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A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01872689
First received: June 5, 2013
Last updated: July 20, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention Phase
Idiopathic Pulmonary Fibrosis Drug: Lebrikizumab Drug: Pirfenidone Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52 [ Time Frame: Baseline, Week 52 ]

Secondary Outcome Measures:
  • Progression Free Survival (PFS), Defined as Time From Randomization to Death, Non-elective Hospitalization, or a Decrease From Baseline of Greater Than or Equal to (>/=) 10 Percent (%) in FVC, Whichever Occurs First [ Time Frame: Baseline up to 18 weeks after last dose (last dose = Week 104) ]
  • Annualized Rate of Change in FVC (in Liters) [ Time Frame: Baseline up to Week 52 ]
  • Time to First Decrease From Baseline of >/=10% in FVC [ Time Frame: Baseline up to 18 weeks after last dose (last dose = Week 104) ]
  • Time to First Decrease From Baseline of >/= 15% in Diffusion Capacity of the Lung for Carbon Monoxide (DLco) [ Time Frame: Baseline up to 18 weeks after last dose (last dose = Week 104) ]
  • Change From Baseline in the A Tool to Assess Quality of Life in IPF (ATAQ-IPF) Questionnaire Score at Week 52 [ Time Frame: Baseline, Week 52 ]
  • Time to Non-elective Hospitalization From any Cause [ Time Frame: Baseline up to 18 weeks after last dose (last dose = Week 104) ]
  • Change From Baseline in 6-Minute Walk Test (6MWT) Distance at Week 52 [ Time Frame: Baseline, Week 52 ]
  • Time to First Event of Acute IPF Exacerbation [ Time Frame: Baseline up to 18 weeks after last dose (last dose = Week 104) ]
  • Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Score at Week 52 [ Time Frame: Baseline, Week 52 ]
  • Percentage of Participants with Adverse Events or Serious Adverse Events [ Time Frame: Baseline up to 18 weeks after last dose (last dose = Week 104) ]
  • Percentage of Participants with Anti-therapeutic Antibody (ATA) to Lebrikizumab [ Time Frame: Baseline up to 18 weeks after last dose (last dose = Week 104) ]
  • Serum Lebrikizumab Concentration at Week 52 (Cwk52) [ Time Frame: Pre-dose (at Hour 0) at Week 52 ]
  • Minimum Observed Serum Trough Lebrikizumab Concentration (Cmin) at Week 4, 12, 24, and 36 [ Time Frame: Pre-dose (at Hour 0) at Weeks 4, 12, 24, and 36 ]
  • Elimination Half-Life (t1/2) of Lebrikizumab [ Time Frame: Pre-dose (at Hour 0) at Weeks 1, 4, 12, 24, 36, 64, 76, 88, 104; at 4, 12, and 18 weeks post-last dose (last dose = Week 104) ]

Enrollment: 507
Actual Study Start Date: October 30, 2013
Estimated Study Completion Date: November 15, 2017
Estimated Primary Completion Date: November 15, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A: Monotherapy Lebrikizumab
Monotherapy of lebrikizumab 250 milligrams (mg) will be administered SC once every 4 week up to 52 weeks placebo-controlled treatment period and thereafter for additional 52 weeks (i.e., up to Week 104) in the open-label period.
Drug: Lebrikizumab
Administered SC every 4 weeks
Placebo Comparator: Cohort A: Monotherapy Placebo
Placebo matched to lebrikizumab will be administered SC once every 4 week up to 52 week placebo-controlled treatment period. Thereafter will be followed by lebrikizumab 250 mg administered SC every 4 week for additional for 52 weeks (i.e., up to Week 104) in the open-label period.
Drug: Lebrikizumab
Administered SC every 4 weeks
Drug: Placebo
Administered SC every 4 weeks
Experimental: Cohort B: Combination Therapy (Lebrikizumab + Pirfenidone)
Pirfenidone </=2403 mg once daily (maximum tolerated dose) will be administered in combination with lebrikizumab 250 mg SC once every 4 week up to 52 week placebo-controlled treatment period.
Drug: Lebrikizumab
Administered SC every 4 weeks
Drug: Pirfenidone
Administered daily at the maximum tolerated dose
Placebo Comparator: Cohort B: Combination Therapy (Placebo + Pirfenidone)
Pirfenidone </=2403 mg once daily (maximum tolerated dose) will be administered in combination with placebo matched to lebrikizumab SC once every 4 week up to 52 week placebo-controlled treatment period.
Drug: Pirfenidone
Administered daily at the maximum tolerated dose
Drug: Placebo
Administered SC every 4 weeks

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 (</=) 100% predicted at screening
  • 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 </=90% predicted at screening
  • 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 </=2403 milligrams once daily (mg/QD) for >/=4 weeks required prior to randomization and throughout the placebo-controlled study period

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01872689

  Hide Study Locations
Locations
United States, Alabama
University Alabama At Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Mayo Clinic- Scottsdale
Scottsdale, Arizona, United States, 85259
Southern Arizona Veterans Administration Healthcare Systems
Tucson, Arizona, United States, 85723
University of Arizona
Tucson, Arizona, United States, 85724-5030
United States, California
UCSD Medical Center
La Jolla, California, United States, 92093
University of California, San Francisco
San Francisco, California, United States, 94116
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
Rocky Mountain Center For Clinical Research
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
United States, Florida
Research Alliance Inc
Clearwater, Florida, United States, 33756
Mayo Clinic-Jacksonville
Jacksonville, Florida, United States, 32224
University Miami
Miami, Florida, United States, 33136
Central Florida Pulmonary Group, PA
Orlando, Florida, United States, 32803
USF Tampa General Hospital
Tampa, Florida, United States, 33606
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Georgia
Piedmont Healthcare Pulmonary and Critical Care Research
Austell, Georgia, United States, 30106
Southeastern Lung Care
Decatur, Georgia, United States, 30033
United States, Illinois
University of Chicago; Pulmonary and Critical Care
Chicago, Illinois, United States, 60637
Loyola University Med Center
Maywood, Illinois, United States, 60153
United States, Iowa
Univ of Iowa Hosp & Clinics; Pulmonary
Iowa City, Iowa, United States, 52242
United States, Kansas
Uni of Kansas Medical Center
Kansas, Kansas, United States, 66160
Via Christi Hospital Inc. DBA Via Christi Research; Research Dept.
Wichita, Kansas, United States, 67208
United States, Maine
Maine Medical Center -Division of Pulmomary and Critical Care Medicine
Portland, Maine, United States, 04106
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Johns Hopkins Bayview Medical Center - Johns Hopkins Asthma & Allergy Center
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Minnesota
University of Minnesota Hospital & Clinic
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, Missouri
Cardiopulmonary Associates LLC Cardiopulmonary Research
Chesterfield, Missouri, United States, 63017
United States, Nebraska
University of Nebraska
Omaha, Nebraska, United States, 68198-5300
United States, New Mexico
Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, United States, 87108
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021-5663
Mt Sinai School Medical Pulmo And Critical Care Med
New York, New York, United States, 10029
Highland Hospital—University of Rochester Medical Center
Rochester, New York, United States, 14620
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45203-0542
Case Western Research University; University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106-5067
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oklahoma
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
The Oregon Clinic.
Portland, Oregon, United States, 97220
United States, Pennsylvania
Penn State University College Medical Allergy And Care Med
Hershey, Pennsylvania, United States, 17033
Temple Lung Center, Temple Universtiy-Of the Commomwealth System of Higher Education
Philadelphia, Pennsylvania, United States, 19140
University of Pittsburgh Med Cen; Dorothy P And Richard P Simmons Cen For Interstitial Lung Disease
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor College Med
Houston, Texas, United States, 77030
Houston Methodist Hospital
Houston, Texas, United States, 77030
Audie Murphy Va Hospital
San Antonio, Texas, United States, 78229
United States, Utah
University of Utah Health Sciences Center, Lung Health Research Center
Salt Lake City, Utah, United States, 84108
United States, Vermont
University Vermont College Medicine Fletcher Allen Health Care
Colchester, Vermont, United States, 05446
United States, Virginia
Inova Transplant Center Fairfax Hospital
Falls Church, Virginia, United States, 22042
United States, Washington
Pulmonary Consultants
Tacoma, Washington, United States, 98405
United States, Wisconsin
University Wisconsin Hospitals and Clinics
Madison, Wisconsin, United States, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Royal Prince Alfred Hospital; Department of Respiratory Medicine
Camperdown, New South Wales, Australia, 2050
ST VINCENT'S HOSPITAL; Thoracic Medicine
Darlinghurst, New South Wales, Australia, 2010
Australia, Victoria
Box Hill Hospital; Eastern Clinical Research Unit
Box Hill, Victoria, Australia, 3128
Alfred Hospital; Allergy Immuno Resp
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Institute for Respiratory Health Inc
Nedlands, Western Australia, Australia, 6009
Belgium
Clin Univ de Bxl Hôpital Erasme
Bruxelles, Belgium, 1070
Cliniques Universitaires St-Luc
Bruxelles, Belgium, 1200
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
CHU UCL Mont-Godinne
Mont-godinne, Belgium, 5530
Canada, British Columbia
University of British Columbia - Vancouver Coastal Health Authority
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, New Brunswick
Dr. Georges-L. Dumont Regional Hospital
Moncton, New Brunswick, Canada, E1G 2K5
Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N4A6
Lawson Health Research Institute a joint venture of LHSC Research Inc and Lawson Research Institute
London, Ontario, Canada, N6C 2R5
Canada, Quebec
Institut universitaire de cardiologie et de pneumologie de Québec (Hôpital Laval)
Ste. Foy, Quebec, Canada, G1V 4G5
France
Hopital Avicenne; Pneumologie
Bobigny, France, 93000
Hopital Louis Pradel; Pneumologie
Bron, France, 69677
Hopital Calmette; Pneumologie
Lille, France, 59037
Hopital Bichat Claude Bernard ; Service de Pneumologie
Paris, France, 75877
Hopital de Pontchaillou; Service de Pneumologie
Rennes, France, 35033
Germany
Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie
Essen, Germany, 45239
Universitätsklinikum Standort Gießen Medizinische Klinik II u. Poliklinik Innere Med./Pneumologie
Gießen, Germany, 35392
LungenClinic Großhansdorf
Großhansdorf, Germany, 22927
Thoraxklinik Heidelberg gGmbH
Heidelberg, Germany, 69126
Fachklinik für Lungenerkrankungen
Immenhausen, Germany, 34376
CPC Comprehensive Pneumology Center / Forschungsambulanz, Helmholtz Zentrum
München, Germany, 81377
Italy
Ospedale Morgagni-Pierantoni; U.O. Pneumologia
Forlì, Emilia-Romagna, Italy, 47121
Policlinico Tor Vergata di Roma; U.O. Malattie Respiratorie; Centro delle malattie rare del Polmone
Roma, Lazio, Italy, 00133
Ospedale San Giuseppe; U.O. di Pneumologia
Milano, Lombardia, Italy, 20123
A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone
Orbassano (TO), Piemonte, Italy, 10043
A.O.U. Policlinico Vittorio Emanuele; Centro per la cura delle Malattie Rare del Polmone
Catania, Sicilia, Italy, 95123
A.O. Univ. Senese Policlinico S. Maria alle Scotte; UOC Malattie Resepiratorie e Trapianto Polmonare
Siena, Toscana, Italy, 53100
Japan
Kanagawa Cardiovascular and Respiratory Center; Respiratory Medicine
Kanagawa, Japan, 236-0051
Kinki-Chuo Chest Medical Center
Osaka, Japan, 591-8555
Tosei General Hospital
Seto-shi, Japan, 489-8642
Mexico
Hospital General Del Estado De Sonora "Dr. Ernesto Ramos Bours"; Servicio De Neumologia
Hermosillo, Mexico, 83000
Instituto Nacional De Enfermedades Respiratorias;Unidad de Investigación
Mexico City, Mexico, 14080
Universidad Autonoma De Nuevo Leon, Hospital Universitario Doctor Jose Eleuterio Gonzalez
Monterrey, Mexico, 64460
Unidad de Investigacion Clinica En Medicina (Udicem) S.C.
Monterrey, Mexico, 64718
Peru
Clinica San Pablo
Lima, Peru, Lima 33
Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
Lima, Peru, Lima 41
Clinica San Borja; NEUMOCARE
Lima, Peru, Lima 41
Poland
Uniwersytecki Szpital Kliniczny Nr 1 im.N.Barlickiego Oddzial Kliniczny Pneumonologii i Alergologii
Lodz, Poland, 90-153
Ms Clinsearch Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej
Lublin, Poland, 20-064
Klinika Pulmonologii, Alergologii i Onkologii Pulmonologicznej Uniwersytet Medyczny w Poznaniu
Poznan, Poland, 60-569
Instytut Gruzlicy i Chorob Płuc
Warszawa, Poland, 01-138
Klinika Chorob Pluc i Gruzlicy w Zabrzu; Slaski Uniwersytet Medyczny
Zabrze, Poland, 41-803
Spain
Hospital Universitari de Bellvitge ; Servicio de Neumologia
Hospitalet de Llobregat, Barcelona, Spain, 08097
Hospital Universitario La Princesa; Servicio de Neumologia
Madrid, Spain, 28006
Hospital Clínico San Carlos - Servicio de Neumologia
Madrid, Spain, 28040
Hospital Universitario Virgen del Rocio; Servicio de Neumologia
Sevilla, Spain, 41013
Hospital General Universitario De Valencia; Servicio de Neumologia
Valencia, Spain, 46014
United Kingdom
Southmead Hospital; Respiratory Department
Bristol, United Kingdom, BS10-5NB
Papworth Hospital NHS Foundation Trust; Respiratory Department
Cambridge, United Kingdom, CB23 3RE
Southampton General Hospital; Respiratory Department
Hampshire, United Kingdom, SO16 6YD
St James University Hospital; Respiratory Department
Leeds, United Kingdom, LS9 7TF
Respiratory research department clinical science building
Liverpool, United Kingdom, L9 7AL
Royal Brompton Hospital; Respiratory Department
London, United Kingdom, SW3 6NP
North Manchester Hospital; Respiratory Department
Manchester, United Kingdom, M8 5RB
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01872689     History of Changes
Other Study ID Numbers: GB28547
2013-001163-24 ( EudraCT Number )
Study First Received: June 5, 2013
Last Updated: July 20, 2017

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Pirfenidone
Antibodies, Monoclonal
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 25, 2017