AGN-242428 in the Treatment of Plaque Psoriasis

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03339999
• Other study ID #: 1957-201-001
• Status: Terminated
• Phase: Phase 2
• Start date: November 15, 2017
• Est. completion date: April 20, 2018

Study information

• Verified date: March 2021
• Source: Vitae Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: April 20, 2018
• Est. primary completion date: March 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 (TNFa) 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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• AGN-242428
AGN-242428 administered as an oral capsule(s) once daily.
• Placebo
Placebo administered as an oral capsule(s) once daily.

Locations

Country	Name	City	State
United States	Arlington Research Center, Inc	Arlington	Texas
United States	Total Skin and Beauty Dermatology Center, PC	Birmingham	Alabama
United States	Horizons Clinical Research Center	Denver	Colorado
United States	Johnson Dermatology	Fort Smith	Arkansas
United States	First OC Dermatology	Fountain Valley	California
United States	Dawes Fretzin Dermatology Group	Indianapolis	Indiana
United States	Kansas City Dermatology	Overland Park	Kansas
United States	Belleair Research Center	Pinellas Park	Florida
United States	The Indiana Clinical Trials Center, PC	Plainfield	Indiana
United States	Oregon Medical Research Center	Portland	Oregon
United States	Progressive Clinical Research	San Antonio	Texas
United States	University Clinical Trials	San Diego	California
United States	South Bend Clinic	South Bend	Indiana
United States	Somerset Skin Centre	Troy	Michigan
United States	Radiant Tucson	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Vitae Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (Day 1) to Week 16
Secondary	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.	Baseline (Day 1) to Week 16
Secondary	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.	Week 16
Secondary	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.	Baseline (Day 1) to Week 16
Secondary	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.	Baseline (Day 1) to Week 16
Secondary	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.	First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Secondary	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.	First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Secondary	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.	First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Secondary	Plasma Concentration of AGN-242428		Single sample predose at Week 4 and 8 Visits, single sample 1-2 hours postdose at Weeks 6 and 10 Visits

External Links

•   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.