A Phase 2b Study of LY3009104 in Participants With Moderate to Severe Psoriasis

• Efficacy of LY3009104 in participants with moderate to severe plaque psoriasis. Measure: Static Physician Global Assessment (sPGA) [ Time Frame: Week 12, Week 24, and Week 92 ] [ Designated as safety issue: No ]
• Efficacy of LY3009104 in participants with moderate to severe plaque psoriasis. Measure: Psoriasis Area and Severity Index (PASI) [ Time Frame: Week 12, Week 24, and Week 92 ] [ Designated as safety issue: No ]
• Quality of life and outcome assessments. Measures: Patient Reported Outcomes (PRO) [ Time Frame: Week 12, Week 24, and Week 92 ] [ Designated as safety issue: No ]

This is a dose-ranging study designed to investigate the efficacy and safety of LY3009104 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.

• Psoriasis
• Skin Diseases
• Skin Diseases, Papulosquamous

• Drug: Placebo
  Administered orally
• Drug: LY3009104
  Administered orally
  Other Names:

  • LY3009104
  • JAK1/JAK2 Inhibitor
  • Janus Kinase 1/2 Inhibitor
  • INCB028050

• Placebo Comparator: Placebo
  Administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose may be increased to LY3009104 8 mg or 10 mg orally once daily for an additional 12 weeks.
  Intervention: Drug: Placebo
• Experimental: 2 mg LY3009104
  Administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose may be increased to LY3009104 8 mg or 10 mg orally once daily for an additional 12 weeks.
  Intervention: Drug: LY3009104
• Experimental: 4 mg LY3009104
  Administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose may be increased to LY3009104 8 mg or 10 mg orally once daily for an additional 12 weeks.
  Intervention: Drug: LY3009104
• Experimental: 8 mg LY3009104
  Administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose may be increased to LY3009104 10 mg orally once daily for an additional 12 weeks.
  Intervention: Drug: LY3009104
• Experimental: 10 mg LY3009104
  Administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, LY3009104 10 mg orally once daily may be continued for an additional 12 weeks.
  Intervention: Drug: LY3009104

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