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

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

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 subcutaneously (SC) 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. During double-blind active treatment extension period, all participants will receive SC injection of lebrikizumab from Week 53 to Week 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Lebrikizumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1081
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426ABP
    • Centro Médico Dra de Salvo
  • Buenos Aires, Argentina, C1122AAK
    • Fundacion Faicep
  • Mar Del Plata, Argentina, CP 7600
    • Instituto Ave Pulmo
  • Quilmes, Argentina, 1878
    • Centro Respiratorio Quilmes
  • San Miguel de Tucuman, Argentina, 4000
    • Investigaciones en Patologias Respiratorias
• Australia
  • New South Wales
    • Liverpool BC, New South Wales, Australia, 1871
      • Liverpool Hospital
  • South Australia
    • Fitzroy, South Australia, Australia, 3065
      • St. Vincent's Hospital Melbourne
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital; Eastern Clinical Research Unit
    • Footscray, Victoria, Australia, 3011
      • Western Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • The Lung Institute of Western Australia; Sir Charles Gairdner Hospital
• Belgium
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires St-Luc
  • Gent, Belgium, 9000
    • UZ Gent
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Alberta Health services
  • Ontario
    • Mississauga, Ontario, Canada, L5M 2V8
      • Dr. E. Amer
    • Toronto, Ontario, Canada, M5T 3A9
      • Inspiration Research Limited
    • Toronto, Ontario, Canada, M9V4B4
      • Albion Finch Medical Centre
  • Quebec
    • Trois-Rivières, Quebec, Canada, G8T 7A1
      • Centre d'investigation Clinique Mauricie
• Chile
  • Santiago, Chile, 7500692
    • Centro de Investigaciones Medicas Respiratorias
  • Santiago, Chile, 7500698
    • Schonffeldt y Guerrero Limitada
  • Valparaiso, Chile, 2340000
    • Hospital Carlos Van Buren
• Colombia
  • Bogota DC, Colombia, 11001
    • Fundación Neumológica Colombiana
• Czechia
  • Jablonec Nad Nisou, Czechia, 466 01
    • Alergopraktik s.r.o.
  • Jindrichuv Hradec, Czechia, 377 38
    • Interni A Pneumologicka Ambulance
  • Ostrava - Poruba, Czechia, 708 68
    • MephaCentrum, a.s.
  • Teplice, Czechia, 415 01
    • Alergologie Teplice, s.r.o.
• France
  • Lille, France, 59037
    • Hopital Calmette; Pneumologie
  • Marseille, France, 13015
    • Hopital Nord; CIC
  • Montpellier, France, 34295
    • Hopital Arnaud de Villeneuve
  • Nantes, France, 44093
    • CHU Nantes - Hôpital Laennec; Service de Pneumologie
  • Strabourg, France, 67091
    • Nouvel Hôpital Civil; Pôle de Pathologie Thoracique
• Germany
  • Berlin, Germany, 13507
    • Lungenarztpraxis Tegel
  • Wiesloch, Germany, 69168
    • Pneumologisches Zentrum Wiesloch
• Hungary
  • Debrecen, Hungary, 4031
    • Kenezy Korhaz Rendelointezet
  • Gyor, Hungary, 9024
    • Petz Aladár Megyei Oktató Kórház
  • Szeged, Hungary, 6722
    • C.C.C. Hospital Chest Diseases
• Israel
  • Ashkelon, Israel, 78306
    • Barzilai Medical Center; Pulmonary Inst.
  • Haifa, Israel, 34362
    • Lady Davis Carmel Medical Center; Cardiovascular Medicine
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center
  • Kfar Saba, Israel, 44281
    • Meir Medical Center; Pulmonary Dept
  • Rehovot, Israel, 7661041
    • Kaplan Medical Center
• Italy
  • Calabria
    • Catanzaro, Calabria, Italy, 88100
      • University of Catanzaro
  • Emilia-Romagna
    • Parma, Emilia-Romagna, Italy, 43100
      • Azienda Ospedaliero Universitaria di Parma
  • Marche
    • Torrette - Ancona, Marche, Italy, 60100
      • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona
  • Puglia
    • Cassano Murge (BA), Puglia, Italy, 70020
      • Fondazione Salvatore Maugeri. IRCCS - Divisione di Pneumologia
  • Toscana
    • Pisa, Toscana, Italy, 56100
      • A.o. Universitaria Pisana; Dipartimento Cardio Toracico
  • Veneto
    • Padova, Veneto, Italy, 35128
      • Azienda Ospedaliera di Padova
• Japan
  • Aichi, Japan, 489-8642
    • Tosei General Hospital; Respiratory and Allergy Medicine
  • Amagasaki-shi, Japan, 660-0862
    • Ofuji Clinic
  • Fukuoka-shi, Japan, 815-8588
    • Kyushu Central Hospital
  • Higashiibaraki-gun, Japan, 311-3193
    • National Hospital Organization Mito Medical Center
  • Hiroshima, Japan, 734-8551
    • Hiroshima University Hospital
  • Hokkaido, Japan, 070-8644
    • National Hospital Organization Asahikawa Medical Center
  • Hokkaido, Japan, 053-8506
    • Oji General Hospital
  • Iwate, Japan, 020-8505
    • Iwate Medical University Hospital
  • Kanagawa, Japan, 231-8682
    • Yokohama City Minato Red Cross Hospital
  • Kiyose-shi, Japan, 204-8585
    • National Hospital Organization Tokyo National Hospital
  • Kochi, Japan, 783-8505
    • Kochi Medical School Hospital
  • Kodaira-shi, Japan, 187-0024
    • Oki Clinic
  • Kokubunji-shi, Japan, 185-0014
    • Takahashi Clinic
  • Koshigaya-shi, Japan, 343-0845
    • Dokkyo Medical University Koshigaya Hospital
  • Mizunami-shi, Japan, 509-6134
    • Tono Chuo Clinic
  • Nagaoka-shi, Japan, 940-2085
    • Nagaoka Red Cross Hospital
  • Niigata-shi, Japan, 950-11977
    • Niigata City General Hospital
  • Osaka, Japan, 545-8586
    • Osaka City University Hospital
  • Osaka, Japan, 591-8555
    • Kinki-Chuo Chest Medical Center
  • Osaka, Japan, 589-0022
    • Touda Clinic
  • Ota-ku, Japan, 145-0063
    • Senzoku Kokyuuki and Allergy Clinic
  • Sapporo-shi, Japan, 062-8618
    • Japan Community Health care Organization Hokkaido Hospital
  • Tokyo, Japan, 142-8666
    • Showa University Hospital
  • Tokyo, Japan, 173-8605
    • Teikyo University Hospital
  • Tokyo, Japan, 103-0027
    • Fukuwa Clinic
  • Tokyo, Japan, 103-0028
    • Tokyo Center Clinic; Internal Medicine
  • Tokyo, Japan, 105-0003
    • Sano Toranomon Clinic
  • Toshima, Japan, 171-0014
    • Sekino Hospital
  • Yoshida-gun, Japan, 910-1193
    • University of Fukui Hospital
• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 130-709
    • St. Paul's Hospital, The Catholic University of Korea, College of Medicine
  • Wonju, Korea, Republic of, 220-701
    • Wonju Christian Hospital
• Mexico
  • Guadalajara, Mexico, 44100
    • Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
  • Zapopan, Mexico, 45200
    • Hospital Dr Angel Leaño universidad Autonoma de Guadalajara AC
• New Zealand
  • Auckland, New Zealand, 1051
    • NZ Respiratory & Sleep Institute
  • Dunedin, New Zealand
    • Dunedin Hospital
  • Dunedin, New Zealand
    • RMC Medical Research Ltd
  • Tauranga, New Zealand, 3110
    • P3 Research
• Poland
  • Bialystok, Poland, 15-003
    • Centrum Medycyny Oddechowej Robert M. Mróz
  • Bialystok, Poland, 15-430
    • Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny
  • Krakow, Poland, 31-023
    • Grazyna Pulka Specjalistyczny Osrodek All-med
  • Kraków, Poland, 31-637
    • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.
  • Kraków, Poland, 30-349
    • Specjalistyczne Centrum Medyczne NOWOMED
  • Lódz, Poland, 90-153
    • Poradnia Pulmonologiczna dla Doroslych
  • Poznan, Poland, 60-214
    • Centrum Alergologii Teresa Hofman
  • Proszowice, Poland, 32-100
    • SPZOZ Proszowice
  • Skarżysko-Kamienna, Poland, 26-110
    • Niepubliczny Specjalistyczny ZOZ Puls-Med s.c.
  • Warszawa, Poland, 02-507
    • Klinika Chorób Wewnetrznych i Alergologii MSW
  • Warszawa, Poland, 01-868
    • Medica Pro Familia sp. z o.o. S.K.A.
  • Wroclaw, Poland, 50-445
    • ALL-MED Specjalistyczna Opieka Medyczna
• Romania
  • Bucharest, Romania, 020125
    • Colentina Clinical Hospital
  • Cluj-Napoca, Romania, 400162
    • Prof.Dr.Octavian Fodor Emergency Clinical Hospital
  • Craiova, Romania, 200515
    • Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Victor Babes Craiova
  • Timisoara, Romania, 300310
    • Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital
• Russian Federation
  • Kemerovo, Russian Federation, 650002
    • SIH Kemerovo Regional Clinical Hospital
  • Moscow, Russian Federation, 117292
    • Russian Uni of People'S Friendship, Med. Faculty; City Clinical Hospital No 64, Internal Diseases
  • Moscow, Russian Federation, 125367
    • Central Clinical Hospital #1 of RZhD JCS
  • Novosibirsk, Russian Federation, 630008
    • Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2
  • Ryazan, Russian Federation, 390039
    • Ryazan Regional Clinical Hosp
  • Saint Petersburg, Russian Federation
    • St. George the Martyr City Hospital
  • Saint-Petersburg, Russian Federation, 197022
    • St.-Petersburg SMU n. a. Academician I.P.Pavlov; Therapy Department
  • Smolensk, Russian Federation, 4812
    • Smolensk State Medical Academy
  • St Petersburg, Russian Federation, 193231
    • City Outpatient Dept #94
  • St. Petersburg, Russian Federation, 195271
    • SHI Ctr Occupational Pathology
  • St. Petersburg, Russian Federation, 194354
    • St-Petersburg Diagnostic Ctr#1; Pulmonology
  • St. Petersburg, Russian Federation, 197022
    • St. Petersburg State Budget Medical Institution Pokrovskaya City Hospital
  • Tomsk, Russian Federation, 634063
    • Tomsk Regional Clinical Hospital
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Center of Serbia
  • Belgrade, Serbia, 11000
    • Clinical Hospital Center Zvezdara
  • Belgrade, Serbia, 11080
    • Clinical Hospital Center ''Bezanijska Kosa''; Department of Pulmology
• Slovakia
  • Bardejov, Slovakia, 08501
    • ALIAN s.r.o.
  • Bratislava, Slovakia, 831 03
    • Tehelná Clinic, Inc; IMUNO-ALERGO, s. r.o.
  • Spisska Nova Ves, Slovakia, 052 01
    • Plucna ambulancia
• South Africa
  • Cape Town, South Africa, 7925
    • Uni of Cape Town Lung Inst.
  • Cape Town, South Africa, 7764
    • Melomed Hospital Gatesville
  • Durban, South Africa, 4091
    • Vawda Z.Fa Practice
  • Gatesville, South Africa, 7746
    • Gatesville Medical Centre
  • Johannesburg, South Africa, 1820
    • Deepak Lakha MBCHB Private Practice
  • Pretoria, South Africa, 0101
    • Botho Ke Bontle Health Services
  • Pretoria, South Africa, 84
    • Dr Johannes Breedt; Emmed Research
• Spain
  • Barcelona, Spain, 08916
    • Hospital Germans Trias i Pujol
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu; i Sant Pau
  • Madrid, Spain, 28922
    • Hosp Univ Fundacion Alcorcon
  • Sevilla, Spain, 41013
    • Hospital Virgen del Rocio
  • Valencia, Spain, 46017
    • Hospital Universitario Doctor Peset
  • Alava
    • Vitoria, Alava, Spain, 01004
      • Hospital Universitario Araba
• Turkey
  • Ankara, Turkey, 06290
    • Atatürk Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi
  • Ankara, Turkey, 06510
    • Turgut Ozal Universitesi Tip Fakultesi Bestepe Hastanesi
  • Bursa, Turkey, 16059
    • Uludag University; Pulmonology and Allergy Department
  • Canakkale, Turkey, 17110
    • Canakkale Onsekiz Mart Universitesi Tip Fakultesi Hastanesi
  • Izmir, Turkey, 35100
    • Ege University Medical Faculty
  • Izmir, Turkey, 35110
    • Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
  • Kirikkale, Turkey, 71100
    • Kirikkale Universitesi Tip Fakultesi Hastanesi
  • Mersin, Turkey, 33169
    • Mersin University Medical Faculty
• Ukraine
  • Dnepropetrovsk, Ukraine, 49000
    • Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board
  • Donetsk, Ukraine, 83003
    • Educational Scientific Medical Centre of Donetsk National Medical University;
  • Ivano-Frankivsk, Ukraine, 76018
    • Regional Phthisiology and Pulmonology Center
  • Kharkiv, Ukraine, 61002
    • City Clinical Hospital #27
  • Kharkiv, Ukraine, 61007
    • Medical and Sanitary Unit of OJSC "Kharkiv Tractor Plant n.a. Ordzhonikidze"; Department of Therapy
  • Kyiv, Ukraine, 04107
    • Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
  • Kyiv, Ukraine, 03680
    • Yanovskyy Inst of Phth. & Pulm; Clinical-functional
  • Kyiv, Ukraine, 04201
    • Kyiv City Clinical Hospital #8
  • Kyiv, Ukraine, 02232
    • Central Outpatient Hospital of Desnyansky District
  • Lviv, Ukraine, 79010
    • Danylo Halytskyy National Medical University; Lviv
  • Vinnytsya, Ukraine, 21001
    • Small Business Private Enterprise Medical Centre Pulse
  • Yevpatoriya, Ukraine, 97403
    • Municipal Institution of Health Care "Yevpatoriya City Hospital №1
  • Zaporizhzhia, Ukraine, 69104
    • SI Dept. Clin. Hospital of Zaporizhzhia-2 Railway Station of SE Prydniprovska Zaliznytsia
• United Kingdom
  • Chertsey, United Kingdom, KT16 0PZ
    • St Peters Hospital
  • Cottingham, United Kingdom, HU16 5JQ
    • Castle Hill Hospital; Respiratory Medicine
  • Dundee, United Kingdom, DD1 9SY
    • Ninewells Hospital; Asthma and Allergy Research Group
  • Leeds, United Kingdom, LS9 7TF
    • St James University Hospital; Respiratory Department
  • Teesside, United Kingdom, TS27
    • University North Tees
• United States
  • Alabama
    • Pell City, Alabama, United States, 35128
      • Alabama Clinical Research Associates
  • Arizona
    • Flagstaff, Arizona, United States, 86001
      • Clinical Trial Connection
    • Tucson, Arizona, United States, 85710
      • Desert Sun Clinical Research LLC
  • California
    • Fountain Valley, California, United States, 92708
      • Allianz Medical and Research Center
    • Long Beach, California, United States, 90813
      • Alliance Research LLC
    • Long Beach, California, United States, 90808
      • Allergy & Asthma Medical Group & Research Center, Pc
    • Los Angeles, California, United States, 90025
      • Allergy Medical Clinic
    • Los Angeles, California, United States, 90025
      • CA Allergy & Asthma Med Grp
    • Napa, California, United States, 94558
      • North Bay Clinical Trials
    • Orange, California, United States, 92868
      • Choc Psf, Amc
    • Rancho Mirage, California, United States, 92270
      • Advances in Medicine
    • San Diego, California, United States, 92108
      • Allergy Assoc Medical Group
    • San Francisco, California, United States
      • UCSF School of Medicine
    • Stockton, California, United States, 95207
      • Bensch Research Associates
  • Colorado
    • Centennial, Colorado, United States, 80112
      • IMMUNOe International Research Centers
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Waterbury Pulmonary Associates
  • Florida
    • Clearwater, Florida, United States, 33765
      • St. Francis Sleep; Allergy & Lung Institute
    • DeLand, Florida, United States, 32720
      • Creekside Medical Research
    • Miami, Florida, United States, 33135
      • Suncoast Research Group LLC
    • Miami, Florida, United States, 33165
      • South Florida Research Phase I-IV, Inc
    • Ocala, Florida, United States, 34471
      • Allergy & Asthma Care of FL; Clinical Research
    • Panama City, Florida, United States, 32405
      • Emerald Coast Research Associates
    • Tallahassee, Florida, United States, 32308
      • Allergy & Asthma Diagnostic; Treatment Center
    • Winter Park, Florida, United States, 32789
      • Florida Pulmonary Research Institute, LLC
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Southeastern Lung Care
    • Woodstock, Georgia, United States, 30188
      • Atlanta Allergy & Asthma Clini
  • Indiana
    • Michigan City, Indiana, United States, 46360
      • LaPorte County Institute for Clinical Research
  • Iowa
    • Iowa City, Iowa, United States, 52240
      • Iowa Clinical Research Corporation
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • Northeast Medical Research Associates, Inc
  • Michigan
    • Grand Rapids, Michigan, United States, 49525
      • Infusion Associates
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Midwest Clinical Research LLC
    • Saint Louis, Missouri, United States, 63141
      • Washington Univ. School of Med
  • Montana
    • Missoula, Montana, United States, 59808
      • Montana Medical Research LLC
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Heartland Clinical Research Inc.
    • Papillion, Nebraska, United States, 68046
      • Asthma & Allergy Center, P.C.
  • Nevada
    • Las Vegas, Nevada, United States, 89104
      • Allergy & Asthma Associates
  • New Jersey
    • Mount Laurel, New Jersey, United States, 08054
      • Allergy & Asthma Research of Nj, Inc
    • Ocean City, New Jersey, United States, 07712
      • Atlantic Research Center, LLC
    • Skillman, New Jersey, United States, 08558
      • Princeton Center for Clinical Research
  • New York
    • New Hyde Park, New York, United States, 11042
      • North Shore University Hosp
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Allergy & Asthma Center of NC
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington
  • Ohio
    • Toledo, Ohio, United States, 43617
      • Asthma & Allergy Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Oklahoma City, Oklahoma, United States, 73103
      • COR Clinical Research
  • Oregon
    • Eugene, Oregon, United States, 97401-7721
      • Allergy & Asthma Research Grp
    • Medford, Oregon, United States, 97504
      • Clinical Research Inst. of Southern Oregon, PC
    • Portland, Oregon, United States, 97202
      • Allergy Associates Research Center
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16601
      • Central PA Asth & Allergy Care; Research Division
    • Philadelphia, Pennsylvania, United States, 19107
      • Asthma Allergy Pulm Associates
    • Sellersville, Pennsylvania, United States, 18960
      • Grand View Hospital; Clinical Research Department
  • Rhode Island
    • Lincoln, Rhode Island, United States, 02865
      • Asthma Allergy Phys of RI
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • ADAC Research PA
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Research
  • Texas
    • Austin, Texas, United States, 78717
      • Tekton Research Inc
    • Boerne, Texas, United States, 78006
      • TTS research
    • Dallas, Texas, United States, 75231
      • Pharmaceutical Research & Consulting, Inc.
    • El Paso, Texas, United States, 79925
      • Allergy & Asthma Research Center of El Paso
    • Houston, Texas, United States, 77008
      • Pioneer Research Solutions
    • McKinney, Texas, United States, 75069
      • Metroplex Pulmonology & Sleep Center
    • San Antonio, Texas, United States, 78205
      • Quality Assurance Research Ctr
  • Virginia
    • Fairfax, Virginia, United States, 22030
      • O & O Alpan, LLC
    • Henrico, Virginia, United States, 23233
      • Clinical Research Partners, LLC
    • Manassas, Virginia, United States, 20110
      • Manassas Clinical Research Center
  • Washington
    • Bellingham, Washington, United States, 98225
      • Bellingham Asthma, Allergy & Immunology
    • Seattle, Washington, United States, 98105
      • ASTHMA, Inc
    • Spokane, Washington, United States, 99204
      • Marycliff Allergy Specialists
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • Dean Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Asthma diagnosis for greater than equal to (>/=) 12 months prior to 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 micrograms (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 infection that required treatment with oral antibiotics within 2 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lebrikizumab (37.5 mg); Participants will receive SC injection of lebrikizumab (37.5 mg) every 4 weeks for 104 weeks.	Drug: Lebrikizumab; Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.; Other Names: RO5490255; Drug: Placebo; Lebrikizumab matching placebo will be administered as SC injection every 4 weeks for 52 weeks.
Placebo Comparator: Placebo; Participants will receive SC injection of lebrikizumab matching placebo every 4 weeks for 52 weeks during placebo-controlled period and then SC injection of lebrikizumab at 125 or 37.5 mg for 52 weeks during active treatment extension period.	Drug: Lebrikizumab; Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.; Other Names: RO5490255; Drug: Placebo; Lebrikizumab matching placebo will be administered as SC injection every 4 weeks for 52 weeks.
Experimental: Lebrikizumab (125 mg); Participants will receive SC injection of lebrikizumab (125 milligrams [mg]) every 4 weeks for 104 weeks.	Drug: Lebrikizumab; Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.; Other Names: RO5490255

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of Asthma Exacerbations During the 52-Week Placebo-Controlled Period	Baseline up to 52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	Baseline, Week 52
Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ) Score	Baseline, Week 52
Change from Baseline In Asthma Rescue Medication (Number of Puffs or Nebulized Treatments)	Baseline, Week 52
Rate of Urgent Asthma-Related Urgent Health Care Utilization	Baseline up to Week 52
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)
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score	Baseline, Week 52
Minimum Serum Concentration (Cmin) of Lebrikizumab	Predose (0 hour) on Weeks 4, 12, 24, 36, and 52
Time to First Asthma Exacerbation	Baseline up to 52 weeks
Percentage of Participants With Adverse Events	Baseline, Week 124

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• Chen M, Shepard K 2nd, Yang M, Raut P, Pazwash H, Holweg CTJ, Choo E. Overlap of allergic, eosinophilic and type 2 inflammatory subtypes in moderate-to-severe asthma. Clin Exp Allergy. 2021 Apr;51(4):546-555. doi: 10.1111/cea.13790. Epub 2021 Jan 7.
• N Bauer R, Yang X, L Staton T, Olsson J, Holweg CTJ, R Arron J, Matthews JG, Choy DF. Seasonal variability of lung function and Asthma Quality of Life Questionnaire Scores in adults with uncontrolled asthma. BMJ Open Respir Res. 2019 Nov 11;6(1):e000406. doi: 10.1136/bmjresp-2019-000406. eCollection 2019.
• Hanania NA, Korenblat P, Chapman KR, Bateman ED, Kopecky P, Paggiaro P, Yokoyama A, Olsson J, Gray S, Holweg CT, Eisner M, Asare C, Fischer SK, Peng K, Putnam WS, Matthews JG. Efficacy and safety of lebrikizumab in patients with uncontrolled asthma (LAVOLTA I and LAVOLTA II): replicate, phase 3, randomised, double-blind, placebo-controlled trials. Lancet Respir Med. 2016 Oct;4(10):781-796. doi: 10.1016/S2213-2600(16)30265-X. Epub 2016 Sep 5.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2013
• Primary Completion (Actual): January 2, 2017
• Study Completion (Actual): January 2, 2017

Study Registration Dates

• First Submitted: May 29, 2013
• First Submitted That Met QC Criteria: May 29, 2013
• First Posted (Estimate): June 3, 2013

Study Record Updates

• Last Update Posted (Actual): May 19, 2017
• Last Update Submitted That Met QC Criteria: May 18, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: GB28688; 2013-000175-33 (EudraCT Number)