A Study of Lebrikizumab in Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
Status: | Completed |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 5/20/2017 |
Start Date: | July 31, 2013 |
End Date: | January 2, 2017 |
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
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.
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.
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
We found this trial at
70
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3816 Woodruff Avenue
Long Beach, California 90808
Long Beach, California 90808
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Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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