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Summary

Eligibility
for people ages 40 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab as monotherapy in the absence of background idiopathic pulmonary fibrosis (IPF) therapy or as combination therapy with pirfenidone background therapy in participants with idiopathic pulmonary fibrosis. Participants will be randomized to receive either lebrikizumab or placebo subcutaneously (SC) every 4 weeks.

Official Title

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis Pirfenidone Antibodies, Monoclonal

Eligibility

You can join if…

Open to people ages 40 years and up

  • Have a diagnosis of IPF within the previous 5 years from time of screening and confirmed at baseline
  • FVC>/=40 % and less than or equal to (

  • Stable baseline lung function as evidenced by a difference of less than (<) 10% in FVC(liters) measurements between screening and Day 1/Visit 2 prior to randomization
  • Diffusion capacity of the lung for carbon monoxide>/=25% and

  • Ability to walk>/=100 meters unassisted in 6 minutes
  • Cohort A: No background IPF therapy for>/=4 weeks allowed prior to randomization and throughout the placebo-controlled study period
  • Cohort B: Tolerated dose of pirfenidone /=4 weeks required prior to randomization and throughout the placebo-controlled study period

You CAN'T join if...

  • History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
  • Evidence of other known causes of interstitial lung disease (ILD)
  • Lung transplant expected within 12 months of screening
  • Evidence of clinically significant lung disease other than IPF
  • Post bronchodilator forced expiratory volume in 1 second (FEV1)/FVC ratio < 0.7 at screening
  • Positive bronchodilator response, evidenced by an increase of>/=12% predicted and 200 milliliters (mL) increase in FEV1 or FVC
  • Class IV New York Heart Association chronic heart failure or historical evidence of left ventricular ejection fraction <35%
  • Hospitalization due to an exacerbation of IPF within 4 weeks prior to or during screening
  • Known current malignancy or current evaluation for potential malignancy
  • Listeria monocytogenes infection or active parasitic infections within 6 months prior to randomization
  • Active tuberculosis requiring treatment within 12 months of screening
  • Known immunodeficiency, including but not limited to human immunodeficiency virus(HIV) infection
  • Past use of any anti-interleukin (IL)-13 or anti-IL-14/IL-13 therapy, including lebrikizumab
  • Evidence of acute or chronic hepatitis or known liver cirrhosis

Exclusions Limited to Cohort B:

  • Known achalasia, esophageal stricture, or esophageal dysfunction sufficient to limit the ability to swallow oral medication
  • Tobacco smoking or use of tobacco-related products within 3 months of screening or unwillingness to avoid smoking throughout the study period
  • Known or suspected peptic ulcer
  • Any condition that, as assessed by the investigator, might be significantly exacerbated by the known side effects associated with pirfenidone
  • Creatinine clearance <40 mL/minute, calculated using the Cockcroft-Gault formula
  • Use of following therapies within 4 weeks of randomization (Day 1/Visit 2) or during the study
  • Strong inhibitors of CYP1A2 (Cytochrome P450 family 1 subfamily A member 2) (example:fluvoxamine or enoxacin)
  • Moderate inducers of CYP1A2 (limited to tobacco smoking and tobacco-related products)

Locations

  • UCSD Medical Center
    La Jolla, California, 92093, United States
  • Mayo Clinic- Scottsdale
    Scottsdale, Arizona, 85259, United States
  • University of Utah Health Sciences Center, Lung Health Research Center
    Salt Lake City, Utah, 84108, United States
  • The Oregon Clinic.
    Portland, Oregon, 97220, United States
  • University of Arizona
    Tucson, Arizona, 85724-5030, United States
  • Southern Arizona Veterans Administration Healthcare Systems
    Tucson, Arizona, 85723, United States
  • Pulmonary Consultants
    Tacoma, Washington, 98405, United States
  • Lovelace Scientific Resources, Inc.
    Albuquerque, New Mexico, 87108, United States
  • University of British Columbia - Vancouver Coastal Health Authority
    Vancouver, British Columbia, V5Z 1M9, Canada
  • Rocky Mountain Center For Clinical Research
    Wheat Ridge, Colorado, 80033, United States
  • National Jewish Health
    Denver, Colorado, 80206, United States
  • Via Christi Hospital Inc. DBA Via Christi Research; Research Dept.
    Wichita, Kansas, 67208, United States
  • Oklahoma University Health Sciences Center
    Oklahoma City, Oklahoma, 73104, United States
  • University of Nebraska
    Omaha, Nebraska, 68198-5300, United States
  • Audie Murphy Va Hospital
    San Antonio, Texas, 78229, United States
  • Uni of Kansas Medical Center
    Kansas, Kansas, 66160, United States
  • Universidad Autonoma De Nuevo Leon, Hospital Universitario Doctor Jose Eleuterio Gonzalez
    Monterrey, 64460, Mexico
  • Unidad de Investigacion Clinica En Medicina (Udicem) S.C.
    Monterrey, 64718, Mexico
  • Baylor College Med
    Houston, Texas, 77030, United States
  • Houston Methodist Hospital
    Houston, Texas, 77030, United States
  • University of Minnesota Hospital & Clinic
    Minneapolis, Minnesota, 55455, United States
  • Mayo Clinic Rochester
    Rochester, Minnesota, 55905, United States
  • Univ of Iowa Hosp & Clinics; Pulmonary
    Iowa City, Iowa, 52242, United States
  • Cardiopulmonary Associates LLC Cardiopulmonary Research
    Chesterfield, Missouri, 63017, United States
  • University Wisconsin Hospitals and Clinics
    Madison, Wisconsin, 53792, United States
  • Medical College of Wisconsin
    Milwaukee, Wisconsin, 53226, United States
  • Hospital General Del Estado De Sonora "Dr. Ernesto Ramos Bours"; Servicio De Neumologia
    Hermosillo, 83000, Mexico
  • Instituto Nacional De Enfermedades Respiratorias;Unidad de Investigación
    Mexico City, 14080, Mexico
  • Loyola University Med Center
    Maywood, Illinois, 60153, United States
  • University of Chicago; Pulmonary and Critical Care
    Chicago, Illinois, 60637, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee, 37232, United States
  • University Alabama At Birmingham
    Birmingham, Alabama, 35294, United States
  • University of Cincinnati
    Cincinnati, Ohio, 45203-0542, United States
  • Piedmont Healthcare Pulmonary and Critical Care Research
    Austell, Georgia, 30106, United States
  • Ohio State University
    Columbus, Ohio, 43210, United States
  • Southeastern Lung Care
    Decatur, Georgia, 30033, United States
  • Case Western Research University; University Hospitals Case Medical Center
    Cleveland, Ohio, 44106-5067, United States
  • Lawson Health Research Institute a joint venture of LHSC Research Inc and Lawson Research Institute
    London, Ontario, N6C 2R5, Canada
  • St. Joseph's Healthcare Hamilton
    Hamilton, Ontario, L8N4A6, Canada
  • University of Pittsburgh Med Cen; Dorothy P And Richard P Simmons Cen For Interstitial Lung Disease
    Pittsburgh, Pennsylvania, 15213, United States
  • Research Alliance Inc
    Clearwater, Florida, 33756, United States
  • Mayo Clinic-Jacksonville
    Jacksonville, Florida, 32224, United States
  • USF Tampa General Hospital
    Tampa, Florida, 33606, United States
  • Highland Hospital—University of Rochester Medical Center
    Rochester, New York, 14620, United States
  • Medical University of South Carolina
    Charleston, South Carolina, 29425, United States
  • Central Florida Pulmonary Group, PA
    Orlando, Florida, 32803, United States
  • Inova Transplant Center Fairfax Hospital
    Falls Church, Virginia, 22042, United States
  • Penn State University College Medical Allergy And Care Med
    Hershey, Pennsylvania, 17033, United States
  • University of Maryland Medical Center
    Baltimore, Maryland, 21201, United States
  • Johns Hopkins Bayview Medical Center - Johns Hopkins Asthma & Allergy Center
    Baltimore, Maryland, 21224, United States
  • Temple Lung Center, Temple Universtiy-Of the Commomwealth System of Higher Education
    Philadelphia, Pennsylvania, 19140, United States
  • Cleveland Clinic Florida
    Weston, Florida, 33331, United States
  • University Miami
    Miami, Florida, 33136, United States
  • Weill Medical College of Cornell University
    New York, New York, 10021-5663, United States
  • Mt Sinai School Medical Pulmo And Critical Care Med
    New York, New York, 10029, United States
  • University Vermont College Medicine Fletcher Allen Health Care
    Colchester, Vermont, 05446, United States
  • Yale New Haven Hospital
    New Haven, Connecticut, 06520, United States
  • Institut universitaire de cardiologie et de pneumologie de Québec (Hôpital Laval)
    Ste. Foy, Quebec, G1V 4G5, Canada
  • Rhode Island Hospital
    Providence, Rhode Island, 02903, United States
  • Tufts Medical Center
    Boston, Massachusetts, 02111, United States
  • Maine Medical Center -Division of Pulmomary and Critical Care Medicine
    Portland, Maine, 04106, United States
  • Dr. Georges-L. Dumont Regional Hospital
    Moncton, New Brunswick, E1G 2K5, Canada
  • Clinica San Pablo
    Lima, Lima 33, Peru
  • Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
    Lima, Lima 41, Peru
  • Clinica San Borja; NEUMOCARE
    Lima, Lima 41, Peru
  • Southmead Hospital; Respiratory Department
    Bristol, BS10-5NB, United Kingdom
  • Papworth Hospital NHS Foundation Trust; Respiratory Department
    Cambridge, CB23 3RE, United Kingdom
  • Southampton General Hospital; Respiratory Department
    Hampshire, SO16 6YD, United Kingdom
  • St James University Hospital; Respiratory Department
    Leeds, LS9 7TF, United Kingdom
  • Respiratory research department clinical science building
    Liverpool, L9 7AL, United Kingdom
  • Royal Brompton Hospital; Respiratory Department
    London, SW3 6NP, United Kingdom
  • North Manchester Hospital; Respiratory Department
    Manchester, M8 5RB, United Kingdom
  • Kanagawa Cardiovascular and Respiratory Center; Respiratory Medicine
    Kanagawa, 236-0051, Japan
  • Kinki-Chuo Chest Medical Center
    Osaka, 591-8555, Japan
  • Tosei General Hospital
    Seto-shi, 489-8642, Japan
  • Clin Univ de Bxl Hôpital Erasme
    Bruxelles, 1070, Belgium
  • Cliniques Universitaires St-Luc
    Bruxelles, 1200, Belgium
  • UZ Leuven Gasthuisberg
    Leuven, 3000, Belgium
  • CHU UCL Mont-Godinne
    Mont-godinne, 5530, Belgium
  • Hopital Avicenne; Pneumologie
    Bobigny, 93000, France
  • Hopital Louis Pradel; Pneumologie
    Bron, 69677, France
  • Hopital Calmette; Pneumologie
    Lille, 59037, France
  • Hopital Bichat Claude Bernard ; Service de Pneumologie
    Paris, 75877, France
  • Hopital de Pontchaillou; Service de Pneumologie
    Rennes, 35033, France
  • Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie
    Essen, 45239, Germany
  • Universitätsklinikum Standort Gießen Medizinische Klinik II u. Poliklinik Innere Med./Pneumologie
    Gießen, 35392, Germany
  • LungenClinic Großhansdorf
    Großhansdorf, 22927, Germany
  • Thoraxklinik Heidelberg gGmbH
    Heidelberg, 69126, Germany
  • Fachklinik für Lungenerkrankungen
    Immenhausen, 34376, Germany
  • CPC Comprehensive Pneumology Center / Forschungsambulanz, Helmholtz Zentrum
    München, 81377, Germany
  • Hospital Universitari de Bellvitge ; Servicio de Neumologia
    Hospitalet de Llobregat, Barcelona, 08097, Spain
  • Hospital Universitario La Princesa; Servicio de Neumologia
    Madrid, 28006, Spain
  • Hospital Clínico San Carlos - Servicio de Neumologia
    Madrid, 28040, Spain
  • Hospital Universitario Virgen del Rocio; Servicio de Neumologia
    Sevilla, 41013, Spain
  • Hospital General Universitario De Valencia; Servicio de Neumologia
    Valencia, 46014, Spain
  • Uniwersytecki Szpital Kliniczny Nr 1 im.N.Barlickiego Oddzial Kliniczny Pneumonologii i Alergologii
    Lodz, 90-153, Poland
  • Ms Clinsearch Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej
    Lublin, 20-064, Poland
  • Klinika Pulmonologii, Alergologii i Onkologii Pulmonologicznej Uniwersytet Medyczny w Poznaniu
    Poznan, 60-569, Poland
  • Instytut Gruzlicy i Chorob Płuc
    Warszawa, 01-138, Poland
  • Klinika Chorob Pluc i Gruzlicy w Zabrzu; Slaski Uniwersytet Medyczny
    Zabrze, 41-803, Poland
  • Ospedale Morgagni-Pierantoni; U.O. Pneumologia
    Forlì, Emilia-Romagna, 47121, Italy
  • Policlinico Tor Vergata di Roma; U.O. Malattie Respiratorie; Centro delle malattie rare del Polmone
    Roma, Lazio, 00133, Italy
  • Ospedale San Giuseppe; U.O. di Pneumologia
    Milano, Lombardia, 20123, Italy
  • A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone
    Orbassano (TO), Piemonte, 10043, Italy
  • A.O.U. Policlinico Vittorio Emanuele; Centro per la cura delle Malattie Rare del Polmone
    Catania, Sicilia, 95123, Italy
  • A.O. Univ. Senese Policlinico S. Maria alle Scotte; UOC Malattie Resepiratorie e Trapianto Polmonare
    Siena, Toscana, 53100, Italy
  • Royal Prince Alfred Hospital; Department of Respiratory Medicine
    Camperdown, New South Wales, 2050, Australia
  • ST VINCENT'S HOSPITAL; Thoracic Medicine
    Darlinghurst, New South Wales, 2010, Australia
  • Box Hill Hospital; Eastern Clinical Research Unit
    Box Hill, Victoria, 3128, Australia
  • Alfred Hospital; Allergy Immuno Resp
    Melbourne, Victoria, 3004, Australia
  • Institute for Respiratory Health Inc
    Nedlands, Western Australia, 6009, Australia

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT01872689
Phase
Phase 2
Lead Scientist
Jeffrey Golden
Study Type
Interventional
Last Updated
May 1, 2017