AGN-242428 in the Treatment of Plaque Psoriasis

Phase 2TerminatedNCT03339999

Vitae Pharmaceuticals, Inc.24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Plaque Psoriasis

Interventions

AGN-242428DRUG

AGN-242428 administered as an oral capsule(s) once daily.

PlaceboDRUG

Placebo administered as an oral capsule(s) once daily.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (15)

Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, United States

Radiant Tucson

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Percentage of Participants Achieving a Reduction (Improvement) in Psoriasis Area and Severity Index (PASI) Score of ≥ 75% From Baseline to Week 16

The PASI score ranges from 0-72 (with a higher score indicating greater severity of psoriasis), based on a combination of the severity (erythema, induration, and desquamation) of psoriasis and percentage of affected area.

Time frame: Baseline (Day 1) to Week 16

Secondary Outcomes

Percentage of Participants Achieving ≥ 2-point Reduction (Improvement) in Physician's Global Assessment (PGA) Score at Week 16

The investigator evaluated the participant's overall severity of psoriasis using the PGA 5-point scale (0 to 4) where 0=Clear and 4=Severe.

Time frame: Baseline (Day 1) to Week 16

Percentage of Participants Achieving a Clear (0) or Almost Clear (1) Score in PGA at Week 16

The investigator evaluated the participant's overall severity of psoriasis using the PGA 5-point scale (0 to 4) where 0=Clear to 4=Severe.

Time frame: Week 16

Percentage of Participants Achieving Reduction (Improvement) in PASI Score of ≥ 50% From Baseline to Week 16

Time frame: Baseline (Day 1) to Week 16

Percentage of Participants Achieving Reduction (Improvement) in PASI Score of ≥ 90% From Baseline to Week 16

Time frame: Baseline (Day 1) to Week 16

Data from ClinicalTrials.gov

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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

...and 5 more locations

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An AE was considered a TEAE if the AE began or worsened (increased in severity or became serious) on or after the date of the first dose of study drug.

Time frame: First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose

Number of Participants With TEAEs Leading to Discontinuation

An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An AE was considered a TEAE if the AE began or worsened (increased in severity or became serious) on or after the date of the first dose of study drug.

Time frame: First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose

Number of Participants With TEAEs Considered Related to the Study Treatment as Per Investigator

Time frame: First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose

Plasma Concentration of AGN-242428

Time frame: Single sample predose at Week 4 and 8 Visits, single sample 1-2 hours postdose at Weeks 6 and 10 Visits