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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lebrikizumab
Placebo
Standard of Care
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Allergy Associates of Tucson
  • Kaiser Permanente Los Angeles
  • Southern California Research Center
  • Allergy & Asthma Consultants
  • Dignity Health Medical Foundation
  • Bensch Research Associates
  • Allergy & Asthma Medical Group; Clinical Research Division
  • Colorado Children's Hospital; The Breathing Institute
  • IMMUNOe International Research Centers
  • Asthma & Allergy; Associates, P.C.
  • National Jewish Medical and Research Center
  • Abel and Buchheim
  • Compass Research East, LLC
  • Sarasota Clinical Research
  • University of South Florida
  • Brookstone Clinical Res Ctr
  • Georgia Pain Clinic
  • Rush University Medical Center
  • The Clinical Research Center
  • Riley Hospital for Children; Pediatric Nephrology
  • Abraham Research PLLC
  • Breathe America Shreveport Inc
  • Asthma, Allergy & Sinus Center
  • Boston Children's Hospital
  • Univ of Michigan Medical Ctr
  • Cardinal Glennon Child's Hosp; Endrocrinology
  • Parikh Institute for Research LLC
  • University of New Mexico; School of Med
  • Parikh Institute for Research LLC
  • Urban Health Plan, Inc.
  • Cincinnati Children's Hospital Medical Center
  • Promedica Toledo Children's Hospital
  • Bend Memorial Clinic
  • Allergy, Asthma, & Dermatology Research Center, Llc
  • Clinical Research Inst. of Southern Oregon, Pc
  • TTS Research
  • Allergy & Asthma Research Center of El Paso
  • Allergy & Asthma Res Ctr PA
  • South Texas Allergy and Asthma Medical Professionals
  • Bridgerland Clinical Research
  • O & O Alpan, LLC
  • Bellingham Asthma, Allergy & Immunology
  • Medical College of Wisconsin
  • Centro Médico Vitae
  • Fundación Faicep
  • Fundacion Cidea
  • INAER
  • INSARES
  • Instituto Respirar
  • Centro Respiratorio Infantil
  • Investigaciones en Patologias Respiratorias
  • Centro Integral de Medicina Respiratoria (CIMER)
  • Instituto Del Buen Aire
  • Sanatorio Británico de Rosario
  • CEMER Centro Médico de Enfermedades Respiratorias
  • Centro de Referencia em Enfermidades Respiratorias e Alergia - CEAR
  • Santa Casa de Misericordia de Porto Alegre
  • Hospital Sao Lucas - PUCRS
  • Faculdade de Medicina do ABC - FMABC
  • Pesquisare Saúde Sociedade Simples
  • Hospital Alemao Oswaldo Cruz; Pesquisa Clinica
  • Instituto de Pesquisa Clínica e Medicina Avançada Ltda
  • CMPC/Clinica de Alergia Martti Antila
  • Dr. Tharwat A. Fera Inc.
  • Brian Lyttle's Private Practice
  • Centre de Recherche Applique En Allergie de Quebec
  • Hospital Santa Clara
  • Hospital Pablo Tobon Uribe
  • Hofstetr Alois MUDr. s.r.o.
  • Alergologie Teplice, s.r.o.
  • Groupe Hospitalier Pellegrin; Pharmacie
  • Groupe Hospitalier Necker Enfants Malades
  • Hopital Armand Trousseau
  • Hopital Charles Nicolle; cic
  • Universitaetsklinikum Frankfurt
  • Evangelisches Krankenhaus Hamm
  • Praxis Dr. med. Jan Feimer
  • Semmelweis Egyetem
  • Heim Pál Gyermekkórház
  • Kenezy Korhaz Rendelointezet
  • Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
  • Papp és Társa Bt.
  • Tudogyogyintezet Torokbalint
  • Barzilai Medical Center
  • Rambam Health Care Campus
  • Shaare Zedek Medical Center
  • Schneider Children's Medical Center
  • Chaim Sheba Medical Center
  • Azienda Policlinico Umberto I; Dipartimento Integrato di Pediatria e Neuropsichiatria Infantile
  • Ospedale Pediatrico Bambino Gesu
  • Fondazione IRCCS Policlinico San Matteo
  • Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
  • National Hospital Organization Mie Hospital
  • National Hospital Organization Shimoshizu National Hospital
  • Inha University Hospital
  • Severance Hospital, Yonsei University Health System
  • KyungHee Medical Center
  • Instituto Nacional de Pediatría
  • Grupo Medico Camino
  • Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
  • Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
  • Unidad Medica de Occidente
  • Hospital Universitario Dr. Jose Eleuterio González; Enfermedades Pulmonares Crónicas
  • Unidad de Investigacion Clinica En Medicina (Udicem) S.C.
  • Consultorio Especialidad Alergologia Pediatrica
  • Hospital Dos de Mayo; Parque Historia De la Medicina Peruana S/n
  • Hospital Nacional Luis N Saenz PNP
  • Clinica Internacional
  • Centro de Investigación Ricardo Palma
  • Clinica Anglo Americana
  • Clinica San Borja
  • Prywatna Praktyka Lekarska
  • Malopolskie Centrum Alergologii
  • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
  • Centrum Alergologii NZOZ
  • Centrum Alergologii Teresa Hofman
  • ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o
  • Klinika Chorób Wewnetrznych i Alergologii MSW
  • Hospital Infante D. Pedro; Servico de Imunoalergologia
  • Hospital Particular do Algarve - Unidade de Faro
  • Hospital Dona Estefania; Servico de Imunoalergologia
  • Hospital CUF Porto; Servico de Imunoalergologia
  • Alersa
  • ALERGOMEA s.r.o.
  • Imunoalergologia Dzurilla s.r.o.
  • Uni of Cape Town Lung Inst.
  • Westville Hospital
  • Sebastian Peter
  • WWCT Lakeview Hospital
  • Medicross Sophiatown
  • GCT Mercantile; Clinical Research Centre
  • Bothe ke Bontle Health Services
  • Soweto Clinical Trial Centre
  • Limpopo Clinical Research Initiative; Tamboti Medical Centre
  • Hospital Universitario Germans Trias i Pujol; Servicio de Farmacia
  • Hospital Sant Joan De Deu
  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
  • Hospital de Manises
  • Hospital Quiron Teknon
  • Hospital Universitari Vall d'Hebron
  • Clínica Dr. Lobatón
  • Clinica Ojeda de Asma Y Alergia
  • Hospital Regional Universitario Carlos Haya
  • Chung Shan M. U. H.
  • China Medical University Hospital
  • Taichung Veterans General Hospital
  • National Cheng Kung Univ Hosp
  • Chang Gung Memorial Hospital
  • Municipal Medical Institution; Chernivtsi Regional Children's Hospital
  • Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board
  • State Institution of Pediatrics Obstetrics and Gynecology of NAMSU
  • Municipal Institution "Kryvyi Rih City Clinical Hospital #8" of Dnipropetrovsk Regional Council
  • SI National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine
  • SI Research Centre of Radiation Medicine of AMSU
  • Municipal Institution Zaporizhzhya Regional Clinical Child Hospital
  • Birmingham Children's Hospital NHS Foundation Trust
  • Birmingham Heartlands Hospital
  • Dumfries and Galloway Royal Infirmary; Department of Paediatrics
  • Royal Hospital For Children
  • University of Leicester
  • Royal Brompton Hospital; Respiratory Department
  • Sheffield Childrens Hospital
  • Southampton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Lebrikizumab High

Lebrikizumab Low

Placebo

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Rate of Asthma Exacerbations During the 52-Week Placebo-Controlled Period
Percentage of Participants With Adverse Events (AEs) or Serious AEs
Percentage of Participants With Anti-Therapeutic Antibodies to Lebrikizumab

Secondary Outcome Measures

Change from Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 second (FEV1) at Week 52
Time to First Asthma Exacerbation
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 52
Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 years and Older (AQLQ + 12) at Week 52
Change From Baseline in Asthma Rescue Medication Use at Week 52
Rate of Urgent Asthma-Related Health Care Utilization
Injection Acceptability Questionnaire (IAQ) Score

Full Information

First Posted
June 7, 2013
Last Updated
May 15, 2017
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01875003
Brief Title
A Study of Lebrikizumab in Adolescent Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 31, 2013 (Actual)
Primary Completion Date
December 28, 2016 (Actual)
Study Completion Date
December 28, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
348 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lebrikizumab High
Arm Type
Experimental
Arm Description
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.
Arm Title
Lebrikizumab Low
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lebrikizumab
Intervention Description
Lebrikizumab will be administered as SC injection at high or low dose Q4W.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Lebrikizumab matching placebo will be administered as SC injection Q4W.
Intervention Type
Drug
Intervention Name(s)
Standard of Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Asthma Exacerbations During the 52-Week Placebo-Controlled Period
Time Frame
Baseline up to Week 52
Title
Percentage of Participants With Adverse Events (AEs) or Serious AEs
Time Frame
Baseline up to Week 124
Title
Percentage of Participants With Anti-Therapeutic Antibodies to Lebrikizumab
Time Frame
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 Measure Information:
Title
Change from Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 second (FEV1) at Week 52
Time Frame
Baseline , Week 52
Title
Time to First Asthma Exacerbation
Time Frame
Baseline up to 52 weeks
Title
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 52
Time Frame
Baseline , Week 52
Title
Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 years and Older (AQLQ + 12) at Week 52
Time Frame
Baseline, Week 52
Title
Change From Baseline in Asthma Rescue Medication Use at Week 52
Time Frame
Baseline, Week 52
Title
Rate of Urgent Asthma-Related Health Care Utilization
Time Frame
Baseline up to 52 weeks
Title
Injection Acceptability Questionnaire (IAQ) Score
Time Frame
Baseline up to Week 104

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Allergy Associates of Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85716
Country
United States
Facility Name
Kaiser Permanente Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Southern California Research Center
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Allergy & Asthma Consultants
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Dignity Health Medical Foundation
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Bensch Research Associates
City
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Facility Name
Allergy & Asthma Medical Group; Clinical Research Division
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Colorado Children's Hospital; The Breathing Institute
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
IMMUNOe International Research Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Asthma & Allergy; Associates, P.C.
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
National Jewish Medical and Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Abel and Buchheim
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Compass Research East, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Sarasota Clinical Research
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Brookstone Clinical Res Ctr
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Georgia Pain Clinic
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
The Clinical Research Center
City
Shiloh
State/Province
Illinois
ZIP/Postal Code
62269
Country
United States
Facility Name
Riley Hospital for Children; Pediatric Nephrology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Abraham Research PLLC
City
Florence
State/Province
Kentucky
ZIP/Postal Code
41042
Country
United States
Facility Name
Breathe America Shreveport Inc
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Asthma, Allergy & Sinus Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Univ of Michigan Medical Ctr
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0718
Country
United States
Facility Name
Cardinal Glennon Child's Hosp; Endrocrinology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104-1095
Country
United States
Facility Name
Parikh Institute for Research LLC
City
New Jersey
State/Province
New Jersey
ZIP/Postal Code
08904
Country
United States
Facility Name
University of New Mexico; School of Med
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Parikh Institute for Research LLC
City
New York
State/Province
New York
Country
United States
Facility Name
Urban Health Plan, Inc.
City
The Bronx
State/Province
New York
ZIP/Postal Code
10459
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Promedica Toledo Children's Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Bend Memorial Clinic
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Allergy, Asthma, & Dermatology Research Center, Llc
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Clinical Research Inst. of Southern Oregon, Pc
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
TTS Research
City
Boerne
State/Province
Texas
ZIP/Postal Code
78006
Country
United States
Facility Name
Allergy & Asthma Research Center of El Paso
City
El Paso
State/Province
Texas
ZIP/Postal Code
79925
Country
United States
Facility Name
Allergy & Asthma Res Ctr PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78251
Country
United States
Facility Name
South Texas Allergy and Asthma Medical Professionals
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78251
Country
United States
Facility Name
Bridgerland Clinical Research
City
North Logan
State/Province
Utah
ZIP/Postal Code
84341
Country
United States
Facility Name
O & O Alpan, LLC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States
Facility Name
Bellingham Asthma, Allergy & Immunology
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Centro Médico Vitae
City
Buenos Aires
ZIP/Postal Code
B6500BWQ
Country
Argentina
Facility Name
Fundación Faicep
City
Buenos Aires
ZIP/Postal Code
C1122AAK
Country
Argentina
Facility Name
Fundacion Cidea
City
Buenos Aires
ZIP/Postal Code
C1125 ABE
Country
Argentina
Facility Name
INAER
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
C1425BEN
Country
Argentina
Facility Name
INSARES
City
Mendoza, Mendoza City
ZIP/Postal Code
M5500CCG
Country
Argentina
Facility Name
Instituto Respirar
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Centro Respiratorio Infantil
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Investigaciones en Patologias Respiratorias
City
San Miguel de Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Centro Integral de Medicina Respiratoria (CIMER)
City
San Miguel de Tucumán
ZIP/Postal Code
T4000CHE
Country
Argentina
Facility Name
Instituto Del Buen Aire
City
Santa Fe
ZIP/Postal Code
3000
Country
Argentina
Facility Name
Sanatorio Británico de Rosario
City
Santa Fé
Country
Argentina
Facility Name
CEMER Centro Médico de Enfermedades Respiratorias
City
Vicente López
ZIP/Postal Code
B1602DQD
Country
Argentina
Facility Name
Centro de Referencia em Enfermidades Respiratorias e Alergia - CEAR
City
Salvador
State/Province
BA
ZIP/Postal Code
41940-455
Country
Brazil
Facility Name
Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Faculdade de Medicina do ABC - FMABC
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Pesquisare Saúde Sociedade Simples
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09080-000
Country
Brazil
Facility Name
Hospital Alemao Oswaldo Cruz; Pesquisa Clinica
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01323-020
Country
Brazil
Facility Name
Instituto de Pesquisa Clínica e Medicina Avançada Ltda
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05437-010
Country
Brazil
Facility Name
CMPC/Clinica de Alergia Martti Antila
City
Sorocaba
State/Province
SP
ZIP/Postal Code
18040-425
Country
Brazil
Facility Name
Dr. Tharwat A. Fera Inc.
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E1
Country
Canada
Facility Name
Brian Lyttle's Private Practice
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5B8
Country
Canada
Facility Name
Centre de Recherche Applique En Allergie de Quebec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4M6
Country
Canada
Facility Name
Hospital Santa Clara
City
Bogota
Country
Colombia
Facility Name
Hospital Pablo Tobon Uribe
City
Medellin-Antioquia
Country
Colombia
Facility Name
Hofstetr Alois MUDr. s.r.o.
City
Jihlava
ZIP/Postal Code
586 01
Country
Czechia
Facility Name
Alergologie Teplice, s.r.o.
City
Teplice
ZIP/Postal Code
415 01
Country
Czechia
Facility Name
Groupe Hospitalier Pellegrin; Pharmacie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Groupe Hospitalier Necker Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hopital Armand Trousseau
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Hopital Charles Nicolle; cic
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Universitaetsklinikum Frankfurt
City
Frankfurt
ZIP/Postal Code
60528
Country
Germany
Facility Name
Evangelisches Krankenhaus Hamm
City
Hamm
ZIP/Postal Code
59063
Country
Germany
Facility Name
Praxis Dr. med. Jan Feimer
City
München
ZIP/Postal Code
80539
Country
Germany
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Heim Pál Gyermekkórház
City
Budapest
ZIP/Postal Code
1089
Country
Hungary
Facility Name
Kenezy Korhaz Rendelointezet
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
Facility Name
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Papp és Társa Bt.
City
Szigetvár
ZIP/Postal Code
7900
Country
Hungary
Facility Name
Tudogyogyintezet Torokbalint
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Schneider Children's Medical Center
City
Petach-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52661
Country
Israel
Facility Name
Azienda Policlinico Umberto I; Dipartimento Integrato di Pediatria e Neuropsichiatria Infantile
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
Ospedale Pediatrico Bambino Gesu
City
Roma
State/Province
Lazio
ZIP/Postal Code
00165
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Facility Name
National Hospital Organization Mie Hospital
City
Tsu-shi
ZIP/Postal Code
514-0125
Country
Japan
Facility Name
National Hospital Organization Shimoshizu National Hospital
City
Yotsukaido
ZIP/Postal Code
284-0003
Country
Japan
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
KyungHee Medical Center
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
Facility Name
Instituto Nacional de Pediatría
City
Ciudad De México
ZIP/Postal Code
04530
Country
Mexico
Facility Name
Grupo Medico Camino
City
DF
ZIP/Postal Code
03310
Country
Mexico
Facility Name
Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
City
Guadalajara
ZIP/Postal Code
44100
Country
Mexico
Facility Name
Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
City
Guadalajara
ZIP/Postal Code
44130
Country
Mexico
Facility Name
Unidad Medica de Occidente
City
Guadalajara
ZIP/Postal Code
44220
Country
Mexico
Facility Name
Hospital Universitario Dr. Jose Eleuterio González; Enfermedades Pulmonares Crónicas
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Unidad de Investigacion Clinica En Medicina (Udicem) S.C.
City
Monterrey
ZIP/Postal Code
64718
Country
Mexico
Facility Name
Consultorio Especialidad Alergologia Pediatrica
City
Villahermosa
ZIP/Postal Code
86035
Country
Mexico
Facility Name
Hospital Dos de Mayo; Parque Historia De la Medicina Peruana S/n
City
Lima
ZIP/Postal Code
Lima 01
Country
Peru
Facility Name
Hospital Nacional Luis N Saenz PNP
City
Lima
ZIP/Postal Code
Lima 11
Country
Peru
Facility Name
Clinica Internacional
City
Lima
ZIP/Postal Code
Lima 1
Country
Peru
Facility Name
Centro de Investigación Ricardo Palma
City
Lima
ZIP/Postal Code
LIMA 27
Country
Peru
Facility Name
Clinica Anglo Americana
City
Lima
ZIP/Postal Code
Lima 27
Country
Peru
Facility Name
Clinica San Borja
City
Lima
ZIP/Postal Code
Lima 41
Country
Peru
Facility Name
Prywatna Praktyka Lekarska
City
Bialystok
ZIP/Postal Code
15-430
Country
Poland
Facility Name
Malopolskie Centrum Alergologii
City
Krakow
ZIP/Postal Code
31-624
Country
Poland
Facility Name
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Centrum Alergologii NZOZ
City
Lublin
ZIP/Postal Code
20-552
Country
Poland
Facility Name
Centrum Alergologii Teresa Hofman
City
Poznan
ZIP/Postal Code
60-214
Country
Poland
Facility Name
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Klinika Chorób Wewnetrznych i Alergologii MSW
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Hospital Infante D. Pedro; Servico de Imunoalergologia
City
Aveiro
ZIP/Postal Code
3814-501
Country
Portugal
Facility Name
Hospital Particular do Algarve - Unidade de Faro
City
Faro
ZIP/Postal Code
8005-226
Country
Portugal
Facility Name
Hospital Dona Estefania; Servico de Imunoalergologia
City
Lisboa
ZIP/Postal Code
1169-045
Country
Portugal
Facility Name
Hospital CUF Porto; Servico de Imunoalergologia
City
Senhora da Hora - Porto
ZIP/Postal Code
4460-188
Country
Portugal
Facility Name
Alersa
City
Kosice
ZIP/Postal Code
040 11
Country
Slovakia
Facility Name
ALERGOMEA s.r.o.
City
Lucenec
ZIP/Postal Code
984 01
Country
Slovakia
Facility Name
Imunoalergologia Dzurilla s.r.o.
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Uni of Cape Town Lung Inst.
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Westville Hospital
City
Durban
ZIP/Postal Code
3630
Country
South Africa
Facility Name
Sebastian Peter
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
WWCT Lakeview Hospital
City
Johannesburg
ZIP/Postal Code
1501
Country
South Africa
Facility Name
Medicross Sophiatown
City
Johannesburg
ZIP/Postal Code
2113
Country
South Africa
Facility Name
GCT Mercantile; Clinical Research Centre
City
Port Elizabeth
ZIP/Postal Code
6014
Country
South Africa
Facility Name
Bothe ke Bontle Health Services
City
Pretoria
ZIP/Postal Code
0101
Country
South Africa
Facility Name
Soweto Clinical Trial Centre
City
Soweto
ZIP/Postal Code
1818
Country
South Africa
Facility Name
Limpopo Clinical Research Initiative; Tamboti Medical Centre
City
Tabazimbi
ZIP/Postal Code
0380
Country
South Africa
Facility Name
Hospital Universitario Germans Trias i Pujol; Servicio de Farmacia
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Sant Joan De Deu
City
Esplugues De Llobregas
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital de Manises
City
Manises
State/Province
Valencia
ZIP/Postal Code
46940
Country
Spain
Facility Name
Hospital Quiron Teknon
City
Barcelona
ZIP/Postal Code
08017
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Clínica Dr. Lobatón
City
Cadiz
ZIP/Postal Code
11008
Country
Spain
Facility Name
Clinica Ojeda de Asma Y Alergia
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Regional Universitario Carlos Haya
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Chung Shan M. U. H.
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
National Cheng Kung Univ Hosp
City
Tainan
ZIP/Postal Code
00704
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Municipal Medical Institution; Chernivtsi Regional Children's Hospital
City
Chernivtsi
ZIP/Postal Code
58023
Country
Ukraine
Facility Name
Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board
City
Dnepropetrovsk
ZIP/Postal Code
49000
Country
Ukraine
Facility Name
State Institution of Pediatrics Obstetrics and Gynecology of NAMSU
City
Kiev
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Municipal Institution "Kryvyi Rih City Clinical Hospital #8" of Dnipropetrovsk Regional Council
City
Kryvyi Rih
ZIP/Postal Code
50082
Country
Ukraine
Facility Name
SI National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
SI Research Centre of Radiation Medicine of AMSU
City
Kyiv
ZIP/Postal Code
3115
Country
Ukraine
Facility Name
Municipal Institution Zaporizhzhya Regional Clinical Child Hospital
City
Zaporizhzhya
ZIP/Postal Code
69063
Country
Ukraine
Facility Name
Birmingham Children's Hospital NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Dumfries and Galloway Royal Infirmary; Department of Paediatrics
City
Dumfries
ZIP/Postal Code
DG1 4AP
Country
United Kingdom
Facility Name
Royal Hospital For Children
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
University of Leicester
City
Leicester
ZIP/Postal Code
LE1 7RH
Country
United Kingdom
Facility Name
Royal Brompton Hospital; Respiratory Department
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Facility Name
Sheffield Childrens Hospital
City
Sheffield
ZIP/Postal Code
S102TH
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35846226
Citation
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.
Results Reference
derived

Learn more about this trial

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

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