![]() The study met the primary objective, showing statistically greater improvements from baseline in Eczema Area and Severity Index (EASI) score at 16 weeks with all four subcutaneous doses of AMG 451/KHK4083 compared with placebo (600 mg every two weeks (Q2W) = -57.4% 600 mg Q4W = -49.7% 300 mg Q2W = -61.1% 150 mg Q4W = -48.3% vs. The Phase 2, multicenter, randomized, double-blind, placebo-controlled trial investigated the efficacy and safety of AMG 451/KHK4083 in adults with moderate-to-severe atopic dermatitis who were not adequately controlled with topical agents. AMG 451/KHK4083 is a potential first-in-class anti-OX40 fully human monoclonal antibody in development for the treatment of moderate-to-severe atopic dermatitis. (TSE:4151) today announced that positive data from a Phase 2 study of AMG 451/KHK4083 were presented at the European Academy of Dermatology and Venereology 30 th Virtual Congress on Oct. 2, 2021 /PRNewswire/ - Amgen (NASDAQ: AMGN) and Kyowa Kirin Co., Ltd. All rights reserved.Clinical Trial Diversity and RepresentationĬlinical Trial Transparency, Data Sharing and Disclosure PracticesĪdverse Event and Product Complaint ReportingĮnvironmental, Social & Governance Report 2022Įnvironment, Social and Governance StrategyĬommunity Investment and Amgen Foundation ![]() Long-term safety phase II studies phase III studies pooled analysis psoriasis secukinumab.Ĭopyright © 2016 American Academy of Dermatology, Inc. Secukinumab had a favorable safety profile, had no meaningful difference between the 300- and 150-mg doses and, in terms of safety, was comparable to etanercept over 52 weeks in patients with moderate to severe plaque psoriasis. There was a limited number of patients in comparator groups and the exposure to placebo was short. AEs were not dose-related except for nonserious, mild/moderate, skin/mucosal candidiasis (IRs 3.55, 1.85, and 1.37 for secukinumab 300 mg, 150 mg, and etanercept, respectively). Over 52 weeks, for secukinumab 300 mg, 150 mg, and etanercept, respectively, exposure-adjusted incidence rates (IRs) per 100 SYs were comparable across treatments for total adverse events (AEs 236.1, 239.9, and 243.4, respectively) infections (91.1, 85.3, and 93.7, respectively) serious AEs (7.4, 6.8, and 7.0, respectively) serious infections (1.4, 1.1, and 1.4, respectively) malignant or unspecified tumors (0.77, 0.97, and 0.68, respectively) and adjudicated major adverse cardiovascular events (0.42, 0.35, and 0.34, respectively). We reviewed safety data from the secukinumab psoriasis phase II/III program.ĭata were pooled from 10 phase II/III secukinumab psoriasis studies.Īnalysis included 3993 subjects 3430 received secukinumab, representing 2725 subject-years (SYs) of exposure. Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, has demonstrated efficacy and safety in patients with moderate to severe plaque psoriasis.
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