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NCT02104674

PHASE3

A Study Evaluating the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This Phase III, randomized, double-blind, placebo-controlled, multicenter study will assess the efficacy and safety of lebrikizumab in adult patients with mild to moderate asthma treated with short-acting beta-agonist (SABA) therapy alone. Patients will be randomized in a 1:1:1 ratio to receive either blinded lebrikizumab or placebo treatment by subcutaneous (SC) injection (every 4 weeks for a total of 3 doses) or open-label treatment with Singulair (Montelukast; 10 mg daily). Time on study treatment will last 12 weeks.

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

313

Start Date

2014-06-07

Completion Date

2016-01-22

Last Updated

2026-07-17

Healthy Volunteers

Conditions

Asthma

Interventions

DRUG

Lebrikizumab

Lebrikizumab 125 mg subcutaneous (SC) injection given on Days 1, 29, and 57

DRUG

Montelukast

10 mg tablet given orally once daily for 12 weeks, according to the approved label.

OTHER

Placebo

Lebrikizumab-matched placebo SC injection given on Days 1, 29, and 57

Inclusion Criteria: * Age 18-75 years old at study start * Asthma diagnosis for \>/= 12 months prior to study start * Bronchodilator response at screening * Pre-bronchodilator FEV1 of 60% - 85% predicted at both screening visits 2 and 3 * No other clinically significant lung disease as confirmed by chest X-ray or computed tomography (CT) scan * Stable and symptomatic asthma during the screening period * Use of effective contraception, as defined by the protocol, until 24 weeks after the last dose Exclusion Criteria: * Maintenance of corticosteroid therapy, defined as daily or alternate-day oral corticosteroid maintenance therapy within 3 months prior to study start * Treatment with systemic or inhaled corticosteroids within 4 weeks prior to study start or during the screening period for any reason, including an acute exacerbation event * Treatment with a leukotriene receptor antagonist (LTRA), long-acting beta-agonist (LABA) long-acting muscarinic antagonist (LAMA), zileuton, roflumilast, or theophylline within 2 weeks prior to study start * Documented prior treatment failure with Montelukast * Treatment with intra-articular corticosteroids within 4 weeks prior to study start or during the screening period or anticipated need for intra articular corticosteroids during the course of the study * Any infection requiring hospital, IV or IM antibiotic treatment or any respiratory infection within 4 weeks of study start. Any infection requiring oral antibiotic treatment within 2 weeks of study start, or any parasitic infection within 6 months of study start * Clinically significant abnormality found during screening or clinically significant medical disease that is uncontrolled despite treatment that is likely, in the opinion of the investigator, to impact the patient's ability to participate in the study, or impact the study assessments * History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma * History of alcohol or drug abuse that would impair or risk the patient's full participation in the study, in the opinion of the investigator * Current or history of smoking (\> 10 pack-years), or unwillingness to abstain from smoking for the duration of the study * Past and/or current use of any anti-IL-13 or anti- IL4/IL-13 therapy, including lebrikizumab * Use of a licensed or investigational monoclonal antibody other than anti IL-13 or anti-IL-4/IL-13, including, but not limited to, omalizumab, anti-IL-5, or anti IL-17, within 6 months or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening * Use of a systemic immunomodulatory or immunosuppressive therapy within 3 months or 5 drug half-lives prior to study start or during screening * Use of other investigational therapy within 4 weeks or 5 drug half-lives prior to study start (whichever is longer) or during screening * Initiation of or change in allergen immunotherapy within 3 months prior to study start or during screening * Receipt of a live attenuated vaccine within 4 weeks prior to study start of during screening * Pregnancy or breast feeding * Body mass index \> 38 kg/m2 * Body weight \< 40 kg * History of bronchial thermoplasty

Locations (82)

Clinical Research Center of Alabama, LLC

Birmingham, Alabama, United States

Allergy & Asthma Immunology Associates

Scottsdale, Arizona, United States

Anaheim Clinical Trials

Anaheim, California, United States

CA Allergy & Asthma Med Grp; Medical Group, Inc.

Los Angeles, California, United States

Southern California Institute For Respiratory

Los Angeles, California, United States

North Bay Clinical Trials

Napa, California, United States

Advances in Medicine

Rancho Mirage, California, United States

Allergy & Asthma Consultants

Redwood City, California, United States

Integrated Research Group Inc

Riverside, California, United States

Storms Clinical Research; Institute

Colorado Springs, Colorado, United States

National Jewish Health

Denver, Colorado, United States

Florida Pulmonary Research Institute, LLC

Winter Park, Florida, United States

In-Quest Medical Research, LLC

Duluth, Georgia, United States

Sneeze, Wheeze, & Itch Associates

Normal, Illinois, United States

Asthma & Allergy Center of Chicago, S.C.

River Forest, Illinois, United States

Family Allergy & Asthma

Louisville, Kentucky, United States

Midwest Clinical Research LLC

St Louis, Missouri, United States

The Clinical Research Ctr

St Louis, Missouri, United States

Asthma & Allergy Center, P.C.

Papillion, Nebraska, United States

Advanced Research Institute

Reno, Nevada, United States

Atlantic Research Center, LLC

Ocean City, New Jersey, United States

Urban Health Plan, Inc.

The Bronx, New York, United States

Allergy, Asthma & Clinical Research Center

Oklahoma City, Oklahoma, United States

Clinical Research Inst. of Southern Oregon, Pc

Medford, Oregon, United States

Allergy Associates Research Center LLC - CRN

Portland, Oregon, United States

Mountainview Clinical Research

Greer, South Carolina, United States

TTS Research

Boerne, Texas, United States

Allergy Asthma Research Assoc

Dallas, Texas, United States

Pharmaceutical Research & Consulting, Inc.

Dallas, Texas, United States

Texas Institute of chest and Sleep Disorder

Houston, Texas, United States

Metroplex Pulmonology & Sleep Center

McKinney, Texas, United States

Quality Assurance Research Center

San Antonio, Texas, United States

Bandera Family Health Care

San Antonio, Texas, United States

South Texas Allergy and Asthma Medical Professionals

San Antonio, Texas, United States

Allergy & Asthma Center

Waco, Texas, United States

O & O Alpan, LLC

Fairfax, Virginia, United States

Clinical Research Partners, LLC

Richmond, Virginia, United States

Allergy Asthma & Sinus Center

Greenfield, Wisconsin, United States

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Ufsc - Nupaiva

Florianópolis, Santa Catarina, Brazil

Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia

Santo André, São Paulo, Brazil

Pesquisare Saúde Sociedade Simples

Santo André, São Paulo, Brazil

SHATPD ? Gabrovo EOOD; Department of pneumology

Gabrovo, Bulgaria

MHAT "Sv. Ivan Rilski" ? Razgrad AD; Department of pnemology and phthisiatry

Razgrad, Bulgaria

SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.

Rousse, Bulgaria

Medical Center Excelsior OOD

Sofia, Bulgaria

Medical Center Researchexpert OOD

Varna, Bulgaria

Medical Center Tara OOD

Veliko Tarnovo, Bulgaria

Aggarwal and Associates

Brampton, Ontario, Canada

Dr. Anil K. Gupta Medicine Professional Corporation

Toronto, Ontario, Canada

MediTrial s.r.o.

Jind?ich?v Hradec, Czechia

Pneumo - KV; Ordinace pneumologie a diagnostiky plicních funkcí

Karlovy Vary ? Stará Role, Czechia

Ordinace pro tuberkulozu a respiracni nemoci

Strakonice, Czechia

Optimal Clinical Trials

Auckland, New Zealand

Southern Clinical Trials, Ltd

Beckenham, New Zealand

Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika Alergologii i Chorob Wewnetrznych

Bialystok, Poland

Grazyna Pulka Specjalistyczny Osrodek ALL-MED

Krakow, Poland

GRA?YNA JASIENIAK-PINIS ATOPIA Niepubliczny Zak?ad Opieki Zdrowotnej Poradnie Specjalistyczne

Krakow, Poland

Specjalistyczny Niepubliczny Zespol Opieki Zdrowotnej; Alergologia Plus Osrodek Diagnostyki.

Poznan, Poland

NZOZ Alergo-Med. Specjalistyczna Przychodnia Lekarska; Poradnia Alergologiczna

Poznan, Poland

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

Tarnów, Poland

NZOZ ALL-MED Specjalistyczna Opieka Medyczna

Wroclaw, Poland

Compartiment Pneumologie; Fundatia Dr. Victor Babes

Bucharest, Romania

Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes; Sectia Pneumologie II

Craiova, Romania

Spitalul Clinic de Pneumoftiziologie Iasi; Sectia Clinica I Pneumoftiziologie

Iași, Romania

Spitalul Clinic Municipal Dr. Gavril Curteanu Oradea; Sectia Pneumologie I

Oradea, Romania

Ryazan State Medical University Named after I.P.Pavlov

Ryazan, Ryazan Oblast, Russia

SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

Saint Petersburg, Sankt-Peterburg, Russia

St. Petersburg State Medical University n.a. I.P. Pavlov

Saint Petersburg, Sankt-Peterburg, Russia

City Hospital #40 of Resort Administrative District

Saint Petersburg, Sankt-Peterburg, Russia

LLC Medical Center "Alliance-Biomedical - Russian Group"

Saint Petersburg, Russia

LLC Medical Center"REAVITA"

Saint Petersburg, Russia

Multiple-discipline City Hospital #2

Saint Petersburg, Russia

Regional Clinical Hospital

Saratov, Russia

Ural State Medical University; Pulmonology

Yekaterinburg, Russia

Tiervalei Trial Centre

Cape Town, South Africa

University of Cape Town Lung Institute; Lung Clinical Research

Cape Town, South Africa

Newtown Clinical Research

Johannesburg, South Africa

I Engelbrecht Research

Lyttleton, South Africa

Syzygy Clinical Research; ?Unit 3 to 7

Pretoria Gauteng Province, South Africa

Soweto Clinical Trial Centre

Soweto, South Africa

The Medicines Evaluation Unit

Manchester, United Kingdom

Clinical Research Directory

A Study Evaluating the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (82)