186/s12890-019-1030-4.

Reference Type DERIVED
PMID: 31914963 (View on PubMed)

Kreuter M, Koegler H, Trampisch M, Geier S, Richeldi L. Differing severities of acute exacerbations of idiopathic pulmonary fibrosis (IPF): insights from the INPULSIS(R) trials. Respir Res. 2019 Apr 11;20(1):71. doi: 10.1186/s12931-019-1037-7.

Reference Type DERIVED
PMID: 30971229 (View on PubMed)

Xu Z, Li H, Wen F, Bai C, Chen P, Fan F, Hu N, Stowasser S, Kang J. Subgroup Analysis for Chinese Patients Included in the INPULSIS(R) Trials on Nintedanib in Idiopathic Pulmonary Fibrosis. Adv Ther. 2019 Mar;36(3):621-631. doi: 10.1007/s12325-019-0887-1. Epub 2019 Feb 7.

Reference Type DERIVED
PMID: 30729456 (View on PubMed)

Costabel U, Behr J, Crestani B, Stansen W, Schlenker-Herceg R, Stowasser S, Raghu G. Anti-acid therapy in idiopathic pulmonary fibrosis: insights from the INPULSIS(R) trials. Respir Res. 2018 Sep 3;19(1):167. doi: 10.1186/s12931-018-0866-0.

Reference Type DERIVED
PMID: 30176872 (View on PubMed)

Collard HR, Richeldi L, Kim DS, Taniguchi H, Tschoepe I, Luisetti M, Roman J, Tino G, Schlenker-Herceg R, Hallmann C, du Bois RM. Acute exacerbations in the INPULSIS trials of nintedanib in idiopathic pulmonary fibrosis. Eur Respir J. 2017 May 19;49(5):1601339. doi: 10.1183/13993003.01339-2016. Print 2017 May.

Reference Type DERIVED
PMID: 28526798 (View on PubMed)

Paterniti MO, Bi Y, Rekic D, Wang Y, Karimi-Shah BA, Chowdhury BA. Acute Exacerbation and Decline in Forced Vital Capacity Are Associated with Increased Mortality in Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2017 Sep;14(9):1395-1402. doi: 10.1513/AnnalsATS.201606-458OC.

Reference Type DERIVED
PMID: 28388260 (View on PubMed)

Rinciog C, Watkins M, Chang S, Maher TM, LeReun C, Esser D, Diamantopoulos A. A Cost-Effectiveness Analysis of Nintedanib in Idiopathic Pulmonary Fibrosis in the UK. Pharmacoeconomics. 2017 Apr;35(4):479-491. doi: 10.1007/s40273-016-0480-2.

Reference Type DERIVED
PMID: 28039616 (View on PubMed)

Kolb M, Richeldi L, Behr J, Maher TM, Tang W, Stowasser S, Hallmann C, du Bois RM. Nintedanib in patients with idiopathic pulmonary fibrosis and preserved lung volume. Thorax. 2017 Apr;72(4):340-346. doi: 10.1136/thoraxjnl-2016-208710. Epub 2016 Sep 26.

Reference Type DERIVED
PMID: 27672117 (View on PubMed)

Corte T, Bonella F, Crestani B, Demedts MG, Richeldi L, Coeck C, Pelling K, Quaresma M, Lasky JA. Safety, tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis. Respir Res. 2015 Sep 24;16:116. doi: 10.1186/s12931-015-0276-5.

Reference Type DERIVED
PMID: 26400368 (View on PubMed)

Richeldi L, du Bois RM, Raghu G, Azuma A, Brown KK, Costabel U, Cottin V, Flaherty KR, Hansell DM, Inoue Y, Kim DS, Kolb M, Nicholson AG, Noble PW, Selman M, Taniguchi H, Brun M, Le Maulf F, Girard M, Stowasser S, Schlenker-Herceg R, Disse B, Collard HR; INPULSIS Trial Investigators. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2071-82. doi: 10.1056/NEJMoa1402584. Epub 2014 May 18.

Reference Type DERIVED
PMID: 24836310 (View on PubMed)

Richeldi L, Cottin V, Flaherty KR, Kolb M, Inoue Y, Raghu G, Taniguchi H, Hansell DM, Nicholson AG, Le Maulf F, Stowasser S, Collard HR. Design of the INPULSIS trials: two phase 3 trials of nintedanib in patients with idiopathic pulmonary fibrosis. Respir Med. 2014 Jul;108(7):1023-30. doi: 10.1016/j.rmed.2014.04.011. Epub 2014 Apr 29.

Reference Type DERIVED
PMID: 24834811 (View on PubMed)

Other Identifiers

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2010-024252-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1199.34

Identifier Type: -

Identifier Source: org_study_id

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