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

NCT02104674 | Completed Phase 3

• 1 other identifier: WA29249
• Study Type: interventional
• Target: 313
• Locations: 14 countries
• Sites: 112

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)

• Absolute change in pre-bronchodilator forced expiratory volume in 1 second (FEV1)

  From Baseline to Week 12

Secondary Outcomes (8)

• Relative change in morning pre-bronchodilator peak expiratory flow (PEF)

  From Baseline to Week 12

• Time to treatment failure

  From Baseline to Week 12

• Change in asthma rescue medication use

  From Baseline to Week 12

• Incidence of adverse events

  Approximately 20 weeks

• Pharmacodynamics: Relative change in fractional exhaled nitric oxide (FeNO)

  From Baseline to Week 12

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Other: placebo

Singulair (montelukast)

ACTIVE COMPARATOR

Drug: montelukast [Singulair]

lebrikizumab

EXPERIMENTAL

Drug: lebrikizumab

Interventions

lebrikizumab DRUG

Given SC on Days 1, 29, and 57

lebrikizumab

montelukast [Singulair] DRUG

10 mg given orally once daily for 12 weeks

Singulair (montelukast)

placebo OTHER

SC injection given on Days 1, 29, and 57

Placebo

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 (112)

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Birmingham, Alabama, 35209, United States

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Flagstaff, Arizona, 86001, United States

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Scottsdale, Arizona, 85251, United States

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Alhambra, California, 91801, United States

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Anaheim, California, 92801, United States

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Los Angeles, California, 90025, United States

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Los Angeles, California, 90048, United States

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Napa, California, 94558, United States

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Rancho Mirage, California, 92270, United States

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Redwood City, California, 94063, United States

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Stockton, California, 95207, United States

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Upland, California, 91786, United States

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Colorado Springs, Colorado, 80907, United States

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Denver, Colorado, 80206, United States

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Waterbury, Connecticut, 06708, United States

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Cooper City, Florida, 33024, United States

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Kissimmee, Florida, 34741, United States

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New Port Richey, Florida, 34653, United States

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Winter Park, Florida, 32789, United States

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Columbus, Georgia, 31904, United States

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Duluth, Georgia, 30096, United States

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Normal, Illinois, 61761, United States

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Oak Lawn, Illinois, 60453, United States

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River Forest, Illinois, 60305, United States

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Avon, Indiana, 46123, United States

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Louisville, Kentucky, 40223, United States

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Minneapolis, Minnesota, 55402, United States

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Plymouth, Minnesota, 55441, United States

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St Louis, Missouri, 63141, United States

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Papillion, Nebraska, 68046, United States

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Ocean City, New Jersey, 07712, United States

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Rochester, New York, 14618, United States

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The Bronx, New York, 10459, United States

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Hendersonville, North Carolina, 28739, United States

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High Point, North Carolina, 27262, United States

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Oklahoma City, Oklahoma, 73120, United States

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Medford, Oregon, 97504, United States

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Portland, Oregon, 97202, United States

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Greer, South Carolina, 29651, United States

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Boerne, Texas, 78006, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77034, United States

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Humble, Texas, 77338, United States

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McKinney, Texas, 75069, United States

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San Antonio, Texas, 78207, United States

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San Antonio, Texas, 78249, United States

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San Antonio, Texas, 78251, United States

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Tomball, Texas, 77375, United States

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Waco, Texas, 76712, United States

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Fairfax, Virginia, 22030, United States

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Henrico, Virginia, 23233, United States

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Greenfield, Wisconsin, 53228, United States

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Rio de Janeiro, Rio de Janeiro, 22271-100, Brazil

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

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Florianópolis, Santa Catarina, 88040-970, Brazil

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Santo André, São Paulo, 09060-650, Brazil

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Santo André, São Paulo, 09080-000, Brazil

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Gabrovo, 5300, Bulgaria

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Razgrad, 7200, Bulgaria

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Rousse, 7002, Bulgaria

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Sofia, 1000, Bulgaria

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Sofia, 1431, Bulgaria

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Varna, 9019, Bulgaria

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Veliko Tarnovo, 5000, Bulgaria

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Brampton, Ontario, L6T 0G1, Canada

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Toronto, Ontario, M9V 4B4, Canada

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Jablonec nad Nisou, 46601, Czechia

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Jindřichův Hradec, 37701, Czechia

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Karlovy Vary - Stará Role, 360 17, Czechia

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Strakonice, 38601, Czechia

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Tbilisi, 0119, Georgia

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Auckland, 0626, New Zealand

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Auckland, 1010, New Zealand

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Beckenham, 8024, New Zealand

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Bialystok, 15-276, Poland

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Krakow, 31-023, Poland

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Krakow, 31-159, Poland

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Lodz, 90-153, Poland

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Lublin, 20-089, Poland

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Poznan, 60-693, Poland

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Poznan, 60-823, Poland

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Tarnów, 33-100, Poland

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Wroclaw, 53-201, Poland

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Wroclaw, 54-239, Poland

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Caguas, 00725, Puerto Rico

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San Juan, 00909-1711, Puerto Rico

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San Juan, 00918, Puerto Rico

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Bucharest, 030303, Romania

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Cluj-Napoca, 400371, Romania

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Iași, 700115, Romania

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Oradea, 410176, Romania

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Timișoara, 300310, Romania

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Moscow, 119991, Russia

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Ryazan, 390011, Russia

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Saint Petersburg, 190068, Russia

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Saint Petersburg, 193231, Russia

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Saint Petersburg, 194295, Russia

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Saint Petersburg, 194354, Russia

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Saint Petersburg, 197089, Russia

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Saint Petersburg, 197706, Russia

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Saratov, 410053, Russia

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Yekaterinburg, 620109, Russia

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Spišská Nová Ves, 052 01, Slovakia

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Cape Town, 7130, South Africa

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Cape Town, 7530, South Africa

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Cape Town, 7700, South Africa

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Johannesburg, 2113, South Africa

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Lyttleton, 0157, South Africa

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Parow, 7505, South Africa

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Pretoria Gauteng Province, 0087, South Africa

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Soweto, 1818, South Africa

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Manchester, M23 9QZ, United Kingdom

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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

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

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: March 26, 2014
• First Posted: April 4, 2014
• Study Start: June 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

ZA (8); BR (5); GE (1); SL (1); US (52); GB (1); CZ (4); NZ (3); CA (2); RO (5); BU (7); PR (3); RU (10); PL (10)