Clinical trial NCT01490632 (phase 2, status: completed)
Conditions: psoriasis, skin diseases, skin diseases, papulosquamous
ICD codes: L40.0, L40.4, L40.8, L40.9, L40.1, L40.50, L99, O99.711, O99.712, O99.713, O99.719, O99.72, O99.73
Drugs: placebo, baricitinib
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CCS(=O)(=O)N1CC(CC#N)(C1)N1C=C(C=N1)C1=C2C=CNC2=NC=N1
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