Status:
TERMINATED
AGN-242428 in the Treatment of Plaque Psoriasis
Lead Sponsor:
Vitae Pharmaceuticals, Inc.
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 ps...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03339999
Start Date
November 15 2017
End Date
April 20 2018
Last Update
April 6 2021
Active Locations (15)
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1
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States, 35205
2
Radiant Tucson
Tucson, Arizona, United States, 85712
3
Johnson Dermatology
Fort Smith, Arkansas, United States, 72916
4
First OC Dermatology
Fountain Valley, California, United States, 92708