search
Back to results

Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
700 mg IV
350 mg SC
Placebo
140 mg SC
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Part A:

  • Able to provide written informed consent
  • Healthy male or female between 18 to 45 years of age, inclusive at the time of screening
  • Additional inclusion criteria apply

Part B:

  • 18 - 55 years old inclusive at Screening
  • Active but clinically stable, plaque psoriasis
  • Psoriasis involving ≥ 10% of the body surface area
  • A minimum PASI score of ≥ 10 obtained during the screening period
  • Additional inclusion criteria apply

Exclusion Criteria:

Part A:

  • History or evidence of a clinically significant disorder (including but not limited to cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric), condition or disease that, in the opinion of the Investigator and Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
  • Underlying condition that predisposes the subject to infections (eg, uncontrolled diabetes - HbA1c > 7%, history of splenectomy)
  • Additional exclusion criteria apply

Part B:

  • Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
  • Evidence of skin conditions other than psoriasis (eg, eczema) at the time of the screening visit or between the screening visit and study drug initiation that would interfere with evaluations of the effect of investigational product on psoriasis
  • Any condition that, in the judgment of the investigator, might cause this study to be detrimental to the subject
  • Additional exclusion criteria apply

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Experimental

    Active Comparator

    Experimental

    Arm Label

    Placebo

    140 mg SC

    350 mg SC

    700 mg IV

    Arm Description

    Placebo treatment

    140 mg SC PsO

    350 mg SC PsO

    700 mg IV PsO

    Outcomes

    Primary Outcome Measures

    Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43
    Summary of percent change in PASI (Psoriasis Area Severity Index) Scores over time by treatment groups between baseline and day 43, PASI score ranging from (0) no disease to (72) maximal disease.
    Part B: All Treatment Adverse Events Reported for Safety Evaluation
    This primary outcome assesses number of participants iwth any reported adverse events emerging during treatment period.
    Part A: All Treatment Adverse Events Reported for Safety Evaluation
    This primary outcome assesses the number of participants with any reported adverse events emerging during treatment period.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 20, 2009
    Last Updated
    July 26, 2018
    Sponsor
    Bausch Health Americas, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00867100
    Brief Title
    Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827
    Official Title
    A Randomized, Double-blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2007 (undefined)
    Primary Completion Date
    September 2009 (Actual)
    Study Completion Date
    September 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bausch Health Americas, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose.
    Detailed Description
    This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    84 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo treatment
    Arm Title
    140 mg SC
    Arm Type
    Experimental
    Arm Description
    140 mg SC PsO
    Arm Title
    350 mg SC
    Arm Type
    Active Comparator
    Arm Description
    350 mg SC PsO
    Arm Title
    700 mg IV
    Arm Type
    Experimental
    Arm Description
    700 mg IV PsO
    Intervention Type
    Drug
    Intervention Name(s)
    700 mg IV
    Intervention Description
    single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
    Intervention Type
    Drug
    Intervention Name(s)
    350 mg SC
    Intervention Description
    single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
    Intervention Type
    Drug
    Intervention Name(s)
    140 mg SC
    Intervention Description
    single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
    Primary Outcome Measure Information:
    Title
    Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43
    Description
    Summary of percent change in PASI (Psoriasis Area Severity Index) Scores over time by treatment groups between baseline and day 43, PASI score ranging from (0) no disease to (72) maximal disease.
    Time Frame
    Through day 43
    Title
    Part B: All Treatment Adverse Events Reported for Safety Evaluation
    Description
    This primary outcome assesses number of participants iwth any reported adverse events emerging during treatment period.
    Time Frame
    85 days
    Title
    Part A: All Treatment Adverse Events Reported for Safety Evaluation
    Description
    This primary outcome assesses the number of participants with any reported adverse events emerging during treatment period.
    Time Frame
    Cohort 1-4 43 days, Cohort 5-8 64 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Part A: Able to provide written informed consent Healthy male or female between 18 to 45 years of age, inclusive at the time of screening Additional inclusion criteria apply Part B: 18 - 55 years old inclusive at Screening Active but clinically stable, plaque psoriasis Psoriasis involving ≥ 10% of the body surface area A minimum PASI score of ≥ 10 obtained during the screening period Additional inclusion criteria apply Exclusion Criteria: Part A: History or evidence of a clinically significant disorder (including but not limited to cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric), condition or disease that, in the opinion of the Investigator and Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion Underlying condition that predisposes the subject to infections (eg, uncontrolled diabetes - HbA1c > 7%, history of splenectomy) Additional exclusion criteria apply Part B: Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit Evidence of skin conditions other than psoriasis (eg, eczema) at the time of the screening visit or between the screening visit and study drug initiation that would interfere with evaluations of the effect of investigational product on psoriasis Any condition that, in the judgment of the investigator, might cause this study to be detrimental to the subject Additional exclusion criteria apply
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    22622425
    Citation
    Papp KA, Reid C, Foley P, Sinclair R, Salinger DH, Williams G, Dong H, Krueger JG, Russell CB, Martin DA. Anti-IL-17 receptor antibody AMG 827 leads to rapid clinical response in subjects with moderate to severe psoriasis: results from a phase I, randomized, placebo-controlled trial. J Invest Dermatol. 2012 Oct;132(10):2466-2469. doi: 10.1038/jid.2012.163. Epub 2012 May 24. No abstract available.
    Results Reference
    derived
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

    Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827

    We'll reach out to this number within 24 hrs