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Psoriasis Clinical Trial Now Enrolling at Avail Clinical Research near Orlando, Florida; Accepting M/F Patients with Psoriasis 18 or Older, Get Paid for Participation

August 27, 2013

Avail is conducting a randomized, Phase 3 study comparing the efficacy and safety of a new psoriasis drug with Etanercept and a placebo in patients with moderate-to-severe moderate-to-severe plaque psoriasis.

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.

PRIMARY OBJECTIVES

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:

  • Proportion of patients with an sPGA (0,1) with at least a 2-point improvement from baseline.
  • Proportion of patients achieving a ≥75% improvement in PASI (PASI 75) from baseline.
  • Non-inferior to etanercept at Week 12 in the treatment of patients with moderate-to-severe plaque psoriasis as measured by:
  • Proportion of patients with an sPGA (0,1) with at least a 2-point improvement from baseline.
  • Proportion of patients achieving a ≥75% improvement in PASI (PASI 75) from baseline.
  • Superior to etanercept at Week 12 in the treatment of patients with moderate-to-severe plaque psoriasis as measured by:
  • Proportion of patients with an sPGA (0,1) with at least a 2-point improvement from baseline.
  • Proportion of patients achieving a ≥75% improvement in PASI (PASI 75) from baseline.

INCLUSION CRITERIA

  • Patients are eligible to be included in the study only if they meet all of the following criteria:
  • Are male or female patients 18 years or older.
  • Male patients agree to use a reliable method of birth control during the study.
  • Female patients:

– Are women of childbearing potential who test negative for pregnancy and agree to use a reliable method of birth control or remain abstinent during the study and for at least 12 weeks following the last dose of investigational product, whichever is longer. Methods of contraception considered acceptable include oral contraceptives, contraceptive patch, intrauterine device, vaginal ring, diaphragm with contraceptive gel, or condom with contraceptive gel.

– Are women of non-childbearing potential

– Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic plaque psoriasis for at least 6 months prior to baseline (Week 0; Visit 2).

– Have ≥10% BSA involvement at screening (Visit 1) and baseline (Week 0; Visit 2).

– Have both an sPGA score of ≥3 and PASI score ≥12 at screening (Visit 1) and baseline (Week 0; Visit 2).

– Are a candidate for phototherapy and/or systemic therapy.

– Have given written informed consent approved by the sponsor, or its designee, and the Investigational — – — Review Board (IRB)/ERB governing the site.

For the original version on PRWeb visit: http://www.prweb.com/releases/2013/8/prweb11049587.htm


Source: prweb



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