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Multiple-loading Dose Regimen Study in Patients With Chronic Plaque-type Psoriasis

Primary Purpose

Chronic Plaque Psoriasis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AIN457
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Plaque Psoriasis focused on measuring Plaque, psoriasis, inflammatory skin disease, skin condition, thickening, flaking, scaly patches, skin disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criterion:

    1. Coverage of the body surface area (BSA) of 10% or more with plaques
    2. A score of 3 or more on the IGA scale

    3. A PASI score of at least 12 at baseline

      Exclusion Criteria:

  • Have forms of psoriasis other than the required "plaque psoriasis"
  • Women of childbearing potential
  • Recent use of investigational drugs or treatment with other biological therapies (wash-out periods required)
  • Previous treatment with this investigational drug
  • Subjects with active or history of clinically significant cardiac, kidney or liver abnormalities;

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    AIN457 3 mg/kg

    AIN457 10 mg/kg

    AIN457 10 mg/kg x3

    Placebo

    Arm Description

    Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.

    Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.

    Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.

    Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
    PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
    Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
    This outcome measure shows the proportion of participants in each of the AIN457 treatment groups who were relapse free throughout the study up to and including week 56.

    Secondary Outcome Measures

    Percentage of Participants With at Least 50% Improvement From Baseline in PASI
    PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
    Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
    PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
    Percentage of Participants in Each Investigator Global Assessment (IGA) Category
    The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.

    Full Information

    First Posted
    December 5, 2008
    Last Updated
    January 28, 2015
    Sponsor
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00805480
    Brief Title
    Multiple-loading Dose Regimen Study in Patients With Chronic Plaque-type Psoriasis
    Official Title
    Phase II Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Multiple-loading Dose Regimen Study to Assess the Safety, Efficacy and Duration of Response of AIN457 in Patients With Chronic Plaque-type Psoriasis.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2008 (undefined)
    Primary Completion Date
    September 2010 (Actual)
    Study Completion Date
    September 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Loading dose, four arm, double-blind, parallel group, placebo-controlled study comparing single and multiple doses of AIN457 to placebo in patients with a diagnosis of moderate to severe chronic plaque psoriasis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Plaque Psoriasis
    Keywords
    Plaque, psoriasis, inflammatory skin disease, skin condition, thickening, flaking, scaly patches, skin disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    130 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AIN457 3 mg/kg
    Arm Type
    Experimental
    Arm Description
    Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
    Arm Title
    AIN457 10 mg/kg
    Arm Type
    Experimental
    Arm Description
    Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
    Arm Title
    AIN457 10 mg/kg x3
    Arm Type
    Experimental
    Arm Description
    Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
    Intervention Type
    Drug
    Intervention Name(s)
    AIN457
    Other Intervention Name(s)
    Secukinumab
    Intervention Description
    AIN457 was administered intravenously.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Matching placebo to AIN457 was administered intravenously.
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
    Description
    PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
    Time Frame
    Baseline, Week 12
    Title
    Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
    Description
    This outcome measure shows the proportion of participants in each of the AIN457 treatment groups who were relapse free throughout the study up to and including week 56.
    Time Frame
    Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With at Least 50% Improvement From Baseline in PASI
    Description
    PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
    Time Frame
    Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, end of study (EOS) (up to week 56)
    Title
    Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
    Description
    PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
    Time Frame
    Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56)
    Title
    Percentage of Participants in Each Investigator Global Assessment (IGA) Category
    Description
    The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.
    Time Frame
    Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criterion: Coverage of the body surface area (BSA) of 10% or more with plaques A score of 3 or more on the IGA scale A PASI score of at least 12 at baseline Exclusion Criteria: Have forms of psoriasis other than the required "plaque psoriasis" Women of childbearing potential Recent use of investigational drugs or treatment with other biological therapies (wash-out periods required) Previous treatment with this investigational drug Subjects with active or history of clinically significant cardiac, kidney or liver abnormalities; Other protocol-defined inclusion/exclusion criteria may apply
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals
    Organizational Affiliation
    Novartis Pharmaceuticals
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Novartis
    Organizational Affiliation
    Novartis Investigator Site
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Multiple-loading Dose Regimen Study in Patients With Chronic Plaque-type Psoriasis

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