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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,068

Participants

Timeline

Start Date

July 31, 2013

Primary Completion Date

January 2, 2017

Study Completion Date

January 2, 2017

Conditions
Asthma
Interventions
DRUG

Lebrikizumab

Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.

DRUG

Placebo

Lebrikizumab matching placebo will be administered as SC injection every 4 weeks for 52 weeks.

Trial Locations (232)

1051

Greenlane Clinical Centre, Auckland

1233

5TH MHAT; Pulmonology, Sofia

National Multiprofile Hospital Tsar Boris III, Sofia

1431

Medical Center for Specialized Outpatient Medical Care for Pulmonary Diseases, Sofia

SHATPD Sveta Sofia; Clin Pulmonary Diseases, Sofia

1618

Alitera - Med - Medical Center EOOD, Sofia

2000

Centro Respiratorio Infantil, Rosario

2139

Concord Repatriation General Hospital; Department Thoracic Medicine, Sydney

2900

Selye János Kórház és Rendelőintézet; Allergológiai Szakrendelés, Komárom

3000

UZ Leuven Gasthuisberg, Leuven

3110

P3 Research, Tauranga

4000

Centro Modelo de Cardiologia, San Miguel de Tucumán

4001

St Augustines Hospital; Infectoilogy, Durban

4032

Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika, Debrecen

4075

AusTrials, Brisbane

4092

Dr PJ Sebastian, Durban

4102

Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine, Brisbane

4170

Aliwal Shoal Medical Center, eMkhomazi

4700

Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD, Smolyan

5000

Medical Center Tara OOD, Veliko Tarnovo

5065

Respiratory Clinical Trials Pty Ltd, Toorak Gardens

5100

Private Practice, Jambes

6003

Multiprofile Hospital For Active Treatment prof Kirkovich, Stara Zagora

6009

The Lung Institute of Western Australia; Sir Charles Gairdner Hospital, Nedlands

6850

Clinical Projects Research, Worcester

7002

Specialized Hospital for Active Treatment for pneumo-phtysiatric diseases, Rousse

7505

Respiratory Research Unit, Cape Town

7530

Tiervalei Trial Centre, Cape Town

8011

Canterbury Respiratory Research Group; Respiratory, Christchurch

9020

Diagnostic and Consulting Centre Mladost - M OOD, Varna

9700

Markusovszky Egyetemi Oktatokorhaz, Szombathely

11000

Clinical Center of Serbia, Belgrade

11080

Clinical Hospital Centre Zemun, Zemun

11501

Winthrop Univ Hospital, Mineola

14584

Soonchunhyang University Bucheon Hospital, Gyeonggi-do

15241

Allergy and Clinical Immunology Associates, Pittsburgh

15706

Complexo Hospitalario Universitario de Santiago CHUS - Hospital de Conxo, Santiago de Compostela

16100

Nazareth EMMS Hospital, Nazareth

17005

Institut Catala de Serveis Medics, Girona

17033

Penn State Milton S. Hershey Medical Center, Hershey

18009

Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council, Cherkasy

19013

Asthma and Allergy Research Associates, Upland

20099

P.O. Citta' Di Sesto S. Giovanni, Sesto San Giovanni

20142

Asst Santi Paolo E Carlo, Milan

21029

Scientific and Research Institute of Invalid Rehabilitation of Moh of Ukraine, Vinnytsia

21044

Howard County Center for Lung and Sleep, LLC, Columbia

21204

Institute of Lung Diseases Vojvodina, Kamenitz

21236

Asthma, Allergy & Sinus Center, Baltimore

Chesapeake Clinical Research, Baltimore

22927

Pneumologisches Forschungsinstitut, Großhansdorf

24210

Pulmonary Research of Albingdon, Abingdon

27100

Fondazione IRCCS Policlinico San Matteo di Pavia; S.S. Fisiopatologia Respiratoria, Pavia

28046

Hospital Universitario la Paz; Servicio de Alergologia, Madrid

28222

Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología, Majadahonda

28801

Allergy Partners of Western NC, Asheville

29201

Neem Research Group, Inc., Columbia

29615

Greenville Pharmaceutical Research, Greenville

Upstate Pharmaceutical Research; Greenville, Greenville

30045

DataQuest Medical Research, Lawrenceville

30188

Atlanta Allergy & Asthma Clini, Woodstock

31096

Rambam Health Care Campus, Haifa

31406

Aeroallergy Research Labs, Savannah

31707

Georgia Pollens, Albany

31904

Brookstone Clinical Res Ctr, Columbus

Southeast Regional Research Group, Columbus

33173

Research Institute of South Florida Inc, Miami

33431

Allergy Consultants PA, Boca Raton

34239

Sarasota Clinical Research, Sarasota

35037

Praxis Dr. med. Hermann A. Trauth, Marburg

35209

Clinical Research Center of Alabama, LLC, Birmingham

36038

City Clinical Hospital No.1; Therap Ukr Med Stom Acad, Poltava

38601

Ordinace pro tuberkulozu a respiracni nemoci, Strakonice

41071

Hospital Universitario Virgen Macarena, Seville

41100

Azienda Ospedaliera Universitaria di Modena, Modena

44130

Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C., Guadalajara

45458

Allergy & Asthma Centre of Dayton, Centerville

46804

The Allergy and Asthma Center, Fort Wayne

49006

MI Dnipropetrovsk clinical association of emergency care of Dnipropetrovsk regional council, Dnipropetrovsk

49100

Rabin Medical Center, Petah Tikva

53792

University of Wisconsin;Allergy & Asthma Clinical Research, Madison

54003

City Hospital #1, Mykolaiv

55402

Clinical Research Inst, Minneapolis

60596

Medaimun GmbH, Frankfurt am Main

61035

Municipal Institution of Health Care City Clinical Hospital #13, Kharkiv

61039

SI Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine, Kharkiv

61469

Chonnam National University Hospital, Gwangju

63017

Allergy Associates, Inc., Chesterfield

63141

Clinical Research Center, L.L.C., St Louis

64114

Center For Pharmaceutical Research, Kansas City

64718

Unidad de Investigacion Clinica En Medicina (Udicem) S.C., Monterrey

65025

Municipal Institution Odesa Regional Clinical Hospital, Odesa

66606

Cotton O'Neil Clinic; Stormont-Vail Hlth Care, Topeka

69004

Hôpital de La Croix Rousse, Lyon

69063

Municipal Institution Zaporizhzhia City Multifield Clinical Hospital #9, Zaporizhzhye

69106

LLC Diaservis, Zaporizhzhia

73103

Integrity People Services Research Company, Oklahoma City

73131

Oklahoma Institute of Allergy and Asthma Clinical Research LLC, Oklahoma City

74136

Vital Prospects Clin Res Pc, Tulsa

75014

Groupe Hospitalier Cochin St Vincent de Paul La Roche Guyon, Paris

75230

Elliot J. Ginchansky, MD, PA, Dallas

75877

Hopital Bichat Claude Bernard ; Service de Pneumologie, Paris

77030

Baylor College of Medicine; Dept of Medicine, Houston

78205

Quality Assurance Research Ctr, San Antonio

78224

Discovery Clinical Trials, San Antonio

78229

Allergy & Asthma Research Center, San Antonio

78233

Live Oak Allergy & Asthma Clinic, San Antonio

78681

Allergy & Asthma Clin Cen TX, Round Rock

78756

Future Search Clinical Trials L.P., Austin

79903

EPIMRD, Inc. DBA Western Sky Medical Research, El Paso

80033

Western States Clinical Research, Inc, Wheat Ridge

80131

Azienda Ospedaliera Monaldi, Napoli

80206

National Jewish Health, Denver

80230

Colorado Allergy & Asthma Centers, Pc, Denver

80907

Asthma & Allergy; Associates, P.C., Colorado Springs

Storms Clinical Research; Institute, Colorado Springs

83114

Donetsk Municipal Treatment and Prophylactic Institution Central City Clinical Hospital #1, Donetsk

83301

Asthma & Allergy of Idaho, Twin Falls

84107

Allergy Associates of Utah, Murray

85251

Medical Research of Arizona; Allergy, Asthma & Immu, Scottsdale

85712

Quality of Life Medical & Research Center, Tucson

86035

Consultorio Especialidad Alergologia Pediatrica, Villahermosa

87131

University of New Mexico; School of Med, Albuquerque

89119

Clinical Research Consortium, Las Vegas

90048

Southern California Institute For Respiratory, Los Angeles

91344

Allergy and Asthma Relief Experts, Granada Hills

91786

Integrated Research Group Inc, Upland

93301

Kern Allergy Med Clinic, Inc., Bakersfield

94063

Allergy & Asthma Consultants, Redwood City

94275

Centre Hospitalier Universitaire de Bicêtre, Le Kremlin-Bicêtre

94598

Allergy & Asthma Medical Group; Clinical Research Division, Walnut Creek

95123

Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia, Catania

96814

East-West Medical Research Institute, Honolulu

115280

City Clinical Hospital #13, Moscow

115446

I.M. Sechenov Moscow State Medical University the Ministry of Health and Social Development of RF, Moscow

150002

Municipal Budgetery Clinical Institution of Healthcare; NA Semashko City Hospital, Yaroslavl

150010

Yaroslavl State Medical Academy - Clinical Hospital #2, Yaroslavl

193312

Municipal Polyclinic #25, Saint Petersburg

197022

St.Petersburg State Budget Healthcare Institution City Hospital of Saint Venerable Martyr Elizabeth, Saint Petersburg

197089

St. Petersburg State Medical University n.a. I.P. Pavlov, Saint Petersburg

197706

City Hospital #40 of Resort Administrative District, Saint Petersburg

300310

Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital, Timișoara

390026

Ryazan Regional Clinincal Cardiology Dispensary, Ryazan

400371

Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca, Sectia Clinica Pneumologie I, Cluj-Napoca

410012

Saratov State Medical Univ; Clinical Immun & Allerg, Saratov

440026

Penza Regional Clinical Hospital Named After N. N. Burdenko; Therapy Department, Penza

540100

Targu Mures Clinical Emergency County Hospital, Târgu Mureş

630051

City Clinical Hospital #2, Novosibirsk

634050

Siberian State Medical University, Tomsk

900002

Spitalul Clinic de Pneumoftiziologie Palazu Mare Constanta, Palazu Mare

5262100

Chaim Sheba Medical Center; Oncology Dept, Ramat Gan

9112001

Hadassah Medical Center; Pulmonary Institute, Jerusalem

06510

Yale University School Of Medicine, New Haven

04401

Dr. Paul Shapero, Bangor

02747

Infinity Medical Research Inc, North Dartmouth

02301

Asthma and Allergy Physicians LLC, Brockton

08820

Adult Pediatric Allergy Central Jersey, Edison

07666

Patrick V. Perin, MD, Teaneck

B7600FZN

Instituto de Investigaciones Clinicas-Mar del Plata, Buenos Aires

C1125 ABE

Fundacion Cidea, Buenos Aires

B1602DQD

CEMER Centro Médico de Enfermedades Respiratorias, Vicente López

L5A 3V4

Cheema Research, Inc, Mississauga

K1Y 4G2

Ottawa Allergy Research Corp, Ottawa

M9W 4L6

Manna Research, Toronto

N8X-5A6

Dr Anil Dhar Professional Medicine Corporation, Windsor

H3H 1T8

Del Carpio Jaime Dr - Allergiste & Immunologue, Montreal

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

140 59

Thomayerova nemocnice, Praha 4 - Krc

390 01

KASMED, s.r.o.; Alergologie a klinicka imunologie, Tábor

00168

Università Cattolica del Sacro Cuore UOC Allergologia- Policlinico Gemelli, Rome

454-8509

Banbuntane Hotokukai Hospital, Aichi

811-1394

Fukuoka National Hospital, Fukuoka

732-0052

Hiroshima Allegy & Respiratory Clinic, Hiroshima

319-1113

Ibarakihigashi National Hospital, Ibaraki

372-0831

Uno Naikakokyukika Clinic, Isesaki-shi

232-0024

Yokohama City University Medical Center; Neurology, Kanagawa

252-0392

Sagamihara National Hospital, Kanagawa

861-1196

Kumamoto Saishunso National Hospital, Koshi-shi

860-8556

Kumamoto University Hospital, Kumamoto

606-8507

Kyoto University Hospital, Respiratory Medicine, Kyoto

194-0023

Machida Municipal Hospital, Machida-shi

983-0833

Hikarigaoka Spellman Hospital; Rheumatology, Miyagi

454-8502

Nagoya Ekisaikai Hospital, Nagoya

700-8558

Okayama University Hospital, Okayama

569-1096

Takatsuki Red Cross Hospital; Division of Diabetes / Endocrinology / Lifestyle-Related Disease, Osaka

589-8511

Kinki University Hospital, Osaka

596-8501

Kishiwada City Hospital, Osaka

984-8560

Tohoku Medical and Pharmaceutical University Wakabayashi Hospital, Sendai

438-8550

Iwata City Hospital, Shizuoka

760-8538

Takamatsu Municipal Hospital, Takamatsu

102-0083

Hanzomon Hospital, Tokyo

103-0027

Tokyo-Eki Center-building Clinic, Tokyo

162-8655

Center Hospital of the National Center for Global Health and Medicine, Tokyo

173-8610

Nihon University Itabashi Hospital, Tokyo

939-8511

Toyama City Hospital, Toyama

Unknown

Medical Research Inst. of New Zealand; Respiratory, Wellington

Cusco 84

Hospital Nacional Adolfo; Guevara Velasco Essalud, Cusco

Lima 11

Hospital Nacional Luis N Saenz PNP, Lima

Lima 1

Clinica Internacional, Lima

Lima 21

ABK Reuma SRL- Medicentro BioCiencias, Lima

LIMA 27

Centro de Investigación Ricardo Palma, Lima

Lima 32

Instituto Peruano de Investigacion en Ciencias Medicas, Lima

Lima 33

Clinica San Pablo, Lima

Lima 41

Clinica San Borja, Lima

Lima 18

Clinica los Andes, Miraflores

34-212

SP ZOZ Bienkowka- Osrodek Zdrowia w Bienkowce, Bieńnkówka

31-159

GRAŻYNA JASIENIAK-PINIS ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne, Krakow

90-153

SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi, Lodz

63-400

Specjalistyczna Poradnia Pulmonologiczna, Ostrów Wielkopolski

64-920

Niepubliczny Zespol Poradni Specjalistycznych PULS Poradnia Chorob Pluc i Gruzlic, Piła

26-600

ABC-PULMO Poradnia Chorob Pluc, Radom

41-707

Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala, Ruda Śląska

96-100

Centrum Medyczne Ogrodowa, Skierniewice

33-100

Alergo Medical Specjalistyczna Przychodnia Lekarska, Tarnów

53-114

Lexmedica, Wroclaw

53-301

Dobrostan Gabinety Lekarskie, Wroclaw

54-239

NZOZ Lekarze Specjalisci, Wroclaw

821 06

Pneumo-Alergo Centrum s.r.o., Bratislava

934 01

ZAPA JJ Sro, Levice

949 01

Imunoalergologia Dzurilla s.r.o., Nitra

0380

Limpopo Clinical Research Initiative; Tamboti Medical Centre, Tabazimbi

02841

Korea University Anam Hospital, Seoul

06591

Seoul St Mary's Hospital, Seoul

110-744

Seoul National University Hospital; Division of Allergy and Clinical Immunology, Seoul

158-050

Ewha Womans University Medical Center, Seoul

03004

Instituto de Ciencias Medicas, Alicante

08036

Hospital Clinic de Barcelona, Barcelona

02091

Kyiv City Tuberculosis Hospital #1; Department of Differential Diagnosis of Lung Diseases, Kyiv

03680

SI National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine, Kyiv

IV2 3UV

Raigmore Hospital, Inverness

PR2 9HT

Royal Preston Hospital, Preston

S10 2JF

Royal Hallamshire Hospital; Department of Oncology, Sheffield

BS10 5NB

Southmead Hospital, Westbury-on-Trym, Bristol

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01868061 - A Study of Lebrikizumab in Participants With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication | Biotech Hunter | Biotech Hunter