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Idiopathic Pulmonary FibrosisPhase 2RAINIERNCT01769196

Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)

A Phase 2 study testing Simtuzumab in people with Idiopathic Pulmonary Fibrosis, run by Gilead Sciences at 175 sites in 14 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The primary objectives of this study are to determine the effect of simtuzumab (GS-6624) on progression-free survival (PFS) as determined by either a categorical decline in forced vital capacity (FVC) or all-cause mortality, in all participants enrolled or in a subset of participants who are classified as lysyl… Read more about this study

Who is it for?
Ages 45 to 85 years
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
Simtuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
544 participants
Where
175 sitesin 14 countries
Study dates
31 Jan 2013to 23 Feb 2016
Phase
Phase 2
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 45 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects from 45 to 85 years of age
  • Definite IPF within 3 years prior to screening
  • Be able to walk at least 50 meters

Who cannot join

  • Significant diseases other than IPF
  • Obstructive lung disease
  • Aortic aneurysm greater than or equal to 3.5 cm in diameter
  • Treatment with immunosuppressive, cytotoxic, or antifibrotic drugs < 28 days prior to randomization are not permitted.
  • N-acetylcysteine is permitted provided the individual has been on a stable dose for > 4 weeks prior to screening
  • Concomitant use of pirfenidone or nintedanib must be in accordance with the approved prescribing instructions in the country where the site is located
  • Individuals actively listed for lung transplant are excluded. However individuals at transplant centers with long waiting times (greater than 1 year) may be permitted to enter the study after discussion with Medical Monitor.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

175 sites in 14 countries.

175 sites in 14 countries

United States72 sites

  • Albany Medical College

    Albany, New York, 12208

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • University of Maryland

    Baltimore, Maryland, 21201

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Tufts University School of Medicine

    Boston, Massachusetts, 02111

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02120

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Massachusetts General Hospital

    Boston, Massachusetts

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • CardioPulmonary Associates

    Chesterfield, Missouri, 63017

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Bay Area Chest Physicians

    Clearwater, Florida, 33756

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Ohio State University

    Columbus, Ohio, 43221

  • Loess Hills Clinical Research Center

    Council Bluffs, Iowa, 51503

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Southeastern Lung Care

    Decatur, Georgia, 30033

  • National Jewish Health

    Denver, Colorado, 80206

  • Henry Ford Hospital

    Detroit, Michigan, 48124

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Providence Everett Medical Center

    Everett, Washington, 98201

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Florida

    Jacksonville, Florida, 32209

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • Jamaica Hospital Medical Center

    Jamaica, New York, 11418

  • Saint Luke's Midwest Pulmonary Consultants

    Kansas City, Missouri, 64111

  • University of California San Diego

    La Jolla, California, 92093

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 55905

  • David Geffen School of Medicine at University of California, Los Angeles

    Los Angeles, California, 90024

  • Kentuckiana Pulmonary Associates

    Louisville, Kentucky, 40202

  • University of Louisville

    Louisville, Kentucky, 40202

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • University of Miami

    Miami, Florida, 33136

  • Froedtert Hospital and Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903-0019

  • Yale University School of Medicine

    New Haven, Connecticut, 06150

  • North Shore University Hospital

    New Hyde Park, New York, 11040

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Columbia University

    New York, New York, 10032

  • Weill Cornell Medical College

    New York, New York, 10065

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Temple University Hospital, Temple Lung Center

    Philadelphia, Pennsylvania, 19140

  • Arizona Pulmonary Specialists, Ltd.

    Phoenix, Arizona, 85012

  • Saint Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85103

  • University of Pittsburgh Presbyterian - Montefiore

    Pittsburgh, Pennsylvania, 15213

  • The Oregon Clinic, PC

    Portland, Oregon, 97220

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14620

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • University of Utah

    Salt Lake City, Utah, 84108

  • University of California San Francisco

    San Francisco, California, 94143

  • Sansum Clinic

    Santa Barbara, California, 93105

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Arizona Pulmonary Specialists, Ltd.

    Scottsdale, Arizona, 85258

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • University of Washington

    Seattle, Washington, 98195

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305

  • Pulmonary and Allergy Associates, PA

    Summit, New Jersey, 07901

  • Tampa General Hospital

    Tampa, Florida, 33606

  • The University of Arizona

    Tucson, Arizona, 85724

  • Cleveland Clinic Florida

    Weston, Florida, 33331

Other trials in United States

United Kingdom16 sites

  • Birmingham Heartlands Hospital

    Birmingham, England, B9 5SS

  • Southmead Hospital

    Bristol, England, BS10 5NB

  • Papworth Hospital

    Cambridge, England, CB23 3RE

  • Castle Hill Hospital

    Cottingham, England, HU16 5JQ

  • Royal Infirmary of Edinburgh

    Edinburgh, Scotland, EH16 4TJ

  • Royal Devon and Exeter Hospital

    Exeter, England, EX2 5DW

  • Glasgow Royal Infirmary

    Glasgow, Scotland, G11 6NT

  • Saint James's University Hospital

    Leeds, England, LS9 7TF

  • Glenfield Hospital

    Leicester, England, LE3 9QP

  • Aintree University Hospitals NHS Foundation Trust

    Liverpool, England, L9 7AL

  • Royal Brompton Hospital

    London, England, SW3 6NP

  • University Hospital of South Manchester NHS Foundation Trust

    Manchester, England, M23 9LT

  • Nottingham City Hospital

    Nottingham, England, NG5 1PD

  • Churchill Hospital

    Oxford, England, OX3 7LE

  • Northern General Hospital

    Sheffield, England, S5 7AU

  • Southampton General Hospital

    Southampton, England, SO16 6YD

Other trials in United Kingdom

France13 sites

  • Centre Hospitalier Universitaire Hôpital Avicenne

    Bobigny, Île-de-France Region, 93009

  • Hôpital Louis Pradel

    Bron, Rhone-aples, 69677

  • Centre Hospitalier Universitaire Grenoble Hopital Michalon

    Grenoble, Auvergne-Rhône-Alpes, 38043

  • Hôpital Albert Calmette

    Lille, Hauts-de-France, 59037

  • Centre Hospitalier Universitaire Hôpital Nord

    Marseille, Provence-Alpes-Côte d'Azur Region, 13015

  • Hôpital Arnaud de Villeneuve

    Montpellier, Languedoc-roussillon, 34295

  • Centre Hospitalier Universitaire de Nice-Hôpital Pasteur

    Nice, Poitou-charentes, 06002

  • Hôpital Bichat-Claude Bernard

    Paris, Île-de-France Region, 75018

  • HEGP

    Paris, Île-de-France Region, 75908

  • Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou

    Rennes, Brittany Region, 35033

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, Alsace, 67091

  • Hôpital Larrey, CHU de Toulouse, Service de Pneumologie

    Toulouse, Midi-pyrenees, 31059

  • Centre Hospitalier Régional et Universitaire - Hôpital Bretonneau

    Tours, Centre-Val de Loire, 37044

Other trials in France

Australia10 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Mater Adult Hospital

    Brisbane, Queensland, 4000

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Prince Charles Hospital

    Chermside, Queensland, 4032

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Saint Vincents Hospital

    Darlinghurst, New South Wales, 2010

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Royal Perth Hospital

    Perth, Western Australia, 6000

Other trials in Australia

Germany10 sites

  • Helios Klinikum Emil von Behring, Lungenklinik Heckeshorn

    Berlin, 14165

  • Fachkrankenhaus Coswig

    Coswig, Saxony, 01640

  • Universität Freiburg, Klinikum, Abt für Pneumologie

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH

    Giessen, Hesse, 35392

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Thoraxklinik am Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69126

  • Lungenfachklinik Immenhausen

    Immenhausen, Hesse, 34376

  • Universitätsklinikum Leipzig

    Leipzig, Saxony, 04103

  • Ruhrlandklinik

    Mannheim, Baden-Wurttemberg, 68165

  • Klinikum Großhadern der Ludwig-Maximilians-Universität München

    München, Bavaria, 81377

Other trials in Germany

Italy9 sites

  • Policlinico Universitario di Catania

    Catania, 95123

  • Ospedale "G.B.Morgagni - L. Pierantoni"

    Forlì, Forli-cesena, 47100

  • San Giuseppe Hospital, Dept. of Internal Medicine

    Milan, 20132

  • Azienda Ospedaliero-Universitaria Policlinico di Modena

    Modena, 41100

  • Azienda Ospedaliera San Gerardo di Monza

    Monza, Monza E Brianza, 20052

  • Università degli studi Federico II di Napoli

    Naples, 80131

  • Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)

    Palermo, 90127

  • Fondazione PTV - Policlinico Tor Vergata

    Roma, 00133

  • Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

    Siena, 53100

Other trials in Italy

Canada7 sites

  • Saint Joseph's Healthcare

    Hamilton, Ontario, L8N 4A6

  • Kelowna Respiratory and Allergy Clinic

    Kelowna, British Columbia, V1Y1E4

  • Centre Hospitalier de L'Université de Montréal Hôtel-Dieu

    Montreal, Quebec, H2W 1T8

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec

    Québec, Quebec, G1V4G5

  • University Health Network

    Toronto, Ontario, M5G2C4

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

  • University of British Columbia

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

Czechia7 sites

  • Fakultní nemocnice Brno

    Brno, Jihormoravsky Kraj, 625 00

  • Nemocnice Jihlava

    Jihlava, Jihormoravsky Kraj, 689 32

  • Krajská nemocnice Liberec a.s.

    Liberec, Severocesky Kraj, 460 63

  • Fakultní Nemocnice Ostrava

    Ostrava - Poruba, Severomoravsky Kraj, 708 52

  • Fakultní nemocnice Plzen

    Pilsen, Zapadocesky Kraj, 305 99

  • Thomayerova nemocnice

    Prague 4 - Krc, 140 59

  • Masarykova nemocnice v Ústí nad Labem o.z.

    Ústí nad Labem, Severocesky Kraj, 401 13

Other trials in Czechia

South Korea7 sites

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si, Gyeonggi-do, 420-767

  • Gachon University Gil Medical Center

    Incheon, Gyeonggi-do, 405-760

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 463-707

  • Samsung Medical Center

    Seoul, Gyeonggi-do, 135-710

  • Seoul National University Hospital

    Seoul, 110-744

  • Korea University Anam Hospital

    Seoul, 136-705

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

Spain7 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitario La Princesa

    Madrid, 28006

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Hospital Quirón Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

Other trials in Spain

Israel6 sites

  • Soroka University Medical Center

    Beersheba, Beersheba, 84100

  • Hadassah-Hebrew University Medical Center

    Jerusalem, 91120

  • Meir Medical Center

    Kfar Saba, 44281

  • Rabin Medical Center

    Petach Tikvah, 49100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

  • Chaim Sheba Medical Center

    Tel HaShomer, Tel Aviv, 52621

Other trials in Israel

Poland5 sites

  • 10 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ w Bydgoszczy

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-681

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, 80-952

  • Samodzielny Publiczny ZOZ, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego

    Lódz, Łódź Voivodeship, 90-153

  • Instytut Gruzlicy i Chorób Pluc

    Warsaw, Masovian Voivodeship, 01-138

  • Samodzielny Publiczny Szpital Kliniczny nr 3 w Zabrzu Slaskiego Uniwersytetu Medycznego w Katowicach

    Zabrze, Silesian Voivodeship, 41-803

Other trials in Poland

Belgium3 sites

  • ULB Erasme

    Anderlecht, Brussels Capital, 1070

  • Universitair Ziekenhuis Leuven

    Leuven, Flemish Brabant, 3000

  • Cliniques Universitaires UCL de Mont-Godinne

    Yvoir, Namur, 5530

Other trials in Belgium

Switzerland3 sites

  • Universitätsspital Basel

    Basel, 4031

  • Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)

    Lausanne, Canton of Vaud, CH 1011

  • Kantonsspital St. Gallen

    Sankt Gallen, Canton of St. Gallen, 9007

Other trials in Switzerland

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

The primary objectives of this study are to determine the effect of simtuzumab (GS-6624) on progression-free survival (PFS) as determined by either a categorical decline in forced vital capacity (FVC) or all-cause mortality, in all participants enrolled or in a subset of participants who are classified as lysyl oxidase-like-2 (LOXL2) high based on a prespecified level in serum at baseline.

Being tested
Simtuzumab, Simtuzumab placebo
Keywords
Idiopathic, Pulmonary, Fibrosis, IPF
Medical subject headings
Idiopathic Pulmonary Fibrosis, Fibrosis

What participants receive

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

  • SimtuzumabDrug

    Also called GS-6624

    125 mg/mL single-dose vials administered subcutaneously once a week

  • Simtuzumab placeboDrug

    Simtuzumab placebo single-dose vials administered subcutaneously once a week

Study groups in NCT01769196
Study groupRoleWhat they receive
SimtuzumabExperimentalParticipants will receive simtuzumab for up to 254 weeks.
Receives: Drug: Simtuzumab
Simtuzumab PlaceboPlacebo comparatorParticipants will receive simtuzumab placebo for up to 254 weeks.
Receives: Drug: Simtuzumab placebo

What is being measured

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

  1. Progression Free Survival

    Progression free survival (PFS) was defined as the categorical decrease in forced vital capacity (FVC) % predicted (≥ 10% relative decrease in FVC and ≥ 5% absolute decrease in FVC from baseline) with confirmation at a consecutive visit at least 2 weeks later using the same criteria.

    Measured: Up to 148 weeks

  2. PFS Among the Participants With sLOXL2 ≥ 50th Percentile

    Measured: Up to 148 weeks

  3. PFS Among the Participants With sLOXL2 ≥ 75th Percentile

    Measured: Up to 148 weeks

Secondary outcomes (9)

  1. Overall Survival (OS)

    Overall survival was defined as the time from randomization date to death that occurred prior to the last dose date plus 30 days.

    Measured: Up to 151 weeks

  2. Overall Survival Among the Participants With sLOXL2 ≥ 50th Percentile

    Measured: Up to 151 weeks

  3. Overall Survival Among the Participants With sLOXL2 ≥ 75th Percentile

    Measured: Up to 151 weeks

  4. Relative Change From Baseline in FVC % Predicted

    • FVC was defined as the volume of air (liters) that can forcibly be blown out after taking a full breath. FVC % predicted was defined as FVC % of the participant divided by the average FVC % in the population for any person of similar age, sex, and body composition.
    • Adjusted means were from mixed model repeated measures (MMRM) model with baseline FVC % predicted, sLOXL2 level, concomitant pirfenidone/nintedanib use (never vs. ever), treatment, visit, and treatment-by-visit interaction terms, including all data up to Week 130
    • The relative change was calculated as 100% * ( value at later time point minus value at baseline ) / value at baseline, with lower values indicating a decrease and higher values indicating an increase.

    Measured: Weeks 54, 106, and 130

  5. Definite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations

    Measured: Up to 148 weeks

  6. Number of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations

    Measured: Up to 148 weeks

  7. Number of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death

    Measured: Up to 148 weeks

  8. Absolute Change From Baseline in 6 Minute Walk Distance (6MWD)

    • Adjusted means were from MMRM model with baseline 6MWD, FVC % predicted, sLOXL2 level, concomitant pirfenidone/nintedanib use (never vs. ever), treatment, visit, and treatment-by-visit interaction terms, including all data up to Week 130.
    • The absolute change was calculated as value at later time point minus value at baseline, with lower values indicating a decrease and higher values indicating an increase.

    Measured: Weeks 58, 106, and 130

  9. Absolute Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Score

    • The SGRQ is a disease-specific questionnaire designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Patients respond to questions about symptoms (frequency \& severity) and impact components (social functioning and psychological disturbances resulting from airways disease). Scores range from 0 to 100, with higher scores indicating more limitations.
    • The absolute change was calculated as value at later time point minus value at baseline, with lower values indicating a decrease and higher values indicating an increase.

    Measured: Week 58, 106, and 130

Timeline

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

  1. First posted16 Jan 2013 (estimated)
  2. Study start31 Jan 2013
  3. Primary completion23 Feb 2016
  4. Study completion23 Feb 2016

Why it stopped: The Study was terminated due to lack of efficacy.

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
544 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01769196
Sponsor's protocol ID
GS-US-322-0207
Other IDs
2012-001571-36
Acronym
RAINIER
Status last verified
Apr 2017
First submitted
14 Jan 2013
Last updated
30 May 2017
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Raghu G, Brown KK, Collard HR, Cottin V, Gibson KF, Kaner RJ, Lederer DJ, Martinez FJ, Noble PW, Song JW, Wells AU, Whelan TP, Wuyts W, Moreau E, Patterson SD, Smith V, Bayly S, Chien JW, Gong Q, Zhang JJ, O'Riordan TG. Efficacy of simtuzumab versus placebo in patients with idiopathic pulmonary fibrosis: a randomised, double-blind, controlled, phase 2 trial. Lancet Respir Med. 2017 Jan;5(1):22-32. doi: 10.1016/S2213-2600(16)30421-0. Epub 2016 Dec 7.

    PubMed 27939076

  • Humphries SM, O'Riordan TG, Zhang JJ, Bayly S, Sood R, Hayden A, Lynch DA; Relationship Baseline Fibrosis Score to Lung Function in A Clinical Trial Population with Idiopathic Pulmonary Fibrosis. ATS International Conference, 2016 May 13-18, San Francisco CA.

  • Raghu G, Brown K, Collard H, Lederer D, Martinez F, Noble P, Song JW, Wells A, Whelan T, Moreau E, Patterson S, Bayly S, Chien J, Zhang J, O'Riordan T; Simtuzumab in Idiopathic Pulmonary Fibrosis: Results of a Randomized Clinical Trial. ERS Congress, 2016 September 3-7, London, UK.

  • Raghu G, Brown KK, Collard HR, Lederer DJ, Martinez FJ, Noble PW, Song JW, Wells AU, Whalen TP, Lambert L, Chien JW, Zhang JJ, O'Riordan TG; Simtuzumab in Idiopathic Pulmonary Fibrosis (IPF): Baseline Demographic and Lung Function Data from a Clinical Trial. ATS International Conference, 2016 May 13-18, San Francisco CA.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Simtuzumab in people with Idiopathic Pulmonary Fibrosis, run by Gilead Sciences at 175 sites in 14 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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 175 sites in United States, United Kingdom, France, Australia, Germany and 9 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 13 Apr 2017). 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?

Progression Free Survival (time frame: Up to 148 weeks). The study lists 3 primary outcomes in all. 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 NCT01769196, which also lists 4 linked publications.

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 30 May 2017.

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