Clinical trial NCT02905331 (phase 3, status: completed)
Conditions: psoriasis
ICD codes: L40.0, L40.4, L40.8, L40.9, L40.1, L40.50
Drugs: guselkumab, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  A woman of childbearing potential must have a negative urine pregnancy test
             (beta-human chorionic gonadotropin) at screening and at Week 0

          -  Before randomization, a woman must be either: a) Not of childbearing potential:
             premenarchal; postmenopausal (greater than [>] 45 years of age with amenorrhea for at
             least 12 months or any age with amenorrhea for at least 6 months and a serum
             follicle-stimulating hormone level (FSH) >40 International Units Per Liter [IU/L]);
             permanently sterile (example, tubal occlusion, hysterectomy, bilateral salpingectomy);
             or otherwise be incapable of pregnancy, b) Of childbearing potential and practicing a
             highly effective method of birth control, consistent with local regulations regarding
             the use of birth control methods for subjects participating in clinical studies:
             example, established use of oral, injected or implanted hormonal methods of
             contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS);
             barrier methods: condom or occlusive cap (diaphragm or cervical/vault caps) plus
             spermicidal foam/gel/ film/cream/suppository (if available in their locale); male
             partner sterilization (the vasectomized partner should be the sole partner for that
             participant); true abstinence (when this is in line with the preferred and usual
             lifestyle of the participant)

          -  Agree not to receive a Bacillus Calmette Guerin (BCG) vaccination during the study, or
             within 12 months after the last administration of study drug

          -  Have a Psoriasis Area and Severity Index (PASI) greater than or equal to [>=] 12 at
             screening and at baseline

          -  Have an involved body surface area (BSA) >= 10 percent (%) at screening and at
             baseline

        Exclusion Criteria:

          -  Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg,
             unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac
             hospitalization within the last 3 months

          -  Has a history of lymphoproliferative disease, including lymphoma; a history of
             monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms
             suggestive of possible lymphoproliferative disease, such as lymphadenopathy or
             splenomegaly

          -  Has a transplanted organ (with exception of a corneal transplant >3 months before the
             first administration of study drug)

          -  Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular)

          -  Has received any anti-tumor necrosis factor alpha (TNF-alpha) biologic therapy within
             3 months before the first administration of study drug