A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis
2 other identifiers
interventional
505
13 countries
112
Brief 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 IPF therapy and as combination therapy with pirfenidone background therapy in participants with IPF. Participants will be randomized to receive either lebrikizumab or placebo subcutaneously every 4 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2013
Typical duration for phase_2
112 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
June 5, 2013
CompletedFirst Posted
Study publicly available on registry
June 7, 2013
CompletedStudy Start
First participant enrolled
October 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2017
CompletedResults Posted
Study results publicly available
August 24, 2018
CompletedAugust 24, 2018
August 1, 2018
3.8 years
June 5, 2013
July 24, 2018
August 22, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Annualized Rate of Decrease in Percent Predicted Forced Vital Capacity (FVC) Over 52 Weeks
Annualized rates of decrease (slope throughout time from baseline to Week 52) for percent predicted FVC was assessed and reported. FVC is a standard pulmonary function test. FVC is defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted FVC is based on sex, age, and height of a person. Percent predicted FVC (in %) = \[(observed FVC)/(predicted FVC)\]\*100.
Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)
Secondary Outcomes (20)
Annualized Rate of Decline in 6-Minute Walk Test (6MWT) Distance Over 52 Weeks
Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)
Percentage of Participants With Event of Greater Than or Equal to (>/=) 10% Absolute Decline in Percent Predicted FVC or Death From Any Cause
Baseline up to the event of >/=10% absolute decline in percent predicted FVC or death from any cause, whichever occurred first (up to Week 122)
Time to First Occurrence of a >/=10% Absolute Decline in Percent Predicted FVC or Death From Any Cause
Baseline up to the event of >/=10% absolute decline in percent predicted FVC or death from any cause, whichever occurred first (up to Week 122)
Annualized Rate of Decrease in Diffusion Capacity of the Lung for Carbon Monoxide (DLco) Over 52 Weeks
Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)
Percentage of Participants With Event of Death, All Cause Hospitalization, or a Decrease From Baseline of >/=10% in FVC
Baseline up to the event of death from any cause, all cause hospitalization, or a decrease from baseline of >/=10% in FVC, whichever occurred first (up to Week 122)
- +15 more secondary outcomes
Study Arms (4)
Monotherapy (Cohort A): Placebo
PLACEBO COMPARATORParticipants will receive monotherapy with placebo matched to lebrikizumab administered via subcutaneous (SC) injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants will be allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Monotherapy (Cohort A): Lebrikizumab
EXPERIMENTALParticipants will receive monotherapy with lebrikizumab at a dose of 250 milligrams (mg) administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants will be allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
Combination Therapy (Cohort B): Placebo + Pirfenidone
PLACEBO COMPARATORParticipants will receive pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day \[9 capsules daily\] for a total of 2403 mg/day) or at maximum tolerated dose (MTD) administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
EXPERIMENTALParticipants will receive pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day \[9 capsules daily\] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
Interventions
Lebrikizumab will be administered at a dose of 250 mg via SC injection once every 4 weeks.
Pirfenidone will be administered orally at a stable dose of 2403 mg per day or at MTD.
Placebo matched to lebrikizumab will be administered via SC injection once every 4 weeks.
Eligibility Criteria
You may qualify if:
- Have a diagnosis of IPF within the previous 5 years from time of screening and confirmed at baseline
- FVC \>/=40 percent (%) and \</=100% of predicted at screening
- Stable baseline lung function as evidenced by a difference of less than (\<) 10% in FVC (in liters) measurements between screening and Day 1, Visit 2 prior to randomization
- DLco \>/=25% and \</=90% of 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/day) for \>/=4 weeks required prior to randomization and throughout the placebo-controlled study period
You may not qualify 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
- 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 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 infection within 6 months prior to Day 1, Visit 2
- Active tuberculosis requiring treatment within 12 months of screening
- Known immunodeficiency, including but not limited to human immunodeficiency virus infection
- Past use of any anti-interleukin (IL)-13 or anti-IL-4/IL-13 therapy, including lebrikizumab
- Evidence of acute or chronic hepatitis or known liver cirrhosis
- Known achalasia, esophageal stricture, or esophageal dysfunction sufficient to limit the ability to swallow oral medication
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (112)
University Alabama At Birmingham
Birmingham, Alabama, 35294, United States
Mayo Clinic- Scottsdale
Scottsdale, Arizona, 85259, United States
Southern Arizona Veterans Administration Healthcare Systems
Tucson, Arizona, 85723, United States
University of Arizona
Tucson, Arizona, 85724-5030, United States
UCSD Medical Center
La Jolla, California, 92093, United States
University of California, San Francisco
San Francisco, California, 94116, United States
National Jewish Health
Denver, Colorado, 80206, United States
Rocky Mountain Center For Clinical Research
Wheat Ridge, Colorado, 80033, United States
Yale New Haven Hospital
New Haven, Connecticut, 06520, United States
Research Alliance Inc
Clearwater, Florida, 33756, United States
Mayo Clinic-Jacksonville
Jacksonville, Florida, 32224, United States
University Miami
Miami, Florida, 33136, United States
Central Florida Pulmonary Group, PA
Orlando, Florida, 32803, United States
USF Tampa General Hospital
Tampa, Florida, 33606, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Piedmont Healthcare Pulmonary and Critical Care Research
Austell, Georgia, 30106, United States
Southeastern Lung Care
Decatur, Georgia, 30033, United States
University of Chicago; Pulmonary and Critical Care
Chicago, Illinois, 60637, United States
Loyola University Med Center
Maywood, Illinois, 60153, United States
Univ of Iowa Hosp & Clinics; Pulmonary
Iowa City, Iowa, 52242, United States
Uni of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Via Christi Hospital Inc. DBA Via Christi Research; Research Dept.
Wichita, Kansas, 67208, United States
Maine Medical Center -Division of Pulmomary and Critical Care Medicine
Portland, Maine, 04106, 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
Tufts Medical Center
Boston, Massachusetts, 02111, United States
University of Minnesota Hospital & Clinic
Minneapolis, Minnesota, 55455, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55902, United States
Cardiopulmonary Associates LLC Cardiopulmonary Research
Chesterfield, Missouri, 63017, United States
University of Nebraska
Omaha, Nebraska, 68198-5300, United States
Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, 87108, 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
Highland Hospital-University of Rochester Medical Center
Rochester, New York, 14620, United States
University of Cincinnati
Cincinnati, Ohio, 45203-0542, United States
Case Western Research University; University Hospitals Case Medical Center
Cleveland, Ohio, 44106-5067, United States
Ohio State University
Columbus, Ohio, 43210, United States
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
The Oregon Clinic.
Portland, Oregon, 97220, United States
Penn State University College Medical Allergy And Care Med
Hershey, Pennsylvania, 17033, United States
Temple Lung Center, Temple Universtiy-Of the Commomwealth System of Higher Education
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh Med Cen; Dorothy P And Richard P Simmons Cen For Interstitial Lung Disease
Pittsburgh, Pennsylvania, 15213, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Baylor College Med
Houston, Texas, 77030, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Audie Murphy Va Hospital
San Antonio, Texas, 78229, United States
University of Utah Health Sciences Center, Lung Health Research Center
Salt Lake City, Utah, 84108, United States
University Vermont College Medicine Fletcher Allen Health Care
Colchester, Vermont, 05446, United States
Inova Transplant Center Fairfax Hospital
Falls Church, Virginia, 22042, United States
Pulmonary Consultants
Tacoma, Washington, 98405, United States
University Wisconsin Hospitals and Clinics
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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
Hospital Erasme; Neurologie
Brussels, 1070, Belgium
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
CHU UCL Mont-Godinne
Mont-godinne, 5530, Belgium
University of British Columbia - Vancouver Coastal Health Authority
Vancouver, British Columbia, V5Z 1M9, Canada
Dr. Georges-L. Dumont Regional Hospital
Moncton, New Brunswick, E1G 2K5, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N4A6, Canada
Lawson Health Research Institute a joint venture of LHSC Research Inc and Lawson Research Institute
London, Ontario, N6C 2R5, Canada
Institut universitaire de cardiologie et de pneumologie de Québec (Hôpital Laval)
Ste. Foy, Quebec, G1V 4G5, Canada
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
Ospedale Morgagni-Pierantoni; U.O. Pneumologia
Forlì, Emilia-Romagna, 47121, Italy
Policlinico Tor Vergata; UO Mal. Respiratorie; Centro Malattie rare polmone
Rome, Lazio, 00133, Italy
Ospedale San Giuseppe; U.O. di Pneumologia
Milan, Lombardy, 20123, Italy
A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone
Orbassano (TO), Piedmont, 10043, Italy
A.O.U. Policlinico Vittorio Emanuele; Centro per la cura delle Malattie Rare del Polmone
Catania, Sicily, 95123, Italy
A.O. Univ. Senese Policlinico S. Maria alle Scotte; UOC Malattie Resepiratorie e Trapianto Polmonare
Siena, Tuscany, 53100, Italy
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
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
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
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
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
Warsaw, 01-138, Poland
Klinika Chorob Pluc i Gruzlicy w Zabrzu; Slaski Uniwersytet Medyczny
Zabrze, 41-803, Poland
Hospital Universitari de Bellvitge ; Servicio de Neumologia
L'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
Seville, 41013, Spain
Hospital General Universitario De Valencia; Servicio de Neumologia
Valencia, 46014, Spain
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
Related Publications (1)
Allen RJ, Stockwell A, Oldham JM, Guillen-Guio B, Schwartz DA, Maher TM, Flores C, Noth I, Yaspan BL, Jenkins RG, Wain LV; International IPF Genetics Consortium. Genome-wide association study across five cohorts identifies five novel loci associated with idiopathic pulmonary fibrosis. Thorax. 2022 Aug;77(8):829-833. doi: 10.1136/thoraxjnl-2021-218577. Epub 2022 Jun 10.
PMID: 35688625DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2013
First Posted
June 7, 2013
Study Start
October 13, 2013
Primary Completion
July 28, 2017
Study Completion
November 6, 2017
Last Updated
August 24, 2018
Results First Posted
August 24, 2018
Record last verified: 2018-08