AGN-242428 in the Treatment of Plaque Psoriasis



Status:Terminated
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 75
Updated:3/17/2019
Start Date:November 15, 2017
End Date:April 20, 2018

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A Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AGN-242428 in Patients With Plaque Psoriasis

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.


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.
We found this trial at
15
sites
Pinellas Park, Florida 33781
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4495 Hale Parkway
Denver, Colorado 80220
303-399-4067
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Denver, CO
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4499 Medical Drive
San Antonio, Texas 78229
210-614-5557
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San Antonio, TX
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Arlington, Texas 76011
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Arlington, TX
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Birmingham, Alabama 35205
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Birmingham, AL
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Fort Smith, Arkansas 72916
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Fort Smith, AR
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17271 Brookhurst Street
Fountain Valley, California 92708
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Fountain Valley, CA
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Indianapolis, Indiana 46256
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Indianapolis, IN
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Overland Park, Kansas 66215
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Overland Park, KS
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Plainfield, Indiana 46168
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Plainfield, IN
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Portland, Oregon 97223
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Portland, OR
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San Diego, California 92123
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San Diego, CA
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211 North Eddy St.
South Bend, Indiana 46617
574-234-8161
South Bend Clinic The South Bend Clinic employs a staff of 610 at its five...
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South Bend, IN
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Troy, Michigan 48084
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Troy, MI
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Tucson, Arizona 85712
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Tucson, AZ
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