A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
2 other identifiers
interventional
435
15 countries
121
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2019
Typical duration for phase_3
121 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2019
CompletedFirst Posted
Study publicly available on registry
January 29, 2019
CompletedStudy Start
First participant enrolled
April 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2022
CompletedResults Posted
Study results publicly available
September 13, 2023
CompletedSeptember 13, 2023
August 1, 2023
3.4 years
January 28, 2019
August 18, 2023
August 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Any Adverse Events
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.
Study Arms (1)
Nintedanib
EXPERIMENTALPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (121)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
University of California Davis
Sacramento, California, 95817, United States
National Jewish Health
Denver, Colorado, 80206, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Pulmonary and Sleep of Tampa Bay
Brandon, Florida, 33511, United States
University of Florida College of Medicine
Jacksonville, Florida, 32209, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Chicago
Chicago, Illinois, 60637, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21224, United States
Pulmonary and Critical Care Associates of Baltimore
Towson, Maryland, 21286, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Mayo Clinic, Rochester
Rochester, Minnesota, 55905, United States
The Lung Research Center, LLC
Chesterfield, Missouri, 63017, United States
Creighton University
Omaha, Nebraska, 68124, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, 10032, United States
NewYork-Presbyterian/Weill Cornell Medical Center
New York, New York, 10065, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
The Oregon Clinic
Portland, Oregon, 97220, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Diagnostics Research Group
San Antonio, Texas, 78229, United States
Medical Arts and Research Center (MARC)
San Antonio, Texas, 78229, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84108, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042, United States
Centro Dr. Lazaro Langer S.R.L
Alberdi Sur, X5003DCE, Argentina
Centro de Investigaciones Metabólicas (CINME)
C.a.b.a, 1056, Argentina
CEMER-Centro Medico De Enfermedades Respiratorias
Florida, B1602DQD, Argentina
INSARES
Mendoza, M5500CCG, Argentina
Instituto Médico de la Fundación Estudios Clínicos
Rosario, S2000DEJ, Argentina
ULB Hopital Erasme
Brussels, 1070, Belgium
UZ Leuven
Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liège
Liège, 4000, Belgium
Yvoir - UNIV UCL de Mont-Godinne
Yvoir, 5530, Belgium
Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
CHUS Fleurimont
Sherbrooke, Quebec, J1H 5N4, Canada
Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"
Concepción, 4070038, Chile
Instituto Nacional del Tórax
Providencia, Santiago de Chile, 7500691, Chile
Centro de Investigación del Maule
Talca, 3465586, Chile
Peking Union Medical College Hospital
Beijing, 100730, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
The First Hospital of China Medical University
Shenyang, 110001, China
HOP Avicenne
Bobigny, 93009, France
HOP Louis Pradel
Bron, 69677, France
HOP Côte de Nacre
Caen, 14033, France
CHRU Lille
Lille, 59037, France
HOP Nord
Marseille, 13915, France
HOP Arnaud de Villeneuve
Montpellier, 34295, France
HOP Pasteur
Nice, 06001, France
HOP Bichat
Paris, 75018, France
HOP Maison Blanche
Reims, 51092, France
HOP Pontchaillou
Rennes, 35033, France
HOP Civil
Strasbourg, 67091, France
HOP Bretonneau
Tours, 37044, France
Universitätsklinikum Bonn AöR
Bonn, 53105, Germany
Fachkrankenhaus Coswig GmbH
Coswig, 01640, Germany
Klinik Donaustauf
Donaustauf, 93093, Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45239, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, 69126, Germany
Petrus-Krankenhaus
Wuppertal, 42283, Germany
A.O.U. Policlinico Vittorio Emanuele
Catania, 95124, Italy
Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli
Forlì, 47121, Italy
Azienda Ospedaliera Policlinico di Modena
Modena, 41100, Italy
A.O. San Gerardo di Monza
Monza, 20052, Italy
Poli Univ A. Gemelli
Roma, 00168, Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, 53100, Italy
Tosei General Hospital
Aichi, Seto, 489-8642, Japan
Kurume University Hospital
Fukuoka, Kurume, 830-0011, Japan
Sapporo Medical University Hospital
Hokkaido, Sapporo, 060-8543, Japan
National Hospital Organization Himeji Medical Center
Hyogo, Himeji, 670-8520, Japan
Kobe City Medical Center General Hospital
Hyogo, Kobe, 650-0047, Japan
Ibarakihigashi National Hospial
Ibaraki, Naka-gun, 319-1113, Japan
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, 236-0051, Japan
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, 861-4193, Japan
Tohoku University Hospital
Miyagi, Sendai, 980-8574, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, 591-8555, Japan
Osaka Medical College Hospital
Osaka, Takatsuki, 569-8686, Japan
Hamamatsu University Hospital
Shizuoka, Hamamatsu, 431-3192, Japan
Tokushima University Hospital
Tokushima, Tokushima, 770-8503, Japan
Tokyo Medical and Dental University Hospital
Tokyo, Bunkyo-ku, 113-8519, Japan
Toranomon Hospital
Tokyo, Minato-ku, 105-8470, Japan
JR Tokyo General Hospital
Tokyo, Shibuya-ku, 151-8528, Japan
Center Hospital of the National Center for Global Health and Medicine
Tokyo, Shinjuku-ku, 162-8655, Japan
University Clinical Center, Gdansk
Gdansk, 80-214, Poland
Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ.
Katowice, 40-752, Poland
Norbert Barlicki University Clinical Hospital No.1, Lodz
Lodz, 90-153, Poland
Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
Warsaw, 01-138, Poland
Clinical Hospital No. 1, n.a. Prof. Szyszko from Silesian MA
Zabrze, 41-803, Poland
Res.Inst.-Compl.Iss.Cardi.Dis.
Kemerovo, 650002, Russia
Central Scientific Research Insitute of Tuberculosis
Moscow, 107564, Russia
Moscow 1st State Med.Univ.n.a.I.M.Sechenov
Moscow, 119992, Russia
1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.
Saint Petersburg, 197022, Russia
Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl
Yaroslavl, 150003, Russia
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon-si, 14647, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Hospital Santa Creu i Sant Pau
Barcelona, 08026, Spain
Hospital de Galdakao
Galdakao, 48960, Spain
Hospital de Bellvitge
L'Hospitalet de Llobregat, 08907, Spain
Hospital La Princesa
Madrid, 28006, Spain
Hospital Central de Asturias
Oviedo, 33011, Spain
Hospital Son Espases
Palma de Mallorca, 07120, Spain
Hospital de Canarias
San Cristóbal de La Laguna, 38320, Spain
Hospital Virgen del Rocío
Seville, 41013, Spain
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA, United Kingdom
St James's University Hospital
Leeds, LS9 7TF, United Kingdom
Royal Brompton Hospital
London, SW3 6NP, United Kingdom
Wythenshawe Hospital
Manchester, M23 9LT, United Kingdom
University Hospital Llandough
Penarth, CF64 2XX, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG, United Kingdom
Related Publications (1)
Wuyts WA, Bonella F, Chaudhuri N, Varone F, Antin-Ozerkis D, Song JW, Miede C, Dumistracel M, Coeck C, Cottin V. Continued Treatment with Nintedanib in Patients with Progressive Pulmonary Fibrosis: Data from INBUILD-ON. Lung. 2025 Jan 9;203(1):25. doi: 10.1007/s00408-024-00778-z.
PMID: 39789408DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2019
First Posted
January 29, 2019
Study Start
April 16, 2019
Primary Completion
August 30, 2022
Study Completion
August 30, 2022
Last Updated
September 13, 2023
Results First Posted
September 13, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- 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'.
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.