AGN-242428 in the Treatment of Plaque Psoriasis

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Plaque Psoriasis

In brief

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.

Key facts

Study ID

NCT03339999

Run by

Vitae Pharmaceuticals, Inc.

People needed

24

Starts

2017-11-15

Expected to finish

2018-04-20

Last updated by the study team

2021-04-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Total Skin and Beauty Dermatology Center, PC — Birmingham, Alabama, United States
• Radiant Tucson — Tucson, Arizona, United States
• Johnson Dermatology — Fort Smith, Arkansas, United States
• First OC Dermatology — Fountain Valley, California, United States
• University Clinical Trials — San Diego, California, United States
• Horizons Clinical Research Center — Denver, Colorado, United States
• Belleair Research Center — Pinellas Park, Florida, United States
• Dawes Fretzin Dermatology Group — Indianapolis, Indiana, United States
• The Indiana Clinical Trials Center, PC — Plainfield, Indiana, United States
• South Bend Clinic — South Bend, Indiana, United States
• Kansas City Dermatology — Overland Park, Kansas, United States
• Somerset Skin Centre — Troy, Michigan, United States
• Oregon Medical Research Center — Portland, Oregon, United States
• Arlington Research Center, Inc — Arlington, Texas, United States
• Progressive Clinical Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.