DeLand, Florida (PRWEB) August 27, 2013
*To see if you qualify for this Psoriasis Clinical Trial in Florida, visit Avail Clinical Research on the web (http://www.availclinical.com) or contact us directly at (386) 785-2404. There is no cost to participate, no insurance is required, and you may receive compensation for time and travel.
STUDY DESIGN AND DURATION
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, active-comparator, parallel-group study examining the effect on primary efficacy endpoint measures after 12 weeks of 2 dose regimens of the new psoriasis drug versus placebo and versus etanercept in patients with moderate-to-severe plaque psoriasis. All investigational products will be administered subcutaneously. (Unsure if you have psoriasis? Read more about the symptoms of psoriasis here.)
A blinded Maintenance Dosing Period will follow to evaluate the maintenance of response at Week 60 with 2 different dosing intervals of the new psoriasis drug, as well as relapse or rebound following treatment withdrawal, and response to retreatment with the new drug following relapse. Long-term efficacy and safety of the experimental drug will be evaluated for up to a total of 5 years in patients who participate through the entire study.
BACKGROUND & RATIONALE
This new psoriasis drug is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (MAb) that neutralizes the cytokine interleukin-17A (IL-17A, also known as IL-17). It has a high affinity for and neutralizes the activity of both human and monkey IL-17. It has high specificity to IL-17A (IL-17) and has no cross-reactivity to other IL-17 family members (IL-17B-F). This experimental drug blocks IL-17 binding to the IL-17 receptor (IL-17R).
Specific inhibition of IL-17 represents a new approach to the management of psoriasis and a novel mechanism of action compared to other psoriatic therapies. As such, the drug may provide a therapeutic option for patients who are candidates for initial systemic treatment as well as those patients who have lost response, failed to respond, or are intolerant to current marketed drugs. This new drug may provide an alternative therapy providing a favorable benefit/risk profile.
Specifically, targeting IL-17 with this drug is hypothesized to provide optimal therapeutic benefit while reducing the risk of impacting host defenses, which may be inherent with some other biologic-based immunomodulatory treatments.
The primary objectives of the study are to assess whether this new psoriasis drug is:
Superior to placebo at Week 12 in the treatment of patients with moderate-to-severe plaque psoriasis as measured by: