Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
24 participants
INTERVENTIONAL
2017-11-15
2018-04-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo-matching AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
Placebo
Placebo administered as an oral capsule(s) once daily.
AGN-242428 Higher Dose
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
AGN-242428
AGN-242428 administered as an oral capsule(s) once daily.
AGN-242428 Medium Dose
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
AGN-242428
AGN-242428 administered as an oral capsule(s) once daily.
AGN-242428 Lower Dose
AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks.
AGN-242428
AGN-242428 administered as an oral capsule(s) once daily.
Placebo
Placebo administered as an oral capsule(s) once daily.
Interventions
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AGN-242428
AGN-242428 administered as an oral capsule(s) once daily.
Placebo
Placebo administered as an oral capsule(s) once daily.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Vitae Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Christy Harutunian
Role: STUDY_DIRECTOR
Allergan
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact [email protected] for assistance.
Other Identifiers
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1957-201-001
Identifier Type: -
Identifier Source: org_study_id
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