Status:
COMPLETED
A Study of Lebrikizumab in Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 uncontrolle...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 31 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 2 2017
Estimated Enrollment :
1081 Patients enrolled
Trial Details
Trial ID
NCT01867125
Start Date
July 31 2013
End Date
January 2 2017
Last Update
May 19 2017
Active Locations (230)
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1
Alabama Clinical Research Associates
Pell City, Alabama, United States, 35128
2
Clinical Trial Connection
Flagstaff, Arizona, United States, 86001
3
Desert Sun Clinical Research LLC
Tucson, Arizona, United States, 85710
4
Allianz Medical and Research Center
Fountain Valley, California, United States, 92708