A Study to Assess the Efficacy and Safety of XP23829 in Subjects With Moderate-to-Severe Chronic Plaque-Type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: XP23829 400 mg QD; XP 23829 800 mg QD; XP23829 400 mg BID; Placebo
Intervention description: active dose 1; active dose 2; active dose 3; control
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study objectives are the following:

        1. To evaluate the efficacy of 3 doses of XP23829 compared to placebo for the treatment of
           moderate-to-severe chronic plaque-type psoriasis.

        2. To evaluate the safety and tolerability of XP23829 in subjects with psoriasis.

        3. To evaluate the pharmacodynamics (PD) of XP23829 through immunological analysis of
           peripheral blood samples.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female subjects, age ≥ 18.

          2. Stable, moderate-to-severe plaque-type psoriasis diagnosed for at least 6 months prior
             to randomization (no morphology changes or significant flares of disease activity in
             the last 6 months in the opinion of the investigator).

          3. Severity of disease meeting all of the following three criteria prior to
             randomization:

               1. Psoriasis Area and Severity Index (PASI) score of 12 or greater

               2. Total Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater

               3. Static Physician's Global Assessment (sPGA) score of 3 or greater

          4. Must be a candidate for phototherapy and/or systemic therapy for psoriasis.

        Exclusion Criteria:

          1. Subjects with current inverse, erythrodermic, predominantly guttate, or pustular
             psoriasis.

          2. Subjects with current drug-induced or drug-exacerbated psoriasis.

          3. Subjects with moderate-to-severe psoriatic arthritis of any type; and subjects with
             mild psoriatic arthritis, who require systemic disease-modifying therapy.

          4. Subjects with unstable or significant illness, including the presence of laboratory
             abnormalities at screening that in the opinion of the investigator would place the
             subject at unacceptable risk if he/she were to participate in the study.

          5. Any skin condition (e.g. eczema) which confounds the ability to interpret data from
             the study.

          6. Treatment with a topical anti-psoriatic therapy within 14 days prior to randomization
             (including topical steroids, topical vitamin A or D analog preparations, tacrolimus,
             pimecrolimus, or anthralin).

          7. Phototherapy or prolonged sun exposure or use of ultraviolet (UV) light sources within
             28 days of randomization.

          8. Use of investigational or approved biologic treatments that are known to affect
             psoriasis, such as adalimumab, etanercept, golimumab or infliximab within 12 weeks of
             randomization and ustekinumab within 24 weeks of randomization.

          9. Use of systemic medications (non-biologics) that are known to affect psoriasis
             (including but not limited to oral corticosteroids, cyclosporine, methotrexate,
             lithium, and beta-adrenergic blockers) within 4 weeks of randomization, or 5
             half-lives, whichever is longer.

         10. Prior treatment with Dimethyl Fumarate (Fumaderm® or Tecfidera®) or any other Fumaric
             Acid Ester (FAE) containing products.

         11. Have failed (due to inadequate response) more than 3 approved systemic agents for the
             treatment of psoriasis.