A Phase 2b Study of Baricitinib in Participants With Moderate to Severe Psoriasis (NCT01490632) | Clinical Trial Compass
CompletedPhase 2
A Phase 2b Study of Baricitinib in Participants With Moderate to Severe Psoriasis
United States271 participantsStarted 2011-12
Plain-language summary
This is a dose-ranging study designed to investigate the efficacy and safety of Baricitinib 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.
Who can participate
Age range18 Years
SexALL
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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 immunodeficie…
What they're measuring
1
Percentage of Participants Achieving Psoriasis Area and Severity Index Score ≥75% (PASI 75) Improvement (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])