Clinical trial NCT03339999: AGN-242428 in the Treatment of Plaque Psoriasis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AGN-242428 in Patients With Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Vitae Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2017-11-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 psoriasis.


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.

Primary outcomes:
measure: Percentage of Participants Achieving a Reduction (Improvement) in Psoriasis Area and Severity Index (PASI) Score of ≥ 75% From Baseline to Week 16
timeFrame: Baseline (Day 1) to Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving ≥ 2-point Reduction (Improvement) in Physician's Global Assessment (PGA) Score at Week 16
timeFrame: Baseline (Day 1) to Week 16
measure: Percentage of Participants Achieving a Clear (0) or Almost Clear (1) Score in PGA at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving Reduction (Improvement) in PASI Score of ≥ 50% From Baseline to Week 16
timeFrame: Baseline (Day 1) to Week 16
measure: Percentage of Participants Achieving Reduction (Improvement) in PASI Score of ≥ 90% From Baseline to Week 16
timeFrame: Baseline (Day 1) to Week 16
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
measure: Number of Participants With TEAEs Leading to Discontinuation
timeFrame: First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
measure: Number of Participants With TEAEs Considered Related to the Study Treatment as Per Investigator
timeFrame: First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
measure: Plasma Concentration of AGN-242428
timeFrame: Single sample predose at Week 4 and 8 Visits, single sample 1-2 hours postdose at Weeks 6 and 10 Visits
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center, PC
state: Alabama
city: Tucson
country: United States
facility: Radiant Tucson
state: Arizona
city: Fort Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: San Diego
country: United States
facility: University Clinical Trials
state: California
city: Denver
country: United States
facility: Horizons Clinical Research Center
state: Colorado
city: Pinellas Park
country: United States
facility: Belleair Research Center
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin Dermatology Group
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
state: Indiana
city: South Bend
country: United States
facility: South Bend Clinic
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Dermatology
state: Kansas
city: Troy
country: United States
facility: Somerset Skin Centre
state: Michigan
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Arlington
country: United States
facility: Arlington Research Center, Inc
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
Study officials:
affiliation: Allergan
name: Christy Harutunian
role: STUDY_DIRECTOR
References: