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, B7602DCK
    • Instituto Ave Pulmo
  • Quilmes, Argentina, B1878FNR
    • Centro Respiratorio Quilmes
  • San Miguel de Tucumán, Argentina, T4000IAR
    • Investigaciones en Patologias Respiratorias
• Australia
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital; Eastern Clinical Research Unit
    • Footscray, Victoria, Australia, 3011
      • Footscray Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • The Lung Institute of Western Australia; Sir Charles Gairdner Hospital
• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires St-Luc
  • Ghent, Belgium, 9000
    • UZ Gent
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 3A9
      • Inspiration Research
    • Toronto, Ontario, Canada, M9V4B4
      • Albion Finch Medical Centre
  • Quebec
    • Trois-Rivières, Quebec, Canada, G8T 7A1
      • C.I.C. Mauricie
• Chile
  • Santiago, Chile, 7500692
    • Centro de Investigaciones Medicas Respiratorias
  • Santiago, Chile, 7500698
    • Schonffeldt y Guerrero Limitada
• Colombia
  • Bogota DC, Colombia, 11001
    • Fundacion Neumologica Colombiana
• Czechia
  • Jablonec nad Nisou, Czechia, 466 01
    • Alergopraktik s.r.o.
  • Jindřichův 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
  • Montpellier, France, 34295
    • Hopital Arnaud de Villeneuve
  • Nantes, France, 44093
    • CHU Nantes - Hôpital Laennec; Service de Pneumologie
  • Strasbourg, France, 67091
    • Nouvel Hopital Civil; Pole de Pathologie Thoracique
• Hungary
  • Debrecen, Hungary, 4031
    • Kenezy Korhaz Rendelointezet
  • Győr, Hungary, 9024
    • Petz Aladar Megyei Oktato Korhaz
  • 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, 9103102
    • Shaare Zedek Medical Center
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center; Pulmonary Dept
  • Rehovot, Israel, 7610001
    • Kaplan Medical Center
• Italy
  • Calabria
    • Catanzaro, Calabria, Italy, 88100
      • Azienda Ospedaliera Mater Domini Di Catanzaro
  • Tuscany
    • Pisa, Tuscany, Italy, 56124
      • Università Degli Studi di Pisa - Ospedale di Cisanello Pisa
• Japan
  • Aichi, Japan, 489-8642
    • Tosei General Hospital; Respiratory and Allergy Medicine
  • Fukuoka, Japan, 815-8588
    • Kyushu Central Hospital
  • Higashiibaraki-gun, Japan, 311-3193
    • National Hospital Organization Mito Medical Center
  • Hokkaido, Japan, 070-8644
    • National Hospital Organization Asahikawa Medical Center
  • Hokkaido, Japan, 053-8506
    • Oji General 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
  • Mizunami-shi, Japan, 509-6134
    • Tono Chuo Clinic
  • Nagaoka-shi, Japan, 940-2085
    • Nagaoka Red Cross Hospital
  • Niigata, Japan, 950-11977
    • Niigata City General Hospital
  • Numakunai, Japan, 028-3695
    • Iwate Medical University Hospital
  • Osaka, Japan, 545-8586
    • Osaka Metropolitan University Hospital
  • Sapporo, Japan, 062-8618
    • Japan Community Health Care Organization Hokkaido Hospital
  • Tokyo, Japan, 142-8666
    • Showa 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 City, Japan, 171-0014
    • Sekino Hospital
  • Yoshida-gun, Japan, 910-1193
    • University of Fukui Hospital
  • Ōta-ku, Japan, 145-0063
    • Senzoku Kokyuuki and Allergy Clinic
• Mexico
  • Zapopan, Mexico, 45200
    • Hospital Dr Angel Leaño universidad Autonoma de Guadalajara AC
  • Jalisco
    • Santa Cecilia, Jalisco, Mexico, 44700
      • Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
• New Zealand
  • Auckland, New Zealand, 1051
    • NZ Respiratory & Sleep Institute
  • Dunedin, New Zealand
    • Dunedin Hospital
  • Dunedin, New Zealand
    • RMC Medical Research Ltd
  • Hastings, New Zealand, 4122
    • P3 Research
• Poland
  • Bialystok, Poland, 15-003
    • Centrum Medycyny Oddechowej Robert M. Mróz
  • Krakow, Poland, 31-023
    • Grazyna Pulka Specjalistyczny Osrodek ALL-MED
  • Krakow, Poland, 31-637
    • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.
  • Krakow, 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
    • Anna Bogusz Gabinet Alergologiczny
  • Warsaw, Poland, 01-868
    • Medica Pro Familia Sp. z o.o. S.K.A.
  • Warsaw, Poland, 02-507
    • Klinika Chorób Wewnetrznych i Alergologii MSW
  • 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
  • Timișoara, Romania, 300310
    • Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital
• Russia
  • Kemerovo, Russia, 650002
    • SIH Kemerovo Regional Clinical Hospital
  • Moscow, Russia, 117292
    • Russian Uni of People'S Friendship, Med. Faculty; City Clinical Hospital No 64, Internal Diseases
  • Moscow, Russia, 125367
    • Central Clinical Hospital #1 of RZhD JCS
  • Novosibirsk, Russia, 630008
    • Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2
  • Saint Petersburg, Russia, 193231
    • City Outpatient Dept #94
  • Saint Petersburg, Russia, 194354
    • St-Petersburg Diagnostic Ctr#1; Pulmonology
  • Saint Petersburg, Russia, 197022
    • St. Petersburg State Budget Medical Institution Pokrovskaya City Hospital
  • Saint Petersburg, Russia, 197022
    • St.-Petersburg SMU n. a. Academician I.P.Pavlov; Therapy Department
  • Smolensk, Russia, 4812
    • Smolensk State Medical Academy
  • Tomsk, Russia, 634063
    • Tomsk Regional Clinical Hospital
  • Ryazan Oblast
    • Ryazan, Ryazan Oblast, Russia, 390039
      • Ryazan Regional Clinical Hosp
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 194354
      • LLC Medical Center Reavita Med SPb
    • Saint Petersburg, Sankt-Peterburg, Russia, 195271
      • SHI Ctr Occupational Pathology
• Serbia
  • Belgrade, Serbia, 11080
    • Clinical Hospital Center ''Bezanijska Kosa''; Department of Pulmology
• Slovakia
  • Bardejov, Slovakia, 085 01
    • Alian s.r.o.
  • Bratislava, Slovakia, 831 03
    • Tehelná Clinic, Inc; IMUNO-ALERGO, s. r.o.
  • Spišská Nová 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
• South Korea
  • Seongnam-si, South Korea, 463-707
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 08308
    • Korea University Guro Hospital
  • Seoul, South Korea, 130-709
    • St. Paul's Hospital, The Catholic University of Korea, College of Medicine
• 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
  • Valencia, Spain, 46017
    • Hospital Universitario Doctor Peset
  • Alava
    • Vitoria-Gasteiz, Alava, Spain, 01004
      • Hospital Universitario Araba
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06290
    • Atatürk Gö?üs Hastal?klar? ve Gö?üs Cerrahisi E?itim ve Ara?t?rma Hastanesi
  • Bursa, Turkey (Türkiye), 16059
    • Uludag University; Pulmonology and Allergy Department
  • Izmir, Turkey (Türkiye), 35110
    • Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
  • Kirikkale, Turkey (Türkiye), 71100
    • Kirikkale Universitesi Tip Fakultesi Hastanesi
  • Mersin, Turkey (Türkiye), 33169
    • Mersin University Medical Faculty
• Ukraine
  • Dnipro, Ukraine, 49000
    • Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board
  • Ivano-Frankivsk, Ukraine, 76018
    • Regional Phthisiology and Pulmonology Center
  • Kharkiv, Ukraine, 61002
    • City Clinical Hospital #27
  • 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
  • Vinnytsia, Ukraine, 21001
    • Small Business Private Enterprise Medical Centre Pulse
  • Zaporizhzhia, Ukraine, 69104
    • Non-Commercial Enterprise City Clinical Hospital 1 of Zaporizhzhia City Council
• United Kingdom
  • Chertsey, United Kingdom, KT16 0PZ
    • St Peters Hospital
  • Cottingham, United Kingdom, HU16 5JQ
    • Castle Hill Hospital; Respiratory Medicine
  • Leeds, United Kingdom, LS9 7TF
    • St James University Hospital; Respiratory Department
• United States
  • Alabama
    • Pell City, Alabama, United States, 35128
      • Alabama Clinical Research Associates
  • Arizona
    • 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, 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
    • Stockton, California, United States, 95207
      • Bensch Research Associates
  • Colorado
    • Centennial, Colorado, United States, 80112
      • IMMUNOe Research Centers
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Waterbury Pulmonary Associates
  • Florida
    • Clearwater, Florida, United States, 33765
      • St. Francis Sleep; Allergy & Lung Institute
    • Miami, Florida, United States, 33135
      • Suncoast Research Group LLC
    • 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
    • Woodstock, Georgia, United States, 30188
      • Atlanta Allergy & Asthma Clini
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • Northeast Medical Research Associates, Inc
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Midwest Clinical Research LLC
  • 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
    • 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, 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 LLC - CRN
  • Pennsylvania
    • 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, 78745
      • Tekton Research Inc
    • Boerne, Texas, United States, 78006
      • TTS Research
    • Dallas, Texas, United States, 75231
      • Pharmaceutical Research & Consulting, Inc.
    • Houston, Texas, United States, 077099
      • 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
    • Manassas, Virginia, United States, 20110
      • Manassas Clinical Research Center
    • Richmond, Virginia, United States, 23220
      • Clinical Research Partners, LLC
  • Washington
    • Bellingham, Washington, United States, 98225
      • Bellingham Asthma, Allergy & Immunology
    • Seattle, Washington, United States, 98105
      • ASTHMA, Inc
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

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

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	Measure Description	Time Frame
Adjusted Exacerbation Rate of Asthma During the 52-Week PCP	Asthma exacerbation is defined as new or increased asthma symptoms (i.e., wheeze, cough, dyspnea, chest tightness, and/or night-time awakening due to these symptoms) that lead to systemic corticosteroid (CS) treatment (oral, intravenous (IV), or intramuscular (IM) CS for ≥ 3 days or an emergency department visit with at least one dose of IV or IM CS) or to hospitalization. Results are reported as a 'Number' representing the model-adjusted incidence rate of asthma exacerbations per person-year. To account for early discontinuation, for each patient, the time at risk (in years) was computed as the duration of this time period (last day minus first day [in days] plus 1) divided by 365.25. The 'first day' was the day of randomization to the PCP. For patients entering the ATE, the 'last day' was the day prior to ATE randomization. For patients not entering the ATE, the 'last day' was at the last study visit on/prior to Study Day 379 (365 days plus a 14-day window).	Baseline up to 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 52	FEV1 is the maximal amount of air, which can be forcefully exhaled in one second. Measurements were performed before use of bronchodilator. Reported is the absolute change from baseline in FEV1 to the end of the placebo-controlled period at Week 52.	Week 52
Time to First Asthma Exacerbation During the 52-week PCP	An asthma exacerbation is defined as new or increased asthma symptoms (including wheeze, cough, dyspnea, chest tightness, and/or night-time awakening due to these symptoms) that lead to treatment with systemic corticosteroids or to hospitalisation. Treatment with systemic corticosteroids is defined as treatment with oral, intravenous (IV), or intramuscular (IM) corticosteroids for at least 3 days or an emergency department visit with at least one dose of IV or IM corticosteroids. Reported is the time to first asthma exacerbation during the 52-week placebo-controlled period.	Baseline up to 52 weeks
Rate of Urgent Asthma-Related Health Care Utilization (HCU) During the 52-week PCP	Urgent health care utilization was defined as hospitalizations, emergency department visits, and acute care visits. Results are reported as a 'Number' representing the model-adjusted incidence rate of urgent asthma-related HCU events per person-year. To account for early discontinuation, for each patient, the time at risk (in years) was computed as the duration of this time period (last day minus first day [in days] plus 1) divided by 365.25. The 'first day' was the day of randomization to the PCP. For patients entering the ATE, the 'last day' was the day prior to ATE randomization. For patients not entering the ATE, the 'last day' was at the last study visit on/prior to Study Day 379 (365 days plus a 14-day window).	Baseline up to Week 52
Absolute Change From Baseline in Standardized AQLQ Score at Week 52	Asthma-specific health-related quality of life was assessed by the overall score of the Standardized AQLQ. The AQLQ is a self-administered test with 32 questions; each with seven possible answers ranging from 1 to 7 with a higher score being more favorable. Total score is calculated as follows: sum of items 1to 32 divided by 32 for a score range of 1 to 7 with a higher score indicating a better outcome. Reported is the change in AQLQ score from baseline to the end of the placebo-controlled period at Week 52.	Week 52
Absolute Change From Baseline In Asthma Rescue Medication Use at Week 52	Reported here is the change in the number of puffs or nebulized treatments of asthma rescue medication from baseline to the end of the PCP at Week 52.	Week 52
Absolute Change From Baseline in ACQ-5 Score at Week 52	The ACQ-5 is test with 5 questions; each with seven possible answers ranging from 0 to 6 with a lower score being more favorable. Total score range is 0 to 30 with a lower score indicating a better outcome. Reported is the change in ACQ-5 score from baseline to the end of the PCP at Week 52.	Baseline, Week 52

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Lebrikizumab	The safety population included all participants who received at least one dose of study medication.	Baseline up to Week 124 (assessed at Baseline, Weeks 4, 12, 24, 36, 52 and safety follow-up [20 weeks] or end of study)
Percentage of Participants With Adverse Events (AEs)	An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. The safety population included all participants who received at least one dose of study medication.	Baseline up to Week 52 for Placebo arm. Week 53 to Week 104 for PBO/Lebrikizumab crossover arms. Baseline up to Week 104 for Lebrikizumab-only arms.
Minimum Serum Concentration (Cmin) of Lebrikizumab		Predose (0 hour) at Weeks 4, 12, 24, 36, and 52

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, 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.
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Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2013
• Primary Completion (Actual): December 28, 2016
• Study Completion (Actual): December 28, 2016

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: June 19, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

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