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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01490632
First received: December 9, 2011
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Drug: Placebo
Drug: LY3009104
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Phase 2b Study of LY3009104 in Patients With Moderate-to-Severe Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Efficacy of LY3009104 in participants with moderate to severe plaque psoriasis. Measure: Psoriasis Area and Severity Index (PASI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 240
Study Start Date: December 2011
Estimated Study Completion Date: August 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Placebo
Administered orally
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.
Drug: LY3009104
Administered orally
Other Names:
  • LY3009104
  • JAK1/JAK2 Inhibitor
  • Janus Kinase 1/2 Inhibitor
  • INCB028050
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.
Drug: LY3009104
Administered orally
Other Names:
  • LY3009104
  • JAK1/JAK2 Inhibitor
  • Janus Kinase 1/2 Inhibitor
  • INCB028050
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.
Drug: LY3009104
Administered orally
Other Names:
  • LY3009104
  • JAK1/JAK2 Inhibitor
  • Janus Kinase 1/2 Inhibitor
  • INCB028050
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.
Drug: LY3009104
Administered orally
Other Names:
  • LY3009104
  • JAK1/JAK2 Inhibitor
  • Janus Kinase 1/2 Inhibitor
  • INCB028050

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490632

  Show 35 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Incyte Corporation
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01490632     History of Changes
Other Study ID Numbers: 14455, I4V-MC-JADP
Study First Received: December 9, 2011
Last Updated: September 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Moderate
Severe
Plaque
Chronic

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on April 16, 2014