A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

August 18, 2023 updated by: Boehringer Ingelheim

An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

The main objective is to assess long term tolerability and safety of treatment with oral nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who have complete (and did not prematurely discontinue trial medication in) the phase III parent trial, INBUILD® (trial 1199.247).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

435

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Alberdi Sur, Argentina, X5003DCE
        • Centro Dr. Lazaro Langer S.R.L
      • C.a.b.a, Argentina, 1056
        • Centro de Investigaciones Metabólicas (CINME)
      • Florida, Argentina, B1602DQD
        • CEMER-Centro Medico De Enfermedades Respiratorias
      • Mendoza, Argentina, M5500CCG
        • INSARES
      • Rosario, Argentina, S2000DEJ
        • Instituto Medico de La Fundacion Estudios Clinicos
  • Belgium
      • Bruxelles, Belgium, 1070
        • ULB Hôpital Erasme
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liège, Belgium, 4000
        • Centre Hospitalier Universitaire de Liege
      • Yvoir, Belgium, 5530
        • Yvoir - UNIV UCL de Mont-Godinne
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 0N2
        • Winnipeg Clinic
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton
      • Toronto, Ontario, Canada, M5G 2N2
        • Toronto General Hospital
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • CHUS Fleurimont
  • Chile
      • Concepción, Chile, 4070038
        • Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"
      • Providencia, Santiago De Chile, Chile, 7500691
        • Instituto Nacional del tórax
      • Talca, Chile, 3465586
        • Centro de Investigación del Maule
  • China
      • Beijing, China, 100730
        • Peking Union Medical College Hospital
      • Nanjing, China, 210008
        • Nanjing Drum Tower Hospital
      • Shenyang, China, 110001
        • The First Hospital of China Medical University
  • France
      • Bobigny, France, 93009
        • HOP Avicenne
      • Bron, France, 69677
        • HOP Louis Pradel
      • Caen, France, 14033
        • HOP Côte de Nacre
      • Lille, France, 59037
        • CHRU Lille
      • Marseille, France, 13915
        • HOP Nord
      • Montpellier, France, 34295
        • HOP Arnaud de Villeneuve
      • Nice, France, 06001
        • HOP Pasteur
      • Paris, France, 75018
        • HOP Bichat
      • Reims, France, 51092
        • HOP Maison Blanche
      • Rennes, France, 35033
        • HOP Pontchaillou
      • Strasbourg, France, 67091
        • HOP Civil
      • Tours, France, 37044
        • HOP Bretonneau
  • Germany
      • Bonn, Germany, 53105
        • Universitätsklinikum Bonn AöR
      • Coswig, Germany, 01640
        • Fachkrankenhaus Coswig GmbH
      • Donaustauf, Germany, 93093
        • Klinik Donaustauf
      • Essen, Germany, 45239
        • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany, 69126
        • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
      • Wuppertal, Germany, 42283
        • Petrus-Krankenhaus
  • Italy
      • Catania, Italy, 95124
        • A.O.U. Policlinico Vittorio Emanuele
      • Forli', Italy, 47121
        • Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli
      • Modena, Italy, 41100
        • Azienda Ospedaliera Policlinico di Modena
      • Monza, Italy, 20052
        • A.O. San Gerardo di Monza
      • Roma, Italy, 00168
        • Poli Univ A. Gemelli
      • Siena, Italy, 53100
        • A.O.U. Senese Policlinico Santa Maria alle Scotte
  • Japan
      • Aichi, Seto, Japan, 489-8642
        • Tosei General Hospital
      • Fukuoka, Kurume, Japan, 830-0011
        • Kurume University Hospital
      • Hokkaido, Sapporo, Japan, 060-8543
        • Sapporo Medical University Hospital
      • Hyogo, Himeji, Japan, 670-8520
        • National Hospital Organization Himeji Medical Center
      • Hyogo, Kobe, Japan, 650-0047
        • Kobe City Medical Center General Hospital
      • Ibaraki, Naka-gun, Japan, 319-1113
        • Ibarakihigashi National Hospial
      • Kanagawa, Yokohama, Japan, 236-0051
        • Kanagawa Cardiovascular And Respiratory Center
      • Kumamoto, Kumamoto, Japan, 861-4193
        • Saiseikai Kumamoto Hospital
      • Miyagi, Sendai, Japan, 980-8574
        • Tohoku University Hospital
      • Osaka, Sakai, Japan, 591-8555
        • National Hospital Organization Kinki-Chuo Chest Medical Center
      • Osaka, Takatsuki, Japan, 569-8686
        • Osaka Medical College Hospital
      • Shizuoka, Hamamatsu, Japan, 431-3192
        • Hamamatsu University Hospital
      • Tokushima, Tokushima, Japan, 770-8503
        • Tokushima University Hospital
      • Tokyo, Bunkyo-ku, Japan, 113-8519
        • Tokyo Medical and Dental University Hospital
      • Tokyo, Minato-ku, Japan, 105-8470
        • Toranomon Hospital
      • Tokyo, Shibuya-ku, Japan, 151-8528
        • JR Tokyo General Hospital
      • Tokyo, Shinjuku-ku, Japan, 162-8655
        • Center Hospital of the National Center for Global Health and Medicine
  • Korea, Republic of
      • Bucheon, Korea, Republic of, 14647
        • The catholic university of Korea, Bucheon St.Mary's Hospital
      • Seongnam, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
  • Poland
      • Gdansk, Poland, 80-214
        • University Clinical Center, Gdansk
      • Katowice, Poland, 40-752
        • Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ.
      • Lodz, Poland, 90-153
        • Norbert Barlicki University Clinical Hospital No.1, Lodz
      • Warszawa, Poland, 01-138
        • Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
      • Zabrze, Poland, 41-803
        • Clinical Hospital No. 1, n.a. Prof. Szyszko from Silesian MA
  • Russian Federation
      • Kemerovo, Russian Federation, 650002
        • Res.Inst.-Compl.Iss.Cardi.Dis.
      • Moscow, Russian Federation, 119992
        • Moscow 1st State Med.Univ.n.a.I.M.Sechenov
      • Moscow, Russian Federation, 107564
        • Central Scientific Research Insitute of Tuberculosis
      • St. Petersburg, Russian Federation, 197022
        • 1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.
      • Yaroslavl, Russian Federation, 150003
        • Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl
  • Spain
      • Barcelona, Spain, 08026
        • Hospital Santa Creu i Sant Pau
      • Galdakao, Spain, 48960
        • Hospital de Galdakao
      • L'Hospitalet de Llobregat, Spain, 08907
        • Hospital de Bellvitge
      • Madrid, Spain, 28006
        • Hospital La Princesa
      • Oviedo, Spain, 33011
        • Hospital Central de Asturias
      • Palma de Mallorca, Spain, 07120
        • Hospital Son Espases
      • San Cristóbal de La Laguna, Spain, 38320
        • Hospital de Canarias
      • Sevilla, Spain, 41013
        • Hospital Virgen Del Rocio
  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh
      • Leeds, United Kingdom, LS9 7TF
        • St James's University Hospital
      • London, United Kingdom, SW3 6NP
        • Royal Brompton Hospital
      • Manchester, United Kingdom, M23 9LT
        • Wythenshawe Hospital
      • Penarth, United Kingdom, CF64 2XX
        • University Hospital Llandough
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • Royal Stoke University Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • California
      • Los Angeles, California, United States, 90095
        • University of California Los Angeles
      • Sacramento, California, United States, 95817
        • University of California Davis
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School Of Medicine
    • Florida
      • Brandon, Florida, United States, 33511
        • Pulmonary and Sleep of Tampa Bay
      • Jacksonville, Florida, United States, 32209
        • University of Florida College of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Hospital
      • Towson, Maryland, United States, 21286
        • Pulmonary and Critical Care Associates of Baltimore
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic, Rochester
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • The Lung Research Center, LLC
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Creighton University
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10032
        • Columbia University Medical Center-New York Presbyterian Hospital
      • New York, New York, United States, 10065
        • NewYork-Presbyterian/Weill Cornell Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97220
        • The Oregon Clinic
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
      • San Antonio, Texas, United States, 78229
        • Diagnostics Research Group
      • San Antonio, Texas, United States, 78229
        • Medical Arts and Research Center (MARC)
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah Health Sciences Center
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female patients who completed the INBUILD® trial as planned and who did not prematurely discontinue blinded treatment.
  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
  • Women of childbearing potential (WOCBP)1 must continue to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method, for 28 days prior to and 3 months after nintedanib administration. A list of contraception methods meeting these criteria is provided in the patient information

Exclusion Criteria:

  • Any disease that may put the patient at risk when participating in this trial. Reconsider carefully all exclusion criteria of the INBUILD® trial. However, patients may qualify for participation even though exclusion criteria may have been met during the course of participation in INBUILD®, if the investigator's benefit-risk assessment remains favourable.
  • Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
  • Patient not compliant in parent trial (INBUILD®), with trial medication or trial visits, according to investigator's judgement.
  • Previous enrolment in this trial. Further exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nintedanib
Patients taking 150 milligram (mg) bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib 150 mg bid in this extension trial. Patients taking 100 mg bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib in this extension trial either at 100 mg bid or at an increased dose of 150 mg bid at the discretion of the investigator orally as soft gelatine capsule, twice daily (bid), together with a glass of water (~250 mL), in a dose interval of 12 hours. With an optional dose reduction to 100 mg bid temporarily or permanently to manage adverse events (AEs). The treatment had a duration of 96 weeks or until nintedanib was made available to the patients outside of the clinical trial. Treatment was stopped if any reason for withdrawal was met.
Drug: Nintedanib
Bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Any Adverse Events
Time Frame: From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
Number of participants with adverse events over the course of the extension trial, AEs defined as any untoward medical occurrence in a patient administered with the investigational product and which does not necessarily have to have a causal relationship with this treatment.
From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2019

Primary Completion (Actual)

August 30, 2022

Study Completion (Actual)

August 30, 2022

Study Registration Dates

First Submitted

January 28, 2019

First Submitted That Met QC Criteria

January 28, 2019

First Posted (Actual)

January 29, 2019

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

August 18, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1199-0248
  • 2018-000525-32 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the criteria in section 'time frame frame' are fulfilled , researchers can use the 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". Furthermore, researchers can 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.

IPD Sharing 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.

IPD Sharing 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'.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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