A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 310)
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: 122-0551 Foam; Vehicle Foam
Intervention description: Topical Foam containing active drug; Topical Foam containing no active drug
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 409.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This Phase 3 study (Study 310) has been designed to determine and compare the efficacy and
      safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with
      plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject is male or non-pregnant female and is at least 18 years of age at the time of
             the Screening Visit.

          2. Subject has provided written informed consent.

          3. Subject is willing and able to apply the test article(s) as directed, comply with
             study instructions and commit to all follow-up visits for the duration of the study.

          4. Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2%
             and no more than 12% body surface area (BSA) (excluding the face, scalp, groin,
             axillae and other intertriginous areas).

          5. Subject has an Investigator's Global Assessment (IGA) score of at least three (3 =
             moderate) at the Baseline Visit.

          6. Females must be post-menopausal , surgically sterile or use an effective method of
             birth control , with a negative urine pregnancy test (UPT) at the Baseline Visit.

        Exclusion Criteria:

          1. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.

          2. Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.

          3. Subject has a physical condition which, in the investigator's opinion, might impair
             evaluation of plaque psoriasis, or which exposes the subject to an unacceptable risk
             by study participation.

          4. Subject has used any phototherapy (including laser), photo-chemotherapy or other forms
             of photo based therapy for the treatment of their psoriasis within 30 days prior to
             the Baseline Visit.

          5. Subject has used any systemic methotrexate, retinoids, systemic corticosteroids
             [including intralesional, intra-articular, and intramuscular corticosteroids],
             cyclosporine or analogous products within 90 days prior to the Baseline Visit.

          6. Subject has used any systemic biologic therapy (i.e., FDA-approved or experimental
             therapy) within five (5) half-lives of the biologic prior to the Baseline Visit.
             Published or documented half-life of the product provided by the commercial supplier
             or Sponsor should be used to establish this value.

          7. Subject had prolonged exposure to natural or artificial sources of ultraviolet
             radiation within 30 days prior to the Baseline Visit or is intending to have such
             exposure during the study which in the opinion of the investigator is thought to
             modify the subject's disease.

          8. Subject has used topical body (excluding the scalp) psoriasis therapy (including coal
             tar, anthralin, steroids, retinoids and vitamin D analogs) within 14 days prior to the
             Baseline Visit.

          9. Subject has used emollients/moisturizers on areas to be treated within four hours
             prior to clinical evaluation at the Baseline Visit.

         10. Subject is currently using lithium or Plaquenil (hydroxychloroquine).

         11. Subject is currently using a beta-blocking medication (e.g., propranolol) or
             angiotensin converting enzyme (ACE) inhibitor at a dose that has not been stabilized,
             in the opinion of the investigator.

         12. Subject has a history of sensitivity to any of the ingredients in the test articles.

         13. Subject is pregnant, lactating, or is planning to become pregnant during the study.

         14. Subject is currently enrolled in an investigational drug or device study.

         15. Subject has used an investigational drug or investigational device treatment within 30
             days prior to the Baseline Visit.

         16. Subject has been previously enrolled in this study and treated with a test article.

         17. Subject is known to be noncompliant or is unlikely to comply with the requirements of
             the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in
             the opinion of the investigator.