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A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lebrikizumab
Pirfenidone
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

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
  • 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

Exclusions Criteria 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 milliliters/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)

Sites / Locations

  • University Alabama At Birmingham
  • Mayo Clinic- Scottsdale
  • Southern Arizona Veterans Administration Healthcare Systems
  • University of Arizona
  • UCSD Medical Center
  • University of California, San Francisco
  • National Jewish Health
  • Rocky Mountain Center For Clinical Research
  • Yale New Haven Hospital
  • Research Alliance Inc
  • Mayo Clinic-Jacksonville
  • University Miami
  • Central Florida Pulmonary Group, PA
  • USF Tampa General Hospital
  • Cleveland Clinic Florida
  • Piedmont Healthcare Pulmonary and Critical Care Research
  • Southeastern Lung Care
  • University of Chicago; Pulmonary and Critical Care
  • Loyola University Med Center
  • Univ of Iowa Hosp & Clinics; Pulmonary
  • Uni of Kansas Medical Center
  • Via Christi Hospital Inc. DBA Via Christi Research; Research Dept.
  • Maine Medical Center -Division of Pulmomary and Critical Care Medicine
  • University of Maryland Medical Center
  • Johns Hopkins Bayview Medical Center - Johns Hopkins Asthma & Allergy Center
  • Tufts Medical Center
  • University of Minnesota Hospital & Clinic
  • Mayo Clinic Rochester
  • Cardiopulmonary Associates LLC Cardiopulmonary Research
  • University of Nebraska
  • Lovelace Scientific Resources, Inc.
  • Weill Medical College of Cornell University
  • Mt Sinai School Medical Pulmo And Critical Care Med
  • Highland Hospital-University of Rochester Medical Center
  • University of Cincinnati
  • Case Western Research University; University Hospitals Case Medical Center
  • Ohio State University
  • Oklahoma University Health Sciences Center
  • The Oregon Clinic.
  • Penn State University College Medical Allergy And Care Med
  • Temple Lung Center, Temple Universtiy-Of the Commomwealth System of Higher Education
  • University of Pittsburgh Med Cen; Dorothy P And Richard P Simmons Cen For Interstitial Lung Disease
  • Rhode Island Hospital
  • Medical University of South Carolina
  • Vanderbilt University Medical Center
  • Baylor College Med
  • Houston Methodist Hospital
  • Audie Murphy Va Hospital
  • University of Utah Health Sciences Center, Lung Health Research Center
  • University Vermont College Medicine Fletcher Allen Health Care
  • Inova Transplant Center Fairfax Hospital
  • Pulmonary Consultants
  • University Wisconsin Hospitals and Clinics
  • Medical College of Wisconsin
  • Royal Prince Alfred Hospital; Department of Respiratory Medicine
  • ST VINCENT'S HOSPITAL; Thoracic Medicine
  • Box Hill Hospital; Eastern Clinical Research Unit
  • Alfred Hospital; Allergy Immuno Resp
  • Institute for Respiratory Health Inc
  • Hospital Erasme; Neurologie
  • Cliniques Universitaires St-Luc
  • UZ Leuven Gasthuisberg
  • CHU UCL Mont-Godinne
  • University of British Columbia - Vancouver Coastal Health Authority
  • Dr. Georges-L. Dumont Regional Hospital
  • St. Joseph's Healthcare Hamilton
  • Lawson Health Research Institute a joint venture of LHSC Research Inc and Lawson Research Institute
  • Institut universitaire de cardiologie et de pneumologie de Québec (Hôpital Laval)
  • Hopital Avicenne; Pneumologie
  • Hopital Louis Pradel; Pneumologie
  • Hopital Calmette; Pneumologie
  • Hopital Bichat Claude Bernard ; Service de Pneumologie
  • Hopital de Pontchaillou; Service de Pneumologie
  • Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie
  • Universitätsklinikum Standort Gießen Medizinische Klinik II u. Poliklinik Innere Med./Pneumologie
  • LungenClinic Großhansdorf
  • Thoraxklinik Heidelberg gGmbH
  • Fachklinik für Lungenerkrankungen
  • CPC Comprehensive Pneumology Center / Forschungsambulanz, Helmholtz Zentrum
  • Ospedale Morgagni-Pierantoni; U.O. Pneumologia
  • Policlinico Tor Vergata; UO Mal. Respiratorie; Centro Malattie rare polmone
  • Ospedale San Giuseppe; U.O. di Pneumologia
  • A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone
  • A.O.U. Policlinico Vittorio Emanuele; Centro per la cura delle Malattie Rare del Polmone
  • A.O. Univ. Senese Policlinico S. Maria alle Scotte; UOC Malattie Resepiratorie e Trapianto Polmonare
  • Kanagawa Cardiovascular and Respiratory Center; Respiratory Medicine
  • Kinki-Chuo Chest Medical Center
  • Tosei General Hospital
  • Hospital General Del Estado De Sonora "Dr. Ernesto Ramos Bours"; Servicio De Neumologia
  • Instituto Nacional De Enfermedades Respiratorias;Unidad de Investigación
  • Universidad Autonoma De Nuevo Leon, Hospital Universitario Doctor Jose Eleuterio Gonzalez
  • Unidad de Investigacion Clinica En Medicina (Udicem) S.C.
  • Clinica San Pablo
  • Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
  • Clinica San Borja; NEUMOCARE
  • Uniwersytecki Szpital Kliniczny Nr 1 im.N.Barlickiego Oddzial Kliniczny Pneumonologii i Alergologii
  • Ms Clinsearch Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej
  • Klinika Pulmonologii, Alergologii i Onkologii Pulmonologicznej Uniwersytet Medyczny w Poznaniu
  • Instytut Gruzlicy i Chorob Płuc
  • Klinika Chorob Pluc i Gruzlicy w Zabrzu; Slaski Uniwersytet Medyczny
  • Hospital Universitari de Bellvitge ; Servicio de Neumologia
  • Hospital Universitario La Princesa; Servicio de Neumologia
  • Hospital Clínico San Carlos - Servicio de Neumologia
  • Hospital Universitario Virgen del Rocio; Servicio de Neumologia
  • Hospital General Universitario De Valencia; Servicio de Neumologia
  • Southmead Hospital; Respiratory Department
  • Papworth Hospital NHS Foundation Trust; Respiratory Department
  • Southampton General Hospital; Respiratory Department
  • St James University Hospital; Respiratory Department
  • Respiratory research department clinical science building
  • Royal Brompton Hospital; Respiratory Department
  • North Manchester Hospital; Respiratory Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Monotherapy (Cohort A): Placebo

Monotherapy (Cohort A): Lebrikizumab

Combination Therapy (Cohort B): Placebo + Pirfenidone

Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone

Arm Description

Participants 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.

Participants 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.

Participants 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.

Participants 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Annualized Rate of Decline in 6-Minute Walk Test (6MWT) Distance Over 52 Weeks
Annualized rates of decline (slope throughout time from baseline to Week 52) in 6MWT was assessed and reported. 6MWT was the distance (in meters [m]) that a participant could walk in 6 minutes.
Percentage of Participants With Event of Greater Than or Equal to (>/=) 10% Absolute Decline in Percent Predicted FVC or Death From Any Cause
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.
Time to First Occurrence of a >/=10% Absolute Decline in Percent Predicted FVC or Death From Any Cause
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. Time from randomization to first occurrence of an event of >/=10% absolute decline in percent predicted FVC or death from any cause was reported. Participants without an event were censored at the last assessment during the double-blind treatment period. Any participant who underwent lung transplantation was censored at the date of the transplant. The median time to event was estimated using Kaplan-Meier method. 95% confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley.
Annualized Rate of Decrease in Diffusion Capacity of the Lung for Carbon Monoxide (DLco) Over 52 Weeks
Annualized rates of decrease (slope throughout time from baseline to Week 52) in DLco was assessed and reported. DLco (in milliliters per minute/millimeters of mercury [mL/min/mmHg]) is a measure of the gas transfer.
Percentage of Participants With Event of Death, All Cause Hospitalization, or a Decrease From Baseline of >/=10% in FVC
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 = [(observed FVC)/(predicted FVC)]*100.
Progression-Free Survival (PFS)
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 = [(observed FVC)/(predicted FVC)]*100. PFS was defined as time from randomization to death from any cause, all cause hospitalization, or a decrease from baseline of >/=10% in FVC, whichever occurred first. Participants without an event were censored at the last assessment during the double-blind treatment period. Any participant who underwent lung transplantation was censored at the date of the transplant. The median PFS was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Annualized Rate of Decrease in FVC Over 52 Weeks
Annualized rates of decrease (slope throughout time from baseline to Week 52) in FVC (in milliliters per year [mL/year]) was assessed and reported. FVC is defined as the volume of air that can forcibly be blown out after full inspiration in the upright position.
Annualized Rate of Decrease in A Tool to Assess Quality of Life in IPF (ATAQ-IPF) Questionnaire Total Score Over 52 Weeks
The ATAQ-IPF Version 3 was utilized that included 31 items within 5 domains: cough (6 items), dyspnea (7 items), exhaustion (6 items), emotional well-being (6 items), and independence (6 items). Each item was assessed on a scale ranging from 1 (Strongly disagree) to 4 (Strongly agree). The ATAQ-IPF had a recall specification of 2 weeks. Simple summation scoring was used to derive individual domain scores as well as a total score. ATAQ-IPF total score ranged from 31 to 124 with lower score indicating better quality of life (QoL). Annualized rates of decrease (slope throughout time from baseline to Week 52) in ATAQ-IPF questionnaire total score was assessed and reported.
Percentage of Participants With an Event of St. George's Respiratory Questionnaire (SGRQ) Total Score Worsening or Death From Any Cause
The SGRQ is a 50-item health-related QoL instrument that measured health impairment. The questionnaire contains 3 domains: symptoms, activity, and impacts. Items were assessed on various response scales, including a 5-point Likert scale and True/False scale. The SGRQ had a recall specification of 4 weeks. The SGRQ total score (summed weights) ranged from 0 to 100 with a lower score denoting a better health status. Percentage of participants with an event of SGRQ total score worsening (defined as reaching minimal important difference [MID], that is, an increase in total score of >/=7) or death from any cause was reported.
Time to First Occurrence of SGRQ Total Score Worsening or Death From Any Cause
The SGRQ is a 50-item health-related QoL instrument that measured health impairment. The questionnaire contains 3 domains: symptoms, activity, and impacts. Items were assessed on various response scales, including a 5-point Likert scale and True/False scale. The SGRQ had a recall specification of 4 weeks. The SGRQ total score (summed weights) ranged from 0 to 100 with a lower score denoting a better health status. Time from randomization to first occurrence of an event of SGRQ total score worsening (defined as reaching minimal important difference [MID], that is, an increase in total score of >/=7) or death from any cause was reported. The median time to event was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Percentage of Participants With an Event of Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation
IPF exacerbation was defined as an event that met all of the following criteria as determined by the investigator: Unexplained worsening or development of dyspnea within the previous 30 days; And radiologic evidence of new bilateral ground-glass abnormality or consolidation, superimposed on a reticular or honeycomb background pattern, that is consistent with usual interstitial pneumonitis; And absence of alternative causes, such as left heart failure, pulmonary embolism, pulmonary infection (on the basis of endotracheal aspirate or bronchoalveolar lavage if available, or investigator judgment), or other events leading to acute lung injury (for example, sepsis, aspiration, trauma, reperfusion pulmonary edema).
Time to First Event of Acute IPF Exacerbation
Time from randomization to first occurrence of an event of IPF exacerbation was reported. IPF exacerbation was defined as an event that met all of the following criteria as determined by the investigator: Unexplained worsening or development of dyspnea within the previous 30 days; And radiologic evidence of new bilateral ground-glass abnormality or consolidation, superimposed on a reticular or honeycomb background pattern, that is consistent with usual interstitial pneumonitis; And absence of alternative causes, or other events leading to acute lung injury. The median time to event was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Percentage of Participants With Respiratory-Related Hospitalization
Time to Respiratory-Related Hospitalization
Time from randomization to first occurrence of an event of respiratory-related hospitalization was reported. Participants without an event were censored at the last known alive day, study Day 368, or the last date during the double-blind period. The median time to event was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Percentage of Participants With an Event of >/=15% Absolute Decrease in Percentage of Predicted DLco or Death From Any Cause
DLco (in mL/min/mmHg) is a measure of the gas transfer. Predicted DLco is based on sex, age, and height of a person. Percent of predicted DLco (in %) = [(observed DLco)/(predicted DLco)]*100.
Time to First Event of >/=15% Absolute Decrease in Percentage of Predicted DLco or Death From Any Cause
DLco is a measure of the gas transfer. Predicted DLco is based on sex, age, and height of a person. Percent of predicted DLco (in %) = [(observed DLco)/(predicted DLco)]*100. Time from randomization to first occurrence of >/=15% absolute decrease in percentage of predicted DLco or death from any cause was reported. The median time to event was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Percentage of Participants With Anti-therapeutic Antibody (ATA) to Lebrikizumab
ATA to lebrikizumab was tested using a validated immunoassay. A positive ATA result was defined as one in which the presence of detectable ATAs could be confirmed by competitive binding with lebrikizumab. Percentage of participants with positive results for ATA at Baseline and at post-baseline time points were reported. Only participants who received lebrikizumab were included in the analysis.
Minimum Observed Serum Concentration (Cmin) of Lebrikizumab at Week 52
Participants who received lebrikizumab were only included in the analysis.
Minimum Observed Serum Concentration (Cmin) of Lebrikizumab
Participants who received lebrikizumab were only included in the analysis.
Elimination Half-Life (t1/2) of Lebrikizumab
Elimination half-life is the time measured for the plasma drug concentration to decrease by one-half during the elimination phase of the drug. Analysis was performed on PK-Evaluable Population. Participants who received lebrikizumab were only included in the analysis.

Full Information

First Posted
June 5, 2013
Last Updated
August 22, 2018
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01872689
Brief Title
A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 13, 2013 (Actual)
Primary Completion Date
July 28, 2017 (Actual)
Study Completion Date
November 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
505 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monotherapy (Cohort A): Placebo
Arm Type
Placebo Comparator
Arm Description
Participants 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.
Arm Title
Monotherapy (Cohort A): Lebrikizumab
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Combination Therapy (Cohort B): Placebo + Pirfenidone
Arm Type
Placebo Comparator
Arm Description
Participants 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.
Arm Title
Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Arm Type
Experimental
Arm Description
Participants 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.
Intervention Type
Drug
Intervention Name(s)
Lebrikizumab
Other Intervention Name(s)
RO5490255
Intervention Description
Lebrikizumab will be administered at a dose of 250 mg via SC injection once every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Pirfenidone
Intervention Description
Pirfenidone will be administered orally at a stable dose of 2403 mg per day or at MTD.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matched to lebrikizumab will be administered via SC injection once every 4 weeks.
Primary Outcome Measure Information:
Title
Annualized Rate of Decrease in Percent Predicted Forced Vital Capacity (FVC) Over 52 Weeks
Description
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.
Time Frame
Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)
Secondary Outcome Measure Information:
Title
Annualized Rate of Decline in 6-Minute Walk Test (6MWT) Distance Over 52 Weeks
Description
Annualized rates of decline (slope throughout time from baseline to Week 52) in 6MWT was assessed and reported. 6MWT was the distance (in meters [m]) that a participant could walk in 6 minutes.
Time Frame
Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)
Title
Percentage of Participants With Event of Greater Than or Equal to (>/=) 10% Absolute Decline in Percent Predicted FVC or Death From Any Cause
Description
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.
Time Frame
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)
Title
Time to First Occurrence of a >/=10% Absolute Decline in Percent Predicted FVC or Death From Any Cause
Description
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. Time from randomization to first occurrence of an event of >/=10% absolute decline in percent predicted FVC or death from any cause was reported. Participants without an event were censored at the last assessment during the double-blind treatment period. Any participant who underwent lung transplantation was censored at the date of the transplant. The median time to event was estimated using Kaplan-Meier method. 95% confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley.
Time Frame
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)
Title
Annualized Rate of Decrease in Diffusion Capacity of the Lung for Carbon Monoxide (DLco) Over 52 Weeks
Description
Annualized rates of decrease (slope throughout time from baseline to Week 52) in DLco was assessed and reported. DLco (in milliliters per minute/millimeters of mercury [mL/min/mmHg]) is a measure of the gas transfer.
Time Frame
Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)
Title
Percentage of Participants With Event of Death, All Cause Hospitalization, or a Decrease From Baseline of >/=10% in FVC
Description
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 = [(observed FVC)/(predicted FVC)]*100.
Time Frame
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)
Title
Progression-Free Survival (PFS)
Description
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 = [(observed FVC)/(predicted FVC)]*100. PFS was defined as time from randomization to death from any cause, all cause hospitalization, or a decrease from baseline of >/=10% in FVC, whichever occurred first. Participants without an event were censored at the last assessment during the double-blind treatment period. Any participant who underwent lung transplantation was censored at the date of the transplant. The median PFS was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Time Frame
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)
Title
Annualized Rate of Decrease in FVC Over 52 Weeks
Description
Annualized rates of decrease (slope throughout time from baseline to Week 52) in FVC (in milliliters per year [mL/year]) was assessed and reported. FVC is defined as the volume of air that can forcibly be blown out after full inspiration in the upright position.
Time Frame
Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)
Title
Annualized Rate of Decrease in A Tool to Assess Quality of Life in IPF (ATAQ-IPF) Questionnaire Total Score Over 52 Weeks
Description
The ATAQ-IPF Version 3 was utilized that included 31 items within 5 domains: cough (6 items), dyspnea (7 items), exhaustion (6 items), emotional well-being (6 items), and independence (6 items). Each item was assessed on a scale ranging from 1 (Strongly disagree) to 4 (Strongly agree). The ATAQ-IPF had a recall specification of 2 weeks. Simple summation scoring was used to derive individual domain scores as well as a total score. ATAQ-IPF total score ranged from 31 to 124 with lower score indicating better quality of life (QoL). Annualized rates of decrease (slope throughout time from baseline to Week 52) in ATAQ-IPF questionnaire total score was assessed and reported.
Time Frame
Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)
Title
Percentage of Participants With an Event of St. George's Respiratory Questionnaire (SGRQ) Total Score Worsening or Death From Any Cause
Description
The SGRQ is a 50-item health-related QoL instrument that measured health impairment. The questionnaire contains 3 domains: symptoms, activity, and impacts. Items were assessed on various response scales, including a 5-point Likert scale and True/False scale. The SGRQ had a recall specification of 4 weeks. The SGRQ total score (summed weights) ranged from 0 to 100 with a lower score denoting a better health status. Percentage of participants with an event of SGRQ total score worsening (defined as reaching minimal important difference [MID], that is, an increase in total score of >/=7) or death from any cause was reported.
Time Frame
Baseline up to the event of SGRQ total score worsening or death from any cause, whichever occurred first (up to Week 122)
Title
Time to First Occurrence of SGRQ Total Score Worsening or Death From Any Cause
Description
The SGRQ is a 50-item health-related QoL instrument that measured health impairment. The questionnaire contains 3 domains: symptoms, activity, and impacts. Items were assessed on various response scales, including a 5-point Likert scale and True/False scale. The SGRQ had a recall specification of 4 weeks. The SGRQ total score (summed weights) ranged from 0 to 100 with a lower score denoting a better health status. Time from randomization to first occurrence of an event of SGRQ total score worsening (defined as reaching minimal important difference [MID], that is, an increase in total score of >/=7) or death from any cause was reported. The median time to event was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Time Frame
Baseline up to the event of SGRQ total score worsening or death from any cause, whichever occurred first (up to Week 122)
Title
Percentage of Participants With an Event of Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation
Description
IPF exacerbation was defined as an event that met all of the following criteria as determined by the investigator: Unexplained worsening or development of dyspnea within the previous 30 days; And radiologic evidence of new bilateral ground-glass abnormality or consolidation, superimposed on a reticular or honeycomb background pattern, that is consistent with usual interstitial pneumonitis; And absence of alternative causes, such as left heart failure, pulmonary embolism, pulmonary infection (on the basis of endotracheal aspirate or bronchoalveolar lavage if available, or investigator judgment), or other events leading to acute lung injury (for example, sepsis, aspiration, trauma, reperfusion pulmonary edema).
Time Frame
Baseline up to the event of acute IPF exacerbation (up to Week 122)
Title
Time to First Event of Acute IPF Exacerbation
Description
Time from randomization to first occurrence of an event of IPF exacerbation was reported. IPF exacerbation was defined as an event that met all of the following criteria as determined by the investigator: Unexplained worsening or development of dyspnea within the previous 30 days; And radiologic evidence of new bilateral ground-glass abnormality or consolidation, superimposed on a reticular or honeycomb background pattern, that is consistent with usual interstitial pneumonitis; And absence of alternative causes, or other events leading to acute lung injury. The median time to event was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Time Frame
Baseline up to the event of acute IPF exacerbation (up to Week 122)
Title
Percentage of Participants With Respiratory-Related Hospitalization
Time Frame
Baseline up to the event of respiratory-related hospitalization (up to Week 122)
Title
Time to Respiratory-Related Hospitalization
Description
Time from randomization to first occurrence of an event of respiratory-related hospitalization was reported. Participants without an event were censored at the last known alive day, study Day 368, or the last date during the double-blind period. The median time to event was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Time Frame
Baseline up to the event of respiratory-related hospitalization (up to Week 122)
Title
Percentage of Participants With an Event of >/=15% Absolute Decrease in Percentage of Predicted DLco or Death From Any Cause
Description
DLco (in mL/min/mmHg) is a measure of the gas transfer. Predicted DLco is based on sex, age, and height of a person. Percent of predicted DLco (in %) = [(observed DLco)/(predicted DLco)]*100.
Time Frame
Baseline up to the event of >/=15% absolute decrease in percentage of predicted DLco or death from any cause (up to Week 122)
Title
Time to First Event of >/=15% Absolute Decrease in Percentage of Predicted DLco or Death From Any Cause
Description
DLco is a measure of the gas transfer. Predicted DLco is based on sex, age, and height of a person. Percent of predicted DLco (in %) = [(observed DLco)/(predicted DLco)]*100. Time from randomization to first occurrence of >/=15% absolute decrease in percentage of predicted DLco or death from any cause was reported. The median time to event was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Time Frame
Baseline up to the event of >/=15% absolute decrease in percentage of predicted DLco or death from any cause (up to Week 122)
Title
Percentage of Participants With Anti-therapeutic Antibody (ATA) to Lebrikizumab
Description
ATA to lebrikizumab was tested using a validated immunoassay. A positive ATA result was defined as one in which the presence of detectable ATAs could be confirmed by competitive binding with lebrikizumab. Percentage of participants with positive results for ATA at Baseline and at post-baseline time points were reported. Only participants who received lebrikizumab were included in the analysis.
Time Frame
Baseline and Post-Baseline (assessed at multiple time points: Weeks 4, 12, 24, 36, 52, 56, 64, 76, and at safety follow-up up to Week 122)
Title
Minimum Observed Serum Concentration (Cmin) of Lebrikizumab at Week 52
Description
Participants who received lebrikizumab were only included in the analysis.
Time Frame
Predose (Hour 0) at Week 52
Title
Minimum Observed Serum Concentration (Cmin) of Lebrikizumab
Description
Participants who received lebrikizumab were only included in the analysis.
Time Frame
Predose (Hour 0) at Weeks 4, 12, 24, and 36
Title
Elimination Half-Life (t1/2) of Lebrikizumab
Description
Elimination half-life is the time measured for the plasma drug concentration to decrease by one-half during the elimination phase of the drug. Analysis was performed on PK-Evaluable Population. Participants who received lebrikizumab were only included in the analysis.
Time Frame
Pre-dose (Hour 0) at Weeks 1, 4, 12, 24, 36, 64, 76, 88, 104; and at 4, 12, and 18 weeks post-last dose (last dose = Week 104)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 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 Exclusions Criteria 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 milliliters/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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
University Alabama At Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mayo Clinic- Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Southern Arizona Veterans Administration Healthcare Systems
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5030
Country
United States
Facility Name
UCSD Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94116
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Rocky Mountain Center For Clinical Research
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Research Alliance Inc
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Mayo Clinic-Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Central Florida Pulmonary Group, PA
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
USF Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Piedmont Healthcare Pulmonary and Critical Care Research
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
Southeastern Lung Care
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
University of Chicago; Pulmonary and Critical Care
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Loyola University Med Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Univ of Iowa Hosp & Clinics; Pulmonary
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Uni of Kansas Medical Center
City
Kansas
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Via Christi Hospital Inc. DBA Via Christi Research; Research Dept.
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Maine Medical Center -Division of Pulmomary and Critical Care Medicine
City
Portland
State/Province
Maine
ZIP/Postal Code
04106
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Bayview Medical Center - Johns Hopkins Asthma & Allergy Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Minnesota Hospital & Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Cardiopulmonary Associates LLC Cardiopulmonary Research
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
University of Nebraska
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-5300
Country
United States
Facility Name
Lovelace Scientific Resources, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021-5663
Country
United States
Facility Name
Mt Sinai School Medical Pulmo And Critical Care Med
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Highland Hospital-University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45203-0542
Country
United States
Facility Name
Case Western Research University; University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5067
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oklahoma University Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
The Oregon Clinic.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220
Country
United States
Facility Name
Penn State University College Medical Allergy And Care Med
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Temple Lung Center, Temple Universtiy-Of the Commomwealth System of Higher Education
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
University of Pittsburgh Med Cen; Dorothy P And Richard P Simmons Cen For Interstitial Lung Disease
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Baylor College Med
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Audie Murphy Va Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Utah Health Sciences Center, Lung Health Research Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
University Vermont College Medicine Fletcher Allen Health Care
City
Colchester
State/Province
Vermont
ZIP/Postal Code
05446
Country
United States
Facility Name
Inova Transplant Center Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Pulmonary Consultants
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
University Wisconsin Hospitals and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Royal Prince Alfred Hospital; Department of Respiratory Medicine
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
ST VINCENT'S HOSPITAL; Thoracic Medicine
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Box Hill Hospital; Eastern Clinical Research Unit
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Alfred Hospital; Allergy Immuno Resp
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Institute for Respiratory Health Inc
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Hospital Erasme; Neurologie
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU UCL Mont-Godinne
City
Mont-godinne
ZIP/Postal Code
5530
Country
Belgium
Facility Name
University of British Columbia - Vancouver Coastal Health Authority
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Dr. Georges-L. Dumont Regional Hospital
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1G 2K5
Country
Canada
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N4A6
Country
Canada
Facility Name
Lawson Health Research Institute a joint venture of LHSC Research Inc and Lawson Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 2R5
Country
Canada
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec (Hôpital Laval)
City
Ste. Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Hopital Avicenne; Pneumologie
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Hopital Louis Pradel; Pneumologie
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Hopital Calmette; Pneumologie
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Bichat Claude Bernard ; Service de Pneumologie
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
Hopital de Pontchaillou; Service de Pneumologie
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie
City
Essen
ZIP/Postal Code
45239
Country
Germany
Facility Name
Universitätsklinikum Standort Gießen Medizinische Klinik II u. Poliklinik Innere Med./Pneumologie
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Facility Name
LungenClinic Großhansdorf
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Thoraxklinik Heidelberg gGmbH
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Fachklinik für Lungenerkrankungen
City
Immenhausen
ZIP/Postal Code
34376
Country
Germany
Facility Name
CPC Comprehensive Pneumology Center / Forschungsambulanz, Helmholtz Zentrum
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Ospedale Morgagni-Pierantoni; U.O. Pneumologia
City
Forlì
State/Province
Emilia-Romagna
ZIP/Postal Code
47121
Country
Italy
Facility Name
Policlinico Tor Vergata; UO Mal. Respiratorie; Centro Malattie rare polmone
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Facility Name
Ospedale San Giuseppe; U.O. di Pneumologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20123
Country
Italy
Facility Name
A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone
City
Orbassano (TO)
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
Facility Name
A.O.U. Policlinico Vittorio Emanuele; Centro per la cura delle Malattie Rare del Polmone
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Facility Name
A.O. Univ. Senese Policlinico S. Maria alle Scotte; UOC Malattie Resepiratorie e Trapianto Polmonare
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
Facility Name
Kanagawa Cardiovascular and Respiratory Center; Respiratory Medicine
City
Kanagawa
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Kinki-Chuo Chest Medical Center
City
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Tosei General Hospital
City
Seto-shi
ZIP/Postal Code
489-8642
Country
Japan
Facility Name
Hospital General Del Estado De Sonora "Dr. Ernesto Ramos Bours"; Servicio De Neumologia
City
Hermosillo
ZIP/Postal Code
83000
Country
Mexico
Facility Name
Instituto Nacional De Enfermedades Respiratorias;Unidad de Investigación
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Universidad Autonoma De Nuevo Leon, Hospital Universitario Doctor Jose Eleuterio Gonzalez
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Unidad de Investigacion Clinica En Medicina (Udicem) S.C.
City
Monterrey
ZIP/Postal Code
64718
Country
Mexico
Facility Name
Clinica San Pablo
City
Lima
ZIP/Postal Code
Lima 33
Country
Peru
Facility Name
Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
City
Lima
ZIP/Postal Code
Lima 41
Country
Peru
Facility Name
Clinica San Borja; NEUMOCARE
City
Lima
ZIP/Postal Code
Lima 41
Country
Peru
Facility Name
Uniwersytecki Szpital Kliniczny Nr 1 im.N.Barlickiego Oddzial Kliniczny Pneumonologii i Alergologii
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Ms Clinsearch Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej
City
Lublin
ZIP/Postal Code
20-064
Country
Poland
Facility Name
Klinika Pulmonologii, Alergologii i Onkologii Pulmonologicznej Uniwersytet Medyczny w Poznaniu
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Instytut Gruzlicy i Chorob Płuc
City
Warszawa
ZIP/Postal Code
01-138
Country
Poland
Facility Name
Klinika Chorob Pluc i Gruzlicy w Zabrzu; Slaski Uniwersytet Medyczny
City
Zabrze
ZIP/Postal Code
41-803
Country
Poland
Facility Name
Hospital Universitari de Bellvitge ; Servicio de Neumologia
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08097
Country
Spain
Facility Name
Hospital Universitario La Princesa; Servicio de Neumologia
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Clínico San Carlos - Servicio de Neumologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Neumologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital General Universitario De Valencia; Servicio de Neumologia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Southmead Hospital; Respiratory Department
City
Bristol
ZIP/Postal Code
BS10-5NB
Country
United Kingdom
Facility Name
Papworth Hospital NHS Foundation Trust; Respiratory Department
City
Cambridge
ZIP/Postal Code
CB23 3RE
Country
United Kingdom
Facility Name
Southampton General Hospital; Respiratory Department
City
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
St James University Hospital; Respiratory Department
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Respiratory research department clinical science building
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Royal Brompton Hospital; Respiratory Department
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Facility Name
North Manchester Hospital; Respiratory Department
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35688625
Citation
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.
Results Reference
derived

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A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

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