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Primary Outcome Measures: Efficacy of ixekizumab in participants with moderate to severe chronic plaque psoriasis

Primary Outcome Measures: Efficacy of ixekizumab in participants with moderate to severe chronic plaque psoriasis. Measure: static Physician Global Assessment (sPGA) Time Frame: 12 Weeks Designated as safety issue: No Efficacy of ixekizumab in participants with moderate to severe chronic plaque psoriasis. Primary Outcome Measures: Proportion of Participants with a 75 Improvement in Psoriasis Area and Severity Index (PASI 75) at Week 24 Time Frame: Week 24 Designated as safety issue: No. Present with moderate-to-severe chronic plaque psoriasis based on a diagnosis of chronic psoriasis for at least 6 months before baseline. The main purpose of this study is to evaluate the efficacy and safety of the study drug ixekizumab compared to placebo in participants with moderate-to-severe genital psoriasis. Safety of Ixekizumab Versus Placebo in Patients With Moderate-to-Severe Genital Psoriasis Resource links provided by NLM:. July 2017 (Final data collection date for primary outcome measure) Arms Assigned Interventions Experimental: Ixekizumab Blinded Treatment Period: 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab every 2 weeks (Q2W) SC from week 2 to week 10. Have chronic plaque psoriasis based on a diagnosis of chronic plaque psoriasis for at least 6 months before baseline.

Primary Outcome Measures: Efficacy of ixekizumab in participants with moderate to severe chronic plaque psoriasis 2Whether ixekizumab can help participants with Psoriasis. Official Title: A Dose-Ranging And Efficacy Study of LY2439821 (An Anti-IL-17 Antibody) In Patients With Moderate-To-Severe Psoriasis Resource links provided by NLM:. Primary Completion Date: January 2011 (Final data collection date for primary outcome measure) Arms Assigned Interventions Experimental: 10 mg ixekizumab Part A:. Moderate Severe Plaque Chronic. (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis (IXORA-P). Purpose The main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in participants with plaque psoriasis. April 2017 (Final data collection date for primary outcome measure) Arms Assigned Interventions Experimental: 80 mg Ixekizumab Q2W 160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 50. Present with chronic plaque psoriasis for at least 6 months prior to enrollment. The primary outcome measure is the efficacy of ixekizumab in participants with moderate to severe chronic plaque psoriasis. Participants who present with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis for at least 6 months prior to randomization, with at least 10 Body Surface Area (BSA) of Psoriasis at screening and at randomization, and/or sPGA score of at least 3 and PASI score of at least 12 at screening and at randomization are eligible, as are candidates for phototherapy and/or systemic therapy.

Clinical Trial Outcome Measures. Primary Measures. Efficacy of ixekizumab in participants with moderate to severe chronic plaque psoriasis. Measure: static Physician Global Assessment (sPGA)Time Frame: 12 WeeksSafety Issue?: No. This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis. Gov Tue 01 May 2012 This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis. Date: March 2014 (Final data collection date for primary outcome measure) Arms: – Experimental: 80 mg ixekizumab Dosing Regimen 1 – Experimental: 80 mg ixekizumab Dosing Regimen 2 – Experimental: 80 mg ixekizumab Dosing Regimen 3 – Active Comparator: 50 mg etanercept – Placebo Comparator: Placebo. The main purpose of this study is to evaluate the efficacy of ixekizumab compared to fumaric acid esters (FAE) and methotrexate (MTX) in participants with moderate-to-severe plaque psoriasis who are naive to systemic treatment. 160 milligrams (mg) ixekizumab given as two subcutaneous injections (SC) followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24. Clinical Trial Outcome Measures. Primary Measures. Present with moderate-to-severe chronic plaque psoriasis based on a diagnosis of chronic psoriasis for at least 6 months before baseline.

A Study In Participants With Moderate To Severe Psoriasis

Efficacy of Ixekizumab in Participants with Moderate to Severe Plaque Psoriasis. Primary Completion Date: May 2014 (Final data collection date for primary outcome measure) Arms Assigned Interventions Experimental: 80 mg Ixekizumab Auto-Injector Ixekizumab administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection thereafter. Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to randomization. Cosentyx is approved by the FDA for moderate to severe plaque psoriasis in adults. Anti-IL-17a or IL-17R mAbs in Phase 3: Secukinumab, ixekizumab and brodalumab. The primary outcome measure was the efficacy of secukinumab compared with placebo as measured by the psoriasis area and severity index (PASI) and investigator’s global assessment at 12 wk. A total of 966 patients with moderate-to-severe chronic plaque psoriasis received induction therapy of 5 once-weekly s. In the single-dose study of s.c. administration, 32 participants received placebo (n 8) or 50, 100, 150 or 250 mg (n 6 per dose) of alirocumab. Keywords: anti-interleukin-17, psoriasis, biologic agents, efficacy, safety, systemic therapy. Clinical potential of brodalumab in the management of psoriasis: the evidence to date Laura F Sandoval,1 Brooke Williams,1 Steven R Feldman1 3 1Department of Dermatology, Center for Dermatology Research, Wake Forest School of Medicine, Winston-Salem, NC, USA; 2Department of Pathology, Wake Forest School of Medicine, Winston-Salem, NC, USA; 3Department of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA Abstract: Brodalumab is an anti-IL-17 receptor monoclonal antibody currently in development for the treatment of moderate-to-severe plaque psoriasis. Currently there are three biological agents, secukinumab, ixekizumab, and brodalumab, under development that target IL-17 produced by Th17 cells. Psoriatic arthritis (PsA) is a chronic inflammatory joint disorder with heterogeneous clinical features that may include plaque psoriasis, joint inflammation, enthesitis, dactylitis, and abnormal bone turn over. Up to 40-50 of patients fail to reach the ACR20 outcome measures in most trials due to primary or secondary non-response, or are unable to tolerate these agents (Fagerli et al. Secukinumab efficacy and safety in Japanese patients with moderate-to-severe plaque psoriasis: subanalysis from ERASURE, a randomized, placebo-controlled, phase 3 study. A Adults with moderate to severe chronic plaque psoriasis. DLQI is the most widely used QOL measure among these instruments in psoriasis-related clinical trials. Overall, secukinumab was considered to be well tolerated; its monthly use in doses of either 3 75 mg or 3 150 mg was found to be statistically efficacious in moderate to severe psoriasis, as measured by the primary outcome of PASI-75 response at 12 weeks.

Study In Participants With Moderate To Severe Psoriasis (uncover-3):