Condition: Asthma · Sponsor: Hoffmann-La Roche
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.
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at least one second controller medication. Participants will be randomized in 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo, administered subcutaneously (SC) every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. During double-blind active treatment extension period, all participants will receive SC injection of lebrikizumab from Week 53 to Week 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Inclusion Criteria: * Asthma diagnosis for greater than equal to (\>/=) 12 months prior to Visit 1 * Bronchodilator response at Visit 1, 2, or 3 * Pre-bronchodilator FEV1 of 40 percent (%) - 80% predicted at both Visits 2 and 3 * On ICS therapy at a total daily dose of 500-2000 micrograms (mcg) of fluticasone propionate dry powder inhaler (DPI) or equivalent for \>/=6 months prior to Visit 1 * On an eligible second controller medication (long-acting beta-agonist \[LABA\], leukotriene receptor antagonist \[LTRA\], long-acting muscarinic antagonist \[LAMA\], or theophylline) for 6 months prior to Visit 1 * Uncontrolled asthma at Visit 1 and/or Visit 2, and at Visit 3 * Chest X-ray or computed tomography (CT) scan within 3 months prior to Visit 1 or chest X-ray during the screening period (prior to Visit 3) confirming the absence of other clinically significant lung disease * Demonstrated adherence with controller medication during the screening period Exclusion Criteria: * History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection * Maintenance oral corticosteroid therapy within 3 months of Visit 1 * Treatment with systemic (oral, intravenous \[IV\], or intramuscular \[IM\]) corticosteroids within 4 weeks prior to Visit 1 or during the screening period * Treatment with intra-articular corticosteroids within 4 weeks prior to Visit 1 or during the screening period or anticipated need for intra-articular corticosteroids during the course of the study * Infection requiring hospital admission for \>/=24 hours or requiring treatment with IV or IM antibiotics within 4 weeks prior to Visit 1 or during screening; Upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening; Active infection that required treatment with oral antibiotics within 2 weeks prior to Visit 1 or during screening; Active parasitic infection or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening * Active tuberculosis requiring treatment within 12 months prior to Visit 1 * Known immunodeficiency, including, but not limited to, human immunodeficiency virus (HIV) infection * Evidence of acute or chronic hepatitis or known liver cirrhosis * History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma * Known current malignancy or current evaluation for potential malignancy * Current smoker or former smoker with a history of greater than (\>) 10 pack-years * History of alcohol or drug abuse * Past and/or current use of any anti-interleukin (IL)-13 or anti-IL-4/IL-13 therapy, including lebrikizumab * Use of other monoclonal antibody therapy, including omalizumab, within 6 months or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening * Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or during screening
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Alabama Clinical Research Associates | Pell City, Alabama, United States | — |
| Desert Sun Clinical Research LLC | Tucson, Arizona, United States | — |
| Allianz Medical and Research Center | Fountain Valley, California, United States | — |
| Allergy & Asthma Medical Group & Research Center, Pc | Long Beach, California, United States | — |
| Allergy Medical Clinic | Los Angeles, California, United States | — |
| CA Allergy & Asthma Med Grp | Los Angeles, California, United States | — |
| North Bay Clinical Trials | Napa, California, United States | — |
| Choc Psf, Amc | Orange, California, United States | — |
| Advances in Medicine | Rancho Mirage, California, United States | — |
| Allergy Assoc Medical Group | San Diego, California, United States | — |
| Bensch Research Associates | Stockton, California, United States | — |
| IMMUNOe Research Centers | Centennial, Colorado, United States | — |
+ 169 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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