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AGN-242428 in the Treatment of Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT03339999
Recruitment Status : Active, not recruiting
First Posted : November 13, 2017
Last Update Posted : March 26, 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)
Estimated Enrollment : 200 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 8, 2017
Estimated Primary Completion Date : September 13, 2019
Estimated Study Completion Date : September 13, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

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, Senior)
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


  Show 40 Study Locations
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: March 26, 2018
Last Verified: March 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