A Study of Lebrikizumab in Adolescent Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
2 other identifiers
interventional
348
23 countries
165
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 asthma
Started Aug 2013
Longer than P75 for phase_3 asthma
165 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2013
CompletedFirst Posted
Study publicly available on registry
June 11, 2013
CompletedStudy Start
First participant enrolled
August 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2016
CompletedMay 16, 2017
May 1, 2017
3.3 years
June 7, 2013
May 15, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
Rate of Asthma Exacerbations During the 52-Week Placebo-Controlled Period
Baseline up to Week 52
Percentage of Participants With Adverse Events (AEs) or Serious AEs
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, 76, 104, 112, and 124 or at early termination [up to 108 weeks])
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (3)
Lebrikizumab High
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
PLACEBO COMPARATORParticipants 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.
Interventions
Lebrikizumab will be administered as SC injection at high or low dose Q4W.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (165)
Allergy Associates of Tucson
Tucson, Arizona, 85716, United States
Kaiser Permanente Los Angeles
Los Angeles, California, 90027, United States
Southern California Research Center
Mission Viejo, California, 92691, United States
Allergy & Asthma Consultants
Redwood City, California, 94063, United States
Dignity Health Medical Foundation
Sacramento, California, 95823, United States
Bensch Research Associates
Stockton, California, 95207, United States
Allergy & Asthma Medical Group; Clinical Research Division
Walnut Creek, California, 94598, United States
Colorado Children's Hospital; The Breathing Institute
Aurora, Colorado, 80045, United States
IMMUNOe International Research Centers
Centennial, Colorado, 80112, United States
Asthma & Allergy; Associates, P.C.
Colorado Springs, Colorado, 80907, United States
National Jewish Medical and Research Center
Denver, Colorado, 80206, United States
Abel and Buchheim
Miami, Florida, 33165, United States
Compass Research East, LLC
Orlando, Florida, 32806, United States
Sarasota Clinical Research
Sarasota, Florida, 34239, United States
University of South Florida
Tampa, Florida, 33613, United States
Brookstone Clinical Res Ctr
Columbus, Georgia, 31904, United States
Georgia Pain Clinic
Marietta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
The Clinical Research Center
Shiloh, Illinois, 62269, United States
Riley Hospital for Children; Pediatric Nephrology
Indianapolis, Indiana, 46202, United States
Abraham Research PLLC
Florence, Kentucky, 41042, United States
Breathe America Shreveport Inc
Shreveport, Louisiana, 71106, United States
Asthma, Allergy & Sinus Center
Baltimore, Maryland, 21236, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Univ of Michigan Medical Ctr
Ann Arbor, Michigan, 48109-0718, United States
Cardinal Glennon Child's Hosp; Endrocrinology
St Louis, Missouri, 63104-1095, United States
Parikh Institute for Research LLC
New Jersey, New Jersey, 08904, United States
University of New Mexico; School of Med
Albuquerque, New Mexico, 87131, United States
Parikh Institute for Research LLC
New York, New York, United States
Urban Health Plan, Inc.
The Bronx, New York, 10459, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Promedica Toledo Children's Hospital
Toledo, Ohio, 43606, United States
Bend Memorial Clinic
Bend, Oregon, 97701, United States
Allergy, Asthma, & Dermatology Research Center, Llc
Lake Oswego, Oregon, 97035, United States
Clinical Research Inst. of Southern Oregon, Pc
Medford, Oregon, 97504, United States
TTS Research
Boerne, Texas, 78006, United States
Allergy & Asthma Research Center of El Paso
El Paso, Texas, 79925, United States
Allergy & Asthma Res Ctr PA
San Antonio, Texas, 78251, United States
South Texas Allergy and Asthma Medical Professionals
San Antonio, Texas, 78251, United States
Bridgerland Clinical Research
North Logan, Utah, 84341, United States
O & O Alpan, LLC
Fairfax, Virginia, 22030, United States
Bellingham Asthma, Allergy & Immunology
Bellingham, Washington, 98225, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Centro Médico Vitae
Buenos Aires, B6500BWQ, Argentina
Fundación Faicep
Buenos Aires, C1122AAK, Argentina
Fundacion Cidea
Buenos Aires, C1125 ABE, Argentina
INAER
Buenos Aires, C1425BEN, Argentina
Instituto Respirar
Mendoza, 5500, Argentina
INSARES
Mendoza, Mendoza City, M5500CCG, Argentina
Centro Respiratorio Infantil
Rosario, 2000, Argentina
Investigaciones en Patologias Respiratorias
San Miguel de Tucumán, 4000, Argentina
Centro Integral de Medicina Respiratoria (CIMER)
San Miguel de Tucumán, T4000CHE, Argentina
Instituto Del Buen Aire
Santa Fe, 3000, Argentina
Sanatorio Británico de Rosario
Santa Fé, Argentina
CEMER Centro Médico de Enfermedades Respiratorias
Vicente López, B1602DQD, Argentina
Centro de Referencia em Enfermidades Respiratorias e Alergia - CEAR
Salvador, Estado de Bahia, 41940-455, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Faculdade de Medicina do ABC - FMABC
Santo André, São Paulo, 09060-650, Brazil
Pesquisare Saúde Sociedade Simples
Santo André, São Paulo, 09080-000, Brazil
Hospital Alemao Oswaldo Cruz; Pesquisa Clinica
São Paulo, São Paulo, 01323-020, Brazil
Instituto de Pesquisa Clínica e Medicina Avançada Ltda
São Paulo, São Paulo, 05437-010, Brazil
CMPC/Clinica de Alergia Martti Antila
Sorocaba, São Paulo, 18040-425, Brazil
Dr. Tharwat A. Fera Inc.
Vancouver, British Columbia, V5Z 4E1, Canada
Brian Lyttle's Private Practice
London, Ontario, N6A 5B8, Canada
Centre de Recherche Applique En Allergie de Quebec
Québec, Quebec, G1V 4M6, Canada
Hospital Santa Clara
Bogotá, Colombia
Hospital Pablo Tobon Uribe
Medellin-Antioquia, Colombia
Hofstetr Alois MUDr. s.r.o.
Jihlava, 586 01, Czechia
Alergologie Teplice, s.r.o.
Teplice, 415 01, Czechia
Groupe Hospitalier Pellegrin; Pharmacie
Bordeaux, 33076, France
Groupe Hospitalier Necker Enfants Malades
Paris, 75015, France
Hopital Armand Trousseau
Paris, 75571, France
Hopital Charles Nicolle; cic
Rouen, 76031, France
Universitaetsklinikum Frankfurt
Frankfurt, 60528, Germany
Evangelisches Krankenhaus Hamm
Hamm, 59063, Germany
Praxis Dr. med. Jan Feimer
München, 80539, Germany
Semmelweis Egyetem
Budapest, 1083, Hungary
Heim Pál Gyermekkórház
Budapest, 1089, Hungary
Kenezy Korhaz Rendelointezet
Debrecen, 4031, Hungary
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
Miskolc, 3526, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, 6720, Hungary
Papp és Társa Bt.
Szigetvár, 7900, Hungary
Tudogyogyintezet Torokbalint
Törökbálint, 2045, Hungary
Barzilai Medical Center
Ashkelon, 78278, Israel
Rambam Health Care Campus
Haifa, 31096, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Schneider Children's Medical Center
Petah Tikva, 49100, Israel
Chaim Sheba Medical Center
Tel Litwinsky, 52661, Israel
Azienda Policlinico Umberto I; Dipartimento Integrato di Pediatria e Neuropsichiatria Infantile
Rome, Lazio, 00161, Italy
Ospedale Pediatrico Bambino Gesu
Rome, Lazio, 00165, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, 27100, Italy
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
Catania, Sicily, 95123, Italy
National Hospital Organization Mie Hospital
Tsu, 514-0125, Japan
National Hospital Organization Shimoshizu National Hospital
Yotsukaidō, 284-0003, Japan
Grupo Medico Camino
DF, 03310, Mexico
Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
Guadalajara, 44100, Mexico
Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
Guadalajara, 44130, Mexico
Unidad Medica de Occidente
Guadalajara, 44220, Mexico
Instituto Nacional de Pediatría
Mexico City, 04530, Mexico
Hospital Universitario Dr. Jose Eleuterio González; Enfermedades Pulmonares Crónicas
Monterrey, 64460, Mexico
Unidad de Investigacion Clinica En Medicina (Udicem) S.C.
Monterrey, 64718, Mexico
Consultorio Especialidad Alergologia Pediatrica
Villahermosa, 86035, Mexico
Hospital Dos de Mayo; Parque Historia De la Medicina Peruana S/n
Lima, Lima 01, Peru
Hospital Nacional Luis N Saenz PNP
Lima, Lima 11, Peru
Clinica Internacional
Lima, Lima 1, Peru
Centro de Investigación Ricardo Palma
Lima, LIMA 27, Peru
Clinica Anglo Americana
Lima, Lima 27, Peru
Clinica San Borja
Lima, Lima 41, Peru
Prywatna Praktyka Lekarska
Bialystok, 15-430, Poland
Malopolskie Centrum Alergologii
Krakow, 31-624, Poland
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, 90-153, Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz, 93-513, Poland
Centrum Alergologii NZOZ
Lublin, 20-552, Poland
Centrum Alergologii Teresa Hofman
Poznan, 60-214, Poland
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o
Tarnów, 33-100, Poland
Klinika Chorób Wewnetrznych i Alergologii MSW
Warsaw, 02-507, Poland
Hospital Infante D. Pedro; Servico de Imunoalergologia
Aveiro, 3814-501, Portugal
Hospital Particular do Algarve - Unidade de Faro
Faro, 8005-226, Portugal
Hospital Dona Estefania; Servico de Imunoalergologia
Lisbon, 1169-045, Portugal
Hospital CUF Porto; Servico de Imunoalergologia
Senhora Da Hora - Porto, 4460-188, Portugal
Alersa
Košice, 040 11, Slovakia
ALERGOMEA s.r.o.
Lučenec, 984 01, Slovakia
Imunoalergologia Dzurilla s.r.o.
Nitra, 949 01, Slovakia
Uni of Cape Town Lung Inst.
Cape Town, 7925, South Africa
Westville Hospital
Durban, 3630, South Africa
Sebastian Peter
Durban, 4001, South Africa
WWCT Lakeview Hospital
Johannesburg, 1501, South Africa
Medicross Sophiatown
Johannesburg, 2113, South Africa
GCT Mercantile; Clinical Research Centre
Port Elizabeth, 6014, South Africa
Bothe ke Bontle Health Services
Pretoria, 0101, South Africa
Soweto Clinical Trial Centre
Soweto, 1818, South Africa
Limpopo Clinical Research Initiative; Tamboti Medical Centre
Tabazimbi, 0380, South Africa
Inha University Hospital
Incheon, 22332, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
KyungHee Medical Center
Seoul, 130-702, South Korea
Hospital Universitario Germans Trias i Pujol; Servicio de Farmacia
Badalona, Barcelona, 08916, Spain
Hospital Sant Joan De Deu
Esplugues de Llobregas, Barcelona, 08950, Spain
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona, 08208, Spain
Hospital de Manises
Manises, Valencia, 46940, Spain
Hospital Quiron Teknon
Barcelona, 08017, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Clínica Dr. Lobatón
Cadiz, 11008, Spain
Clinica Ojeda de Asma Y Alergia
Madrid, 28006, Spain
Hospital Regional Universitario Carlos Haya
Málaga, 29010, Spain
Chung Shan M. U. H.
Taichung, 402, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
National Cheng Kung Univ Hosp
Tainan, 00704, Taiwan
Chang Gung Memorial Hospital
Taoyuan District, 333, Taiwan
Municipal Medical Institution; Chernivtsi Regional Children's Hospital
Chernivtsi, 58023, Ukraine
Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board
Dnipro, 49000, Ukraine
State Institution of Pediatrics Obstetrics and Gynecology of NAMSU
Kiev, 04050, Ukraine
Municipal Institution "Kryvyi Rih City Clinical Hospital #8" of Dnipropetrovsk Regional Council
Kryvyi Rih, 50082, Ukraine
SI National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine
Kyiv, 03680, Ukraine
SI Research Centre of Radiation Medicine of AMSU
Kyiv, 3115, Ukraine
Municipal Institution Zaporizhzhya Regional Clinical Child Hospital
Zaporizhzhya, 69063, Ukraine
Birmingham Children's Hospital NHS Foundation Trust
Birmingham, B4 6NH, United Kingdom
Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
Dumfries and Galloway Royal Infirmary; Department of Paediatrics
Dumfries, DG1 4AP, United Kingdom
Royal Hospital For Children
Glasgow, G51 4TF, United Kingdom
University of Leicester
Leicester, LE1 7RH, United Kingdom
Royal Brompton Hospital; Respiratory Department
London, SW3 6NP, United Kingdom
Sheffield Childrens Hospital
Sheffield, S102TH, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Related Publications (1)
Szefler SJ, Roberts G, Rubin AS, Zielen S, Kuna P, Alpan O, Anzures-Cabrera J, Chen Q, Holweg CTJ, Kaminski J, Putnam WS, Matthews JG, Kamath N. Efficacy, safety, and tolerability of lebrikizumab in adolescent patients with uncontrolled asthma (ACOUSTICS). Clin Transl Allergy. 2022 Jul 14;12(7):e12176. doi: 10.1002/clt2.12176. eCollection 2022 Jul.
PMID: 35846226DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2013
First Posted
June 11, 2013
Study Start
August 31, 2013
Primary Completion
December 28, 2016
Study Completion
December 28, 2016
Last Updated
May 16, 2017
Record last verified: 2017-05