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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Singulair (montelukast) | Active Comparator |
| |
| lebrikizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lebrikizumab | Drug | Given SC on Days 1, 29, and 57 |
| |
| montelukast [Singulair] |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) | From Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35209 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29413502 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 4, 2026 | |
| Reset | May 29, 2026 |
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| Drug |
10 mg given orally once daily for 12 weeks |
|
| placebo | Other | SC injection given on Days 1, 29, and 57 |
|
| 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 |
| Pharmacodynamics: Change in blood eosinophil count | From Baseline to Week 12 |
| Pharmacokinetics: Maximum serum lebrikizumab concentration after the first dose (Cmax) | Week 1 |
| Change in patient-reported outcome, as measured by the Standardized Asthma Quality of Life Questionnaire (AQLQ(S)) | From Baseline to Week 12 |
| Flagstaff |
| Arizona |
| 86001 |
| United States |
| Scottsdale | Arizona | 85251 | United States |
| Alhambra | California | 91801 | United States |
| Anaheim | California | 92801 | United States |
| Los Angeles | California | 90025 | United States |
| Los Angeles | California | 90048 | United States |
| Napa | California | 94558 | United States |
| Rancho Mirage | California | 92270 | United States |
| Redwood City | California | 94063 | United States |
| Stockton | California | 95207 | United States |
| Upland | California | 91786 | United States |
| Colorado Springs | Colorado | 80907 | United States |
| Denver | Colorado | 80206 | United States |
| Waterbury | Connecticut | 06708 | United States |
| Cooper City | Florida | 33024 | United States |
| Kissimmee | Florida | 34741 | United States |
| New Port Richey | Florida | 34653 | United States |
| Winter Park | Florida | 32789 | United States |
| Columbus | Georgia | 31904 | United States |
| Duluth | Georgia | 30096 | United States |
| Normal | Illinois | 61761 | United States |
| Oak Lawn | Illinois | 60453 | United States |
| River Forest | Illinois | 60305 | United States |
| Avon | Indiana | 46123 | United States |
| Louisville | Kentucky | 40223 | United States |
| Minneapolis | Minnesota | 55402 | United States |
| Plymouth | Minnesota | 55441 | United States |
| St Louis | Missouri | 63141 | United States |
| Papillion | Nebraska | 68046 | United States |
| Ocean City | New Jersey | 07712 | United States |
| Rochester | New York | 14618 | United States |
| The Bronx | New York | 10459 | United States |
| Hendersonville | North Carolina | 28739 | United States |
| High Point | North Carolina | 27262 | United States |
| Oklahoma City | Oklahoma | 73120 | United States |
| Medford | Oregon | 97504 | United States |
| Portland | Oregon | 97202 | United States |
| Greer | South Carolina | 29651 | United States |
| Boerne | Texas | 78006 | United States |
| Dallas | Texas | 75231 | United States |
| Houston | Texas | 77034 | United States |
| Humble | Texas | 77338 | United States |
| McKinney | Texas | 75069 | United States |
| San Antonio | Texas | 78207 | United States |
| San Antonio | Texas | 78249 | United States |
| San Antonio | Texas | 78251 | United States |
| Tomball | Texas | 77375 | United States |
| Waco | Texas | 76712 | United States |
| Fairfax | Virginia | 22030 | United States |
| Henrico | Virginia | 23233 | United States |
| Greenfield | Wisconsin | 53228 | United States |
| Rio de Janeiro | Rio de Janeiro | 22271-100 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Florianópolis | Santa Catarina | 88040-970 | Brazil |
| Santo André | São Paulo | 09060-650 | Brazil |
| Santo André | São Paulo | 09080-000 | Brazil |
| Gabrovo | 5300 | Bulgaria |
| Razgrad | 7200 | Bulgaria |
| Rousse | 7002 | Bulgaria |
| Sofia | 1000 | Bulgaria |
| Sofia | 1431 | Bulgaria |
| Varna | 9019 | Bulgaria |
| Veliko Tarnovo | 5000 | Bulgaria |
| Brampton | Ontario | L6T 0G1 | Canada |
| Toronto | Ontario | M9V 4B4 | Canada |
| Jablonec nad Nisou | 46601 | Czechia |
| Jindřichův Hradec | 37701 | Czechia |
| Karlovy Vary - Stará Role | 360 17 | Czechia |
| Strakonice | 38601 | Czechia |
| Tbilisi | 0119 | Georgia |
| Auckland | 0626 | New Zealand |
| Auckland | 1010 | New Zealand |
| Beckenham | 8024 | New Zealand |
| Bialystok | 15-276 | Poland |
| Krakow | 31-023 | Poland |
| Krakow | 31-159 | Poland |
| Lodz | 90-153 | Poland |
| Lublin | 20-089 | Poland |
| Poznan | 60-693 | Poland |
| Poznan | 60-823 | Poland |
| Tarnów | 33-100 | Poland |
| Wroclaw | 53-201 | Poland |
| Wroclaw | 54-239 | Poland |
| Caguas | 00725 | Puerto Rico |
| San Juan | 00909-1711 | Puerto Rico |
| San Juan | 00918 | Puerto Rico |
| Bucharest | 030303 | Romania |
| Cluj-Napoca | 400371 | Romania |
| Iași | 700115 | Romania |
| Oradea | 410176 | Romania |
| Timișoara | 300310 | Romania |
| Moscow | 119991 | Russia |
| Ryazan | 390011 | Russia |
| Saint Petersburg | 190068 | Russia |
| Saint Petersburg | 193231 | Russia |
| Saint Petersburg | 194295 | Russia |
| Saint Petersburg | 194354 | Russia |
| Saint Petersburg | 197089 | Russia |
| Saint Petersburg | 197706 | Russia |
| Saratov | 410053 | Russia |
| Yekaterinburg | 620109 | Russia |
| Spišská Nová Ves | 052 01 | Slovakia |
| Cape Town | 7130 | South Africa |
| Cape Town | 7530 | South Africa |
| Cape Town | 7700 | South Africa |
| Johannesburg | 2113 | South Africa |
| Lyttleton | 0157 | South Africa |
| Parow | 7505 | South Africa |
| Pretoria Gauteng Province | 0087 | South Africa |
| Soweto | 1818 | South Africa |
| Manchester | M23 9QZ | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 4, 2026 | May 29, 2026 | |||
| Jun 19, 2026 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C561806 | lebrikizumab |
| C093875 | montelukast |
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