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

NCT02104674 | Completed Phase 3 Results

• 2 other identifiers: WA292492013-004625-81
• Study Type: interventional
• Target: 313
• Locations: 11 countries
• Sites: 82

Brief 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12

  FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. The active comparator treatment arm of open-label montelukast was included in the study design so that the sensitivity of the study could be evaluated with respect to the primary outcome measure, FEV1. Two mixed-effect models of repeated measures (MMRM) were used to estimate the absolute change from baseline values: one for the lebrikizumab vs. placebo primary comparison and the second for the montelukast vs. placebo sensitivity comparison.

  Baseline through Week 12

Secondary Outcomes (17)

• Lebrikizumab vs. Placebo: Change From Baseline in Asthma Reliever Medication Use at Week 12

  Baseline through Week 12

• Lebrikizumab vs. Placebo: Change From Baseline in the Standardized Asthma Quality of Life Questionnaire (AQLQ[S]) Overall Score at Week 12

  Baseline through Week 12

• Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels at Week 12

  Baseline, Week 12

• Montelukast vs. Placebo: Change Fom Baseline in Morning Pre-bronchodilator Peak Expiratory Flow (PEF) at Week 12

  Baseline through Week 12

• Lebrikizumab vs. Placebo: Change From Baseline in Morning Pre-bronchodilator PEF at Week 12

  Baseline through Week 12

Study Arms (3)

Lebrikizumab

EXPERIMENTAL

Drug: Lebrikizumab

Placebo

PLACEBO COMPARATOR

Other: Placebo

Montelukast

ACTIVE COMPARATOR

Drug: Montelukast

Interventions

Lebrikizumab DRUG

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

Also known as: RO5490255

Lebrikizumab

Placebo OTHER

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

Placebo

Montelukast DRUG

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

Also known as: Singulair

Montelukast

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (82)

Clinical Research Center of Alabama, LLC

Birmingham, Alabama, 35209, United States

Location

Allergy & Asthma Immunology Associates

Scottsdale, Arizona, 85251, United States

Location

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

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

Los Angeles, California, 90025, United States

Location

Southern California Institute For Respiratory

Los Angeles, California, 90048, United States

Location

North Bay Clinical Trials

Napa, California, 94558, United States

Location

Advances in Medicine

Rancho Mirage, California, 92270, United States

Location

Allergy & Asthma Consultants

Redwood City, California, 94063, United States

Location

Integrated Research Group Inc

Riverside, California, 92506, United States

Location

Storms Clinical Research; Institute

Colorado Springs, Colorado, 80907, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Florida Pulmonary Research Institute, LLC

Winter Park, Florida, 32789, United States

Location

In-Quest Medical Research, LLC

Duluth, Georgia, 30096, United States

Location

Sneeze, Wheeze, & Itch Associates

Normal, Illinois, 61761, United States

Location

Asthma & Allergy Center of Chicago, S.C.

River Forest, Illinois, 60305, United States

Location

Family Allergy & Asthma

Louisville, Kentucky, 40223, United States

Location

Midwest Clinical Research LLC

St Louis, Missouri, 63141, United States

Location

The Clinical Research Ctr

St Louis, Missouri, 63141, United States

Location

Asthma & Allergy Center, P.C.

Papillion, Nebraska, 68046, United States

Location

Advanced Research Institute

Reno, Nevada, 89511, United States

Location

Atlantic Research Center, LLC

Ocean City, New Jersey, 07712, United States

Location

Urban Health Plan, Inc.

The Bronx, New York, 10459, United States

Location

Allergy, Asthma & Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

Location

Clinical Research Inst. of Southern Oregon, Pc

Medford, Oregon, 97504, United States

Location

Allergy Associates Research Center LLC - CRN

Portland, Oregon, 97202, United States

Location

Mountainview Clinical Research

Greer, South Carolina, 29651, United States

Location

TTS Research

Boerne, Texas, 78006, United States

Location

Allergy Asthma Research Assoc

Dallas, Texas, 75231, United States

Location

Pharmaceutical Research & Consulting, Inc.

Dallas, Texas, 75231, United States

Location

Texas Institute of chest and Sleep Disorder

Houston, Texas, 77034, United States

Location

Metroplex Pulmonology & Sleep Center

McKinney, Texas, 75069, United States

Location

Quality Assurance Research Center

San Antonio, Texas, 78207, United States

Location

Bandera Family Health Care

San Antonio, Texas, 78249, United States

Location

South Texas Allergy and Asthma Medical Professionals

San Antonio, Texas, 78251, United States

Location

Allergy & Asthma Center

Waco, Texas, 76712, United States

Location

O & O Alpan, LLC

Fairfax, Virginia, 22030, United States

Location

Clinical Research Partners, LLC

Richmond, Virginia, 23220, United States

Location

Allergy Asthma & Sinus Center

Greenfield, Wisconsin, 53228, United States

Location

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Ufsc - Nupaiva

Florianópolis, Santa Catarina, 88040-970, Brazil

Location

Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia

Santo André, São Paulo, 09060-650, Brazil

Location

Pesquisare Saúde Sociedade Simples

Santo André, São Paulo, 09080-000, Brazil

Location

SHATPD ? Gabrovo EOOD; Department of pneumology

Gabrovo, 5300, Bulgaria

Location

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

Razgrad, 7200, Bulgaria

Location

SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.

Rousse, 7002, Bulgaria

Location

Medical Center Excelsior OOD

Sofia, 1000, Bulgaria

Location

Medical Center Researchexpert OOD

Varna, 9000, Bulgaria

Location

Medical Center Tara OOD

Veliko Tarnovo, 5000, Bulgaria

Location

Aggarwal and Associates

Brampton, Ontario, L6T 0G1, Canada

Location

Dr. Anil K. Gupta Medicine Professional Corporation

Toronto, Ontario, M9V 4B4, Canada

Location

MediTrial s.r.o.

Jind?ich?v Hradec, 377 01, Czechia

Location

Pneumo - KV; Ordinace pneumologie a diagnostiky plicních funkcí

Karlovy Vary ? Stará Role, 360 17, Czechia

Location

Ordinace pro tuberkulozu a respiracni nemoci

Strakonice, 38601, Czechia

Location

Optimal Clinical Trials

Auckland, 1010, New Zealand

Location

Southern Clinical Trials, Ltd

Beckenham, 8024, New Zealand

Location

Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika Alergologii i Chorob Wewnetrznych

Bialystok, 15-276, Poland

Location

Grazyna Pulka Specjalistyczny Osrodek ALL-MED

Krakow, 31-023, Poland

Location

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

Krakow, 31-159, Poland

Location

Specjalistyczny Niepubliczny Zespol Opieki Zdrowotnej; Alergologia Plus Osrodek Diagnostyki.

Poznan, 60-693, Poland

Location

NZOZ Alergo-Med. Specjalistyczna Przychodnia Lekarska; Poradnia Alergologiczna

Poznan, 60-823, Poland

Location

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

Tarnów, 33-100, Poland

Location

NZOZ ALL-MED Specjalistyczna Opieka Medyczna

Wroclaw, 53-201, Poland

Location

Compartiment Pneumologie; Fundatia Dr. Victor Babes

Bucharest, 030303, Romania

Location

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

Craiova, 200446, Romania

Location

Spitalul Clinic de Pneumoftiziologie Iasi; Sectia Clinica I Pneumoftiziologie

Iași, 700115, Romania

Location

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

Oradea, 410176, Romania

Location

Ryazan State Medical University Named after I.P.Pavlov

Ryazan, Ryazan Oblast, 390026, Russia

Location

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

Saint Petersburg, Sankt-Peterburg, 197022, Russia

Location

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

Saint Petersburg, Sankt-Peterburg, 197089, Russia

Location

City Hospital #40 of Resort Administrative District

Saint Petersburg, Sankt-Peterburg, 197706, Russia

Location

LLC Medical Center "Alliance-Biomedical - Russian Group"

Saint Petersburg, 190068, Russia

Location

LLC Medical Center"REAVITA"

Saint Petersburg, 194295, Russia

Location

Multiple-discipline City Hospital #2

Saint Petersburg, 194354, Russia

Location

Regional Clinical Hospital

Saratov, 410053, Russia

Location

Ural State Medical University; Pulmonology

Yekaterinburg, 620109, Russia

Location

Tiervalei Trial Centre

Cape Town, 7530, South Africa

Location

University of Cape Town Lung Institute; Lung Clinical Research

Cape Town, 7700, South Africa

Location

Newtown Clinical Research

Johannesburg, 2113, South Africa

Location

I Engelbrecht Research

Lyttleton, 0157, South Africa

Location

Syzygy Clinical Research; ?Unit 3 to 7

Pretoria Gauteng Province, 0087, South Africa

Location

Soweto Clinical Trial Centre

Soweto, 1818, South Africa

Location

The Medicines Evaluation Unit

Manchester, M23 9QZ, United Kingdom

Location

Related Publications (1)

• Korenblat P, Kerwin E, Leshchenko I, Yen K, Holweg CTJ, Anzures-Cabrera J, Martin C, Putnam WS, Governale L, Olsson J, Matthews JG. Efficacy and safety of lebrikizumab in adult patients with mild-to-moderate asthma not receiving inhaled corticosteroids. Respir Med. 2018 Jan;134:143-149. doi: 10.1016/j.rmed.2017.12.006. Epub 2017 Dec 13.

  PMID: 29413502 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

lebrikizumab; montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigators will remain blinded to the lebrikizumab and placebo arms only. Montelukast will be administered in tablet form and given in an open-label fashion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1:1 ratio to receive lebrikizumab 125 mg, placebo, or Montelukast 10 mg.

Study Record Dates

• First Submitted: March 26, 2014
• First Posted: April 4, 2014
• Study Start: June 7, 2014
• Primary Completion: January 22, 2016
• Study Completion: January 22, 2016
• Last Updated: July 17, 2026
• Results First Posted: July 17, 2026

Record last verified: 2026-06

Locations

ZA (6); BR (4); US (38); GB (1); CZ (3); NZ (2); CA (2); RO (4); BU (6); RU (9); PL (7)