A Study of Lebrikizumab in Adolescent Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
- Registration Number
- NCT01875003
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 348
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lebrikizumab High Lebrikizumab Participants with uncontrolled asthma on ICS therapy (total daily dose of 500-2000 micrograms \[mcg\] of fluticasone propionate dry powder inhaler \[DPI\] or equivalent) and a second controller medication, will receive SC injection of lebrikizumab (high dose) Q4W for 52 weeks during placebo-controlled period and up to 76 weeks or 104 weeks for participants who will be willing to take part in optional active-treatment extension period. Placebo Lebrikizumab Participants with uncontrolled asthma on ICS therapy (total daily dose of 500-2000 mcg of fluticasone propionate DPI or equivalent) and a second controller medication, will receive SC injection of lebrikizumab matching placebo Q4W for 52 weeks during placebo-controlled period and then SC injection of lebrikizumab at high or low dose will be administered from Weeks 52 to 76 or 104 to participants who are willing to take part in optional active-treatment extension period. Lebrikizumab Low Lebrikizumab Participants with uncontrolled asthma on ICS therapy (total daily dose of 500-2000 mcg of fluticasone propionate DPI or equivalent) and a second controller medication, will receive SC injection of lebrikizumab (low dose) Q4W for 52 weeks during placebo-controlled period and up to 76 weeks or 104 weeks for participants who will be willing to take part in optional active-treatment extension period. Lebrikizumab High Standard of Care Participants with uncontrolled asthma on ICS therapy (total daily dose of 500-2000 micrograms \[mcg\] of fluticasone propionate dry powder inhaler \[DPI\] or equivalent) and a second controller medication, will receive SC injection of lebrikizumab (high dose) Q4W for 52 weeks during placebo-controlled period and up to 76 weeks or 104 weeks for participants who will be willing to take part in optional active-treatment extension period. Lebrikizumab Low Standard of Care Participants with uncontrolled asthma on ICS therapy (total daily dose of 500-2000 mcg of fluticasone propionate DPI or equivalent) and a second controller medication, will receive SC injection of lebrikizumab (low dose) Q4W for 52 weeks during placebo-controlled period and up to 76 weeks or 104 weeks for participants who will be willing to take part in optional active-treatment extension period. Placebo Standard of Care Participants with uncontrolled asthma on ICS therapy (total daily dose of 500-2000 mcg of fluticasone propionate DPI or equivalent) and a second controller medication, will receive SC injection of lebrikizumab matching placebo Q4W for 52 weeks during placebo-controlled period and then SC injection of lebrikizumab at high or low dose will be administered from Weeks 52 to 76 or 104 to participants who are willing to take part in optional active-treatment extension period. Placebo Placebo Participants with uncontrolled asthma on ICS therapy (total daily dose of 500-2000 mcg of fluticasone propionate DPI or equivalent) and a second controller medication, will receive SC injection of lebrikizumab matching placebo Q4W for 52 weeks during placebo-controlled period and then SC injection of lebrikizumab at high or low dose will be administered from Weeks 52 to 76 or 104 to participants who are willing to take part in optional active-treatment extension period.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events (AEs) or Serious AEs Baseline up to Week 124 Rate of Asthma Exacerbations During the 52-Week Placebo-Controlled Period Baseline up to Week 52 Percentage of Participants With Anti-Therapeutic Antibodies to Lebrikizumab Baseline up to Week 124 (assessed at Baseline, Weeks 4, 12, 24, 36, 52, 76, 104, 112, and 124 or at early termination [up to 108 weeks])
- Secondary Outcome Measures
Name Time Method Rate of Urgent Asthma-Related Health Care Utilization Baseline up to 52 weeks Injection Acceptability Questionnaire (IAQ) Score Baseline up to Week 104 Change from Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 second (FEV1) at Week 52 Baseline , Week 52 Time to First Asthma Exacerbation Baseline up to 52 weeks Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 52 Baseline , Week 52 Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 years and Older (AQLQ + 12) at Week 52 Baseline, Week 52 Change From Baseline in Asthma Rescue Medication Use at Week 52 Baseline, Week 52
Trial Locations
- Locations (164)
Allergy & Asthma Consultants
🇺🇸Redwood City, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
The Clinical Research Center
🇺🇸Shiloh, Illinois, United States
Asthma, Allergy & Sinus Center
🇺🇸Baltimore, Maryland, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Clinical Research Inst. of Southern Oregon, Pc
🇺🇸Medford, Oregon, United States
Allergy Associates of Tucson
🇺🇸Tucson, Arizona, United States
Kaiser Permanente Los Angeles
🇺🇸Los Angeles, California, United States
Southern California Research Center
🇺🇸Mission Viejo, California, United States
Bensch Research Associates
🇺🇸Stockton, California, United States
Allergy & Asthma Medical Group; Clinical Research Division
🇺🇸Walnut Creek, California, United States
IMMUNOe International Research Centers
🇺🇸Centennial, Colorado, United States
Asthma & Allergy; Associates, P.C.
🇺🇸Colorado Springs, Colorado, United States
Georgia Pain Clinic
🇺🇸Marietta, Georgia, United States
Sarasota Clinical Research
🇺🇸Sarasota, Florida, United States
Brookstone Clinical Res Ctr
🇺🇸Columbus, Georgia, United States
Abraham Research PLLC
🇺🇸Florence, Kentucky, United States
Cardinal Glennon Child's Hosp; Endrocrinology
🇺🇸Saint Louis, Missouri, United States
Parikh Institute for Research LLC
🇺🇸New York, New York, United States
University of New Mexico; School of Med
🇺🇸Albuquerque, New Mexico, United States
Urban Health Plan, Inc.
🇺🇸The Bronx, New York, United States
Promedica Toledo Children's Hospital
🇺🇸Toledo, Ohio, United States
Bend Memorial Clinic
🇺🇸Bend, Oregon, United States
TTS Research
🇺🇸Boerne, Texas, United States
Allergy, Asthma, & Dermatology Research Center, Llc
🇺🇸Lake Oswego, Oregon, United States
Allergy & Asthma Research Center of El Paso
🇺🇸El Paso, Texas, United States
Bridgerland Clinical Research
🇺🇸North Logan, Utah, United States
O & O Alpan, LLC
🇺🇸Fairfax, Virginia, United States
Bellingham Asthma, Allergy & Immunology
🇺🇸Bellingham, Washington, United States
Centro Médico Vitae
🇦🇷Buenos Aires, Argentina
Fundacion Cidea
🇦🇷Buenos Aires, Argentina
Fundación Faicep
🇦🇷Buenos Aires, Argentina
INSARES
🇦🇷Mendoza, Mendoza City, Argentina
Investigaciones en Patologias Respiratorias
🇦🇷San Miguel de Tucuman, Argentina
Instituto Del Buen Aire
🇦🇷Santa Fe, Argentina
Centro de Referencia em Enfermidades Respiratorias e Alergia - CEAR
🇧🇷Salvador, BA, Brazil
Santa Casa de Misericordia de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil
Faculdade de Medicina do ABC - FMABC
🇧🇷Santo Andre, SP, Brazil
Hospital Sao Lucas - PUCRS
🇧🇷Porto Alegre, RS, Brazil
Hospital Alemao Oswaldo Cruz; Pesquisa Clinica
🇧🇷Sao Paulo, SP, Brazil
CMPC/Clinica de Alergia Martti Antila
🇧🇷Sorocaba, SP, Brazil
Instituto de Pesquisa ClÃnica e Medicina Avançada Ltda
🇧🇷Sao Paulo, SP, Brazil
Brian Lyttle's Private Practice
🇨🇦London, Ontario, Canada
Centre de Recherche Applique En Allergie de Quebec
🇨🇦Quebec City, Quebec, Canada
Hospital Pablo Tobon Uribe
🇨🇴Medellin-Antioquia, Colombia
Hofstetr Alois MUDr. s.r.o.
🇨🇿Jihlava, Czechia
Groupe Hospitalier Pellegrin; Pharmacie
🇫🇷Bordeaux, France
Hopital Armand Trousseau
🇫🇷Paris, France
Hopital Charles Nicolle; cic
🇫🇷Rouen, France
Universitaetsklinikum Frankfurt
🇩🇪Frankfurt, Germany
Evangelisches Krankenhaus Hamm
🇩🇪Hamm, Germany
Praxis Dr. med. Jan Feimer
🇩🇪München, Germany
Semmelweis Egyetem
ðŸ‡ðŸ‡ºBudapest, Hungary
Heim Pál Gyermekkórház
ðŸ‡ðŸ‡ºBudapest, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
ðŸ‡ðŸ‡ºSzeged, Hungary
Kenezy Korhaz Rendelointezet
ðŸ‡ðŸ‡ºDebrecen, Hungary
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
ðŸ‡ðŸ‡ºMiskolc, Hungary
Papp és Társa Bt.
ðŸ‡ðŸ‡ºSzigetvár, Hungary
Tudogyogyintezet Torokbalint
ðŸ‡ðŸ‡ºTorokbalint, Hungary
Barzilai Medical Center
🇮🇱Ashkelon, Israel
Schneider Children's Medical Center
🇮🇱Petach-Tikva, Israel
Azienda Policlinico Umberto I; Dipartimento Integrato di Pediatria e Neuropsichiatria Infantile
🇮🇹Roma, Lazio, Italy
Chaim Sheba Medical Center
🇮🇱Tel Hashomer, Israel
Ospedale Pediatrico Bambino Gesu
🇮🇹Roma, Lazio, Italy
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
KyungHee Medical Center
🇰🇷Seoul, Korea, Republic of
Unidad Medica de Occidente
🇲🇽Guadalajara, Mexico
Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
🇲🇽Guadalajara, Mexico
Unidad de Investigacion Clinica En Medicina (Udicem) S.C.
🇲🇽Monterrey, Mexico
Hospital Universitario Dr. Jose Eleuterio González; Enfermedades Pulmonares Crónicas
🇲🇽Monterrey, Mexico
Consultorio Especialidad Alergologia Pediatrica
🇲🇽Villahermosa, Mexico
Clinica Internacional
🇵🇪Lima, Peru
Clinica Anglo Americana
🇵🇪Lima, Peru
Hospital Dos de Mayo; Parque Historia De la Medicina Peruana S/n
🇵🇪Lima, Peru
Hospital Nacional Luis N Saenz PNP
🇵🇪Lima, Peru
Centro de Investigación Ricardo Palma
🇵🇪Lima, Peru
Prywatna Praktyka Lekarska
🇵🇱Bialystok, Poland
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
🇵🇱Lodz, Poland
Klinika Chorób Wewnetrznych i Alergologii MSW
🇵🇱Warszawa, Poland
Centrum Alergologii NZOZ
🇵🇱Lublin, Poland
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o
🇵🇱Tarnow, 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
Hospital Dona Estefania; Servico de Imunoalergologia
🇵🇹Lisboa, Portugal
ALERGOMEA s.r.o.
🇸🇰Lucenec, Slovakia
Alersa
🇸🇰Kosice, Slovakia
Uni of Cape Town Lung Inst.
🇿🇦Cape Town, South Africa
Sebastian Peter
🇿🇦Durban, South Africa
Imunoalergologia Dzurilla s.r.o.
🇸🇰Nitra, Slovakia
Westville Hospital
🇿🇦Durban, South Africa
WWCT Lakeview Hospital
🇿🇦Johannesburg, South Africa
GCT Mercantile; Clinical Research Centre
🇿🇦Port Elizabeth, South Africa
Medicross Sophiatown
🇿🇦Johannesburg, South Africa
Bothe ke Bontle Health Services
🇿🇦Pretoria, South Africa
Soweto Clinical Trial Centre
🇿🇦Soweto, South Africa
Limpopo Clinical Research Initiative; Tamboti Medical Centre
🇿🇦Tabazimbi, South Africa
Hospital Quiron Teknon
🇪🇸Barcelona, Spain
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
🇪🇸Sabadell, Barcelona, Spain
ClÃnica Dr. Lobatón
🇪🇸Cadiz, Spain
Clinica Ojeda de Asma Y Alergia
🇪🇸Madrid, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Chung Shan M. U. H.
🇨🇳Taichung, Taiwan
Hospital Regional Universitario Carlos Haya
🇪🇸Malaga, Spain
National Cheng Kung Univ Hosp
🇨🇳Tainan, Taiwan
Municipal Medical Institution; Chernivtsi Regional Children's Hospital
🇺🇦Chernivtsi, Ukraine
Municipal Institution "Kryvyi Rih City Clinical Hospital #8" of Dnipropetrovsk Regional Council
🇺🇦Kryvyi Rih, Ukraine
State Institution of Pediatrics Obstetrics and Gynecology of NAMSU
🇺🇦Kiev, Ukraine
Birmingham Children's Hospital NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Dumfries and Galloway Royal Infirmary; Department of Paediatrics
🇬🇧Dumfries, United Kingdom
Royal Hospital For Children
🇬🇧Glasgow, United Kingdom
University of Leicester
🇬🇧Leicester, United Kingdom
Royal Brompton Hospital; Respiratory Department
🇬🇧London, United Kingdom
Sheffield Childrens Hospital
🇬🇧Sheffield, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom
Abel and Buchheim
🇺🇸Miami, Florida, United States
Riley Hospital for Children; Pediatric Nephrology
🇺🇸Indianapolis, Indiana, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Allergy & Asthma Res Ctr PA
🇺🇸San Antonio, Texas, United States
South Texas Allergy and Asthma Medical Professionals
🇺🇸San Antonio, Texas, United States
Hospital de Manises
🇪🇸Manises, Valencia, Spain
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Grupo Medico Camino
🇲🇽DF, Mexico
National Hospital Organization Mie Hospital
🇯🇵Tsu-shi, Japan
Centrum Alergologii Teresa Hofman
🇵🇱Poznan, Poland
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Lombardia, Italy
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
🇮🇹Catania, Sicilia, Italy
Birmingham Heartlands Hospital
🇬🇧Birmingham, United Kingdom
National Jewish Medical and Research Center
🇺🇸Denver, Colorado, United States
Groupe Hospitalier Necker Enfants Malades
🇫🇷Paris, France
Alergologie Teplice, s.r.o.
🇨🇿Teplice, Czechia
Pesquisare Saúde Sociedade Simples
🇧🇷Santo Andre, SP, Brazil
Compass Research East, LLC
🇺🇸Orlando, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Dignity Health Medical Foundation
🇺🇸Sacramento, California, United States
Colorado Children's Hospital; The Breathing Institute
🇺🇸Aurora, Colorado, United States
Univ of Michigan Medical Ctr
🇺🇸Ann Arbor, Michigan, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Centro Integral de Medicina Respiratoria (CIMER)
🇦🇷San Miguel de Tucumán, Argentina
CEMER Centro Médico de Enfermedades Respiratorias
🇦🇷Vicente López, Argentina
Hospital Santa Clara
🇨🇴Bogota, Colombia
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
🇵🇱Lodz, Poland
Instituto Respirar
🇦🇷Mendoza, Argentina
Breathe America Shreveport Inc
🇺🇸Shreveport, Louisiana, United States
INAER
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Centro Respiratorio Infantil
🇦🇷Rosario, Argentina
Rambam Health Care Campus
🇮🇱Haifa, Israel
National Hospital Organization Shimoshizu National Hospital
🇯🇵Yotsukaido, Japan
Clinica San Borja
🇵🇪Lima, Peru
Sanatorio Británico de Rosario
🇦🇷Santa Fé, Argentina
Instituto Nacional de PediatrÃa
🇲🇽Ciudad De México, Mexico
Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
🇲🇽Guadalajara, Mexico
Malopolskie Centrum Alergologii
🇵🇱Krakow, Poland
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board
🇺🇦Dnepropetrovsk, Ukraine
Dr. Tharwat A. Fera Inc.
🇨🇦Vancouver, British Columbia, Canada
SI National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine
🇺🇦Kyiv, Ukraine
Municipal Institution Zaporizhzhya Regional Clinical Child Hospital
🇺🇦Zaporizhzhya, Ukraine
Chang Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan
SI Research Centre of Radiation Medicine of AMSU
🇺🇦Kyiv, Ukraine
Hospital Universitario Germans Trias i Pujol; Servicio de Farmacia
🇪🇸Badalona, Barcelona, Spain
Hospital Sant Joan De Deu
🇪🇸Esplugues De Llobregas, Barcelona, Spain
China Medical University Hospital
🇨🇳Taichung, Taiwan