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 |
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.
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
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