A Study of Lebrikizumab in Participants With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication

Asthma Clinical Trial

Official title:

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868061
• Other study ID #: GB28689
• Secondary ID: 2013-000176-15
• Status: Completed
• Phase: Phase 3
• First received: May 30, 2013
• Last updated: May 18, 2017
• Start date: July 31, 2013
• Est. completion date: January 2, 2017

Study information

• Verified date: May 2017
• 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 in participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at least one second controller medication. Participants will be randomized in 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo, administered as subcutaneous (SC) injection every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. Participants who were assigned to placebo during the placebo-controlled period of the trial will be re-randomized at Week 52 to receive blinded SC lebrikizumab 37.5 milligrams (mg) or 125 mg every 4 weeks from Weeks 53 to 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1068
• Est. completion date: January 2, 2017
• Est. primary completion date: January 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Asthma diagnosis for greater than equal to (>/=) 12 months at Visit 1

• Bronchodilator response at Visit 1, 2, or 3

• Pre-bronchodilator FEV1 of 40 percent (%) - 80% predicted at both Visits 2 and 3

• On ICS therapy at a total daily dose of 500-2000 microgram (mcg) of fluticasone propionate dry powder inhaler (DPI) or equivalent for >/= 6 months prior to Visit 1

• On an eligible second controller medication (long-acting Beta-agonist [LABA], leukotriene receptor antagonist [LTRA], long-acting muscarinic antagonist [LAMA], or theophylline) for 6 months prior to Visit 1

• Uncontrolled asthma at Visit 1 and/or Visit 2, and at Visit 3

• Chest X-ray or computed tomography (CT) scan within 3 months prior to Visit 1 or chest X-ray during the screening period (prior to Visit 3) confirming the absence of other clinically significant lung disease

• Demonstrated adherence with controller medication during the screening 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

• Maintenance oral corticosteroid therapy within 3 months of Visit 1

• Treatment with systemic (oral, intravenous [IV], or intramuscular [IM]) corticosteroids within 4 weeks prior to Visit 1 or during the screening period

• Treatment with intra-articular corticosteroids within 4 weeks prior to Visit 1 or during the screening period or anticipated need for intra-articular corticosteroids during the course of the study

• Infection requiring hospital admission for >/=24 hours or requiring treatment with IV or IM antibiotics within 4 weeks prior to Visit 1 or during screening; Upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening; Active parasitic infection or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening

• Active tuberculosis requiring treatment within 12 months prior to Visit 1

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

• Evidence of acute or chronic hepatitis or known liver cirrhosis

• History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma

• Known current malignancy or current evaluation for potential malignancy

• Current smoker or former smoker with a history of greater than (>) 10 pack-years

• History of alcohol or drug abuse

• Past and/or current use of any anti-interleukin (IL)-13 or anti-IL-4/IL-13 therapy, including lebrikizumab; use of other monoclonal antibody therapy, including omalizumab, within 6 months or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening

• Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or during screening

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Lebrikizumab
Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.
• Placebo
Lebrikizumab matching placebo will be administered as SC injection every 4 weeks for 52 weeks.

Locations

Country	Name	City	State
Argentina	Fundacion Cidea	Buenos Aires
Argentina	Instituto de Investigaciones Clinicas-Mar del Plata	Buenos Aires
Argentina	Centro Respiratorio Infantil	Rosario
Argentina	Centro Modelo de Cardiologia	San Miguel de Tucuman
Argentina	CEMER Centro Médico de Enfermedades Respiratorias	Vicente López
Australia	AusTrials	Brisbane	Queensland
Australia	Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine	Brisbane	Queensland
Australia	The Lung Institute of Western Australia; Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Concord Repatriation General Hospital; Department Thoracic Medicine	Sydney	New South Wales
Australia	Respiratory Clinical Trials Pty Ltd	Toorak Gardens	South Australia
Belgium	Private Practice	Jambes
Belgium	UZ Leuven Gasthuisberg	Leuven
Bulgaria	Specialized Hospital for Active Treatment for pneumo-phtysiatric diseases	Ruse
Bulgaria	Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD	Smolyan
Bulgaria	5TH MHAT; Pulmonology	Sofia
Bulgaria	Alitera - Med - Medical Center EOOD	Sofia
Bulgaria	Medical Center for Specialized Outpatient Medical Care for Pulmonary Diseases	Sofia
Bulgaria	National Multiprofile Hospital Tsar Boris III	Sofia
Bulgaria	SHATPD Sveta Sofia; Clin Pulmonary Diseases	Sofia
Bulgaria	Multiprofile Hospital For Active Treatment prof Kirkovich	Stara Zagora
Bulgaria	Diagnostic and Consulting Centre Mladost - M OOD	Varna
Bulgaria	Medical Center Tara OOD	Veliko Tarnovo
Canada	Cheema Research, Inc	Mississauga	Ontario
Canada	Del Carpio Jaime Dr - Allergiste & Immunologue	Montreal	Quebec
Canada	Ottawa Allergy Research Corp	Ottawa	Ontario
Canada	Manna Research	Toronto	Ontario
Canada	Dr Anil Dhar Professional Medicine Corporation	Windsor	Ontario
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czechia	Thomayerova nemocnice	Praha 4 - Krc
Czechia	Ordinace pro tuberkulozu a respiracni nemoci	Strakonice
Czechia	KASMED, s.r.o.; Alergologie a klinicka imunologie	Tabor
France	Centre Hospitalier Universitaire de Bicêtre	Le Kremlin-bicêtre
France	Hôpital de La Croix Rousse	Lyon
France	Groupe Hospitalier Cochin St Vincent de Paul La Roche Guyon	Paris
France	Hopital Bichat Claude Bernard ; Service de Pneumologie	Paris
Germany	Medaimun GmbH	Frankfurt am Main
Germany	Pneumologisches Forschungsinstitut	Großhansdorf
Germany	Praxis Dr. med. Hermann A. Trauth	Marburg
Hungary	Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika	Debrecen
Hungary	Selye János Kórház és Rendelointézet; Allergológiai Szakrendelés	Komárom
Hungary	Markusovszky Egyetemi Oktatokorhaz	Szombathely
Israel	Rambam Health Care Campus	Haifa
Israel	Hadassah Medical Center; Pulmonary Institute	Jerusalem
Israel	Nazareth EMMS Hospital	Nazareth
Israel	Rabin Medical Center	Petach Tikva
Israel	Chaim Sheba Medical Center; Oncology Dept	Ramat Gan
Italy	Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia	Catania	Sicilia
Italy	Asst Santi Paolo E Carlo	Milano	Lombardia
Italy	Azienda Ospedaliera Universitaria di Modena	Modena	Emilia-Romagna
Italy	Azienda Ospedaliera Monaldi	Napoli	Campania
Italy	Fondazione IRCCS Policlinico San Matteo di Pavia; S.S. Fisiopatologia Respiratoria	Pavia	Lombardia
Italy	Università Cattolica del Sacro Cuore UOC Allergologia- Policlinico Gemelli	Rome	Lazio
Italy	P.O. Citta` Di Sesto S. Giovanni	Sesto San Giovanni	Lombardia
Japan	Banbuntane Hotokukai Hospital	Aichi
Japan	Fukuoka National Hospital	Fukuoka
Japan	Hiroshima Allegy & Respiratory Clinic	Hiroshima
Japan	Ibarakihigashi National Hospital	Ibaraki
Japan	Uno Naikakokyukika Clinic	Isesaki-shi
Japan	Sagamihara National Hospital	Kanagawa
Japan	Yokohama City University Medical Center; Neurology	Kanagawa
Japan	Kumamoto Saishunso National Hospital	Koshi-shi
Japan	Kumamoto University Hospital	Kumamoto
Japan	Kyoto University Hospital, Respiratory Medicine	Kyoto
Japan	Machida Municipal Hospital	Machida-shi
Japan	Hikarigaoka Spellman Hospital; Rheumatology	Miyagi
Japan	Nagoya Ekisaikai Hospital	Nagoya-shi
Japan	Okayama University Hospital	Okayama
Japan	Kinki University Hospital	Osaka
Japan	Kishiwada City Hospital	Osaka
Japan	Takatsuki Red Cross Hospital; Division of Diabetes / Endocrinology / Lifestyle-Related Disease	Osaka
Japan	Tohoku Medical and Pharmaceutical University Wakabayashi Hospital	Sendai-shi
Japan	Iwata City Hospital	Shizuoka
Japan	Takamatsu Municipal Hospital	Takamatsu-shi
Japan	Center Hospital of the National Center for Global Health and Medicine	Tokyo
Japan	Hanzomon Hospital	Tokyo
Japan	Nihon University Itabashi Hospital	Tokyo
Japan	Tokyo-Eki Center-building Clinic	Tokyo
Japan	Toyama City Hospital	Toyama
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Gyeonggi-do
Korea, Republic of	Ewha Womans University Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Seoul National University Hospital; Division of Allergy and Clinical Immunology	Seoul
Korea, Republic of	Seoul St Mary's Hospital	Seoul
Mexico	Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.	Guadalajara
Mexico	Unidad de Investigacion Clinica En Medicina (Udicem) S.C.	Monterrey
Mexico	Consultorio Especialidad Alergologia Pediatrica	Villahermosa
New Zealand	Greenlane Clinical Centre	Auckland
New Zealand	Canterbury Respiratory Research Group; Respiratory	Christchurch
New Zealand	P3 Research	Tauranga
New Zealand	Medical Research Inst. of New Zealand; Respiratory	Wellington
Peru	Hospital Nacional Adolfo; Guevara Velasco Essalud	Cusco
Peru	ABK Reuma SRL- Medicentro BioCiencias	Lima
Peru	Centro de Investigación Ricardo Palma	Lima
Peru	Clinica Internacional	Lima
Peru	Clinica San Borja	Lima
Peru	Clinica San Pablo	Lima
Peru	Hospital Nacional Luis N Saenz PNP	Lima
Peru	Instituto Peruano de Investigacion en Ciencias Medicas	Lima
Peru	Clinica los Andes	Miraflores
Poland	SP ZOZ Bienkowka- Osrodek Zdrowia w Bienkowce	Biennkówka
Poland	GRAZYNA JASIENIAK-PINIS ATOPIA Niepubliczny Zaklad Opieki Zdrowotnej Poradnie Specjalistyczne	Krakow
Poland	SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi	Lodz
Poland	Specjalistyczna Poradnia Pulmonologiczna	Ostrow Wielkopolski
Poland	Niepubliczny Zespol Poradni Specjalistycznych PULS Poradnia Chorob Pluc i Gruzlic	Pila
Poland	ABC-PULMO Poradnia Chorob Pluc	Radom
Poland	Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala	Ruda Slaska
Poland	Centrum Medyczne Ogrodowa	Skierniewice
Poland	Alergo Medical Specjalistyczna Przychodnia Lekarska	Tarnow
Poland	Dobrostan Gabinety Lekarskie	Wroclaw
Poland	Lexmedica	Wroclaw
Poland	NZOZ Lekarze Specjalisci	Wroclaw
Romania	Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca, Sectia Clinica Pneumologie I	Cluj-Napoca
Romania	Spitalul Clinic de Pneumoftiziologie Palazu Mare Constanta	Palazu Mare
Romania	Targu Mures Clinical Emergency County Hospital	Targu Mures
Romania	Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital	Timisoara
Russian Federation	City Clinical Hospital #13	Moscow
Russian Federation	I.M. Sechenov Moscow State Medical University the Ministry of Health and Social Development of RF	Moscow
Russian Federation	City Clinical Hospital #2	Novosibirsk
Russian Federation	Penza Regional Clinical Hospital Named After N. N. Burdenko; Therapy Department	Penza
Russian Federation	Ryazan Regional Clinincal Cardiology Dispensary	Ryazan
Russian Federation	Saratov State Medical Univ; Clinical Immun & Allerg	Saratov
Russian Federation	Municipal Polyclinic #25	St Petersburg
Russian Federation	City Hospital #40 of Resort Administrative District	St. Petersburg
Russian Federation	St. Petersburg State Medical University n.a. I.P. Pavlov	St. Petersburg
Russian Federation	St.Petersburg State Budget Healthcare Institution City Hospital of Saint Venerable Martyr Elizabeth	St. Petersburg
Russian Federation	Siberian State Medical University	Tomsk
Russian Federation	Municipal Budgetery Clinical Institution of Healthcare; NA Semashko City Hospital	Yaroslavl
Russian Federation	Yaroslavl State Medical Academy - Clinical Hospital #2	Yaroslavl
Serbia	Clinical Center of Serbia	Belgrade
Serbia	Institute of Lung Diseases Vojvodina	Sremska Kamenica
Serbia	Clinical Hospital Centre Zemun	Zemun
Slovakia	Pneumo-Alergo Centrum s.r.o.	Bratislava
Slovakia	ZAPA JJ Sro	Levice
Slovakia	Imunoalergologia Dzurilla s.r.o.	Nitra
South Africa	Respiratory Research Unit	Cape Town
South Africa	Tiervalei Trial Centre	Cape Town
South Africa	Dr PJ Sebastian	Durban
South Africa	St Augustines Hospital; Infectoilogy	Durban
South Africa	Limpopo Clinical Research Initiative; Tamboti Medical Centre	Tabazimbi
South Africa	Aliwal Shoal Medical Center	Umkomaas
South Africa	Clinical Projects Research	Worcester
Spain	Instituto de Ciencias Medicas	Alicante
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Institut Catala de Serveis Medics	Girona
Spain	Hospital Universitario la Paz; Servicio de Alergologia	Madrid
Spain	Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología	Majadahonda	Madrid
Spain	Complexo Hospitalario Universitario de Santiago CHUS - Hospital de Conxo	Santiago de Compostela	La Coruña
Spain	Hospital Universitario Virgen Macarena	Seville	Sevilla
Ukraine	Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council	Cherkasy
Ukraine	MI Dnipropetrovsk clinical association of emergency care of Dnipropetrovsk regional council	Dnipropetrovsk
Ukraine	Donetsk Municipal Treatment and Prophylactic Institution Central City Clinical Hospital #1	Donetsk
Ukraine	Municipal Institution of Health Care City Clinical Hospital #13	Kharkiv
Ukraine	SI Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine	Kharkiv
Ukraine	Kyiv City Tuberculosis Hospital #1; Department of Differential Diagnosis of Lung Diseases	Kyiv	Kiev Governorate
Ukraine	SI National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine	Kyiv
Ukraine	City Hospital #1	Mykolaiv
Ukraine	Municipal Institution Odesa Regional Clinical Hospital	Odesa
Ukraine	City Clinical Hospital No.1; Therap Ukr Med Stom Acad	Poltava
Ukraine	Scientific and Research Institute of Invalid Rehabilitation of Moh of Ukraine	Vinnytsya
Ukraine	LLC Diaservis	Zaporizhzhia
Ukraine	Municipal Institution Zaporizhzhia City Multifield Clinical Hospital #9	Zaporizhzhye
United Kingdom	Raigmore Hospital	Inverness
United Kingdom	Royal Preston Hospital	Preston
United Kingdom	Royal Hallamshire Hospital; Department of Oncology	Sheffield
United Kingdom	Southmead Hospital	Westbury-on-Trym, Bristol
United States	Pulmonary Research of Albingdon	Abingdon	Virginia
United States	Georgia Pollens	Albany	Georgia
United States	University of New Mexico; School of Med	Albuquerque	New Mexico
United States	Allergy Partners of Western NC	Asheville	North Carolina
United States	Future Search Clinical Trials L.P.	Austin	Texas
United States	Kern Allergy Med Clinic, Inc.	Bakersfield	California
United States	Asthma, Allergy & Sinus Center	Baltimore	Maryland
United States	Chesapeake Clinical Research	Baltimore	Maryland
United States	Dr. Paul Shapero	Bangor	Maine
United States	Clinical Research Center of Alabama, LLC	Birmingham	Alabama
United States	Allergy Consultants PA	Boca Raton	Florida
United States	Asthma and Allergy Physicians LLC	Brockton	Mississippi
United States	Allergy & Asthma Centre of Dayton	Centerville	Ohio
United States	Allergy Associates, Inc.	Chesterfield	Missouri
United States	Asthma & Allergy; Associates, P.C.	Colorado Springs	Colorado
United States	Storms Clinical Research; Institute	Colorado Springs	Colorado
United States	Howard County Center for Lung and Sleep, LLC	Columbia	Maryland
United States	Neem Research Group, Inc.	Columbia	South Carolina
United States	Brookstone Clinical Res Ctr	Columbus	Georgia
United States	Southeast Regional Research Group	Columbus	Georgia
United States	Elliot J. Ginchansky, MD, PA	Dallas	Texas
United States	Colorado Allergy & Asthma Centers, Pc	Denver	Colorado
United States	National Jewish Health	Denver	Colorado
United States	Adult Pediatric Allergy Central Jersey	Edison	New Jersey
United States	EPIMRD, Inc. DBA Western Sky Medical Research	El Paso	Texas
United States	The Allergy and Asthma Center	Fort Wayne	Indiana
United States	Allergy and Asthma Relief Experts	Granada Hills	California
United States	Greenville Pharmaceutical Research	Greenville	South Carolina
United States	Upstate Pharmaceutical Research; Greenville	Greenville	South Carolina
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Baylor College of Medicine; Dept of Medicine	Houston	Texas
United States	Center For Pharmaceutical Research	Kansas City	Missouri
United States	Clinical Research Consortium	Las Vegas	Nevada
United States	DataQuest Medical Research	Lawrenceville	Georgia
United States	Southern California Institute For Respiratory	Los Angeles	California
United States	University of Wisconsin;Allergy & Asthma Clinical Research	Madison	Wisconsin
United States	Research Institute of South Florida Inc	Miami	Florida
United States	Winthrop Univ Hospital	Mineola	New York
United States	Clinical Research Inst	Minneapolis	Minnesota
United States	Allergy Associates of Utah	Murray	Utah
United States	Yale University School Of Medicine	New Haven	Connecticut
United States	Infinity Medical Research Inc	North Dartmouth	Massachusetts
United States	Integrity People Services Research Company	Oklahoma City	Oklahoma
United States	Oklahoma Institute of Allergy and Asthma Clinical Research LLC	Oklahoma City	Oklahoma
United States	Allergy and Clinical Immunology Associates	Pittsburgh	Pennsylvania
United States	Allergy & Asthma Consultants	Redwood City	California
United States	Allergy & Asthma Clin Cen TX	Round Rock	Texas
United States	Clinical Research Center, L.L.C.	Saint Louis	Missouri
United States	Allergy & Asthma Research Center	San Antonio	Texas
United States	Discovery Clinical Trials	San Antonio	Texas
United States	Live Oak Allergy & Asthma Clinic	San Antonio	Texas
United States	Quality Assurance Research Ctr	San Antonio	Texas
United States	Sarasota Clinical Research	Sarasota	Florida
United States	Aeroallergy Research Labs	Savannah	Georgia
United States	Medical Research of Arizona; Allergy, Asthma & Immu	Scottsdale	Arizona
United States	Patrick V. Perin, MD	Teaneck	New Jersey
United States	Cotton O'Neil Clinic; Stormont-Vail Hlth Care	Topeka	Kansas
United States	Quality of Life Medical & Research Center	Tucson	Arizona
United States	Vital Prospects Clin Res Pc	Tulsa	Oklahoma
United States	Asthma & Allergy of Idaho	Twin Falls	Idaho
United States	Asthma and Allergy Research Associates	Upland	Pennsylvania
United States	Integrated Research Group Inc	Upland	California
United States	Allergy & Asthma Medical Group; Clinical Research Division	Walnut Creek	California
United States	Western States Clinical Research, Inc	Wheat Ridge	Colorado
United States	Atlanta Allergy & Asthma Clini	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Bulgaria,  Canada,  Czechia,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  New Zealand,  Peru,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Asthma Exacerbations During the 52-Week Placebo-Controlled Period		Baseline up to Week 52
Secondary	Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)		Baseline, Week 52
Secondary	Time to First Asthma Exacerbation		Baseline up to Week 52
Secondary	Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ) Score		Baseline, Week 52
Secondary	Change from Baseline In Asthma Rescue Medication (Number of Puffs or Nebulized Treatments)		Baseline, Week 52
Secondary	Rate of Urgent Asthma-Related Urgent Health Care Utilization		Baseline up to Week 52
Secondary	Percentage of Participants With Adverse Events		Baseline up to Week 124
Secondary	Percentage of Participants With Anti-Therapeutic Antibodies to Lebrikizumab		Baseline up to Week 124 (assessed at Baseline, Weeks 4, 12, 24, 36, 52, 64, 76, 92, 104, 112, and 124)
Secondary	Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score		Baseline, Week 52
Secondary	Minimum Serum Concentration (Cmin) of Lebrikizumab		Predose (0 hour) on Weeks 4, 12, 24, 36, and 52