BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab. Gov Sat 01 Feb 2014 The overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of BI 655066 in adult patients with chronic plaque psoriasis in order to select doses for further clinical trials. BI 655066 Compared to Placebo and Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis. Cosentyx is approved by the FDA for moderate to severe plaque psoriasis in adults.
Alternative Names: BI-655066; Humanised IgG1 monoclonal antibody – Boehringer Ingelheim Latest Information Update: 18 Apr 2016. A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis Not yet recruiting A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS) Completed Tacrolimus, Sirolimus and Ustekinumab vs. BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab Completed. 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. Ustekinumab is a humanized IgG monoclonal antibody that binds to the P40 subunit common to IL12 and IL23. BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab.
Ustekinumab, an inhibitor of the p40 subunit common to IL-12 and 23, was a later addition to the armamentarium of biologic therapies for psoriasis. A phase 2 multicenter, randomized, placeo- and active-comparator-controlled, dose-ranging trial to evaluate guselkumab for the treatment of patients with moderate to severe plaque-type psoriasis (X-PLORE). The establishment of the immunological basis of psoriasis has led to the development of biologic agents targeting specific downstream mediators in the psoriatic cascade. Thus, selective inhibition of IL-23 may be viewed as a refinement on inhibition of both IL-12 and IL-23 by ustekinumab. A phase 2 multicenter, randomized, placebo- and active-comparator-controlled, dose-ranging trial to evaluate guselkumab for the treatment of patients with moderater to severe plaque-type psoriasis (X-PLORE) J Am Acad Dermatol. What role does interleukin-23 play in psoriasis pathogenesis?
Topical therapy may provide symptomatic relief, minimize required doses of systemic medications, and may even be psychologically cathartic for some patients. The concept that many patients with psoriasis in the United States do not receive sufficient treatment to control the disease is suggested by an analysis of surveys performed by the National Psoriasis Foundation between 2003 and 2011 2. The meta-analysis found that more major adverse cardiovascular events were reported in patients who received active treatment with ustekinumab or briakinumab than in those who received placebo (10 out of 3179 patients versus 0 out of 1474 patients). BI 655066 Compared to Placebo & Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis. Multiple Ascending Dose Study of PRX003 in Subjects With Psoriasis. The drug is presently FDA approved for active PsA, rheumatoid arthritis, and ankylosing spondylitis. Psoriasis is a common chronic inflammatory disease that often requires long-term treatment. Biologics, which are protein-based drugs made from living cells, have been shown to improve prognosis and control symptoms and also improve quality of life. Current published estimates of the worldwide prevalence of psoriasis range from approximately 1 to 3. The head-to-head study evaluated the efficacy and safety of BI 655066 versus ustekinumab in 166 patients with moderate-to-severe-plaque psoriasis and found that 39 more patients maintained clear or almost clear skin (PASI 90) on BI 655066 after 9 months compared with ustekinumab. Psoriasis is a skin condition caused by periods of skin cells renewing too quickly.