A Study of Lebrikizumab in Participants With Uncontrolled Asthma 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 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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 1068
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, B7600FZN
    • Instituto de Investigaciones Clinicas-Mar del Plata
  • Buenos Aires, Argentina, C1125 ABE
    • Fundacion Cidea
  • Rosario, Argentina, 2000
    • Centro Respiratorio Infantil
  • San Miguel de Tucuman, Argentina, 4000
    • Centro Modelo de Cardiologia
  • Vicente López, Argentina, B1602DQD
    • CEMER Centro Medico de Enfermedades Respiratorias
• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital; Department Thoracic Medicine
  • Queensland
    • Brisbane, Queensland, Australia, 4075
      • Austrials
    • Brisbane, Queensland, Australia, 4102
      • Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine
  • South Australia
    • Toorak Gardens, South Australia, Australia, 5065
      • Respiratory Clinical Trials Pty Ltd
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • The Lung Institute of Western Australia; Sir Charles Gairdner Hospital
• Belgium
  • Jambes, Belgium, 5100
    • Private Practice
  • Leuven, Belgium, 3000
    • UZ Leuven Gasthuisberg
• Bulgaria
  • Ruse, Bulgaria, 7002
    • Specialized Hospital for Active Treatment for pneumo-phtysiatric diseases
  • Smolyan, Bulgaria, 4700
    • Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
  • Sofia, Bulgaria, 1233
    • National Multiprofile Hospital Tsar Boris III
  • Sofia, Bulgaria, 1618
    • Alitera - Med - Medical Center EOOD
  • Sofia, Bulgaria, 1233
    • 5TH MHAT; Pulmonology
  • Sofia, Bulgaria, 1431
    • Medical Center for Specialized Outpatient Medical Care for Pulmonary Diseases
  • Sofia, Bulgaria, 1431
    • SHATPD Sveta Sofia; Clin Pulmonary Diseases
  • Stara Zagora, Bulgaria, 6003
    • Multiprofile Hospital For Active Treatment prof Kirkovich
  • Varna, Bulgaria, 9020
    • Diagnostic and Consulting Centre Mladost - M OOD
  • Veliko Tarnovo, Bulgaria, 5000
    • Medical Center Tara OOD
• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L5A 3V4
      • Cheema Research, Inc
    • Ottawa, Ontario, Canada, K1Y 4G2
      • Ottawa Allergy Research Corp
    • Toronto, Ontario, Canada, M9W 4L6
      • Manna Research
    • Windsor, Ontario, Canada, N8X-5A6
      • Dr Anil Dhar Professional Medicine Corporation
  • Quebec
    • Montreal, Quebec, Canada, H3H 1T8
      • Del Carpio Jaime Dr - Allergiste & Immunologue
• Czechia
  • Hradec Kralove, Czechia, 500 05
    • Fakultni Nemocnice Hradec Kralove
  • Praha 4 - Krc, Czechia, 140 59
    • Thomayerova nemocnice
  • Strakonice, Czechia, 38601
    • Ordinace pro tuberkulozu a respiracni nemoci
  • Tabor, Czechia, 390 01
    • KASMED, s.r.o.; Alergologie a klinicka imunologie
• France
  • Le Kremlin-bicêtre, France, 94275
    • Centre Hospitalier Universitaire de Bicêtre
  • Lyon, France, 69004
    • Hôpital de La Croix Rousse
  • Paris, France, 75877
    • Hopital Bichat Claude Bernard ; Service de Pneumologie
  • Paris, France, 75014
    • Groupe Hospitalier Cochin St Vincent de Paul La Roche Guyon
• Germany
  • Frankfurt am Main, Germany, 60596
    • Medaimun GmbH
  • Großhansdorf, Germany, 22927
    • Pneumologisches Forschungsinstitut
  • Marburg, Germany, 35037
    • Praxis Dr. med. Hermann A. Trauth
• Hungary
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika
  • Komárom, Hungary, 2900
    • Selye János Kórház és Rendelőintézet; Allergológiai Szakrendelés
  • Szombathely, Hungary, 9700
    • Markusovszky Egyetemi Oktatókórház
• Israel
  • Haifa, Israel, 31096
    • Rambam Health Care Campus
  • Jerusalem, Israel, 9112001
    • Hadassah Medical Center; Pulmonary Institute
  • Nazareth, Israel, 16100
    • Nazareth EMMS Hospital
  • Petach Tikva, Israel, 49100
    • Rabin Medical Center
  • Ramat Gan, Israel, 5262100
    • Chaim Sheba Medical Center; Oncology Dept
• Italy
  • Campania
    • Napoli, Campania, Italy, 80131
      • Azienda Ospedaliera Monaldi
  • Emilia-Romagna
    • Modena, Emilia-Romagna, Italy, 41100
      • Azienda ospedaliera universitaria di Modena
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Università Cattolica del Sacro Cuore UOC Allergologia- Policlinico Gemelli
  • Lombardia
    • Milano, Lombardia, Italy, 20142
      • ASST Santi Paolo e Carlo
    • Pavia, Lombardia, Italy, 27100
      • Fondazione IRCCS Policlinico San Matteo di Pavia; S.S. Fisiopatologia Respiratoria
    • Sesto San Giovanni, Lombardia, Italy, 20099
      • P.O. Citta' Di Sesto S. Giovanni
  • Sicilia
    • Catania, Sicilia, Italy, 95123
      • Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia
• Japan
  • Aichi, Japan, 454-8509
    • Banbuntane Hotokukai Hospital
  • Fukuoka, Japan, 811-1394
    • Fukuoka National Hospital
  • Hiroshima, Japan, 732-0052
    • Hiroshima Allegy & Respiratory Clinic
  • Ibaraki, Japan, 319-1113
    • Ibarakihigashi National Hospital
  • Isesaki-shi, Japan, 372-0831
    • Uno Naikakokyukika Clinic
  • Kanagawa, Japan, 232-0024
    • Yokohama City University Medical Center; Neurology
  • Kanagawa, Japan, 252-0392
    • Sagamihara National Hospital
  • Koshi-shi, Japan, 861-1196
    • Kumamoto Saishunso National Hospital
  • Kumamoto, Japan, 860-8556
    • Kumamoto University Hospital
  • Kyoto, Japan, 606-8507
    • Kyoto University Hospital, Respiratory Medicine
  • Machida-shi, Japan, 194-0023
    • Machida Municipal Hospital
  • Miyagi, Japan, 983-0833
    • Hikarigaoka Spellman Hospital; Rheumatology
  • Nagoya-shi, Japan, 454-8502
    • Nagoya Ekisaikai Hospital
  • Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Osaka, Japan, 569-1096
    • Takatsuki Red Cross Hospital; Division of Diabetes / Endocrinology / Lifestyle-Related Disease
  • Osaka, Japan, 589-8511
    • Kinki University Hospital
  • Osaka, Japan, 596-8501
    • Kishiwada City Hospital
  • Sendai-shi, Japan, 984-8560
    • Tohoku Medical and Pharmaceutical University Wakabayashi Hospital
  • Shizuoka, Japan, 438-8550
    • Iwata City Hospital
  • Takamatsu-shi, Japan, 760-8538
    • Takamatsu Municipal Hospital
  • Tokyo, Japan, 103-0027
    • Tokyo-Eki Center-building Clinic
  • Tokyo, Japan, 162-8655
    • Center Hospital of the National Center for Global Health and Medicine
  • Tokyo, Japan, 173-8610
    • Nihon University Itabashi Hospital
  • Tokyo, Japan, 102-0083
    • Hanzomon Hospital
  • Toyama, Japan, 939-8511
    • Toyama City Hospital
• Korea, Republic of
  • Gwangju, Korea, Republic of, 61469
    • Chonnam National University Hospital
  • Gyeonggi-do, Korea, Republic of, 14584
    • SoonChunHyang University Bucheon Hospital
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 06591
    • Seoul St Mary's Hospital
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital; Division of Allergy and Clinical Immunology
  • Seoul, Korea, Republic of, 158-050
    • Ewha womans university medical center
• Mexico
  • Guadalajara, Mexico, 44130
    • Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
  • Monterrey, Mexico, 64718
    • Unidad de Investigacion Clinica En Medicina (Udicem) S.C.
  • Villahermosa, Mexico, 86035
    • Consultorio Especialidad Alergologia Pediatrica
• New Zealand
  • Auckland, New Zealand, 1051
    • Greenlane Clinical Centre
  • Christchurch, New Zealand, 8011
    • Canterbury Respiratory Research Group; Respiratory
  • Tauranga, New Zealand, 3110
    • P3 Research
  • Wellington, New Zealand
    • Medical Research Inst. of New Zealand; Respiratory
• Peru
  • Cusco, Peru, Cusco 84
    • Hospital Nacional Adolfo; Guevara Velasco Essalud
  • Lima, Peru, Lima 41
    • Clinica San Borja
  • Lima, Peru, Lima 1
    • Clinica Internacional
  • Lima, Peru, Lima 32
    • Instituto Peruano de Investigacion en Ciencias Medicas
  • Lima, Peru, Lima 11
    • Hospital Nacional Luis N Saenz PNP
  • Lima, Peru, Lima 21
    • ABK Reuma SRL- Medicentro BioCiencias
  • Lima, Peru, LIMA 27
    • Centro de Investigacion Ricardo Palma
  • Lima, Peru, Lima 33
    • Clinica San Pablo
  • Miraflores, Peru, Lima 18
    • Clinica los Andes
• Poland
  • Bieńnkówka, Poland, 34-212
    • SP ZOZ Bienkowka- Osrodek Zdrowia w Bienkowce
  • Krakow, Poland, 31-159
    • Grażyna Jasieniak-Pinis ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne
  • Lodz, Poland, 90-153
    • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
  • Ostrow Wielkopolski, Poland, 63-400
    • Specjalistyczna Poradnia Pulmonologiczna
  • Pila, Poland, 64-920
    • Niepubliczny Zespol Poradni Specjalistycznych PULS Poradnia Chorob Pluc i Gruzlic
  • Radom, Poland, 26-600
    • ABC-PULMO Poradnia Chorob Pluc
  • Ruda Śląska, Poland, 41-707
    • Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala
  • Skierniewice, Poland, 96-100
    • Centrum Medyczne Ogrodowa
  • Tarnow, Poland, 33-100
    • Alergo Medical Specjalistyczna Przychodnia Lekarska
  • Wroclaw, Poland, 53-114
    • Lexmedica
  • Wroclaw, Poland, 54-239
    • NZOZ Lekarze Specjalisci
  • Wroclaw, Poland, 53-301
    • Dobrostan Gabinety Lekarskie
• Romania
  • Cluj-Napoca, Romania, 400371
    • Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca, Sectia Clinica Pneumologie I
  • Palazu Mare, Romania, 900002
    • Spitalul Clinic de Pneumoftiziologie Palazu Mare Constanta
  • Targu Mures, Romania, 540100
    • Targu Mures Clinical Emergency County Hospital
  • Timisoara, Romania, 300310
    • Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital
• Russian Federation
  • Moscow, Russian Federation, 115280
    • City Clinical Hospital #13
  • Moscow, Russian Federation, 115446
    • I.M. Sechenov Moscow State Medical University the Ministry of Health and Social Development of RF
  • Novosibirsk, Russian Federation, 630051
    • City Clinical Hospital #2
  • Penza, Russian Federation, 440026
    • Penza Regional Clinical Hospital Named After N. N. Burdenko; Therapy Department
  • Ryazan, Russian Federation, 390026
    • Ryazan Regional Clinincal Cardiology Dispensary
  • Saratov, Russian Federation, 410012
    • Saratov State Medical Univ; Clinical Immun & Allerg
  • St Petersburg, Russian Federation, 193312
    • Municipal Polyclinic #25
  • St. Petersburg, Russian Federation, 197706
    • City Hospital #40 of Resort Administrative District
  • St. Petersburg, Russian Federation, 197089
    • St. Petersburg State Medical University n.a. I.P. Pavlov
  • St. Petersburg, Russian Federation, 197022
    • St.Petersburg State Budget Healthcare Institution City Hospital of Saint Venerable Martyr Elizabeth
  • Tomsk, Russian Federation, 634050
    • Siberian State Medical University
  • Yaroslavl, Russian Federation, 150002
    • Municipal Budgetery Clinical Institution of Healthcare; NA Semashko City Hospital
  • Yaroslavl, Russian Federation, 150010
    • Yaroslavl State Medical Academy - Clinical Hospital #2
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Center of Serbia
  • Sremska Kamenica, Serbia, 21204
    • Institute of Lung Diseases Vojvodina
  • Zemun, Serbia, 11080
    • Clinical Hospital Centre Zemun
• Slovakia
  • Bratislava, Slovakia, 821 06
    • Pneumo-Alergo Centrum s.r.o.
  • Levice, Slovakia, 934 01
    • ZAPA JJ Sro
  • Nitra, Slovakia, 949 01
    • Imunoalergologia Dzurilla s.r.o.
• South Africa
  • Cape Town, South Africa, 7530
    • Tiervalei Trial Centre
  • Cape Town, South Africa, 7505
    • Respiratory Research Unit
  • Durban, South Africa, 4001
    • St Augustines Hospital; Infectoilogy
  • Durban, South Africa, 4092
    • Dr Pj Sebastian
  • Tabazimbi, South Africa, 0380
    • Limpopo Clinical Research Initiative; Tamboti Medical Centre
  • Umkomaas, South Africa, 4170
    • Aliwal Shoal Medical Center
  • Worcester, South Africa, 6850
    • Clinical Projects Research
• Spain
  • Alicante, Spain, 03004
    • Instituto de Ciencias Médicas
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Girona, Spain, 17005
    • Institut Catala de Serveis Medics
  • Madrid, Spain, 28046
    • Hospital Universitario la Paz; Servicio de Alergologia
  • La Coruña
    • Santiago de Compostela, La Coruña, Spain, 15706
      • Complexo Hospitalario Universitario de Santiago CHUS - Hospital de Conxo
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología
  • Sevilla
    • Seville, Sevilla, Spain, 41071
      • Hospital Universitario Virgen Macarena
• Ukraine
  • Cherkasy, Ukraine, 18009
    • Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council
  • Dnipropetrovsk, Ukraine, 49006
    • MI Dnipropetrovsk clinical association of emergency care of Dnipropetrovsk regional council
  • Donetsk, Ukraine, 83114
    • Donetsk Municipal Treatment and Prophylactic Institution Central City Clinical Hospital #1
  • Kharkiv, Ukraine, 61039
    • SI Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine
  • Kharkiv, Ukraine, 61035
    • Municipal Institution of Health Care City Clinical Hospital #13
  • Kyiv, Ukraine, 03680
    • SI National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine
  • Mykolaiv, Ukraine, 54003
    • City Hospital #1
  • Odesa, Ukraine, 65025
    • Municipal Institution Odesa Regional Clinical Hospital
  • Poltava, Ukraine, 36038
    • City Clinical Hospital No.1; Therap Ukr Med Stom Acad
  • Vinnytsya, Ukraine, 21029
    • Scientific and Research Institute of Invalid Rehabilitation of Moh of Ukraine
  • Zaporizhzhia, Ukraine, 69106
    • LLC Diaservis
  • Zaporizhzhye, Ukraine, 69063
    • Municipal Institution Zaporizhzhia City Multifield Clinical Hospital #9
  • Kiev Governorate
    • Kyiv, Kiev Governorate, Ukraine, 02091
      • Kyiv City Tuberculosis Hospital #1; Department of Differential Diagnosis of Lung Diseases
• United Kingdom
  • Inverness, United Kingdom, IV2 3UV
    • Raigmore Hospital
  • Preston, United Kingdom, PR2 9HT
    • Royal Preston Hospital
  • Sheffield, United Kingdom, S10 2JF
    • Royal Hallamshire Hospital; Department of Oncology
  • Westbury-on-Trym, Bristol, United Kingdom, BS10 5NB
    • Southmead Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Clinical Research Center of Alabama, LLC
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Medical Research of Arizona; Allergy, Asthma & Immu
    • Tucson, Arizona, United States, 85712
      • Quality of Life Medical & Research Center
  • California
    • Bakersfield, California, United States, 93301
      • Kern Allergy Med Clinic, Inc.
    • Granada Hills, California, United States, 91344
      • Allergy and Asthma Relief Experts
    • Los Angeles, California, United States, 90048
      • Southern California Institute For Respiratory
    • Redwood City, California, United States, 94063
      • Allergy & Asthma Consultants
    • Upland, California, United States, 91786
      • Integrated Research Group Inc
    • Walnut Creek, California, United States, 94598
      • Allergy & Asthma Medical Group; Clinical Research Division
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Asthma & Allergy; Associates, P.C.
    • Colorado Springs, Colorado, United States, 80907
      • Storms Clinical Research; Institute
    • Denver, Colorado, United States, 80206
      • National Jewish Health
    • Denver, Colorado, United States, 80230
      • Colorado Allergy & Asthma Centers, PC
    • Wheat Ridge, Colorado, United States, 80033
      • Western States Clinical Research, Inc
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Allergy Consultants PA
    • Miami, Florida, United States, 33173
      • Research Institute of South Florida Inc
    • Sarasota, Florida, United States, 34239
      • Sarasota Clinical Research
  • Georgia
    • Albany, Georgia, United States, 31707
      • Georgia Pollens
    • Columbus, Georgia, United States, 31904
      • Southeast Regional Research Group
    • Columbus, Georgia, United States, 31904
      • Brookstone Clinical Res Ctr
    • Lawrenceville, Georgia, United States, 30045
      • DataQuest Medical Research
    • Savannah, Georgia, United States, 31406
      • Aeroallergy Research Labs
    • Woodstock, Georgia, United States, 30188
      • Atlanta Allergy & Asthma Clini
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • East-West Medical Research Institute
  • Idaho
    • Twin Falls, Idaho, United States, 83301
      • Asthma & Allergy of Idaho
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • The Allergy and Asthma Center
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Clinic; Stormont-Vail Hlth Care
  • Maine
    • Bangor, Maine, United States, 04401
      • Dr. Paul Shapero
  • Maryland
    • Baltimore, Maryland, United States, 21236
      • Asthma, Allergy & Sinus Center
    • Baltimore, Maryland, United States, 21236
      • Chesapeake Clinical Research
    • Columbia, Maryland, United States, 21044
      • Howard County Center for Lung and Sleep, LLC
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • Infinity Medical Research Inc
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Inst
  • Mississippi
    • Brockton, Mississippi, United States, 02301
      • Asthma and Allergy Physicians LLC
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Allergy Associates, Inc.
    • Kansas City, Missouri, United States, 64114
      • Center for Pharmaceutical Research
    • Saint Louis, Missouri, United States, 63141
      • Clinical Research Center, L.L.C.
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Clinical Research Consortium
  • New Jersey
    • Edison, New Jersey, United States, 08820
      • Adult Pediatric Allergy Central Jersey
    • Teaneck, New Jersey, United States, 07666
      • Patrick V. Perin, MD
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico; School of Med
  • New York
    • Mineola, New York, United States, 11501
      • Winthrop Univ Hospital
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Allergy Partners of Western NC
  • Ohio
    • Centerville, Ohio, United States, 45458
      • Allergy & Asthma Centre of Dayton
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Integrity People Services Research Company
    • Oklahoma City, Oklahoma, United States, 73131
      • Oklahoma Institute of Allergy and Asthma Clinical Research LLC
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clin Res Pc
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
    • Pittsburgh, Pennsylvania, United States, 15241
      • Allergy and Clinical Immunology Associates
    • Upland, Pennsylvania, United States, 19013
      • Asthma and Allergy Research Associates
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Neem Research Group, Inc.
    • Greenville, South Carolina, United States, 29615
      • Greenville Pharmaceutical Research
    • Greenville, South Carolina, United States, 29615
      • Upstate Pharmaceutical Research; Greenville
  • Texas
    • Austin, Texas, United States, 78756
      • Future Search Clinical Trials L.P.
    • Dallas, Texas, United States, 75230
      • Elliot J. Ginchansky, MD, PA
    • El Paso, Texas, United States, 79903
      • EPIMRD, Inc. DBA Western Sky Medical Research
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine; Dept of Medicine
    • Round Rock, Texas, United States, 78681
      • Allergy & Asthma Clin Cen TX
    • San Antonio, Texas, United States, 78229
      • Allergy & Asthma Research Center
    • San Antonio, Texas, United States, 78233
      • Live Oak Allergy & Asthma Clinic
    • San Antonio, Texas, United States, 78205
      • Quality Assurance Research Ctr
    • San Antonio, Texas, United States, 78224
      • Discovery Clinical Trials
  • Utah
    • Murray, Utah, United States, 84107
      • Allergy Associates of Utah
  • Virginia
    • Abingdon, Virginia, United States, 24210
      • Pulmonary Research of Albingdon
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin;Allergy & Asthma Clinical Research

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 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

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 (125 mg); Participants will receive SC injection of lebrikizumab (125 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
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
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.

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 Week 52

Secondary Outcome Measures

Outcome Measure	Time Frame
Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	Baseline, Week 52
Time to First Asthma Exacerbation	Baseline up to 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 Adverse Events	Baseline up to Week 124
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

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 30, 2013
• First Submitted That Met QC Criteria: May 30, 2013
• First Posted (Estimate): June 4, 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: GB28689; 2013-000176-15 (EudraCT Number)