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

Asthma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01875003
• Other study ID #: WB28183
• Secondary ID: 2012-000180-25
• Status: Completed
• Phase: Phase 3
• First received: June 7, 2013
• Last updated: May 15, 2017
• Start date: August 31, 2013
• Est. completion date: December 28, 2016

Study information

• Verified date: May 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. completion date: December 28, 2016
• Est. primary completion date: December 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Lebrikizumab
Lebrikizumab will be administered as SC injection at high or low dose Q4W.
• Placebo
Lebrikizumab matching placebo will be administered as SC injection Q4W.
• 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.

Locations

Country	Name	City	State
Argentina	Centro Médico Vitae	Buenos Aires
Argentina	Fundacion Cidea	Buenos Aires
Argentina	Fundación Faicep	Buenos Aires
Argentina	INAER	Ciudad Autónoma de Buenos Aires
Argentina	Instituto Respirar	Mendoza
Argentina	INSARES	Mendoza, Mendoza City
Argentina	Centro Respiratorio Infantil	Rosario
Argentina	Investigaciones en Patologias Respiratorias	San Miguel de Tucuman
Argentina	Centro Integral de Medicina Respiratoria (CIMER)	San Miguel de Tucumán
Argentina	Instituto Del Buen Aire	Santa Fe
Argentina	Sanatorio Británico de Rosario	Santa Fé
Argentina	CEMER Centro Médico de Enfermedades Respiratorias	Vicente López
Brazil	Hospital Sao Lucas - PUCRS	Porto Alegre	RS
Brazil	Santa Casa de Misericordia de Porto Alegre	Porto Alegre	RS
Brazil	Centro de Referencia em Enfermidades Respiratorias e Alergia - CEAR	Salvador	BA
Brazil	Faculdade de Medicina do ABC - FMABC	Santo Andre	SP
Brazil	Pesquisare Saúde Sociedade Simples	Santo Andre	SP
Brazil	Hospital Alemao Oswaldo Cruz; Pesquisa Clinica	Sao Paulo	SP
Brazil	Instituto de Pesquisa Clínica e Medicina Avançada Ltda	Sao Paulo	SP
Brazil	CMPC/Clinica de Alergia Martti Antila	Sorocaba	SP
Canada	Brian Lyttle's Private Practice	London	Ontario
Canada	Centre de Recherche Applique En Allergie de Quebec	Quebec City	Quebec
Canada	Dr. Tharwat A. Fera Inc.	Vancouver	British Columbia
Colombia	Hospital Santa Clara	Bogota
Colombia	Hospital Pablo Tobon Uribe	Medellin-Antioquia
Czechia	Hofstetr Alois MUDr. s.r.o.	Jihlava
Czechia	Alergologie Teplice, s.r.o.	Teplice
France	Groupe Hospitalier Pellegrin; Pharmacie	Bordeaux
France	Groupe Hospitalier Necker Enfants Malades	Paris
France	Hopital Armand Trousseau	Paris
France	Hopital Charles Nicolle; cic	Rouen
Germany	Universitaetsklinikum Frankfurt	Frankfurt
Germany	Evangelisches Krankenhaus Hamm	Hamm
Germany	Praxis Dr. med. Jan Feimer	München
Hungary	Heim Pál Gyermekkórház	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Kenezy Korhaz Rendelointezet	Debrecen
Hungary	Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház	Miskolc
Hungary	Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ	Szeged
Hungary	Papp és Társa Bt.	Szigetvár
Hungary	Tudogyogyintezet Torokbalint	Torokbalint
Israel	Barzilai Medical Center	Ashkelon
Israel	Rambam Health Care Campus	Haifa
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Schneider Children's Medical Center	Petach-Tikva
Israel	Chaim Sheba Medical Center	Tel Hashomer
Italy	Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele	Catania	Sicilia
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia	Lombardia
Italy	Azienda Policlinico Umberto I; Dipartimento Integrato di Pediatria e Neuropsichiatria Infantile	Roma	Lazio
Italy	Ospedale Pediatrico Bambino Gesu	Roma	Lazio
Japan	National Hospital Organization Mie Hospital	Tsu-shi
Japan	National Hospital Organization Shimoshizu National Hospital	Yotsukaido
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	KyungHee Medical Center	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Mexico	Instituto Nacional de Pediatría	Ciudad De México
Mexico	Grupo Medico Camino	DF
Mexico	Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.	Guadalajara
Mexico	Instituto Jalisciense de Investigacion Clinica S.A. de C.V.	Guadalajara
Mexico	Unidad Medica de Occidente	Guadalajara
Mexico	Hospital Universitario Dr. Jose Eleuterio González; Enfermedades Pulmonares Crónicas	Monterrey
Mexico	Unidad de Investigacion Clinica En Medicina (Udicem) S.C.	Monterrey
Mexico	Consultorio Especialidad Alergologia Pediatrica	Villahermosa
Peru	Centro de Investigación Ricardo Palma	Lima
Peru	Clinica Anglo Americana	Lima
Peru	Clinica Internacional	Lima
Peru	Clinica San Borja	Lima
Peru	Hospital Dos de Mayo; Parque Historia De la Medicina Peruana S/n	Lima
Peru	Hospital Nacional Luis N Saenz PNP	Lima
Poland	Prywatna Praktyka Lekarska	Bialystok
Poland	Malopolskie Centrum Alergologii	Krakow
Poland	SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi	Lodz
Poland	Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi	Lodz
Poland	Centrum Alergologii NZOZ	Lublin
Poland	Centrum Alergologii Teresa Hofman	Poznan
Poland	ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o	Tarnow
Poland	Klinika Chorób Wewnetrznych i Alergologii MSW	Warszawa
Portugal	Hospital Infante D. Pedro; Servico de Imunoalergologia	Aveiro
Portugal	Hospital Particular do Algarve - Unidade de Faro	Faro
Portugal	Hospital Dona Estefania; Servico de Imunoalergologia	Lisboa
Portugal	Hospital CUF Porto; Servico de Imunoalergologia	Senhora da Hora - Porto
Slovakia	Alersa	Kosice
Slovakia	ALERGOMEA s.r.o.	Lucenec
Slovakia	Imunoalergologia Dzurilla s.r.o.	Nitra
South Africa	Uni of Cape Town Lung Inst.	Cape Town
South Africa	Sebastian Peter	Durban
South Africa	Westville Hospital	Durban
South Africa	Medicross Sophiatown	Johannesburg
South Africa	WWCT Lakeview Hospital	Johannesburg
South Africa	GCT Mercantile; Clinical Research Centre	Port Elizabeth
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
Spain	Hospital Universitario Germans Trias i Pujol; Servicio de Farmacia	Badalona	Barcelona
Spain	Hospital Quiron Teknon	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Clínica Dr. Lobatón	Cadiz
Spain	Hospital Sant Joan De Deu	Esplugues De Llobregas	Barcelona
Spain	Clinica Ojeda de Asma Y Alergia	Madrid
Spain	Hospital Regional Universitario Carlos Haya	Malaga
Spain	Hospital de Manises	Manises	Valencia
Spain	Corporacio Sanitaria Parc Tauli; Servicio de Oncologia	Sabadell	Barcelona
Taiwan	China Medical University Hospital	Taichung
Taiwan	Chung Shan M. U. H.	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng Kung Univ Hosp	Tainan
Taiwan	Chang Gung Memorial Hospital	Taoyuan
Ukraine	Municipal Medical Institution; Chernivtsi Regional Children's Hospital	Chernivtsi
Ukraine	Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board	Dnepropetrovsk
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
United Kingdom	Birmingham Children's Hospital NHS Foundation Trust	Birmingham
United Kingdom	Birmingham Heartlands Hospital	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 States	University of New Mexico; School of Med	Albuquerque	New Mexico
United States	Univ of Michigan Medical Ctr	Ann Arbor	Michigan
United States	Colorado Children's Hospital; The Breathing Institute	Aurora	Colorado
United States	Asthma, Allergy & Sinus Center	Baltimore	Maryland
United States	Bellingham Asthma, Allergy & Immunology	Bellingham	Washington
United States	Bend Memorial Clinic	Bend	Oregon
United States	TTS Research	Boerne	Texas
United States	Boston Children's Hospital	Boston	Massachusetts
United States	IMMUNOe International Research Centers	Centennial	Colorado
United States	Rush University Medical Center	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Asthma & Allergy; Associates, P.C.	Colorado Springs	Colorado
United States	Brookstone Clinical Res Ctr	Columbus	Georgia
United States	National Jewish Medical and Research Center	Denver	Colorado
United States	Allergy & Asthma Research Center of El Paso	El Paso	Texas
United States	O & O Alpan, LLC	Fairfax	Virginia
United States	Abraham Research PLLC	Florence	Kentucky
United States	Riley Hospital for Children; Pediatric Nephrology	Indianapolis	Indiana
United States	Allergy, Asthma, & Dermatology Research Center, Llc	Lake Oswego	Oregon
United States	Kaiser Permanente Los Angeles	Los Angeles	California
United States	Georgia Pain Clinic	Marietta	Georgia
United States	Clinical Research Inst. of Southern Oregon, Pc	Medford	Oregon
United States	Abel and Buchheim	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Southern California Research Center	Mission Viejo	California
United States	Parikh Institute for Research LLC	New Jersey	New Jersey
United States	Parikh Institute for Research LLC	New York	New York
United States	Bridgerland Clinical Research	North Logan	Utah
United States	Compass Research East, LLC	Orlando	Florida
United States	Allergy & Asthma Consultants	Redwood City	California
United States	Dignity Health Medical Foundation	Sacramento	California
United States	Cardinal Glennon Child's Hosp; Endrocrinology	Saint Louis	Missouri
United States	Allergy & Asthma Res Ctr PA	San Antonio	Texas
United States	South Texas Allergy and Asthma Medical Professionals	San Antonio	Texas
United States	Sarasota Clinical Research	Sarasota	Florida
United States	The Clinical Research Center	Shiloh	Illinois
United States	Breathe America Shreveport Inc	Shreveport	Louisiana
United States	Bensch Research Associates	Stockton	California
United States	University of South Florida	Tampa	Florida
United States	Urban Health Plan, Inc.	The Bronx	New York
United States	Promedica Toledo Children's Hospital	Toledo	Ohio
United States	Allergy Associates of Tucson	Tucson	Arizona
United States	Allergy & Asthma Medical Group; Clinical Research Division	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Colombia,  Czechia,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Peru,  Poland,  Portugal,  Slovakia,  South Africa,  Spain,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Asthma Exacerbations During the 52-Week Placebo-Controlled Period		Baseline up to Week 52
Primary	Percentage of Participants With Adverse Events (AEs) or Serious AEs		Baseline up to Week 124
Primary	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	Change from Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 second (FEV1) at Week 52		Baseline , Week 52
Secondary	Time to First Asthma Exacerbation		Baseline up to 52 weeks
Secondary	Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 52		Baseline , Week 52
Secondary	Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 years and Older (AQLQ + 12) at Week 52		Baseline, Week 52
Secondary	Change From Baseline in Asthma Rescue Medication Use at Week 52		Baseline, Week 52
Secondary	Rate of Urgent Asthma-Related Health Care Utilization		Baseline up to 52 weeks
Secondary	Injection Acceptability Questionnaire (IAQ) Score		Baseline up to Week 104