A Phase 2b Study of Baricitinib in Participants With Moderate to Severe Psoriasis
Condition: Psoriasis; Skin Diseases; Skin Diseases, Papulosquamous
MeSH terms: Psoriasis; Skin Diseases; Skin Diseases, Papulosquamous
Intervention: Placebo; Baricitinib
Intervention description: Administered orally; Administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 271.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Moderate; Severe; Plaque; Chronic

Summary:

      This is a dose-ranging study designed to investigate the efficacy and safety of Baricitinib
      in the treatment of participants with moderate to severe, chronic plaque psoriasis as
      assessed by the Psoriasis Area and Severity Index (PASI) score and routine safety
      assessments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  You must have active chronic plaque psoriasis for at least 6 months prior to entry
             into the study

          -  You are a candidate for systemic therapy and/or phototherapy

          -  You must have active plaque psoriasis covering at least 12% body surface area

          -  You must have Psoriasis Area and Severity Index (PASI) score of at least 12

          -  You must have Static Physician's Global Assessment (sPGA) score of at least 3

        Exclusion Criteria:

          -  You must not have received a biologic agent/monoclonal antibody within 8 weeks prior
             to entry into the study

          -  You must not have prior treatment with an oral Janus kinase (JAK) inhibitor

          -  You must not have received a systemic psoriasis (Ps) therapy within 4 weeks prior to
             entry into the study

          -  You must not have received a phototherapy within 4 weeks prior to entry into the study

          -  You must not have received a topical Ps therapy with psoralens within 4 weeks prior to
             entry into the study

          -  You must not be pregnant or nursing

          -  If female of childbearing potential or a male, and do not agree to use 2 forms of
             highly effective methods of birth control for at least 28 days following the last dose
             of investigational product

          -  You must not have had symptomatic herpes zoster or herpes simplex infection within 12
             weeks or have a history of disseminated/complicated herpes zoster

          -  You must not have evidence of active infection, such as fever ≥38.0ºC (100.4ºF)

          -  You must not have a history of active hepatitis B, hepatitis C, or human
             immunodeficiency virus (HIV)

          -  You must not be immunocompromised and, in the opinion of the investigator, are at an
             unacceptable risk for participating in the study

          -  You must not have known history hypogammaglobulinemia

          -  You must not have had a serious systemic or local infection within 12 weeks prior to
             entry into the study

          -  You must not have been exposed to a live vaccine within 12 weeks prior to entry into
             the study, or expected to need/receive a live vaccine (including herpes zoster
             vaccination) during the course of the study

          -  You must not have had household contact with a person with active tuberculosis (TB)
             and did not receive appropriate and documented prophylaxis for TB

          -  You must not have a serious and/or unstable illness that, in the opinion of the
             investigator, poses an unacceptable risk for the your participation in the study

          -  You must not have or have had a history of lymphoproliferative disease; or signs or
             symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy
             or splenomegaly; or active primary or recurrent malignant disease; or been in
             remission from clinically significant malignancy for less than 5 years

          -  You must not have a history of chronic alcohol abuse or intravenous (IV) drug abuse
             within the last 2 years

          -  You must not have donated blood of more than 500 mL within 4 weeks

          -  You must not have received a topical Ps treatment within 2 weeks prior to entry into
             the study

               -  Exceptions:

               -  class 6 (mild, such as desonide) or class 7 (least potent, such as
                  hydrocortisone) topical steroids used on the face, axilla, palms, soles, and/or
                  genitalia

               -  non-medicated shampoos (for example, that do not contain corticosteroids, coal
                  tar, or vitamin D3 analogues)

               -  emollients that do not contain alpha or beta hydroxyl acids