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

• ClinicalTrials.gov Identifier: NCT01872689
• Recruitment Status: Completed
• First Posted: June 7, 2013
• Results First Posted: August 24, 2018
• Last Update Posted: August 24, 2018
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

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.

Condition or disease	Intervention/treatment	Phase
Idiopathic Pulmonary Fibrosis	Drug: Lebrikizumab; Drug: Pirfenidone; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 505 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (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
• Actual Study Start Date: October 13, 2013
• Actual Primary Completion Date: July 28, 2017
• Actual Study Completion Date: November 6, 2017

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Monotherapy (Cohort A): Placebo; 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.	Drug: Lebrikizumab; Lebrikizumab will be administered at a dose of 250 mg via SC injection once every 4 weeks.; Other Name: RO5490255; Drug: Placebo; Placebo matched to lebrikizumab will be administered via SC injection once every 4 weeks.
Experimental: Monotherapy (Cohort A): Lebrikizumab; 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.	Drug: Lebrikizumab; Lebrikizumab will be administered at a dose of 250 mg via SC injection once every 4 weeks.; Other Name: RO5490255
Placebo Comparator: Combination Therapy (Cohort B): Placebo + Pirfenidone; 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.	Drug: Pirfenidone; Pirfenidone will be administered orally at a stable dose of 2403 mg per day or at MTD.; Drug: Placebo; Placebo matched to lebrikizumab will be administered via SC injection once every 4 weeks.
Experimental: Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone; 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.	Drug: Lebrikizumab; Lebrikizumab will be administered at a dose of 250 mg via SC injection once every 4 weeks.; Other Name: RO5490255; Drug: Pirfenidone; Pirfenidone will be administered orally at a stable dose of 2403 mg per day or at MTD.

Outcome Measures

Primary Outcome Measures :

1. Annualized Rate of Decrease in Percent Predicted Forced Vital Capacity (FVC) Over 52 Weeks [ Time Frame: Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52) ]
   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 :

1. Annualized Rate of Decline in 6-Minute Walk Test (6MWT) Distance Over 52 Weeks [ Time Frame: Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52) ]
   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.
2. Percentage of Participants With Event of Greater Than or Equal to (>/=) 10% Absolute Decline in Percent Predicted FVC or Death From Any Cause [ 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) ]
   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.
3. Time to First Occurrence of a >/=10% Absolute Decline in Percent Predicted FVC or Death From Any Cause [ 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) ]
   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.
4. Annualized Rate of Decrease in Diffusion Capacity of the Lung for Carbon Monoxide (DLco) Over 52 Weeks [ Time Frame: Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52) ]
   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.
5. Percentage of Participants With Event of Death, All Cause Hospitalization, or a Decrease From Baseline of >/=10% in FVC [ 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) ]
   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.
6. Progression-Free Survival (PFS) [ 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) ]
   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.
7. Annualized Rate of Decrease in FVC Over 52 Weeks [ Time Frame: Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52) ]
   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.
8. Annualized Rate of Decrease in A Tool to Assess Quality of Life in IPF (ATAQ-IPF) Questionnaire Total Score Over 52 Weeks [ Time Frame: Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52) ]
   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.
9. Percentage of Participants With an Event of St. George's Respiratory Questionnaire (SGRQ) Total Score Worsening or Death From Any Cause [ Time Frame: Baseline up to the event of SGRQ total score worsening or death from any cause, whichever occurred first (up to Week 122) ]
   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.
10. Time to First Occurrence of SGRQ Total Score Worsening or Death From Any Cause [ Time Frame: Baseline up to the event of SGRQ total score worsening or death from any cause, whichever occurred first (up to Week 122) ]
    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.
11. Percentage of Participants With an Event of Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation [ Time Frame: Baseline up to the event of acute IPF exacerbation (up to Week 122) ]
    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).
12. Time to First Event of Acute IPF Exacerbation [ Time Frame: Baseline up to the event of acute IPF exacerbation (up to Week 122) ]
    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.
13. Percentage of Participants With Respiratory-Related Hospitalization [ Time Frame: Baseline up to the event of respiratory-related hospitalization (up to Week 122) ]
14. Time to Respiratory-Related Hospitalization [ Time Frame: Baseline up to the event of respiratory-related hospitalization (up to Week 122) ]
    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.
15. Percentage of Participants With an Event of >/=15% Absolute Decrease in Percentage of Predicted DLco or Death From Any Cause [ 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) ]
    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.
16. Time to First Event of >/=15% Absolute Decrease in Percentage of Predicted DLco or Death From Any Cause [ 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) ]
    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.
17. Percentage of Participants With Anti-therapeutic Antibody (ATA) to Lebrikizumab [ 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) ]
    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.
18. Minimum Observed Serum Concentration (Cmin) of Lebrikizumab at Week 52 [ Time Frame: Predose (Hour 0) at Week 52 ]
    Participants who received lebrikizumab were only included in the analysis.
19. Minimum Observed Serum Concentration (Cmin) of Lebrikizumab [ Time Frame: Predose (Hour 0) at Weeks 4, 12, 24, and 36 ]
    Participants who received lebrikizumab were only included in the analysis.
20. Elimination Half-Life (t1/2) of Lebrikizumab [ 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) ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• 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 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)

Contacts and 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, 55902

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

Hospital Erasme; Neurologie

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; UO Mal. Respiratorie; Centro Malattie rare 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

  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:

Study Protocol and Statistical Analysis Plan  [PDF] October 23, 2016

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01872689
• Other Study ID Numbers: GB28547; 2013-001163-24 ( EudraCT Number )
• First Posted: June 7, 2013
• Results First Posted: August 24, 2018
• Last Update Posted: August 24, 2018
• Last Verified: August 2018

Additional relevant MeSH terms:

Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis; Pathologic Processes; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Pirfenidone; 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