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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872689
• Other study ID #: GB28547
• Secondary ID: 2013-001163-24
• Status: Completed
• Phase: Phase 2
• Start date: October 13, 2013
• Est. completion date: November 6, 2017

Study information

• Verified date: August 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab as monotherapy in the absence of background IPF therapy and as combination therapy with pirfenidone background therapy in participants with IPF. Participants will be randomized to receive either lebrikizumab or placebo subcutaneously every 4 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 505
• Est. completion date: November 6, 2017
• Est. primary completion date: July 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Have a diagnosis of IPF within the previous 5 years from time of screening and confirmed at baseline

• FVC >/=40 percent (%) and </=100% of predicted at screening

• Stable baseline lung function as evidenced by a difference of less than (<) 10% in FVC (in liters) measurements between screening and Day 1, Visit 2 prior to randomization

• DLco >/=25% and </=90% of predicted at screening

• Ability to walk >/=100 meters unassisted in 6 minutes

• Cohort A: No background IPF therapy for >/=4 weeks allowed prior to randomization and throughout the placebo-controlled study period

• Cohort B: Tolerated dose of pirfenidone </=2403 milligrams once daily (mg/day) for >/=4 weeks required prior to randomization and throughout the placebo-controlled study period

Exclusion Criteria:

• History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection

• Evidence of other known causes of interstitial lung disease

• Lung transplant expected within 12 months of screening

• Evidence of clinically significant lung disease other than IPF

• Post-bronchodilator forced expiratory volume in 1 second (FEV1)/FVC ratio <0.7 at screening

• Positive bronchodilator response, evidenced by an increase of >/=12% predicted and 200 milliliters increase in FEV1 or FVC

• Class IV New York Heart Association chronic heart failure or historical evidence of left ventricular ejection fraction <35%

• Hospitalization due to an exacerbation of IPF within 4 weeks prior to or during screening

• Known current malignancy or current evaluation for potential malignancy

• Listeria monocytogenes infection or active parasitic infection within 6 months prior to Day 1, Visit 2

• Active tuberculosis requiring treatment within 12 months of screening

• Known immunodeficiency, including but not limited to human immunodeficiency virus infection

• Past use of any anti-interleukin (IL)-13 or anti-IL-4/IL-13 therapy, including lebrikizumab

• Evidence of acute or chronic hepatitis or known liver cirrhosis

Exclusions Criteria Limited to Cohort B:

• Known achalasia, esophageal stricture, or esophageal dysfunction sufficient to limit the ability to swallow oral medication

• Tobacco smoking or use of tobacco-related products within 3 months of screening or unwillingness to avoid smoking throughout the study period

• Known or suspected peptic ulcer

• Any condition that, as assessed by the investigator, might be significantly exacerbated by the known side effects associated with pirfenidone

• Creatinine clearance <40 milliliters/minute, calculated using the Cockcroft-Gault formula

• Use of following therapies within 4 weeks of randomization (Day 1, Visit 2) or during the study: Strong inhibitors of CYP1A2 (Cytochrome P450 Family 1 Subfamily A Member 2) (example: fluvoxamine or enoxacin); Moderate inducers of CYP1A2 (limited to tobacco smoking and tobacco-related products)

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• Lebrikizumab
Lebrikizumab will be administered at a dose of 250 mg via SC injection once every 4 weeks.
• Pirfenidone
Pirfenidone will be administered orally at a stable dose of 2403 mg per day or at MTD.
• Placebo
Placebo matched to lebrikizumab will be administered via SC injection once every 4 weeks.

Locations

Country	Name	City	State
Australia	Box Hill Hospital; Eastern Clinical Research Unit	Box Hill	Victoria
Australia	Royal Prince Alfred Hospital; Department of Respiratory Medicine	Camperdown	New South Wales
Australia	ST VINCENT'S HOSPITAL; Thoracic Medicine	Darlinghurst	New South Wales
Australia	Alfred Hospital; Allergy Immuno Resp	Melbourne	Victoria
Australia	Institute for Respiratory Health Inc	Nedlands	Western Australia
Belgium	Cliniques Universitaires St-Luc	Bruxelles
Belgium	Hospital Erasme; Neurologie	Bruxelles
Belgium	UZ Leuven Gasthuisberg	Leuven
Belgium	CHU UCL Mont-Godinne	Mont-godinne
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	Lawson Health Research Institute a joint venture of LHSC Research Inc and Lawson Research Institute	London	Ontario
Canada	Dr. Georges-L. Dumont Regional Hospital	Moncton	New Brunswick
Canada	Institut universitaire de cardiologie et de pneumologie de Québec (Hôpital Laval)	Ste. Foy	Quebec
Canada	University of British Columbia - Vancouver Coastal Health Authority	Vancouver	British Columbia
France	Hopital Avicenne; Pneumologie	Bobigny
France	Hopital Louis Pradel; Pneumologie	Bron
France	Hopital Calmette; Pneumologie	Lille
France	Hopital Bichat Claude Bernard ; Service de Pneumologie	Paris
France	Hopital de Pontchaillou; Service de Pneumologie	Rennes
Germany	Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie	Essen
Germany	Universitätsklinikum Standort Gießen Medizinische Klinik II u. Poliklinik Innere Med./Pneumologie	Gießen
Germany	LungenClinic Großhansdorf	Großhansdorf
Germany	Thoraxklinik Heidelberg gGmbH	Heidelberg
Germany	Fachklinik für Lungenerkrankungen	Immenhausen
Germany	CPC Comprehensive Pneumology Center / Forschungsambulanz, Helmholtz Zentrum	München
Italy	A.O.U. Policlinico Vittorio Emanuele; Centro per la cura delle Malattie Rare del Polmone	Catania	Sicilia
Italy	Ospedale Morgagni-Pierantoni; U.O. Pneumologia	Forlì	Emilia-Romagna
Italy	Ospedale San Giuseppe; U.O. di Pneumologia	Milano	Lombardia
Italy	A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone	Orbassano (TO)	Piemonte
Italy	Policlinico Tor Vergata; UO Mal. Respiratorie; Centro Malattie rare polmone	Roma	Lazio
Italy	A.O. Univ. Senese Policlinico S. Maria alle Scotte; UOC Malattie Resepiratorie e Trapianto Polmonare	Siena	Toscana
Japan	Kanagawa Cardiovascular and Respiratory Center; Respiratory Medicine	Kanagawa
Japan	Kinki-Chuo Chest Medical Center	Osaka
Japan	Tosei General Hospital	Seto-shi
Mexico	Hospital General Del Estado De Sonora "Dr. Ernesto Ramos Bours"; Servicio De Neumologia	Hermosillo
Mexico	Instituto Nacional De Enfermedades Respiratorias;Unidad de Investigación	Mexico City
Mexico	Unidad de Investigacion Clinica En Medicina (Udicem) S.C.	Monterrey
Mexico	Universidad Autonoma De Nuevo Leon, Hospital Universitario Doctor Jose Eleuterio Gonzalez	Monterrey
Peru	Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional	Lima
Peru	Clinica San Borja; NEUMOCARE	Lima
Peru	Clinica San Pablo	Lima
Poland	Uniwersytecki Szpital Kliniczny Nr 1 im.N.Barlickiego Oddzial Kliniczny Pneumonologii i Alergologii	Lodz
Poland	Ms Clinsearch Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej	Lublin
Poland	Klinika Pulmonologii, Alergologii i Onkologii Pulmonologicznej Uniwersytet Medyczny w Poznaniu	Poznan
Poland	Instytut Gruzlicy i Chorob Pluc	Warszawa
Poland	Klinika Chorob Pluc i Gruzlicy w Zabrzu; Slaski Uniwersytet Medyczny	Zabrze
Spain	Hospital Universitari de Bellvitge ; Servicio de Neumologia	Hospitalet de Llobregat	Barcelona
Spain	Hospital Clínico San Carlos - Servicio de Neumologia	Madrid
Spain	Hospital Universitario La Princesa; Servicio de Neumologia	Madrid
Spain	Hospital Universitario Virgen del Rocio; Servicio de Neumologia	Sevilla
Spain	Hospital General Universitario De Valencia; Servicio de Neumologia	Valencia
United Kingdom	Southmead Hospital; Respiratory Department	Bristol
United Kingdom	Papworth Hospital NHS Foundation Trust; Respiratory Department	Cambridge
United Kingdom	Southampton General Hospital; Respiratory Department	Hampshire
United Kingdom	St James University Hospital; Respiratory Department	Leeds
United Kingdom	Respiratory research department clinical science building	Liverpool
United Kingdom	Royal Brompton Hospital; Respiratory Department	London
United Kingdom	North Manchester Hospital; Respiratory Department	Manchester
United States	Lovelace Scientific Resources, Inc.	Albuquerque	New Mexico
United States	Piedmont Healthcare Pulmonary and Critical Care Research	Austell	Georgia
United States	Johns Hopkins Bayview Medical Center - Johns Hopkins Asthma & Allergy Center	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	University Alabama At Birmingham	Birmingham	Alabama
United States	Tufts Medical Center	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cardiopulmonary Associates LLC Cardiopulmonary Research	Chesterfield	Missouri
United States	University of Chicago; Pulmonary and Critical Care	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Research Alliance Inc	Clearwater	Florida
United States	Case Western Research University; University Hospitals Case Medical Center	Cleveland	Ohio
United States	University Vermont College Medicine Fletcher Allen Health Care	Colchester	Vermont
United States	Ohio State University	Columbus	Ohio
United States	Southeastern Lung Care	Decatur	Georgia
United States	National Jewish Health	Denver	Colorado
United States	Inova Transplant Center Fairfax Hospital	Falls Church	Virginia
United States	Penn State University College Medical Allergy And Care Med	Hershey	Pennsylvania
United States	Baylor College Med	Houston	Texas
United States	Houston Methodist Hospital	Houston	Texas
United States	Univ of Iowa Hosp & Clinics; Pulmonary	Iowa City	Iowa
United States	Mayo Clinic-Jacksonville	Jacksonville	Florida
United States	Uni of Kansas Medical Center	Kansas	Kansas
United States	UCSD Medical Center	La Jolla	California
United States	University Wisconsin Hospitals and Clinics	Madison	Wisconsin
United States	Loyola University Med Center	Maywood	Illinois
United States	University Miami	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota Hospital & Clinic	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Mt Sinai School Medical Pulmo And Critical Care Med	New York	New York
United States	Weill Medical College of Cornell University	New York	New York
United States	Oklahoma University Health Sciences Center	Oklahoma City	Oklahoma
United States	University of Nebraska	Omaha	Nebraska
United States	Central Florida Pulmonary Group, PA	Orlando	Florida
United States	Temple Lung Center, Temple Universtiy-Of the Commomwealth System of Higher Education	Philadelphia	Pennsylvania
United States	University of Pittsburgh Med Cen; Dorothy P And Richard P Simmons Cen For Interstitial Lung Disease	Pittsburgh	Pennsylvania
United States	Maine Medical Center -Division of Pulmomary and Critical Care Medicine	Portland	Maine
United States	The Oregon Clinic.	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Highland Hospital—University of Rochester Medical Center	Rochester	New York
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	University of Utah Health Sciences Center, Lung Health Research Center	Salt Lake City	Utah
United States	Audie Murphy Va Hospital	San Antonio	Texas
United States	University of California, San Francisco	San Francisco	California
United States	Mayo Clinic- Scottsdale	Scottsdale	Arizona
United States	Pulmonary Consultants	Tacoma	Washington
United States	USF Tampa General Hospital	Tampa	Florida
United States	Southern Arizona Veterans Administration Healthcare Systems	Tucson	Arizona
United States	University of Arizona	Tucson	Arizona
United States	Cleveland Clinic Florida	Weston	Florida
United States	Rocky Mountain Center For Clinical Research	Wheat Ridge	Colorado
United States	Via Christi Hospital Inc. DBA Via Christi Research; Research Dept.	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Italy,  Japan,  Mexico,  Peru,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)
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.	Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)
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.	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)
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.	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)
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.	Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)
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.	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)
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.	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)
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.	Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)
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.	Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)
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.	Baseline up to the event of SGRQ total score worsening or death from any cause, whichever occurred first (up to Week 122)
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.	Baseline up to the event of SGRQ total score worsening or death from any cause, whichever occurred first (up to Week 122)
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).	Baseline up to the event of acute IPF exacerbation (up to Week 122)
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.	Baseline up to the event of acute IPF exacerbation (up to Week 122)
Secondary	Percentage of Participants With Respiratory-Related Hospitalization		Baseline up to the event of respiratory-related hospitalization (up to Week 122)
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.	Baseline up to the event of respiratory-related hospitalization (up to Week 122)
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.	Baseline up to the event of >/=15% absolute decrease in percentage of predicted DLco or death from any cause (up to Week 122)
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.	Baseline up to the event of >/=15% absolute decrease in percentage of predicted DLco or death from any cause (up to Week 122)
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.	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)
Secondary	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
Secondary	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
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.	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)