AGN-242428 in the Treatment of Plaque Psoriasis

Launched by VITAE PHARMACEUTICALS, INC. · Nov 8, 2017

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants who have a confirmed diagnosis of plaque psoriasis, diagnosed at least 6 months before study with a Physician's Global Assessment (PGA) score ≥ 3 at screening and baseline
• • Severity of disease must be at least moderate, defined as Psoriasis Area and Severity Index (PASI) ≥ 12 and % body surface area (BSA) ≥ 10
• • Participant is a candidate for phototherapy or systemic therapy for psoriasis
• • Body weight of at least 55 kilograms (kg) (121 (pound) lbs)
• Exclusion Criteria:
• • Non-plaque forms of psoriasis (erythrodermic, guttate, pustular) or drug-induced psoriasis
• • Psoriasis which has not been stable for the 4 weeks prior to screening and which is unstable at Study Day 1
• • History of Gilbert's, Rotor, or Dubin-Johnson syndromes or any other disorder of bilirubin metabolism
• • History of active mycobacterium tuberculosis (TB) infection or untreated or inadequately treated latent TB
• • Positive QuantiFERON test for TB infection at screening
• • Had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months prior to baseline
• • Positive drug and/or alcohol test at screening (with the exception of marijuana). Retesting in the case of a positive alcohol test is allowed at the discretion of the sponsor
• • Current treatment or history of treatment with any anti-Tumor Necrosis Factor alpha (TNFα) biologic therapy within 3 months or 5 half-lives of study, and/or all other biologics within 6 months of study (Day 1)
• • Efficacy failure on 2 or more biologic agents for the treatment of psoriasis when the failures occurred within 1 year of the initiation of the therapy of the first biologic agent
• • Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin (TBL) exceeding 1.5 times the upper limit of normal (ULN) at screening.