NCT03339999

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

15 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

November 15, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2018

Completed
3 years until next milestone

Results Posted

Study results publicly available

April 6, 2021

Completed
Last Updated

April 6, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

November 8, 2017

Results QC Date

March 10, 2021

Last Update Submit

March 10, 2021

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Percentage of Participants Achieving ≥ 2-point Reduction (Improvement) in Physician's Global Assessment (PGA) Score at Week 16

    Baseline (Day 1) to Week 16

  • Percentage of Participants Achieving a Clear (0) or Almost Clear (1) Score in PGA at Week 16

    Week 16

  • Percentage of Participants Achieving Reduction (Improvement) in PASI Score of ≥ 50% From Baseline to Week 16

    Baseline (Day 1) to Week 16

  • Percentage of Participants Achieving Reduction (Improvement) in PASI Score of ≥ 90% From Baseline to Week 16

    Baseline (Day 1) to Week 16

  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose

  • +3 more secondary outcomes

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

AGN-242428 Higher Dose

EXPERIMENTAL

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

Drug: AGN-242428

AGN-242428 Medium Dose

EXPERIMENTAL

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

Drug: AGN-242428

AGN-242428 Lower Dose

EXPERIMENTAL

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

Drug: AGN-242428Drug: Placebo

Interventions

AGN-242428DRUG

AGN-242428 administered as an oral capsule(s) once daily.

AGN-242428 Higher DoseAGN-242428 Lower DoseAGN-242428 Medium Dose
PlaceboDRUG

Placebo administered as an oral capsule(s) once daily.

AGN-242428 Lower DosePlacebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, 35205, United States

Location

Radiant Tucson

Tucson, Arizona, 85712, United States

Location

Johnson Dermatology

Fort Smith, Arkansas, 72916, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

University Clinical Trials

San Diego, California, 92123, United States

Location

Horizons Clinical Research Center

Denver, Colorado, 80220, United States

Location

Belleair Research Center

Pinellas Park, Florida, 33781, United States

Location

Dawes Fretzin Dermatology Group

Indianapolis, Indiana, 46256, United States

Location

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, 46168, United States

Location

South Bend Clinic

South Bend, Indiana, 46617, United States

Location

Kansas City Dermatology

Overland Park, Kansas, 66215, United States

Location

Somerset Skin Centre

Troy, Michigan, 48084, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97223, United States

Location

Arlington Research Center, Inc

Arlington, Texas, 76011, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Related Links

Results Point of Contact

Title
Therapeutic Area, Head
Organization
Allergan
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Christy Harutunian

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2017

First Posted

November 13, 2017

Study Start

November 15, 2017

Primary Completion

March 22, 2018

Study Completion

April 20, 2018

Last Updated

April 6, 2021

Results First Posted

April 6, 2021

Record last verified: 2021-03

Locations

US(15)