Psoriasis Clinical Trial

AGN-242428 in the Treatment of Plaque Psoriasis

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 psoriasis.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

24

Study ID:

NCT03339999

Recruitment Status:

Terminated

Sponsor:

Vitae Pharmaceuticals, Inc.

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There are 15 Locations for this study

See Locations Near You

Total Skin and Beauty Dermatology Center, PC
Birmingham Alabama, 35205, United States
Radiant Tucson
Tucson Arizona, 85712, United States
Johnson Dermatology
Fort Smith Arkansas, 72916, United States
First OC Dermatology
Fountain Valley California, 92708, United States
University Clinical Trials
San Diego California, 92123, United States
Horizons Clinical Research Center
Denver Colorado, 80220, United States
Belleair Research Center
Pinellas Park Florida, 33781, United States
Dawes Fretzin Dermatology Group
Indianapolis Indiana, 46256, United States
The Indiana Clinical Trials Center, PC
Plainfield Indiana, 46168, United States
South Bend Clinic
South Bend Indiana, 46617, United States
Kansas City Dermatology
Overland Park Kansas, 66215, United States
Somerset Skin Centre
Troy Michigan, 48084, United States
Oregon Medical Research Center
Portland Oregon, 97223, United States
Arlington Research Center, Inc
Arlington Texas, 76011, United States
Progressive Clinical Research
San Antonio Texas, 78213, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

24

Study ID:

NCT03339999

Recruitment Status:

Terminated

Sponsor:


Vitae Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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