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Lung Diseases, InterstitialPhase 3NCT03313180

A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis

A Phase 3 study testing Nintedanib in people with Lung Diseases, Interstitial, run by Boehringer Ingelheim at 159 sites in 30 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Diseases, Interstitial
What is being tested?
Nintedanib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
444 participants
Where
159 sitesin 30 countries
Study dates
27 Nov 2017to 25 Jan 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who completed the parent trial 1199.214/1199-0340 per protocol and did not permanently discontinue study treatment
  • Signed and dated written informed consent in accordance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
  • Women of childbearing potential must be ready and able 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 nintedanib treatment initiation, during the trial and for 3 months after last intake of nintedanib.
  • Further inclusion criteria apply

Who cannot join

  • Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 3 x Upper Limit of Normal (ULN)
  • Bilirubin > 2 x ULN
  • Creatinine clearance <30 mL/min calculated by Cockcroft-Gault formula.
  • Clinically relevant anaemia at investigators discretion.
  • Bleeding risk, any of the following
  • Known genetic predisposition to bleeding according to the judgement of the investigator
Show all 30Show fewer
  • Patients who require
  • Fibrinolysis, full-dose therapeutic anticoagulation
  • High dose antiplatelet therapy.
  • Hemorrhagic central nervous system (CNS) event after completion of the parent trial 1199.214/1199-0340
  • Any of the following after last treatment of 1199.214/1199-0340:
  • Haemoptysis or haematuria
  • Active gastro-intestinal bleeding or Gastrointestinal (GI) - ulcers
  • Gastric antral vascular ectasia (GAVE)
  • Major injury or surgery
  • Coagulation parameters: International normalised ratio (INR) >2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by >1.5 x ULN at Visit 1.
  • New major thrombo-embolic events developed after completion of the parent trial 1199.214/1199-0340:
  • Stroke;
  • Deep vein thrombosis;
  • Pulmonary embolism;
  • Myocardial infarction.
  • Major surgery performed within the next 3 months
  • Time period > 12 weeks between last drug intake in 1199.214 or > 1 week between last nintedanib intake in trial 1199-0340 and Visit 2 of this trial
  • Usage of any investigational drug after completion of 1199.214/1199-0340 or planned usage of an investigational drug during the course of this trial.
  • A disease or condition which may put the patient at risk because of participation in this trial (e.g. clinically relevant intestinal pseudoobstruction) or limit the patient's ability to participate in this trial
  • Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable trial subject or unlikely to complete the trial
  • Known hypersensitivity to the trial medication or its components (i.e. soya lecithin).
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial
  • Previous enrolment in this trial
  • Further exclusion criteria apply

Trial locations and contacts

159 sites in 30 countries.

159 sites in 30 countries

United States39 sites

  • The Emory Clinic

    Atlanta, Georgia, 30322

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21224

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Boston University School of Medicine

    Boston, Massachusetts, 02118

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Florida College of Medicine

    Jacksonville, Florida, 32209

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • University of California Los Angeles

    Los Angeles, California, 90095

  • University of Miami

    Miami, Florida, 33125

  • Froedtert and The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 Oaks

    Nashville, Tennessee, 37204

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • Tulane University Hospital and Clinic

    New Orleans, Louisiana, 70112

  • Hospital for Special Surgery

    New York, New York, 10021

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Columbia University Medical Center-New York Presbyterian Hospital

    New York, New York, 10032

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 55905

  • University of California Davis

    Sacramento, California, 95817

  • University of Utah Health Sciences Center

    Salt Lake City, Utah, 84108

  • University of California San Francisco

    San Francisco, California, 94143

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • University of Washington

    Seattle, Washington, 98195

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305

  • University of Toledo

    Toledo, Ohio, 43614

  • Georgetown University

    Washington D.C., District of Columbia, 20007

Other trials in United States

Japan18 sites

  • Tosei General Hospital

    Aichi, Seto, 489-8642

  • Kurume University Hospital

    Fukuoka, Kurume, 830-0011

  • Sapporo Medical University Hospital

    Hokkaido, Sapporo, 060-8543

  • National Hospital Organization Himeji Medical Center

    Hyogo, Himeji, 670-8520

  • St. Marianna University Hospital

    Kanagawa, Kawasaki, 216-8511

  • Kitasato University Hospital

    Kanagawa, Sagamihara, 252-0375

  • Kanagawa Cardiovascular and Respiratory Center

    Kanagawa, Yokohama, 236-0051

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501

  • Kindai University Hospital

    Osaka, Osakasayama, 589-8511

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Osaka, Sakai, 591-8555

  • Osaka Medical College Hospital

    Osaka, Takatsuki, 569-8686

  • Saitama Medical University Hospital

    Saitama, Iruma-gun, 350-0495

  • Hamamatsu University Hospital

    Shizuoka, Hamamatsu, 431-3192

  • Tokushima University Hospital

    Tokushima, Tokushima, 770-8503

  • Juntendo University Hospital

    Tokyo, Bunkyo-Ku, 113-8431

  • Nippon Medical School Hospital

    Tokyo, Bunkyo-Ku, 113-8603

  • Toho University Omori Medical Center

    Tokyo, Ota-ku, 143-8541

  • Institute of Rheumatology Tokyo Women's Medical University

    Tokyo, Shinjyuku-ku, 162-0054

Other trials in Japan

France12 sites

  • HOP Avicenne

    Bobigny, 93009

  • HOP Louis Pradel

    Bron, 69677

  • CHRU Lille

    Lille, 59037

  • HOP Claude Huriez

    Lille, 59037

  • HOP Arnaud de Villeneuve

    Montpellier, 34295

  • HOP Hôtel-Dieu

    Nantes, 44093

  • HOP Pasteur

    Nice, 06001

  • HOP Bichat

    Paris, 75877

  • HOP Pontchaillou

    Rennes, 35033

  • HOP Charles Nicolle

    Rouen, 76000

  • HOP Larrey

    Toulouse, 31059

  • HOP Bretonneau

    Tours, 37044

Other trials in France

Germany10 sites

  • Klinik Donaustauf

    Donaustauf, 93093

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Universitätsmedizin Greifswald

    Greifswald, 17475

  • Asklepios Klinik Altona

    Hamburg, 22763

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

    Heidelberg, 69126

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105

  • Universitätsklinikum Münster

    Münster, 48149

  • Universitätsklinikum Tübingen

    Tübingen, 72076

Other trials in Germany

India9 sites

  • Ramaiah Medical College and Hospitals

    Bangalore, 560054

  • Post Graduate Institute of Medical Education and Research

    Chandigarh, 160012

  • Sir Gangaram Hospital

    Delhi, 110060

  • Care Hospital

    Hyderabad, 500034

  • Nizam's Institute of Medical Sciences

    Hyderabad, 500082

  • Asthma Bhawan

    Jaipur, 302039

  • Getwell Hospital & Research Institute

    Nagpur, 440012

  • All India Institute of Medical Sciences

    New Delhi, 110029

  • B.J. Medical College and Sasoon General Hospital

    Pune, 411001

Other trials in India

Spain7 sites

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08026

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Dr. Peset

    Valencia, 46017

  • Hospital Politècnic La Fe

    Valencia, 46026

  • Hospital Álvaro Cunqueiro

    Vigo, 36312

Other trials in Spain

China6 sites

  • Peking Union Medical College Hospital

    Beijing, 100032

  • The First Hospital of Jilin University

    Changchun, 130021

  • West China Hospital

    Chengdu, 610041

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022

  • Huashan Hospital, Fudan University

    Shanghai, 200040

  • The First Hospital of China Medical University

    Shenyang, 110001

Other trials in China

Portugal6 sites

  • Hospital Garcia de Orta, EPE

    Almada, 2801-951

  • Hospital Fernando Fonseca, EPE

    Amadora, 2720-276

  • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

    Coimbra, 3000-075

  • ULSAM, EPE - Hospital Conde de Bertiandos

    Ponte de Lima, 4990-041

  • Centro Hospitalar Universitário São João,EPE

    Porto, 4200-319

  • Centro Hospitalar de Vila Nova de Gaia

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Italy5 sites

  • Università degli Studi di Genova

    Genova, 16132

  • A.O. San Gerardo di Monza

    Monza, 20900

  • A.O Universitaria - Università degli Studi della Campania Luigi Vanvitelli

    Naples, 80138

  • Università degli Studi Padova

    Padova, 35128

  • Azienda Universitaria-Universita' La Sapienza

    Roma, 00161

Other trials in Italy

Australia4 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Liverpool Hospital

    Sydney, New South Wales, 2170

Other trials in Australia

Israel4 sites

  • Bnei Zion Medical Center, Haifa

    Haifa, 31048

  • Rambam Medical Center

    Haifa, 3109601

  • Rabin Medical Center Beilinson

    Petah Tikva, 49100

  • Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Netherlands4 sites

  • Amsterdam UMC Locatie VUMC

    Amsterdam, 1081HV

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden, 2333 ZA

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GA

  • Erasmus Medisch Centrum

    Rotterdam, 3015 CE

Other trials in Netherlands

Poland4 sites

  • Dr.Biziel UnivHosp#2,Rheumat&Connec.Tissue Disease,Bydgoszcz

    Bydgoszcz, 85168

  • Specialist Allergy-Internist Center ALL-MED

    Krakow, 30033

  • EMED, Center of Medical Services,Private Prac,Rzeszow

    Rzeszów, 35205

  • Indep.Pblic Clin.Hosp#1,Dermatol,Venereol&Allerg.dep,Wroclaw

    Wroclaw, 50-368

Other trials in Poland

United Kingdom4 sites

  • Royal Free Hospital

    London, NW3 2QG

  • Guy's Hospital

    London, SE1 9RT

  • Royal Brompton Hospital

    London, SW3 6NP

  • Salford Royal Hospital

    Salford, M6 8HD

Other trials in United Kingdom

Argentina3 sites

  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

    Buenos Aires, C1426BOR

  • APRILLUS-Asistencia e Investigación

    Ciudad Autonoma Buenos Aires, C1046AAQ

  • CEMER-Centro Medico De Enfermedades Respiratorias

    Florida, B1602DQD

Other trials in Argentina

Belgium3 sites

  • UNIV UZ Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000

Other trials in Belgium

Thailand3 sites

  • Ramathibodi Hospital

    Bangkok, 10400

  • Srinagarind Hospital

    Muang, 40002

  • Songklanagarind Hospital

    Songkhla, 90110

Other trials in Thailand

Chile2 sites

  • Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"

    Concepción, 4070038

  • Centro de Investigación del Maule

    Talca, 3465586

Other trials in Chile

Denmark2 sites

  • Aarhus University Hospital

    Aarhus N, 8200

  • Odense University Hospital

    Odense, 5000 C

Other trials in Denmark

Finland2 sites

  • HYKS Keuhkosairauksien tutkimusyksikkö

    Helsinki, 00290

  • TYKS

    Turku, 20521

Other trials in Finland

Malaysia2 sites

  • Hospital Pulau Pinang

    Georgetown Pulau Pinang, 10990

  • University of Malaya Medical Centre

    Kuala Lumpur, 59100

Other trials in Malaysia

Norway2 sites

  • Oslo Universitetssykehus HF, Rikshospitalet

    Oslo, N-0372

  • Universitetssykehuset Nord-Norge, Tromsø

    Tromsø, N-9038

Other trials in Norway

Austria1 site

  • Medical University of Innsbruck

    Innsbruck, A-6020

Other trials in Austria

Brazil1 site

  • Edumed - Educacao e Saude SA

    Curitiba, 80440-080

Other trials in Brazil

Canada1 site

  • HSCM

    Montreal, Quebec, H4J 1C5

Other trials in Canada

Czechia1 site

  • Institute of Rheumathology Prague

    Prague, 12850

Other trials in Czechia

Greece1 site

  • General Hospital of Athens "Laiko"

    Athens, 11527

Other trials in Greece

Mexico1 site

  • Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas

    Mexico City, 14080

Other trials in Mexico

Sweden1 site

  • Clinical Rheumatology Research Center Sahlgrenska

    Gothenburg, 413 45

Other trials in Sweden

Switzerland1 site

  • University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With 'Systemic Sclerosis Associated Interstitial Lung Disease' (SSc-ILD)

The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).

Being tested
Nintedanib
Medical subject headings
Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NintedanibDrug

    Also called OVEF

    Administered twice daily

Study groups in NCT03313180
Study groupRoleWhat they receive
NintedanibExperimentalPatients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) who took part in the parent trials 1199.214 (Nintedanib or Placebo) or 1199-0340 (Nintedanib). Patients continued in this trial and received Nintedanib 150 mg (milligram) twice daily (bid) unless they had reduced their dose to 100 mg bid trial medication (Nintedanib or Placebo) in the parent trial. Patients receiving 100 mg bid trial medication at the end of the parent trial could receive either Nintedanib 100 mg bid or 150 mg bid at the discretion of the investigator.
Receives: Drug: Nintedanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients With Any Adverse Event (AE) Over the Course of the Trial

    Number of patients with any adverse event (AE) over the course of the trial.

    Measured: First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to approximate 60 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2017
  2. Study start27 Nov 2017
  3. Primary completion25 Jan 2023
  4. Study completion25 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
444 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03313180
Sponsor's protocol ID
1199-0225
Other IDs
2016-003403-66, 2016
Status last verified
Jan 2024
First submitted
13 Oct 2017
Last updated
20 Feb 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this 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". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to 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. The data shared are the raw clinical study data sets.
Expanded access
Available

Publications

  • Allanore Y, Khanna D, Smith V, Aringer M, Hoffmann-Vold AM, Kuwana M, Merkel PA, Stock C, Sambevski S, Denton CP; SENSCIS Trial Investigators. Effects of nintedanib in patients with limited cutaneous systemic sclerosis and interstitial lung disease. Rheumatology (Oxford). 2024 Mar 1;63(3):639-647. doi: 10.1093/rheumatology/kead280.

    PubMed 37294870

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nintedanib in people with Lung Diseases, Interstitial, run by Boehringer Ingelheim at 159 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 159 sites in United States, Japan, France, Germany, India and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Any Adverse Event (AE) Over the Course of the Trial (time frame: First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to approximate 60 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03313180, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.

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