AGN-242428 in the Treatment of Plaque Psoriasis

• Status: Terminated
• Trial end date: 2018-04-20
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of 3 doses of AGN-242428 in adult participants with moderate to severe plaque-type psoriasis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vitae Pharmaceuticals Inc., an Allergan affiliate; Vitae Pharmaceuticals, Inc.

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.