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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001163-24 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy (Cohort A): Placebo | Placebo Comparator | 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. |
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| Monotherapy (Cohort A): Lebrikizumab | Experimental | 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. |
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| Combination Therapy (Cohort B): Placebo + Pirfenidone | Placebo Comparator | 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. |
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| Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lebrikizumab | Drug | Lebrikizumab will be administered at a dose of 250 mg via SC injection once every 4 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52) |
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Inclusion Criteria:
Exclusion Criteria:
Exclusions Criteria Limited to Cohort B:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Alabama At Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Mayo Clinic- Scottsdale |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35688625 | Derived | 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. |
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A total of 505 participants (154 participants in Monotherapy Cohort and 351 participants in Combination Therapy Cohort) were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Monotherapy (Cohort A): Placebo | Participants received 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 were allowed to receive treatment with lebrikizumab at a dose of 250 milligrams (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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind/Placebo-Controlled Period |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 23, 2016 |
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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. |
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| Pirfenidone | Drug | Pirfenidone will be administered orally at a stable dose of 2403 mg per day or at MTD. |
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| Placebo | Drug | Placebo matched to lebrikizumab will be administered via SC injection once every 4 weeks. |
|
| 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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) |
| 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. | 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) |
| 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. | Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52) |
| 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. | Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52) |
| 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. | Baseline up to the event of SGRQ total score worsening or death from any cause, whichever occurred first (up to Week 122) |
| 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. | Baseline up to the event of SGRQ total score worsening or death from any cause, whichever occurred first (up to Week 122) |
| 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). | Baseline up to the event of acute IPF exacerbation (up to Week 122) |
| 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. | Baseline up to the event of acute IPF exacerbation (up to Week 122) |
| Percentage of Participants With Respiratory-Related Hospitalization | Baseline up to the event of respiratory-related hospitalization (up to Week 122) |
| 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. | Baseline up to the event of respiratory-related hospitalization (up to Week 122) |
| 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. | Baseline up to the event of >/=15% absolute decrease in percentage of predicted DLco or death from any cause (up to Week 122) |
| 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. | Baseline up to the event of >/=15% absolute decrease in percentage of predicted DLco or death from any cause (up to Week 122) |
| 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. | 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) |
| Minimum Observed Serum Concentration (Cmin) of Lebrikizumab at Week 52 | Participants who received lebrikizumab were only included in the analysis. | Predose (Hour 0) at Week 52 |
| Minimum Observed Serum Concentration (Cmin) of Lebrikizumab | Participants who received lebrikizumab were only included in the analysis. | Predose (Hour 0) at Weeks 4, 12, 24, and 36 |
| 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. | 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) |
| 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 |
| FG001 | Monotherapy (Cohort A): Lebrikizumab | Participants received monotherapy 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. Participants were 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. |
| FG002 | Combination Therapy (Cohort B): Placebo + Pirfenidone | Participants received 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. |
| FG003 | Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone | Participants received 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. |
| COMPLETED |
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| NOT COMPLETED |
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| Open-Label Period (Only For Monotherapy) |
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|
Analysis was performed on Intent-to-Treat (ITT) Population, which included all participants who were randomized in the study, with participants grouped according to the treatment assignment at randomization.
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| ID | Title | Description |
|---|---|---|
| BG000 | Monotherapy (Cohort A): Placebo | Participants received monotherapy with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were 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. |
| BG001 | Monotherapy (Cohort A): Lebrikizumab | Participants received monotherapy 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. Participants were 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. |
| BG002 | Combination Therapy (Cohort B): Placebo + Pirfenidone | Participants received 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 placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. |
| BG003 | Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone | Participants received 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure at Week 52. | Posted | Mean | Standard Error | percent predicted FVC/year | Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52) |
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| Secondary | 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. | Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure at Week 52. | Posted | Mean | Standard Error | m/year | Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52) |
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| Secondary | 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. | Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Number | percentage of participants | 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) |
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| Secondary | 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. | Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | weeks | 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) |
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| Secondary | 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. | Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure at Week 52. | Posted | Mean | Standard Error | mL/min/mmHg/year | Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52) |
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| Secondary | 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. | Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Number | percentage of participants | 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) |
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| Secondary | 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. | Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | weeks | 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) |
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| Secondary | 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. | Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure at Week 52. | Posted | Mean | Standard Error | mL/year | Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52) |
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| Secondary | 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. | Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure at Week 52. | Posted | Mean | Standard Error | units on a scale/year | Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52) |
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| Secondary | 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. | Analysis was performed on ITT Population for monotherapy cohort only. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline up to the event of SGRQ total score worsening or death from any cause, whichever occurred first (up to Week 122) |
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| Secondary | 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. | Analysis was performed on ITT Population for monotherapy cohort only. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | weeks | Baseline up to the event of SGRQ total score worsening or death from any cause, whichever occurred first (up to Week 122) |
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| Secondary | 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). | Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline up to the event of acute IPF exacerbation (up to Week 122) |
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| Secondary | 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. | Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | weeks | Baseline up to the event of acute IPF exacerbation (up to Week 122) |
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| Secondary | Percentage of Participants With Respiratory-Related Hospitalization | Analysis was performed on ITT Population for combination therapy cohorts only. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline up to the event of respiratory-related hospitalization (up to Week 122) |
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| Secondary | 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. | Analysis was performed on ITT Population for combination therapy cohorts only. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | weeks | Baseline up to the event of respiratory-related hospitalization (up to Week 122) |
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| Secondary | 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. | Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline up to the event of >/=15% absolute decrease in percentage of predicted DLco or death from any cause (up to Week 122) |
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| Secondary | 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. | Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | weeks | Baseline up to the event of >/=15% absolute decrease in percentage of predicted DLco or death from any cause (up to Week 122) |
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| Secondary | 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. | Analysis was performed on Safety Population (all participants who received at least one dose of study drug grouped according to the actual treatment received). 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure; 'Number Analyzed' = number of participants evaluable at indicated time points. | Posted | Number | percentage of participants | 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) |
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| Secondary | Minimum Observed Serum Concentration (Cmin) of Lebrikizumab at Week 52 | Participants who received lebrikizumab were only included in the analysis. | Analysis was performed on Pharmacokinetic (PK)-Evaluable Population, which included all participants who received at least one dose of study drug and had at least one non-missing PK observation. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure at Week 52. | Posted | Mean | Standard Deviation | micrograms per milliliter (mcg/mL) | Predose (Hour 0) at Week 52 |
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| Secondary | Minimum Observed Serum Concentration (Cmin) of Lebrikizumab | Participants who received lebrikizumab were only included in the analysis. | Analysis was performed on PK-Evaluable Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points. | Posted | Mean | Standard Deviation | mcg/mL | Predose (Hour 0) at Weeks 4, 12, 24, and 36 |
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| Secondary | 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. | Analysis was performed on PK-Evaluable Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | days | 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) |
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Baseline up to Week 122
Safety Population
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Monotherapy (Cohort A): Placebo | Participants received monotherapy with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants were 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. | 4 | 76 | 19 | 76 | 70 | 76 |
| EG001 | Monotherapy (Cohort A): Lebrikizumab | Participants received monotherapy 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. Participants were 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. | 4 | 78 | 23 | 78 | 73 | 78 |
| EG002 | Combination Therapy (Cohort B): Placebo + Pirfenidone | Participants received 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 placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. | 15 | 177 | 47 | 177 | 158 | 177 |
| EG003 | Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone | Participants received 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. | 7 | 174 | 56 | 174 | 142 | 174 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Atrioventricular block | Cardiac disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Atrioventricular block second degree | Cardiac disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Cardiomegaly | Cardiac disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Coronary artery occlusion | Cardiac disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Right ventricular failure | Cardiac disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Vertigo positional | Ear and labyrinth disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Intestinal prolapse | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Death | General disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Sudden death | General disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Drug-induced liver injury | Hepatobiliary disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Graft versus host disease | Immune system disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Bronchitis bacterial | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Campylobacter infection | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Fungal infection | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
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| H1N1 influenza | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Lung infection | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Pneumonia haemophilus | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Pneumonia influenzal | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Pneumonia viral | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Respiratory syncytial virus infection | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Urinary tract infection enterococcal | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Wound infection bacterial | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Non-systematic Assessment |
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| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Non-systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Non-systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Non-systematic Assessment |
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| Spinal fracture | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Non-systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Basosquamous carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Chondrosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Lung Adenocarcinoma Stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Lung Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Lung squamous cell carcinoma Stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Neuroendocrine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Axillary vein thrombosis | Vascular disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Mycobacterium avium complex infection | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Forced vital capacity decreased | Investigations | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 20.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 20.1 | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| Aug 22, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C561806 | lebrikizumab |
| C093844 | pirfenidone |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| Physician Decision |
|
| Lost to Follow-up |
|
| Death |
|
| Adverse Event |
|
| From 55 to <65 years |
|
| From 65 to <75 years |
|
| >/=75 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (<50%, 50 to 75%, >75%) and participant by assessment time as random effects with unstructured covariance. |
| Mixed Models Analysis |
| 0.5566 |
| Mean Difference (Final Values) |
| 0.49998 |
| Standard Error of the Mean |
| 0.84946 |
| 2-Sided |
| 95 |
| -1.17 |
| 2.17 |
| Superiority |
| OG002 | Combination Therapy (Cohort B): Placebo + Pirfenidone | Participants received 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 placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. |
| OG003 | Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone | Participants received 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. |
|
|
|
| OG002 | Combination Therapy (Cohort B): Placebo + Pirfenidone | Participants received 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 placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. |
| OG003 | Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone | Participants received 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. |
|
|
| OG001 | Monotherapy (Cohort A): Lebrikizumab | Participants received monotherapy 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. Participants were 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. |
| OG002 | Combination Therapy (Cohort B): Placebo + Pirfenidone | Participants received 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 placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. |
| OG003 | Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone | Participants received 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. |
|
|
|
| OG002 | Combination Therapy (Cohort B): Placebo + Pirfenidone | Participants received 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 placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. |
| OG003 | Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone | Participants received 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. |
|
|
|
| OG002 | Combination Therapy (Cohort B): Placebo + Pirfenidone | Participants received 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 placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. |
| OG003 | Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone | Participants received 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. |
|
|
| OG001 |
| Monotherapy (Cohort A): Lebrikizumab |
Participants received monotherapy 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. Participants were 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. |
| OG002 | Combination Therapy (Cohort B): Placebo + Pirfenidone | Participants received 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 placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. |
| OG003 | Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone | Participants received 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. |
|
|
|
| OG002 | Combination Therapy (Cohort B): Placebo + Pirfenidone | Participants received 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 placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. |
| OG003 | Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone | Participants received 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. |
|
|
|
| Monotherapy (Cohort A): Lebrikizumab |
Participants received monotherapy 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. Participants were 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. |
| OG002 | Combination Therapy (Cohort B): Placebo + Pirfenidone | Participants received 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 placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. |
| OG003 | Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone | Participants received 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. |
|
|
|
| Monotherapy (Cohort A): Lebrikizumab |
Participants received monotherapy 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. Participants were 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. |
|
|
| OG001 | Monotherapy (Cohort A): Lebrikizumab | Participants received monotherapy 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. Participants were 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 received monotherapy 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. Participants were 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. |
| OG002 | Combination Therapy (Cohort B): Placebo + Pirfenidone | Participants received 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 placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. |
| OG003 | Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone | Participants received 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. |
|
|
Participants received monotherapy 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. Participants were 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. |
| OG002 | Combination Therapy (Cohort B): Placebo + Pirfenidone | Participants received 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 placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. |
| OG003 | Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone | Participants received 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. |
|
|
|
| Participants |
|
|
|
|
|
| OG002 | Combination Therapy (Cohort B): Placebo + Pirfenidone | Participants received 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 placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. |
| OG003 | Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone | Participants received 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. |
|
|
| OG002 | Combination Therapy (Cohort B): Placebo + Pirfenidone | Participants received 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 placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. |
| OG003 | Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone | Participants received 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. |
|
|
|
Participants received 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. |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|