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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00805480
Collaborator
(none)
130
Enrollment
4
Arms
21
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Dec 1, 2008
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Sep 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: AIN457 3 mg/kg

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

Drug: AIN457
AIN457 was administered intravenously.
Other Names:
  • Secukinumab

    • Drug: Placebo
    Matching placebo to AIN457 was administered intravenously.
    Experimental: AIN457 10 mg/kg

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

    Drug: AIN457
    AIN457 was administered intravenously.
    Other Names:
  • Secukinumab

    • Drug: Placebo
    Matching placebo to AIN457 was administered intravenously.
    Experimental: AIN457 10 mg/kg x3

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

    Drug: AIN457
    AIN457 was administered intravenously.
    Other Names:
  • Secukinumab

    		•
    Placebo Comparator: Placebo

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

    Drug: Placebo
    Matching placebo to AIN457 was administered intravenously.

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores [Baseline, Week 12]

      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).

    2. Percentage of Participants Who Had Not Relapsed at Any Time in the Trial [Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56]

      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

    1. Percentage of Participants With at Least 50% Improvement From Baseline in PASI [Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, end of study (EOS) (up to week 56)]

      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).

    2. Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI [Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56)]

      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).

    3. Percentage of Participants in Each Investigator Global Assessment (IGA) Category [Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
    • Principal Investigator: Novartis, Novartis Investigator Site

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00805480
    Other Study ID Numbers:
    • CAIN457A2212
    First Posted:
    Dec 9, 2008
    Last Update Posted:
    Feb 10, 2015
    Last Verified:
    Jan 1, 2015
    Keywords provided by Novartis Pharmaceuticals
    Plaque
    psoriasis
    inflammatory skin disease
    skin condition, thickening
    flaking
    scaly patches
    skin disease
    Additional relevant MeSH terms:
    Psoriasis

    Study Results

    Participant Flow

    Recruitment Details The planned enrollment was for 100 participants. However, one center was prematurely terminated and the data from this center could not be used for analysis. Therefore, additional participants were randomized to replace the 30 participants from the early terminated center. As a result, a total of 130 participants were enrolled.
    Pre-assignment Detail
    Arm/Group Title AIN457 3 mg/kg AIN457 10 mg/kg AIN457 10 mg/kg x3 Placebo
    Arm/Group 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
    Period Title: Overall Study
    STARTED 30 29 31 10
    Pharmacodynamic Analysis Set 30 25 29 10
    COMPLETED 16 22 19 5
    NOT COMPLETED 14 7 12 5

    Baseline Characteristics

    Arm/Group Title AIN457 3 mg/kg AIN457 10 mg/kg AIN457 10 mg/kg x3 Placebo Total
    Arm/Group 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 Total of all reporting groups
    Overall Participants 30 29 31 10 100
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    45.7
    (9.29)
    43.5
    (11.75)
    43.4
    (10.90)
    40.1
    (14.89)
    43.8
    (11.09)
    Sex: Female, Male (Count of Participants)
    Female
    6
    20%
    7
    24.1%
    5
    16.1%
    2
    20%
    20
    20%
    Male
    24
    80%
    22
    75.9%
    26
    83.9%
    8
    80%
    80
    80%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Participants from the PD Analysis Set, who had both baseline and week 12 values, were included in the analysis. As such, the population for each treatment group is different from the PD population in the participant flow. The PD analysis set included participants who had at least one dose of study medication and had no protocol deviations.
    Arm/Group Title AIN457 3 mg/kg AIN457 10 mg/kg AIN457 10 mg/kg x3 Placebo
    Arm/Group 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
    Measure Participants 27 23 27 5
    Mean (Standard Deviation) [scores on a scale]
    -12.46
    (7.668)
    -13.35
    (6.195)
    -18.02
    (6.792)
    -4.18
    (4.698)
    2. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    PD analysis set participants (AIN457 groups only), who had not yet relapsed were included in the analysis at each time point. As a result, the number of participants at risk for relapse may decrease as the number of weeks on study increases. The PD set included participants who had at least one dose of study medication and no protocol deviations.
    Arm/Group Title AIN457 3 mg/kg AIN457 10 mg/kg AIN457 10 mg/kg x3
    Arm/Group 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.
    Measure Participants 30 25 29
    Week 1 (n=30,25,29)
    100.0
    333.3%
    100.0
    344.8%
    100.0
    322.6%
    Week 2 (n=30,25,28)
    100.0
    333.3%
    100.0
    344.8%
    96.6
    311.6%
    Week 4 (n=30,25,27)
    100.0
    333.3%
    100.0
    344.8%
    93.1
    300.3%
    Week 6 (n=30,24,27)
    100.0
    333.3%
    96.0
    331%
    93.1
    300.3%
    Week 8 (n=30,24,27)
    100.0
    333.3%
    96.0
    331%
    93.1
    300.3%
    Week 10 (n=28,22,27)
    93.3
    311%
    88.0
    303.4%
    93.1
    300.3%
    Week 12 (n=23,22,27)
    76.7
    255.7%
    88.0
    303.4%
    93.1
    300.3%
    Week 14 (n=20,20,27)
    66.7
    222.3%
    80.0
    275.9%
    93.1
    300.3%
    Week 16 (n=16,19,26)
    53.3
    177.7%
    76.0
    262.1%
    89.7
    289.4%
    Week 20 (n=15,17,26)
    50.0
    166.7%
    68.0
    234.5%
    89.7
    289.4%
    Week 24 (n=13,17,25)
    43.3
    144.3%
    68.0
    234.5%
    86.2
    278.1%
    Week 28 (n=11,12,24)
    36.7
    122.3%
    48.0
    165.5%
    82.8
    267.1%
    Week 32 (n=9,9,19)
    30.0
    100%
    36.0
    124.1%
    65.5
    211.3%
    Week 36 (n=7,9,17)
    23.3
    77.7%
    36.0
    124.1%
    58.6
    189%
    Week 40 (n=6,7,14)
    20.0
    66.7%
    28.0
    96.6%
    48.3
    155.8%
    Week 44 (n=4,7,10)
    13.3
    44.3%
    28.0
    96.6%
    34.5
    111.3%
    Week 48 (n=3,6,8)
    10.0
    33.3%
    24.0
    82.8%
    27.6
    89%
    Week 52 (n=3,5,5)
    10.0
    33.3%
    20.0
    69%
    17.2
    55.5%
    Week 56 (n=2,4,5)
    12.5
    41.7%
    22.2
    76.6%
    27.8
    89.7%
    3. Secondary Outcome
    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)

    Outcome Measure Data

    Analysis Population Description
    PD analysis set: The PD analysis set included participants who had at least one dose of study medication and had no major protocol deviations which could impact the PD analysis. At weeks 28, 36, 44 and 48, only 28 of the 29 participants in the AIN457 10mg/kg X3 group had values for analysis.
    Arm/Group Title AIN457 3 mg/kg AIN457 10 mg/kg AIN457 10 mg/kg x3 Placebo
    Arm/Group 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
    Measure Participants 30 25 29 10
    Week 4
    56.7
    189%
    84.0
    289.7%
    89.7
    289.4%
    10.0
    100%
    Week 8
    73.3
    244.3%
    80.0
    275.9%
    93.1
    300.3%
    0.0
    0%
    Week 12
    66.7
    222.3%
    79.2
    273.1%
    93.1
    300.3%
    10.0
    100%
    Week 16
    50.0
    166.7%
    68.0
    234.5%
    89.7
    289.4%
    10.0
    100%
    Week 20
    46.7
    155.7%
    68.0
    234.5%
    89.7
    289.4%
    10.0
    100%
    Week 24
    40.0
    133.3%
    68.0
    234.5%
    86.2
    278.1%
    10.0
    100%
    Week 28 (n=30,25,28,10)
    33.3
    111%
    48.0
    165.5%
    82.1
    264.8%
    10.0
    100%
    Week 32
    30.0
    100%
    36.0
    124.1%
    65.5
    211.3%
    10.0
    100%
    Week 36 (n=30,25,28,10)
    23.3
    77.7%
    36.0
    124.1%
    51.7
    166.8%
    0.0
    0%
    Week 40
    20.0
    66.7%
    28.0
    96.6%
    48.3
    155.8%
    10.0
    100%
    Week 44 (n=30,25,28,10)
    13.3
    44.3%
    28.0
    96.6%
    32.1
    103.5%
    10.0
    100%
    Week 48 (n=30,25,28,10)
    6.7
    22.3%
    24.0
    82.8%
    28.6
    92.3%
    10.0
    100%
    Week 52
    6.7
    22.3%
    20.0
    69%
    20.7
    66.8%
    0.0
    0%
    End of study (up to week 56)
    6.7
    22.3%
    16.0
    55.2%
    31.0
    100%
    20.0
    200%
    4. Secondary Outcome
    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)

    Outcome Measure Data

    Analysis Population Description
    PD analysis set: The PD analysis set included participants who had at least one dose of study medication and had no major protocol deviations which could impact the PD analysis. At weeks 28, 36, 44 and 48, only 28 of the 29 participants in the AIN457 10mg/kg X3 group had values for analysis.
    Arm/Group Title AIN457 3 mg/kg AIN457 10 mg/kg AIN457 10 mg/kg x3 Placebo
    Arm/Group 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
    Measure Participants 30 25 29 10
    Week 4 - PASI 75
    30.0
    100%
    56.0
    193.1%
    65.5
    211.3%
    0.0
    0%
    Week 4 - PASI 90
    3.3
    11%
    28.0
    96.6%
    48.3
    155.8%
    0.0
    0%
    Week 8 - PASI 75
    53.3
    177.7%
    72.0
    248.3%
    89.7
    289.4%
    0.0
    0%
    Week 8 - PASI 90
    6.7
    22.3%
    44.0
    151.7%
    72.4
    233.5%
    0.0
    0%
    Week 12 - PASI 75
    40.0
    133.3%
    75.0
    258.6%
    82.6
    266.5%
    10.0
    100%
    Week 12 - PASI 90
    10.0
    33.3%
    54.2
    186.9%
    75.9
    244.8%
    0.0
    0%
    Week 16 - PASI 75
    30.0
    100%
    60.0
    206.9%
    82.8
    267.1%
    0.0
    0%
    Week 16 - PASI 90
    3.3
    11%
    40.0
    137.9%
    79.3
    255.8%
    0.0
    0%
    Week 20 - PASI 75
    23.3
    77.7%
    52.0
    179.3%
    82.8
    267.1%
    0.0
    0%
    Week 20 - PASI 90
    0.0
    0%
    28.0
    96.6%
    65.5
    211.3%
    0.0
    0%
    Week 24 - PASI 75
    20.0
    66.7%
    40.0
    137.9%
    69.0
    222.6%
    0.0
    0%
    Week 24 - PASI 90
    0.0
    0%
    24.0
    82.8%
    62.1
    200.3%
    0.0
    0%
    Week 28 - PASI 75 (n=30,25,28,10)
    16.7
    55.7%
    36.0
    124.1%
    60.7
    195.8%
    0.0
    0%
    Week 28 - PASI 90 (n=30,25,28,10)
    0.0
    0%
    16.0
    55.2%
    42.9
    138.4%
    0.0
    0%
    Week 32 - PASI 75
    3.3
    11%
    24.0
    82.8%
    44.8
    144.5%
    0.0
    0%
    Week 32 - PASI 90
    0.0
    0%
    16.0
    55.2%
    31.0
    100%
    0.0
    0%
    Week 36 - PASI 75 (n=30,25,28,10)
    0.0
    0%
    24.0
    82.8%
    28.6
    92.3%
    0.0
    0%
    Week 36 - PASI 90 (n=30,25,28,10)
    0.0
    0%
    8.0
    27.6%
    14.3
    46.1%
    0.0
    0%
    Week 40 - PASI 75
    0.0
    0%
    16.0
    55.2%
    21.4
    69%
    0.0
    0%
    Week 40 - PASI 90
    0.0
    0%
    12.0
    41.4%
    6.9
    22.3%
    0.0
    0%
    Week 44 - PASI 75 (n=30,25,28,10)
    0.0
    0%
    16.0
    55.2%
    10.7
    34.5%
    0.0
    0%
    Week 44 - PASI 90 (n=30,25,28,10)
    0.0
    0%
    8.0
    27.6%
    3.6
    11.6%
    0.0
    0%
    Week 48 - PASI 75 (n=30,25,28,10)
    0.0
    0%
    12.0
    41.4%
    10.7
    34.5%
    0.0
    0%
    Week 48 - PASI 90 (n=30,25,28,10)
    0.0
    0%
    4.0
    13.8%
    3.6
    11.6%
    0.0
    0%
    Week 52 - PASI 75
    0.0
    0%
    12.0
    41.4%
    6.9
    22.3%
    0.0
    0%
    Week 52 - PASI 90
    0.0
    0%
    4.0
    13.8%
    3.4
    11%
    0.0
    0%
    End of study (up to week 56) - PASI 75
    0.0
    0%
    12.0
    41.4%
    13.8
    44.5%
    0.0
    0%
    End of study (up to week 56) - PASI 90
    0.0
    0%
    0.0
    0%
    10.3
    33.2%
    0.0
    0%
    5. Secondary Outcome
    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)

    Outcome Measure Data

    Analysis Population Description
    PD analysis set participants, who had values at each week category, were included in the analysis. As such, the population at each week varies from the PD population in the participant flow. The PD analysis set included participants who had at least one dose of study medication and had no major protocol deviations.
    Arm/Group Title AIN457 3 mg/kg AIN457 10 mg/kg AIN457 10 mg/kg x3 Placebo
    Arm/Group 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
    Measure Participants 30 25 29 10
    Baseline - Clear (n=30,25,29,10)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Baseline - Almost clear (n=30,25,29,10)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Baseline - Mild disease (n=30,25,29,10)
    0.0
    0%
    0.0
    0%
    3.4
    11%
    0.0
    0%
    Baseline - Moderate disease (n=30,25,29,10)
    60.0
    200%
    68.0
    234.5%
    55.2
    178.1%
    70.0
    700%
    Baseline - Severe disease (n=30,25,29,10)
    36.7
    122.3%
    32.0
    110.3%
    41.4
    133.5%
    10.0
    100%
    Baseline - Very severe (n=30,25,29,10)
    3.3
    11%
    0.0
    0%
    0.0
    0%
    20.0
    200%
    Week 1 - Clear (n=30,25,29,10)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Week 1 - Almost clear (n=30,25,29,10)
    3.3
    11%
    12.0
    41.4%
    13.8
    44.5%
    0.0
    0%
    Week 1 - Mild disease (n=30,25,29,10)
    23.3
    77.7%
    32.0
    110.3%
    48.3
    155.8%
    10.0
    100%
    Week 1 - Moderate disease (n=30,25,29,10)
    66.7
    222.3%
    56.0
    193.1%
    37.9
    122.3%
    70.0
    700%
    Week 1 - Severe disease (n=30,25,29,10)
    6.7
    22.3%
    0.0
    0%
    0.0
    0%
    10.0
    100%
    Week 1 - Very severe disease (n=30,25,29,10)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    10.0
    100%
    Week 2 - Clear (n=30,25,27,10)
    0.0
    0%
    4.0
    13.8%
    6.9
    22.3%
    0.0
    0%
    Week 2 - Almost clear (n=30,25,27,10)
    3.3
    11%
    20.0
    69%
    24.1
    77.7%
    10.0
    100%
    Week 2 - Mild disease (n=30,25,27,10)
    50.0
    166.7%
    64.0
    220.7%
    44.8
    144.5%
    0.0
    0%
    Week 2 - Moderate disease (n=30,25,27,10)
    46.7
    155.7%
    12.0
    41.4%
    17.2
    55.5%
    80.0
    800%
    Week 2 - Severe disease (n=30,25,27,10)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Week 2 - Very severe disease (n=30,25,27,10)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    10.0
    100%
    Week 4 - Clear (n=30,25,27,9)
    0.0
    0%
    16.0
    55.2%
    17.2
    55.5%
    0.0
    0%
    Week 4 - Almost clear (n=30,25,27,9)
    16.7
    55.7%
    32.0
    110.3%
    44.8
    144.5%
    0.0
    0%
    Week 4 - Mild disease (n=30,25,27,9)
    46.7
    155.7%
    44.0
    151.7%
    24.1
    77.7%
    20.0
    200%
    Week 4 - Moderate disease (n=30,25,27,9)
    36.7
    122.3%
    8.0
    27.6%
    6.9
    22.3%
    40.0
    400%
    Week 4 - Severe disease(n=30,25,27,9)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    20.0
    200%
    Week 4 - Very severe disease (n=30,25,27,9)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    10.0
    100%
    Week 6 - Clear (n=30,24,27,7)
    0.0
    0%
    24.0
    82.8%
    31.0
    100%
    0.0
    0%
    Week 6 - Almost clear (n=30,24,27,7)
    23.3
    77.7%
    28.0
    96.6%
    48.3
    155.8%
    0.0
    0%
    Week 6 - Mild disease (n=30,24,27,7)
    50.0
    166.7%
    32.0
    110.3%
    10.3
    33.2%
    0.0
    0%
    Week 6 - Moderate disease (n=30,24,27,7)
    26.7
    89%
    12.0
    41.4%
    3.4
    11%
    60.0
    600%
    Week 6 - Severe disease(n=30,24,27,7)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Week 6 - Very severe disease(n=30,24,27,7)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    10.0
    100%
    Week 8 - Clear (n=30,24,27,7)
    0.0
    0%
    28.0
    96.6%
    41.4
    133.5%
    0.0
    0%
    Week 8 - Almost clear (n=30,24,27,7)
    33.3
    111%
    32.0
    110.3%
    34.5
    111.3%
    0.0
    0%
    Week 8- Mild disease (n=30,24,27,7)
    40.0
    133.3%
    20.0
    69%
    13.8
    44.5%
    0.0
    0%
    Week 8 - Moderate disease(n=30,24,27,7)
    26.7
    89%
    16.0
    55.2%
    3.4
    11%
    60.0
    600%
    Week 8 - Severe disease (n=30,24,27,7)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Week 8 - Very severe disease (n=30,24,27,7)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    10.0
    100%
    Week 10 - Clear (n=28,24,25,5)
    0.0
    0%
    28.0
    96.6%
    48.3
    155.8%
    0.0
    0%
    Week 10 - Almost clear (n=28,24,25,5)
    30.0
    100%
    28.0
    96.6%
    31.0
    100%
    0.0
    0%
    Week 10 - Mild disease (n=28,24,25,5)
    36.7
    122.3%
    20.0
    69%
    6.9
    22.3%
    0.0
    0%
    Week 10 - Moderate disease (n=28,24,25,5)
    26.7
    89%
    16.0
    55.2%
    0.0
    0%
    40.0
    400%
    Week 10 - Severe disease (n=28,24,25,5)
    0.0
    0%
    4.0
    13.8%
    0.0
    0%
    10.0
    100%
    Week 10 - Very severe disease (n=28,24,25,5)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Week 12 - Clear (n=27,23,27,5)
    0.0
    0%
    32.0
    110.3%
    48.3
    155.8%
    0.0
    0%
    Week 12 - Almost clear (n=27,23,27,5)
    26.7
    89%
    16.0
    55.2%
    27.6
    89%
    0.0
    0%
    Week 12 - Mild disease (n=27,23,27,5)
    33.3
    111%
    16.0
    55.2%
    13.8
    44.5%
    10.0
    100%
    Week 12- Moderate disease (n=27,23,27,5)
    16.7
    55.7%
    20.0
    69%
    3.4
    11%
    30.0
    300%
    Week 12 - Severe disease (n=27,23,27,5)
    13.3
    44.3%
    8.0
    27.6%
    0.0
    0%
    10.0
    100%
    Week 12 - Very severe disease (n=27,23,27,5)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Week 14 - Clear (n=22,22,26,4)
    0.0
    0%
    32.0
    110.3%
    58.6
    189%
    0.0
    0%
    Week 14 - Almost clear (n=22,22,26,4)
    16.7
    55.7%
    12.0
    41.4%
    17.2
    55.5%
    0.0
    0%
    Week 14 - Mild disease (n=22,22,26,4)
    30.0
    100%
    24.0
    82.8%
    10.3
    33.2%
    0.0
    0%
    Week 14 - Moderate disease (n=22,22,26,4)
    16.7
    55.7%
    8.0
    27.6%
    3.4
    11%
    30.0
    300%
    Week 14 - Severe (n=22,22,26,4)
    10.0
    33.3%
    12.0
    41.4%
    0.0
    0%
    10.0
    100%
    Week 14 - Very severe (n=22,22,26,4)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Week 16 - Clear (n=20,21,26,4)
    0.0
    0%
    24.0
    82.8%
    55.2
    178.1%
    0.0
    0%
    Week 16 - Almost clear(n=20,21,26,4)
    13.3
    44.3%
    24.0
    82.8%
    20.7
    66.8%
    0.0
    0%
    Week 16 - Mild disease(n=20,21,26,4)
    23.3
    77.7%
    16.0
    55.2%
    10.3
    33.2%
    10.0
    100%
    Week 16 - Moderate disease (n=20,21,26,4)
    20.0
    66.7%
    12.0
    41.4%
    3.4
    11%
    10.0
    100%
    Week 16 - Severe disease (n=20,21,26,4)
    6.7
    22.3%
    8.0
    27.6%
    0.0
    0%
    20.0
    200%
    Week 16 - Very severe disease (n=20,21,26,4)
    3.3
    11%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Week 20 - Clear (n=17,18,26,3)
    0.0
    0%
    12.0
    41.4%
    44.8
    144.5%
    0.0
    0%
    Week 20 - Almost clear (n=17,18,26,3)
    6.7
    22.3%
    32.0
    110.3%
    20.7
    66.8%
    10.0
    100%
    Week 20 - Mild disease (n=17,18,26,3)
    33.3
    111%
    8.0
    27.6%
    20.7
    66.8%
    0.0
    0%
    Week 20 - Moderate disease (n=17,18,26,3)
    10.0
    33.3%
    20.0
    69%
    3.4
    11%
    20.0
    200%
    Week 20 - Severe disease (n=17,18,26,3)
    6.7
    22.3%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Week 20 - Very severe disease (n=17,18,26,3)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Week 24 - Clear (n=15,18,26,3)
    0.0
    0%
    8.0
    27.6%
    37.9
    122.3%
    0.0
    0%
    Week 24 - Almost clear (n=15,18,26,3)
    6.7
    22.3%
    28.0
    96.6%
    31.0
    100%
    10.0
    100%
    Week 24 - Mild disease(n=15,18,26,3)
    30.0
    100%
    12.0
    41.4%
    10.3
    33.2%
    0.0
    0%
    Week 24 - Moderate disease(n=15,18,26,3)
    10.0
    33.3%
    20.0
    69%
    10.3
    33.2%
    20.0
    200%
    Week 24 - Severe disease(n=15,18,26,3)
    3.3
    11%
    4.0
    13.8%
    0.0
    0%
    0.0
    0%
    Week 24 - Very severe disease(n=15,18,26,3)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Week 28 - Clear (n=14,17,24,2)
    0.0
    0%
    4.0
    13.8%
    13.8
    44.5%
    0.0
    0%
    Week 28 - Almost clear (n=14,17,24,2)
    3.3
    11%
    28.0
    96.6%
    24.1
    77.7%
    10.0
    100%
    Week 28 - Mild disease (n=14,17,24,2)
    23.3
    77.7%
    4.0
    13.8%
    37.9
    122.3%
    0.0
    0%
    Week 28 - Moderate disease (n=14,17,24,2)
    16.7
    55.7%
    24.0
    82.8%
    6.9
    22.3%
    10.0
    100%
    Week 28 - Severe disease (n=14,17,24,2)
    3.3
    11%
    8.0
    27.6%
    0.0
    0%
    0.0
    0%
    Week 28 - Very severe disease (n=14,17,24,2)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Week 32 - Clear (n=11,12,23,2)
    0.0
    0%
    8.0
    27.6%
    10.3
    33.2%
    0.0
    0%
    Week 32 - Almost clear (n=11,12,23,2)
    0.0
    0%
    12.0
    41.4%
    24.1
    77.7%
    0.0
    0%
    Week 32 - Mild disease (n=11,12,23,2)
    20.0
    66.7%
    16.0
    55.2%
    27.6
    89%
    10.0
    100%
    Week 32 - Moderate disease (n=11,12,23,2)
    16.7
    55.7%
    8.0
    27.6%
    13.8
    44.5%
    10.0
    100%
    Week 32 - Severe disease (n=11,12,23,2)
    0.0
    0%
    4.0
    13.8%
    3.4
    11%
    0.0
    0%
    Week 32 - Very severe disease (n=11,12,23,2)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Week 36 - Clear (n=9,9,19,2)
    0.0
    0%
    4.0
    13.8%
    6.9
    22.3%
    0.0
    0%
    Week 36 - Almost clear (n=9,9,19,2)
    0.0
    0%
    12.0
    41.4%
    13.8
    44.5%
    0.0
    0%
    Week 36 - Mild disease (n=9,9,19,2)
    16.7
    55.7%
    8.0
    27.6%
    20.7
    66.8%
    0.0
    0%
    Week 36 - Moderate disease (n=9,9,19,2)
    13.3
    44.3%
    12.0
    41.4%
    20.7
    66.8%
    20.0
    200%
    Week 36 - Severe disease (n=9,9,19,2)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Week 36 - Very severe disease (n=9,9,19,2)
    0.0
    0%
    0.0
    0%
    3.4
    11%
    0.0
    0%
    Week 40 - Clear (n=8,8,18,2)
    0.0
    0%
    8.0
    27.6%
    3.4
    11%
    0.0
    0%
    Week 40 - Almost clear (n=8,8,18,2)
    0.0
    0%
    8.0
    27.6%
    10.3
    33.2%
    0.0
    0%
    Week 40 - Mild disease (n=8,8,18,2)
    6.7
    22.3%
    4.0
    13.8%
    31.0
    100%
    0.0
    0%
    Week 40 - Moderate disease (n=8,8,18,2)
    20.0
    66.7%
    12.0
    41.4%
    17.2
    55.5%
    20.0
    200%
    Week 40 - Severe disease (n=8,8,18,2)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Week 40 - Very severe disease (n=8,8,18,2)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Week 44 - Clear (n=6,8,14,2)
    0.0
    0%
    0.0
    0%
    3.4
    11%
    0.0
    0%
    Week 44 - Almost clear (n=6,8,14,2)
    0.0
    0%
    12.0
    41.4%
    3.4
    11%
    0.0
    0%
    Week 44 - Mild disease (n=6,8,14,2)
    6.7
    22.3%
    4.0
    13.8%
    13.8
    44.5%
    10.0
    100%
    Week 44 - Moderate disease (n=6,8,14,2)
    13.3
    44.3%
    16.0
    55.2%
    20.7
    66.8%
    10.0
    100%
    Week 44 - Severe disease (n=6,8,14,2)
    0.0
    0%
    0.0
    0%
    6.9
    22.3%
    0.0
    0%
    Week 44 - Very severe disease (n=6,8,14,2)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Week 48 - Clear (n=3,7,11,1)
    0.0
    0%
    0.0
    0%
    3.4
    11%
    0.0
    0%
    Week 48 - Almost clear (n=3,7,11,1)
    0.0
    0%
    8.0
    27.6%
    0.0
    0%
    0.0
    0%
    Week 48 - Mild disease (n=3,7,11,1)
    3.3
    11%
    8.0
    27.6%
    17.2
    55.5%
    0.0
    0%
    Week 48 - Moderate disease (n=3,7,11,1)
    6.7
    22.3%
    12.0
    41.4%
    17.2
    55.5%
    10.0
    100%
    Week 48 - Severe disease (n=3,7,11,1)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Week 48 - Very severe disease (n=3,7,11,1)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Week 52 - Clear (n=3,7,10,0)
    0.0
    0%
    0.0
    0%
    3.4
    11%
    0.0
    0%
    Week 52 - Almost clear (n=3,7,10,0)
    0.0
    0%
    8.0
    27.6%
    0.0
    0%
    0.0
    0%
    Week 52 - Mild disease (n=3,7,10,0)
    6.7
    22.3%
    4.0
    13.8%
    6.9
    22.3%
    0.0
    0%
    Week 52 - Moderate disease (n=3,7,10,0)
    3.3
    11%
    16.0
    55.2%
    17.2
    55.5%
    0.0
    0%
    Week 52 - Severe disease (n=3,7,10,0)
    0.0
    0%
    0.0
    0%
    6.9
    22.3%
    0.0
    0%
    Week 52 - Very severe disease (n=3,7,10,0)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    End of study - Clear (n=12,8,13,5)
    0.0
    0%
    0.0
    0%
    6.9
    22.3%
    0.0
    0%
    End of study - Almost clear (n=12,8,13,5)
    3.3
    11%
    4.0
    13.8%
    3.4
    11%
    0.0
    0%
    End of study - Mild disease (n=12,8,13,5)
    6.7
    22.3%
    8.0
    27.6%
    3.4
    11%
    20.0
    200%
    End of study - Moderate disease (n=12,8,13,5)
    30.0
    100%
    16.0
    55.2%
    27.6
    89%
    30.0
    300%
    End of study - Severe disease (n=12,8,13,5)
    0.0
    0%
    4.0
    13.8%
    3.4
    11%
    0.0
    0%
    End of study - Very severe disease (n=12,8,13,5)
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title AIN457 3 mg/kg AIN457 10 mg/kg AIN457 10 mg/kg x3 Placebo
    Arm/Group 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
    All Cause Mortality
    AIN457 3 mg/kg AIN457 10 mg/kg AIN457 10 mg/kg x3 Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    AIN457 3 mg/kg AIN457 10 mg/kg AIN457 10 mg/kg x3 Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/30 (6.7%) 3/29 (10.3%) 2/31 (6.5%) 0/10 (0%)
    Cardiac disorders
    ANGINA PECTORIS 0/30 (0%) 1/29 (3.4%) 0/31 (0%) 0/10 (0%)
    CORONARY ARTERY DISEASE 0/30 (0%) 0/29 (0%) 1/31 (3.2%) 0/10 (0%)
    MYOCARDIAL INFARCTION 0/30 (0%) 1/29 (3.4%) 0/31 (0%) 0/10 (0%)
    Gastrointestinal disorders
    PANCREATITIS 1/30 (3.3%) 0/29 (0%) 1/31 (3.2%) 0/10 (0%)
    PANCREATITIS RELAPSING 0/30 (0%) 0/29 (0%) 1/31 (3.2%) 0/10 (0%)
    Injury, poisoning and procedural complications
    FIBULA FRACTURE 1/30 (3.3%) 0/29 (0%) 0/31 (0%) 0/10 (0%)
    TIBIA FRACTURE 1/30 (3.3%) 0/29 (0%) 0/31 (0%) 0/10 (0%)
    Skin and subcutaneous tissue disorders
    PSORIASIS 0/30 (0%) 1/29 (3.4%) 0/31 (0%) 0/10 (0%)
    Other (Not Including Serious) Adverse Events
    AIN457 3 mg/kg AIN457 10 mg/kg AIN457 10 mg/kg x3 Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 15/30 (50%) 22/29 (75.9%) 19/31 (61.3%) 3/10 (30%)
    Gastrointestinal disorders
    DIARRHOEA 1/30 (3.3%) 1/29 (3.4%) 3/31 (9.7%) 1/10 (10%)
    DYSPEPSIA 0/30 (0%) 0/29 (0%) 2/31 (6.5%) 0/10 (0%)
    VOMITING 2/30 (6.7%) 0/29 (0%) 1/31 (3.2%) 0/10 (0%)
    Infections and infestations
    INFLUENZA 1/30 (3.3%) 4/29 (13.8%) 1/31 (3.2%) 0/10 (0%)
    NASOPHARYNGITIS 9/30 (30%) 8/29 (27.6%) 4/31 (12.9%) 0/10 (0%)
    ORAL HERPES 0/30 (0%) 1/29 (3.4%) 0/31 (0%) 1/10 (10%)
    PHARYNGITIS 0/30 (0%) 1/29 (3.4%) 2/31 (6.5%) 0/10 (0%)
    SINUSITIS 0/30 (0%) 1/29 (3.4%) 2/31 (6.5%) 0/10 (0%)
    UPPER RESPIRATORY TRACT INFECTION 1/30 (3.3%) 5/29 (17.2%) 3/31 (9.7%) 0/10 (0%)
    Injury, poisoning and procedural complications
    LIMB INJURY 0/30 (0%) 0/29 (0%) 2/31 (6.5%) 0/10 (0%)
    MUSCLE STRAIN 0/30 (0%) 1/29 (3.4%) 0/31 (0%) 1/10 (10%)
    Investigations
    BLOOD AMYLASE INCREASED 0/30 (0%) 0/29 (0%) 0/31 (0%) 1/10 (10%)
    Musculoskeletal and connective tissue disorders
    BACK PAIN 1/30 (3.3%) 0/29 (0%) 2/31 (6.5%) 0/10 (0%)
    MUSCLE SPASMS 0/30 (0%) 2/29 (6.9%) 1/31 (3.2%) 0/10 (0%)
    PSORIATIC ARTHROPATHY 0/30 (0%) 2/29 (6.9%) 1/31 (3.2%) 0/10 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    BENIGN LUNG NEOPLASM 0/30 (0%) 0/29 (0%) 0/31 (0%) 1/10 (10%)
    Nervous system disorders
    HEADACHE 1/30 (3.3%) 2/29 (6.9%) 5/31 (16.1%) 0/10 (0%)
    Psychiatric disorders
    DEPRESSION 0/30 (0%) 3/29 (10.3%) 0/31 (0%) 0/10 (0%)
    Vascular disorders
    HYPERTENSION 4/30 (13.3%) 3/29 (10.3%) 2/31 (6.5%) 0/10 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.

    Results Point of Contact

    Name/Title Study Director
    Organization Novartis Pharmaceuticals
    Phone 862-778-8300
    Email
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00805480
    Other Study ID Numbers:
    • CAIN457A2212
    First Posted:
    Dec 9, 2008
    Last Update Posted:
    Feb 10, 2015
    Last Verified:
    Jan 1, 2015