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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03339999
Other study ID # 1957-201-001
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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