Safety and Efficacy Study of a Novel Ointment to Treat Plaque Type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: AN2728; Placebo
Intervention description: Ointment B, 2% or 0.5% applied once or twice daily; Ointment B Vehicle applied once or twice daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Topical; Plaque type psoriasis

Summary:

      The purpose of this study is to evaluate the safety and efficacy of AN2728 Ointment B, 2.0%
      and 0.5%, compared to Ointment Vehicle B, applied once or twice daily for 12 weeks, in the
      treatment of plaque type psoriasis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female >18 years of age at time of enrollment

          -  Clinical diagnosis of stable plaque type psoriasis

          -  Two target plaques of similar severity meeting the following criteria:

               -  5 cm2 and ≤ 100 cm2, computed by multiplying the greatest diameter of the plaque
                  by the diameter of the plaque perpendicular to the greatest diameter Bilaterally
                  located (right/left) plaques on the arms or plaques located on the trunk. Plaques
                  located on the trunk must be separated by at least 10 cm Overall target plaque
                  severity score (OTPSS) of 2-4 (mild to moderate) with no more than a 1 point
                  difference in the scores of the two target plaques

          -  Willing and able to apply study drug as directed, comply with study instructions and
             commit to all follow-up visits

          -  Ability to understand, agree to and sign the study Informed Consent Form (ICF) prior
             to initiation of any protocol related procedures

        Exclusion Criteria:

          -  Any dermatological conditions, disease state or physical condition that could
             interfere with clinical evaluations or might expose the patient to an unacceptable
             risk by study participation

          -  Any underlying disease(s) or other dermatological conditions that require the use of
             exclusionary topical or systemic therapy (see below)

          -  Clinically significant, abnormal Screening laboratory results (unless approved by the
             medical monitor)

          -  Known sensitivity to any of the components of the study medication

          -  Spontaneously improving or rapidly deteriorating psoriatic plaques or
             pustular/exfoliative, guttate, erythrodermic or other non-plaque form of psoriasis

          -  Concomitant use of topical or systemic therapies that might alter the course of
             psoriasis

          -  Females of child bearing potential. Females must be post-menopausal (based on FSH
             levels) or surgically sterile (hysterectomy or bilateral oophorectomy)

          -  Washout periods for exclusionary therapies:

        Oral retinoids: 8 weeks Non-retinoid systemic drugs that might alter the course of
        psoriasis: 4 weeks Psoralens with UV-A (PUVA): 4 weeks Ultraviolet-B (UVB) therapy: 4 weeks
        Topical drugs that might alter the course of psoriasis: 2 weeks Use of
        emollients/moisturizers on area(s) to be treated: 2 days prior to Baseline visit

          -  AIDS or AIDS-related illness

          -  Concurrent participation in another drug or device research study or within 30 days
             prior to enrollment

          -  Use of lithium- or hydroxychloroquine-containing products (e.g., Plaquenil)

          -  Use of a beta-blocking medication (e.g., Propranolol) if the dose has not been
             stabilized for at least 3 months

          -  Use of AN2728 in a previous clinical trial