A Study for Adults With Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: LY2525623 Intravenous; LY2525623 Subcutaneous; Placebo Intravenous; Placebo Subcutaneous
Intervention description: administered intravenously at randomization and every 2 weeks for 6 weeks; administered subcutaneously at randomization and every 2 weeks for 6 weeks; administered intravenously at randomization and every 2 weeks for 6 weeks; administered subcutaneously at randomization and every 2 weeks for 6 weeks
Intervention MeSH terms: Interleukin-23; Antibodies; Immunoglobulins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis

Summary:

      In this study, we will evaluate clinical activity, safety, tolerability, pharmacokinetics,
      pharmacodynamics, and immunogenicity of 5 LY2525623 dosing groups compared to placebo in
      adults with plaque psoriasis.
    

Eligibility criteria:

        Inclusion criteria:

          -  Are ambulatory and greater than or equal to 18 years of age. Females of child-bearing
             potential must test negative for pregnancy at the time of enrollment based on a serum
             pregnancy test and agree to use a highly reliable method of birth control as defined
             by those which result in a low failure rate(<1% per year) during the study.

          -  Chronic psoriasis vulgaris for at least 6 months prior to randomization.

          -  Moderate and severe (plaque) psoriasis involving at least 10% body surface area (BSA)
             or at least 8% BSA in subjects with severe palmar-plantar involvement at
             randomization.

          -  Psoriasis Area and Severity Index (PASI) total score of at least 12 at screening.

        Exclusion criteria:

          -  Have had a clinically significant flare of psoriasis during the 12 weeks prior to
             randomization or a biologic agent/monoclonal antibody within the longer of 5 half
             lives or 12 weeks prior to dosing, had systemic treatment for psoriasis or
             phototherapy within 4 weeks prior to dosing, or had topical psoriasis treatment within
             2 weeks prior to dosing.

          -  Have had a vaccination within 4 to 12 weeks (depending on type) prior to or intend to
             have one within 4 weeks after the dosing period.

          -  Are immunocompromised or have evidence of active infection (such as viral hepatitis
             and/or positive testing for tuberculosis or human immunodeficiency virus [HIV]); or
             have had a recent serious systemic infection (such as mononucleosis or herpes zoster).

          -  Have a history of or current lymphoproliferative disease or malignant disease (except
             for resolved cervical dysplasia; or no more than 3 successfully treated basal- or
             squamous- cell carcinomas of the skin), or severe drug allergies/hypersensitivity.

          -  Have a history of serious cardiac disease within 12 weeks before randomization; or
             have serious or unstable/uncontrolled illnesses including hepatic, renal,
             gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic,
             psychiatric, immunologic, or hematologic disease and other conditions that, in the
             investigator's opinion, could interfere with the analyses of safety and efficacy in
             this study.

          -  Have laboratory test values outside the reference range for the population or
             investigative site that are considered clinically significant and/or have any of the
             following specific abnormalities:

               -  Aspartate transaminase (AST) or alanine transaminase (ALT) >2 x the upper limit
                  of normal (ULN; upper reference range of the central laboratory for the study)

               -  Hemoglobin <100 g/L (10 g/dL)

               -  White blood cell (WBC) <3.0 G/L (3,000/mm3)

               -  Neutrophils <1.5 G/L (1,500/mm3)

               -  Platelets <75 G/L (75,000/mm3)

               -  Serum creatinine >133 µmol/L (1.5 mg/dL)

               -  Random glucose >11.1mmol/L (200 mg/dL).

          -  Have significant allergies to humanized monoclonal antibodies, or clinically
             significant multiple or severe drug allergies, or intolerance to topical
             corticosteroids