A Study of Ixekizumab in Participants With Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Drug Cocktail; Ixekizumab
Intervention description: Administered orally; Administered SC
Intervention MeSH terms: Vitamin K; Midazolam; Dextromethorphan; Caffeine; Ixekizumab; Omeprazole; Warfarin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is known as a "drug interaction study." The purpose is to learn about how
      ixekizumab may affect the blood levels of a mixture of commonly used drugs (caffeine,
      omeprazole, warfarin, dextromethorphan, and midazolam) that are metabolized by cytochrome
      P450. Each participant will complete two study periods. Participants will take the mixture of
      commonly used drugs (plus vitamin K) by mouth on 3 occasions (prior to treatment with
      ixekizumab and after 1 and 12 weeks of treatment with ixekizumab). The study will last about
      17 weeks, including follow-up. Screening must be completed prior to study start.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females with chronic moderate or severe plaque psoriasis for at least 6
             months who are candidates for systemic therapy or phototherapy

          -  Men and women of childbearing potential must agree to use a reliable method of birth
             control and men may not donate sperm for the duration of the study. Women must test
             negative for pregnancy at screening and agree not to become pregnant during the study
             and until the first normal period following the end of the study

          -  Have a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m²),
             inclusive, at screening

          -  Have greater than or equal to (≥) 10 percent body surface area (BSA) involvement at
             screening and first admission to the clinical research unit (CRU)

          -  Have both a Static Physicians Global Assessment (sPGA) score of ≥3 and Psoriasis Area
             Severity Index (PASI) score ≥12 at screening and first admission to the CRU

        Exclusion Criteria:

          -  Forms of psoriasis other than chronic plaque-type

          -  Pregnant or nursing (lactating women)

          -  History of an ongoing, chronic or recurrent infectious disease, or evidence of
             tuberculosis infection

          -  Have major surgery within 8 weeks prior to first admission to the clinical research
             unit or during the study

          -  Have a history of lymphoproliferative disease, or signs or symptoms of
             lymphoproliferative disease, or have active or history of malignant disease, or have
             uncontrolled cerebrocardiovascular or neuropsychiatric disease

          -  Require treatment with the cocktail drugs or with inhibitors of cytochrome P450 (CYP)
             3A, CYP2C9, CYP2D6, CYP2C19, CYP1A2, or with inducers of CYP3A or CYP1A2, or with
             rifampin (inducer of multiple CYPs) or with substrates of CYP3A, CYP2C9, CYP2D6,
             CYP2C19, or CYP1A2 with narrow therapeutic indices within 14 days prior to the first
             administration of the drug cocktail through the end of Week 12 assessments

          -  Have any known allergy or hypersensitivity to any component of the study cocktail or
             ixekizumab

          -  Have participated in any other study with ixekizumab, secukinumab or brodalumab, or
             have been prescribed ixekizumab or secukinumab