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AGN-242428 in the Treatment of Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT03339999
Recruitment Status : Terminated (safety reason)
First Posted : November 13, 2017
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Vitae Pharmaceuticals, Inc. ( Vitae Pharmaceuticals Inc., an Allergan affiliate )

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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: AGN-242428 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 15, 2017
Actual Primary Completion Date : March 22, 2018
Actual Study Completion Date : April 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: AGN-242428 Lower Dose
AGN-242428 and placebo, oral administration, once-daily for 16 weeks
Drug: AGN-242428
AGN-242428 administered as an oral capsule(s) once daily

Drug: Placebo
Placebo administered as an oral capsule(s) once daily

Experimental: AGN-242428 Medium Dose
AGN-242428, oral administration, once-daily for 16 weeks
Drug: AGN-242428
AGN-242428 administered as an oral capsule(s) once daily

Experimental: AGN-242428 Higher Dose
AGN-242428, oral administration, once-daily for 16 weeks
Drug: AGN-242428
AGN-242428 administered as an oral capsule(s) once daily

Placebo Comparator: Placebo
Placebo, oral administration, once-daily for 16 weeks
Drug: Placebo
Placebo administered as an oral capsule(s) once daily




Primary Outcome Measures :
  1. The percentage of participants achieving a reduction (improvement) in Psoriasis Area and Severity Index (PASI) score of ≥ 75% from baseline to Week 16 [ Time Frame: 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 :
  1. Percentage of participants achieving ≥ 2-point improvement in Physician's Global Assessment (PGA) score at Week 16 [ Time Frame: Baseline to Week 16 ]
    The investigator evaluates the participant's overall severity of psoriasis using a 5-point scale (0 to 4) where 0=Clear and 4=Severe.

  2. Percentage of participants achieving a clear (0) or almost clear (1) score in PGA at Week 16 [ Time Frame: Week 16 ]
    The investigator evaluates the participant's overall severity of psoriasis using a 5-point scale (0 to 4) where 0=Clear and 4=Severe.

  3. Percentage of participants achieving a reduction of 50% from baseline in PASI score at Week 16 [ Time Frame: 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.

  4. Percentage of participants achieving a reduction of 90% from baseline in PASI score at Week 16 [ Time Frame: 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.

  5. Patients with a clinically relevant change from baseline in electrocardiogram (ECG) [ Time Frame: Baseline up to Week 18 plus 3 days ]
    Standard 12-lead ECGs will be performed at each scheduled visit throughout study. Follow-up visit occurs up to 17 days after after completion or premature discontinuation of study medication. While the last dose of study medication is given at Week 16, there will be an additional visit (Week 18), no later than 17 days after Week 16, where participant ECG values are recorded.

  6. Plasma concentrations of AGN-242428 at Week 4 [ Time Frame: Week 4 ]
    Blood samples for the analysis of AGN-242428 plasma concentrations will be collected at Week 4.

  7. Plasma concentrations of AGN-242428 at Week 6 [ Time Frame: Week 6 ]
    Blood samples for the analysis of AGN-242428 plasma concentrations will be collected at Week 6.

  8. Plasma concentrations of AGN-242428 at Week 8 [ Time Frame: Week 8 ]
    Blood samples for the analysis of AGN-242428 plasma concentrations will be collected at Week 8.

  9. Plasma concentrations of AGN-242428 at Week 10 [ Time Frame: Week 10 ]
    Blood samples for the analysis of AGN-242428 plasma concentrations will be collected at Week 10.

  10. Plasma concentrations of AGN-242428 at Week 12 [ Time Frame: Week 12 ]
    Blood samples for the analysis of AGN-242428 plasma concentrations will be collected at Week 12.

  11. Plasma concentrations of AGN-242428 at Week 16 [ Time Frame: Week 16 ]
    Blood samples for the analysis of AGN-242428 plasma concentrations will be collected at Week 16.

  12. Plasma concentrations of AGN-242428 at Early Termination [ Time Frame: Early Termination (From Day 1 until Week 16) ]
    Blood samples for the analysis of AGN-242428 plasma concentrations will be collected at the early termination visit.

  13. Number of patients who experienced an Adverse Event (AE) [ Time Frame: From Consent (Week -4) up to Week 18 plus 30 Days ]
    An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. While the last dose of study medication is given at Week 16, there will be an additional visit (Week 18), no later than 17 days after Week 16, where participant adverse events are recorded. Adverse events are recorded for an additional 30 days after visit 18.

  14. Number of patients who experienced an Adverse Event related to study treatment [ Time Frame: Baseline up to Week 18 plus 30 Days ]
    An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. While the last dose of study medication is given at Week 16, there will be an additional visit (Week 18), no later than 17 days after Week 16, where participant adverse events are recorded. Adverse events are recorded for an additional 30 days after visit 18.

  15. Number of patients who experienced an Adverse Event (AE) leading to discontinuation [ Time Frame: Baseline to Week 18 ]
    An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. While the last dose of study medication is given at Week 16, there will be an additional visit (Week 18), no later than 17 days after Week 16.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants who have a confirmed diagnosis of plaque psoriasis, diagnosed at least 6 months before study with a 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 kg (121 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-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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339999


Locations
United States, Alabama
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States, 35205
United States, Arizona
Radiant Tucson
Tucson, Arizona, United States, 85712
United States, Arkansas
Johnson Dermatology
Fort Smith, Arkansas, United States, 72916
United States, California
First OC Dermatology
Fountain Valley, California, United States, 92708
University Clinical Trials
San Diego, California, United States, 92123
United States, Colorado
Horizons Clinical Research Center
Denver, Colorado, United States, 80220
United States, Florida
Belleair Research Center
Pinellas Park, Florida, United States, 33781
United States, Indiana
Dawes Fretzin Dermatology Group
Indianapolis, Indiana, United States, 46256
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States, 46168
South Bend Clinic
South Bend, Indiana, United States, 46617
United States, Kansas
Kansas City Dermatology
Overland Park, Kansas, United States, 66215
United States, Michigan
Somerset Skin Centre
Troy, Michigan, United States, 48084
United States, Oregon
Oregon Medical Research Center
Portland, Oregon, United States, 97223
United States, Texas
Arlington Research Center, Inc
Arlington, Texas, United States, 76011
Progressive Clinical Research
San Antonio, Texas, United States, 78213
Sponsors and Collaborators
Vitae Pharmaceuticals Inc., an Allergan affiliate
Investigators
Study Director: Christy Harutunian Allergan

Additional Information:
Responsible Party: Vitae Pharmaceuticals Inc., an Allergan affiliate
ClinicalTrials.gov Identifier: NCT03339999     History of Changes
Other Study ID Numbers: 1957-201-001
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018

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

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases