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AGN-242428 in the Treatment of Plaque Psoriasis

Primary Purpose

Plaque Psoriasis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AGN-242428
Placebo
Sponsored by
Vitae Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Total Skin and Beauty Dermatology Center, PC
  • Radiant Tucson
  • Johnson Dermatology
  • First OC Dermatology
  • University Clinical Trials
  • Horizons Clinical Research Center
  • Belleair Research Center
  • Dawes Fretzin Dermatology Group
  • The Indiana Clinical Trials Center, PC
  • South Bend Clinic
  • Kansas City Dermatology
  • Somerset Skin Centre
  • Oregon Medical Research Center
  • Arlington Research Center, Inc
  • Progressive Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

AGN-242428 Higher Dose

AGN-242428 Medium Dose

AGN-242428 Lower Dose

Arm Description

Placebo-matching AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.

AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.

AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.

AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Percentage of Participants Achieving Reduction (Improvement) in PASI Score of ≥ 50% 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.
Percentage of Participants Achieving Reduction (Improvement) in PASI Score of ≥ 90% 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.
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.
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.
Number of Participants With TEAEs Considered Related to the Study Treatment as Per Investigator
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. The TEAEs related to the study drug, as assessed by Investigator are reported.
Plasma Concentration of AGN-242428

Full Information

First Posted
November 8, 2017
Last Updated
March 10, 2021
Sponsor
Vitae Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03339999
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
safety reason
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
March 22, 2018 (Actual)
Study Completion Date
April 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vitae Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo-matching AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
Arm Title
AGN-242428 Higher Dose
Arm Type
Experimental
Arm Description
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
Arm Title
AGN-242428 Medium Dose
Arm Type
Experimental
Arm Description
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
Arm Title
AGN-242428 Lower Dose
Arm Type
Experimental
Arm Description
AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks.
Intervention Type
Drug
Intervention Name(s)
AGN-242428
Intervention Description
AGN-242428 administered as an oral capsule(s) once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered as an oral capsule(s) once daily.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving a Reduction (Improvement) in Psoriasis Area and Severity Index (PASI) Score of ≥ 75% From Baseline to Week 16
Description
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 Outcome Measure Information:
Title
Percentage of Participants Achieving ≥ 2-point Reduction (Improvement) in Physician's Global Assessment (PGA) Score at Week 16
Description
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
Title
Percentage of Participants Achieving a Clear (0) or Almost Clear (1) Score in PGA at Week 16
Description
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
Title
Percentage of Participants Achieving Reduction (Improvement) in PASI Score of ≥ 50% From Baseline to Week 16
Description
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
Title
Percentage of Participants Achieving Reduction (Improvement) in PASI Score of ≥ 90% From Baseline to Week 16
Description
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
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
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
Title
Number of Participants With TEAEs Leading to Discontinuation
Description
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
Title
Number of Participants With TEAEs Considered Related to the Study Treatment as Per Investigator
Description
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. The TEAEs related to the study drug, as assessed by Investigator are reported.
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christy Harutunian
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Total Skin and Beauty Dermatology Center, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Radiant Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Johnson Dermatology
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Facility Name
First OC Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
University Clinical Trials
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Horizons Clinical Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Belleair Research Center
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Dawes Fretzin Dermatology Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
The Indiana Clinical Trials Center, PC
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Kansas City Dermatology
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Somerset Skin Centre
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Arlington Research Center, Inc
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States

12. IPD Sharing Statement

Links:
URL
http://AllerganClinicalTrials.com
Description
Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.

Learn more about this trial

AGN-242428 in the Treatment of Plaque Psoriasis

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