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

PHASE3CompletedINTERVENTIONAL
Enrollment

348

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

December 28, 2016

Study Completion Date

December 28, 2016

Conditions
Asthma
Interventions
DRUG

Lebrikizumab

Lebrikizumab will be administered as SC injection at high or low dose Q4W.

DRUG

Placebo

Lebrikizumab matching placebo will be administered as SC injection Q4W.

DRUG

Standard of Care

Participants will continue to receive ICS therapy (total daily dose of 500-2000 mcg fluticasone propionate DPI or equivalent) along with at least one second controller medications (e.g. long-acting beta agonists \[LABAs\], leukotriene receptor antagonists (LTRAs), long-acting muscarinic antagonists (LAMAs), or theophylline) as standard of care.

Trial Locations (165)

333

Chang Gung Memorial Hospital, Taoyuan District

402

Chung Shan M. U. H., Taichung

407

Taichung Veterans General Hospital, Taichung

1083

Semmelweis Egyetem, Budapest

1089

Heim Pál Gyermekkórház, Budapest

1501

WWCT Lakeview Hospital, Johannesburg

1818

Soweto Clinical Trial Centre, Soweto

2000

Centro Respiratorio Infantil, Rosario

2045

Tudogyogyintezet Torokbalint, Törökbálint

2113

Medicross Sophiatown, Johannesburg

3000

Instituto Del Buen Aire, Santa Fe

3115

SI Research Centre of Radiation Medicine of AMSU, Kyiv

3526

Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház, Miskolc

3630

Westville Hospital, Durban

4000

Investigaciones en Patologias Respiratorias, San Miguel de Tucumán

4001

Sebastian Peter, Durban

4031

Kenezy Korhaz Rendelointezet, Debrecen

5500

Instituto Respirar, Mendoza

6014

GCT Mercantile; Clinical Research Centre, Port Elizabeth

6720

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ, Szeged

7900

Papp és Társa Bt., Szigetvár

7925

Uni of Cape Town Lung Inst., Cape Town

10459

Urban Health Plan, Inc., The Bronx

11008

Clínica Dr. Lobatón, Cadiz

21236

Asthma, Allergy & Sinus Center, Baltimore

22030

O & O Alpan, LLC, Fairfax

22332

Inha University Hospital, Incheon

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

28006

Clinica Ojeda de Asma Y Alergia, Madrid

29010

Hospital Regional Universitario Carlos Haya, Málaga

31096

Rambam Health Care Campus, Haifa

31904

Brookstone Clinical Res Ctr, Columbus

32806

Compass Research East, LLC, Orlando

33076

Groupe Hospitalier Pellegrin; Pharmacie, Bordeaux

33165

Abel and Buchheim, Miami

33613

University of South Florida, Tampa

34239

Sarasota Clinical Research, Sarasota

40447

China Medical University Hospital, Taichung

41042

Abraham Research PLLC, Florence

43606

Promedica Toledo Children's Hospital, Toledo

44100

Instituto Jalisciense de Investigacion Clinica S.A. de C.V., Guadalajara

44130

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

44220

Unidad Medica de Occidente, Guadalajara

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Riley Hospital for Children; Pediatric Nephrology, Indianapolis

46940

Hospital de Manises, Manises

49000

Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board, Dnipro

49100

Schneider Children's Medical Center, Petah Tikva

50082

"Municipal Institution Kryvyi Rih City Clinical Hospital #8 of Dnipropetrovsk Regional Council", Kryvyi Rih

52661

Chaim Sheba Medical Center, Tel Litwinsky

53226

Medical College of Wisconsin, Milwaukee

58023

Municipal Medical Institution; Chernivtsi Regional Children's Hospital, Chernivtsi

59063

Evangelisches Krankenhaus Hamm, Hamm

60528

Universitaetsklinikum Frankfurt, Frankfurt

60612

Rush University Medical Center, Chicago

62269

The Clinical Research Center, Shiloh

64460

Hospital Universitario Dr. Jose Eleuterio González; Enfermedades Pulmonares Crónicas, Monterrey

64718

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

69063

Municipal Institution Zaporizhzhya Regional Clinical Child Hospital, Zaporizhzhya

71106

Breathe America Shreveport Inc, Shreveport

75015

Groupe Hospitalier Necker Enfants Malades, Paris

75571

Hopital Armand Trousseau, Paris

76031

Hopital Charles Nicolle; cic, Rouen

78006

TTS Research, Boerne

78251

Allergy & Asthma Res Ctr PA, San Antonio

South Texas Allergy and Asthma Medical Professionals, San Antonio

78278

Barzilai Medical Center, Ashkelon

79925

Allergy & Asthma Research Center of El Paso, El Paso

80045

Colorado Children's Hospital; The Breathing Institute, Aurora

80112

IMMUNOe International Research Centers, Centennial

80206

National Jewish Medical and Research Center, Denver

80539

Praxis Dr. med. Jan Feimer, München

80907

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

84341

Bridgerland Clinical Research, North Logan

85716

Allergy Associates of Tucson, Tucson

86035

Consultorio Especialidad Alergologia Pediatrica, Villahermosa

87131

University of New Mexico; School of Med, Albuquerque

90027

Kaiser Permanente Los Angeles, Los Angeles

91031

Shaare Zedek Medical Center, Jerusalem

92691

Southern California Research Center, Mission Viejo

94063

Allergy & Asthma Consultants, Redwood City

94598

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

95123

Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele, Catania

95207

Bensch Research Associates, Stockton

95823

Dignity Health Medical Foundation, Sacramento

97035

Allergy, Asthma, & Dermatology Research Center, Llc, Lake Oswego

97504

Clinical Research Inst. of Southern Oregon, Pc, Medford

97701

Bend Memorial Clinic, Bend

98225

Bellingham Asthma, Allergy & Immunology, Bellingham

Unknown

Georgia Pain Clinic, Marietta

Parikh Institute for Research LLC, New York

Sanatorio Británico de Rosario, Santa Fé

Hospital Santa Clara, Bogotá

Hospital Pablo Tobon Uribe, Medellin-Antioquia

02115

Boston Children's Hospital, Boston

48109-0718

Univ of Michigan Medical Ctr, Ann Arbor

63104-1095

Cardinal Glennon Child's Hosp; Endrocrinology, St Louis

08904

Parikh Institute for Research LLC, New Jersey

B6500BWQ

Centro Médico Vitae, Buenos Aires

C1122AAK

Fundación Faicep, Buenos Aires

C1125 ABE

Fundacion Cidea, Buenos Aires

C1425BEN

INAER, Buenos Aires

M5500CCG

INSARES, Mendoza, Mendoza City

T4000CHE

Centro Integral de Medicina Respiratoria (CIMER), San Miguel de Tucumán

B1602DQD

CEMER Centro Médico de Enfermedades Respiratorias, Vicente López

41940-455

Centro de Referencia em Enfermidades Respiratorias e Alergia - CEAR, Salvador

90020-090

Santa Casa de Misericordia de Porto Alegre, Porto Alegre

90610-000

Hospital Sao Lucas - PUCRS, Porto Alegre

09060-650

Faculdade de Medicina do ABC - FMABC, Santo André

09080-000

Pesquisare Saúde Sociedade Simples, Santo André

01323-020

Hospital Alemao Oswaldo Cruz; Pesquisa Clinica, São Paulo

05437-010

Instituto de Pesquisa Clínica e Medicina Avançada Ltda, São Paulo

18040-425

CMPC/Clinica de Alergia Martti Antila, Sorocaba

V5Z 4E1

Dr. Tharwat A. Fera Inc., Vancouver

N6A 5B8

Brian Lyttle's Private Practice, London

G1V 4M6

Centre de Recherche Applique En Allergie de Quebec, Québec

586 01

Hofstetr Alois MUDr. s.r.o., Jihlava

415 01

Alergologie Teplice, s.r.o., Teplice

00161

Azienda Policlinico Umberto I; Dipartimento Integrato di Pediatria e Neuropsichiatria Infantile, Rome

00165

Ospedale Pediatrico Bambino Gesu, Rome

514-0125

National Hospital Organization Mie Hospital, Tsu

284-0003

National Hospital Organization Shimoshizu National Hospital, Yotsukaidō

03310

Grupo Medico Camino, DF

04530

Instituto Nacional de Pediatría, Mexico City

Lima 01

Hospital Dos de Mayo; Parque Historia De la Medicina Peruana S/n, Lima

Lima 11

Hospital Nacional Luis N Saenz PNP, Lima

Lima 1

Clinica Internacional, Lima

LIMA 27

Centro de Investigación Ricardo Palma, Lima

Lima 27

Clinica Anglo Americana, Lima

Lima 41

Clinica San Borja, Lima

15-430

Prywatna Praktyka Lekarska, Bialystok

31-624

Malopolskie Centrum Alergologii, Krakow

90-153

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

93-513

Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi, Lodz

20-552

Centrum Alergologii NZOZ, Lublin

60-214

Centrum Alergologii Teresa Hofman, Poznan

33-100

ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o, Tarnów

02-507

Klinika Chorób Wewnetrznych i Alergologii MSW, Warsaw

3814-501

Hospital Infante D. Pedro; Servico de Imunoalergologia, Aveiro

8005-226

Hospital Particular do Algarve - Unidade de Faro, Faro

1169-045

Hospital Dona Estefania; Servico de Imunoalergologia, Lisbon

4460-188

Hospital CUF Porto; Servico de Imunoalergologia, Senhora Da Hora - Porto

040 11

Alersa, Košice

984 01

ALERGOMEA s.r.o., Lučenec

949 01

Imunoalergologia Dzurilla s.r.o., Nitra

0101

Bothe ke Bontle Health Services, Pretoria

0380

Limpopo Clinical Research Initiative; Tamboti Medical Centre, Tabazimbi

03722

Severance Hospital, Yonsei University Health System, Seoul

130-702

KyungHee Medical Center, Seoul

08916

Hospital Universitario Germans Trias i Pujol; Servicio de Farmacia, Badalona

08950

Hospital Sant Joan De Deu, Esplugues de Llobregas

08208

Corporacio Sanitaria Parc Tauli; Servicio de Oncologia, Sabadell

08017

Hospital Quiron Teknon, Barcelona

08035

Hospital Universitari Vall d'Hebron, Barcelona

00704

National Cheng Kung Univ Hosp, Tainan City

04050

State Institution of Pediatrics Obstetrics and Gynecology of NAMSU, Kiev

03680

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

B4 6NH

Birmingham Children's Hospital NHS Foundation Trust, Birmingham

B9 5SS

Birmingham Heartlands Hospital, Birmingham

DG1 4AP

Dumfries and Galloway Royal Infirmary; Department of Paediatrics, Dumfries

G51 4TF

Royal Hospital For Children, Glasgow

LE1 7RH

University of Leicester, Leicester

SW3 6NP

Royal Brompton Hospital; Respiratory Department, London

S102TH

Sheffield Childrens Hospital, Sheffield

SO16 6YD

Southampton General Hospital, Southampton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01875003 - A Study of Lebrikizumab in Adolescent Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication | Biotech Hunter | Biotech Hunter