Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

TERMINATED

NCT01875003

PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy, safety, and tolerability of lebrikizumab in adolescent participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroids (ICS) therapy and at least one second controller medication. Participants will be randomized in a 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ('High' or 'Low') or placebo, administered as subcutaneous (SC) every 4 weeks (Q4W) for 52 weeks, in addition to their standard-of-care therapy. This will be followed by an optional 52-week double-blind active-treatment extension. The anticipated time on study treatment is up to 104 weeks. Participants who complete the study to Week 104, discontinue prematurely or decide not to take part in the optional active-treatment extension will transition to the 20-week safety follow-up period.

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Lebrikizumab in Adolescent Patients With Uncontrolled Asthma Who Are On Inhaled Corticosteroids and a Second Controller Medication.

Key Details

Gender

All

Age Range

12 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

346

Start Date

2013-08-13

Completion Date

2016-12-28

Last Updated

2026-06-30

Healthy Volunteers

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.

Inclusion Criteria: * Asthma diagnosis for greater than or equal to (\>/=) 12 months prior to Visit 1 * Bronchodilator response during screening * Pre-bronchodilator FEV1 of 40 percent (%) - 90% predicted at both Visits 2 and 3 * On high dose ICS therapy for \>/= 6 months prior to Visit 1 * On an eligible second controller medication for 6 months prior to Visit 1 * Uncontrolled asthma as defined by the protocol both during screening and at the time of randomization * 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 prior to 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 that meets the following criteria: Any infection requiring hospital admission or requiring treatment with IV or IM antibiotics within 4 weeks prior to Visit 1 or during screening; any active infection that required treatment with oral antibiotics within 2 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 * History of active tuberculosis requiring treatment * Known immunodeficiency, including, but not limited to, human immunodeficiency virus (HIV) infection * Evidence of acute or chronic hepatitis or known liver cirrhosis * History of cystic fibrosis, bronchiectasis, and/or other clinically significant lung disease other than asthma * Diagnosis or history of 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 (whichever is longer) prior to Visit 1 * Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or during screening * History of bronchial thermoplasty

Locations (81)

Southern California Research Center

Mission Viejo, California, United States

Bensch Research Associates

Stockton, California, United States

Colorado Children's Hospital; The Breathing Institute

Aurora, Colorado, United States

IMMUNOe Research Centers

Centennial, Colorado, United States

Asthma & Allergy; Associates, P.C.

Colorado Springs, Colorado, United States

Abel and Buchheim

Miami, Florida, United States

Sarasota Clinical Research

Sarasota, Florida, United States

Georgia Pain Clinic

Marietta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Asthma, Allergy & Sinus Center

Baltimore, Maryland, United States

Urban Health Plan, Inc.

The Bronx, New York, United States

TTS Research

Boerne, Texas, United States

Allergy & Asthma Res Ctr PA

San Antonio, Texas, United States

South Texas Allergy and Asthma Medical Professionals

San Antonio, Texas, United States

Bridgerland Clinical Research

North Logan, Utah, United States

O & O Alpan, LLC

Fairfax, Virginia, United States

INAER

Buenos Aires, Argentina

Instituto Respirar

Mendoza, Argentina

Centro Integral de Medicina Respiratoria (CIMER)

San Miguel de Tucumán, Argentina

Investigaciones en Patologias Respiratorias

San Miguel de Tucumán, Argentina

Instituto Del Buen Aire

Santa Fe, Argentina

CEMER Centro Médico de Enfermedades Respiratorias

Vicente López, Argentina

Centro de Referencia em Enfermidades Respiratorias e Alergia - CEAR

Salvador, Estado de Bahia, Brazil

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Faculdade de Medicina do ABC - FMABC

Santo André, São Paulo, Brazil

Pesquisare Saúde Sociedade Simples

Santo André, São Paulo, Brazil

Instituto de Pesquisa Clínica e Medicina Avançada Ltda

São Paulo, São Paulo, Brazil

CMPC/Clinica de Alergia Martti Antila

Sorocaba, São Paulo, Brazil

Private Practice - Dr. Brian D. Lyttle

London, Ontario, Canada

Hospital Santa Clara

Bogotá, Colombia

Hofstetr Alois MUDr. s.r.o.

Jihlava, Czechia

Alergologie Teplice, s.r.o.

Teplice, Czechia

Hopital Charles Nicolle; cic

Rouen, France

Universitaetsklinikum Frankfurt

Frankfurt, Germany

Evangelisches Krankenhaus Hamm

Hamm, Germany

Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika

Budapest, Hungary

Heim Pál Gyermekkórház

Budapest, Hungary

Kenezy Korhaz Rendelointezet

Debrecen, Hungary

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, Hungary

Papp és Társa Bt.

Szigetvár, Hungary

Rambam Health Care Campus

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Schneider Children's Medical Center

Petah Tikva, Israel

Chaim Sheba Medical Center

Ramat Gan, Israel

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, Italy

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

Guadalajara, Jalisco, Mexico

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

Santa Cecilia, Jalisco, Mexico

Grupo Medico Camino

DF, Mexico CITY (federal District), Mexico

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

Monterrey, Nuevo León, Mexico

Consultorio Especialidad Alergologia Pediatrica

Villahermosa, Mexico

Clinica Internacional

Lima, Peru

Centro de Investigación Ricardo Palma

Lima, Peru

Malopolskie Centrum Alergologii

Krakow, Poland

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

Lodz, Poland

Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

Lodz, Poland

Centrum Alergologii Teresa Hofman

Poznan, Poland

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

Tarnów, Poland

Klinika Chorób Wewnetrznych i Alergologii MSW

Warsaw, Poland

Hospital Infante D. Pedro; Servico de Imunoalergologia

Aveiro, Portugal

Hospital Particular do Algarve - Unidade de Faro

Faro, Portugal

Hospital CUF Porto; Servico de Imunoalergologia

Senhora Da Hora - Porto, Portugal

Imunoalergologia Dzurilla s.r.o.

Nitra, Slovakia

Uni of Cape Town Lung Inst.

Cape Town, South Africa

Sebastian Peter

Durban, South Africa

WWCT Lakeview Hospital

Johannesburg, South Africa

Bothe ke Bontle Health Services

Pretoria, South Africa

Soweto Clinical Trial Centre

Soweto, South Africa

Hospital Universitario Germans Trias i Pujol; Servicio de Farmacia

Badalona, Barcelona, Spain

Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

Sabadell, Barcelona, Spain

Hospital de Manises

Manises, Valencia, Spain

National Cheng Kung Univ Hosp

Tainan, Taiwan

Municipal Medical Institution; Chernivtsi Regional Children's Hospital

Chernivtsi, Ukraine

Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board

Dnipro, Ukraine

State Institution of Pediatrics Obstetrics and Gynecology of NAMSU

Kiev, Ukraine

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

Kryvyi Rih, Ukraine

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

Kyiv, Ukraine

SI Research Centre of Radiation Medicine of AMSU

Kyiv, Ukraine

Municipal Institution Zaporizhzhya Regional Clinical Child Hospital

Zaporizhzhya, Ukraine

Birmingham Heartlands Hospital

Birmingham, United Kingdom

University of Leicester

Leicester, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (81)