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Study identifier: NCT02104674 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Completed

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

Condition: Asthma  ·  Sponsor: Hoffmann-La Roche

PhasePhase 3
Planned participants313
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where82 locations · 11 countries

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (82)

Clinical Research Center of Alabama, LLCBirmingham, Alabama, United States
Allergy & Asthma Immunology AssociatesScottsdale, Arizona, United States
Anaheim Clinical TrialsAnaheim, California, United States
CA Allergy & Asthma Med Grp; Medical Group, Inc.Los Angeles, California, United States
Southern California Institute For RespiratoryLos Angeles, California, United States
North Bay Clinical TrialsNapa, California, United States
Advances in MedicineRancho Mirage, California, United States
Allergy & Asthma ConsultantsRedwood City, California, United States
Integrated Research Group IncRiverside, California, United States
Storms Clinical Research; InstituteColorado Springs, Colorado, United States
National Jewish HealthDenver, Colorado, United States
Florida Pulmonary Research Institute, LLCWinter Park, Florida, United States

+ 70 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

BirminghamScottsdaleAnaheimLos Angeles

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