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
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.
Inclusion Criteria:
Exclusion Criteria:
Nedlands, Western Australia 6009, Australia
Bogota DC, 11001, Colombia
Ostrava - Poruba, 708 68, Czechia
Higashiibaraki-gun, 311-3193, Japan
Hokkaido, 053-8506, Japan
Hokkaido, 070-8644, Japan
Kiyose-shi, 204-8585, Japan
Kodaira-shi, 187-0024, Japan
Kokubunji-shi, 185-0014, Japan
Mizunami-shi, 509-6134, Japan
Nagaoka-shi, 940-2085, Japan
Yoshida-gun, 910-1193, Japan
Krakow, 31-637, Poland
Lódz, 90-153, Poland
Craiova, 200515, Romania
Moscow, 117292, Russia
Saint Petersburg, 197022, Russia
Seoul, 130-709, South Korea
Ankara, 06290, Turkey (Türkiye)
Izmir, 35110, Turkey (Türkiye)
Dnipro, 49000, Ukraine
Zaporizhzhya, 69104, Ukraine