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    Clinical Trial Results:
    A randomized, multicenter STudy to evaluate the Effect of secukinumab 300 mg s.c. administered during 52 weeks to patients suffering from new-onset moderate to severe plaque Psoriasis as early Intervention compared to standard treatment with narrow-band UVB (STEPIn study)

    Summary
    EudraCT number
    		 2015-002423-26
    Trial protocol
    		 ES   FI   GB   EE   SE   NO   DK   CZ   HU   PL   BG   DE  
    Global end of trial date
    16 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jun 2024
    First version publication date
    29 Jun 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CAIN457A2322
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03020199
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Jun 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jun 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of this study was to determine whether early intervention with subcutaneous (s.c.) secukinumab 300 mg in patients with new-onset moderate to severe plaque psoriasis may lead to prolonged symptom-free periods by preventing reactivation of old lesions or ultimately totally hindering the occurrence of new lesions, i.e., changing the natural course of the disease (Main Study).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Mar 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 5
    Country: Number of subjects enrolled
    Bulgaria: 13
    Country: Number of subjects enrolled
    Canada: 11
    Country: Number of subjects enrolled
    Denmark: 5
    Country: Number of subjects enrolled
    Estonia: 14
    Country: Number of subjects enrolled
    Finland: 7
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    Hungary: 9
    Country: Number of subjects enrolled
    Poland: 87
    Country: Number of subjects enrolled
    Spain: 20
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    Switzerland: 4
    Worldwide total number of subjects
    196
    EEA total number of subjects
    166
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    196
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects were enrolled in 2 study sites in Argentina, 4 in Bulgaria, 2 in Canada, 4 in Germany, 1 in Denmark, 3 in Estonia, 2 in Finland, 2 in Hungary, 6 in Poland, 8 in Spain, 2 in Sweden, 1 in Switzerland, and 4 in the United Kingdom.

    Period 1
    Period 1 title
    Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Secukinumab 300 mg
    Arm description
    		 Eligible patients received 300 mg secukinumab by subcutaneous (s.c.) injection at baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 48 inclusive (treatment duration = 52 weeks) OR every 4 weeks until Week 100 inclusive (last dose administered at Week 100) (treatment duration = 104 weeks).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    Other name
    AIN457
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Eligible patients received 300 mg secukinumab by subcutaneous (s.c.) injection at baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 48 inclusive (treatment duration = 52 weeks) OR every 4 weeks until Week 100 inclusive (last dose administered at Week 100) (treatment duration = 104 weeks).

    Arm title
    		 Narrow-band ultraviolet B (nb-UVB)
    Arm description
    		 Eligible patients received 1 or 2 cycles of narrow-band ultraviolet B (nb-UVB) of 12 weeks each with a maximum break of 28 weeks between cycles (patients with PASI 90 at Week 40 will not receive a second treatment cycle) (treatment duration = 52 weeks).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Narrow-band ultraviolet B (nb-UVB)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Radiopharmaceutical precursor
    Routes of administration
    Route of administration not applicable
    Dosage and administration details
    Eligible patients received 1 or 2 cycles of narrow-band ultraviolet B (nb-UVB) of 12 weeks each with a maximum break of 28 weeks between cycles (patients with PASI 90 at Week 40 will not receive a second treatment cycle) (treatment duration = 52 weeks).

    Number of subjects in period 1
    		Secukinumab 300 mg Narrow-band ultraviolet B (nb-UVB)
    Started
    116
    80
    Modified Full Analysis Set (mFAS)
    77 [1]
    76
    Subjects not treated
    3 [2]
    4 [3]
    Main Study
    80 [4]
    80
    Mechanistic Sub-study
    36 [5]
    0 [6]
    Completed
    103
    46
    Not completed
    13
    34
         Subjects not treated
    3
    4
         Physician decision
    -
    1
         Adverse event, non-fatal
    -
    2
         Lost to follow-up
    1
    6
         Subject/guardian decision
    8
    15
         Lack of efficacy
    1
    6
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Only randomized subjects in the Secukinumab 300 mg arm who did not get treated
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: In the Mechanistic Sub-study, 12 new-onset psoriasis patients (Arm A2) and 24 chronic plaque psoriasis patients (12 each in Arms C1 and C2) received similar secukinumab treatment. Arm A2 and C2 patients continued until Week 100 (104-week treatment), while Arm C1 ended at Week 48 (52- week treatment).
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Only subjects from the Mechanistic Study not accounted for as part of the Main study
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: In the Main Study, 80 new-onset psoriasis patients in Arm A1 (68 in Arm A1a, 12 in Arm A1b) received 300 mg secukinumab injections weekly for the first month, then every 4 weeks until Week 48 (52-week treatment).Arm A1b patients also joined the Mechanistic Sub-study.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: All randomized subjects who received at least one dose of study treatment during the Treatment Period
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Only randomized subjects in the Narrow-band ultraviolet B (nb-UVB) arm who did not get treated
    Period 2
    Period 2 title
    Follow-up Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Secukinumab 300 mg
    Arm description
    		 Eligible patients received 300 mg secukinumab by subcutaneous (s.c.) injection at baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 48 inclusive (treatment duration = 52 weeks) OR every 4 weeks until Week 100 inclusive (last dose administered at Week 100) (treatment duration = 104 weeks).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    Other name
    AIN457
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Eligible patients received 300 mg secukinumab by subcutaneous (s.c.) injection at baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 48 inclusive (treatment duration = 52 weeks) OR every 4 weeks until Week 100 inclusive (last dose administered at Week 100) (treatment duration = 104 weeks).

    Arm title
    		 Narrow-band ultraviolet B (nb-UVB)
    Arm description
    		 Eligible patients received 1 or 2 cycles of narrow-band ultraviolet B (nb-UVB) of 12 weeks each with a maximum break of 28 weeks between cycles (patients with PASI 90 at Week 40 will not receive a second treatment cycle) (treatment duration = 52 weeks).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Narrow-band ultraviolet B (nb-UVB)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Radiopharmaceutical precursor
    Routes of administration
    Route of administration not applicable
    Dosage and administration details
    Eligible patients received 1 or 2 cycles of narrow-band ultraviolet B (nb-UVB) of 12 weeks each with a maximum break of 28 weeks between cycles (patients with PASI 90 at Week 40 will not receive a second treatment cycle) (treatment duration = 52 weeks).

    Number of subjects in period 2
    		Secukinumab 300 mg Narrow-band ultraviolet B (nb-UVB)
    Started
    73
    39
    Main Study
    67
    39
    Mechanistic Sub-study
    6 [7]
    0 [8]
    Completed
    13
    8
    Not completed
    60
    31
         Physician decision
    2
    2
         Study terminated by Sponsor
    6
    3
         Disease relapse
    32
    7
         Lost to follow-up
    4
    6
         Subject/guardian decision
    14
    9
         Lack of efficacy
    1
    2
         Protocol deviation
    1
    2
    Notes
    [7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Only subjects from the Mechanistic Study not accounted for as part of the Main study
    [8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: In the Main Study, 80 new-onset psoriasis patients in Arm B1 (68 in Arm B1a and 12 in Arm B1b) received 1 or 2 cycles of nb UVB of 12 weeks each with a maximum break of 28 weeks between cycles (patients with PASI 90 at Week 40 did not receive a second treatment cycle) (treatment duration = 52 weeks).Patients from Arm B1b participated also in the Mechanistic Sub-study, but is accounted as part of the Main Study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Secukinumab 300 mg
    Reporting group description
    		 Eligible patients received 300 mg secukinumab by subcutaneous (s.c.) injection at baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 48 inclusive (treatment duration = 52 weeks) OR every 4 weeks until Week 100 inclusive (last dose administered at Week 100) (treatment duration = 104 weeks).

    Reporting group title
    Narrow-band ultraviolet B (nb-UVB)
    Reporting group description
    		 Eligible patients received 1 or 2 cycles of narrow-band ultraviolet B (nb-UVB) of 12 weeks each with a maximum break of 28 weeks between cycles (patients with PASI 90 at Week 40 will not receive a second treatment cycle) (treatment duration = 52 weeks).

    Reporting group values
    		 Secukinumab 300 mg Narrow-band ultraviolet B (nb-UVB) Total
    Number of subjects
    		 116 80 196
    Age Categorical
    Units: Participants
        18 to 30 years
    		 56 30 86
        31 to 50 years
    		 60 50 110
    Sex: Female, Male
    Units: Participants
        Female
    		 35 25 60
        Male
    		 81 55 136
    Race/Ethnicity, Customized
    Units: Subjects
        Black or African American
    		 1 1 2
        Asian
    		 2 3 5
        American Indian or Alaska Native
    		 0 1 1
        White
    		 113 72 185
        Unknown
    		 0 1 1
        Other
    		 0 2 2

    End points

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    End points reporting groups
    Reporting group title
    Secukinumab 300 mg
    Reporting group description
    		 Eligible patients received 300 mg secukinumab by subcutaneous (s.c.) injection at baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 48 inclusive (treatment duration = 52 weeks) OR every 4 weeks until Week 100 inclusive (last dose administered at Week 100) (treatment duration = 104 weeks).

    Reporting group title
    Narrow-band ultraviolet B (nb-UVB)
    Reporting group description
    		 Eligible patients received 1 or 2 cycles of narrow-band ultraviolet B (nb-UVB) of 12 weeks each with a maximum break of 28 weeks between cycles (patients with PASI 90 at Week 40 will not receive a second treatment cycle) (treatment duration = 52 weeks).
    Reporting group title
    Secukinumab 300 mg
    Reporting group description
    		 Eligible patients received 300 mg secukinumab by subcutaneous (s.c.) injection at baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 48 inclusive (treatment duration = 52 weeks) OR every 4 weeks until Week 100 inclusive (last dose administered at Week 100) (treatment duration = 104 weeks).

    Reporting group title
    Narrow-band ultraviolet B (nb-UVB)
    Reporting group description
    		 Eligible patients received 1 or 2 cycles of narrow-band ultraviolet B (nb-UVB) of 12 weeks each with a maximum break of 28 weeks between cycles (patients with PASI 90 at Week 40 will not receive a second treatment cycle) (treatment duration = 52 weeks).

    Subject analysis set title
    Secukinumab 300 mg A1 (A1a+A1b)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    80 patients (68 in Arm A1a and 12 in Arm A1b) with new-onset psoriasis will receive 300 mg secukinumab by subcutaneous (s.c.) injection at baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 48 inclusive (treatment duration = 52 weeks).

    Subject analysis set title
    Narrow-band ultraviolet B (nb-UVB) B1 (B1a+B1b)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    80 patients (68 in Arm B1a and 12 in Arm B1b) with new-onset psoriasis received 1 or 2 cycles of narrow-band ultraviolet B (nb-UVB) of 12 weeks each with a maximum break of 28 weeks between cycles (patients with PASI 90 at Week 40 will not receive a second treatment cycle) (treatment duration = 52 weeks).

    Primary: Number of participants who achieved Pain Assessment Severity Index (PASI) 90 at Week 52.

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    End point title
    		 Number of participants who achieved Pain Assessment Severity Index (PASI) 90 at Week 52.
    End point description
    The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of Body Surface Area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI composite score varies in increments of 0.1 and range from 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. PASI 90 response is a binary measure defined as at least a 90% improvement in PASI score at Week 52, relative to baseline PASI score.
    End point type
    Primary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Secukinumab 300 mg A1 (A1a+A1b) Narrow-band ultraviolet B (nb-UVB) B1 (B1a+B1b)
    Number of subjects analysed
    77
    76
    Units: Participants
    70
    32
    Statistical analysis title
    		 Week 52 PASI 90
    Comparison groups
    Secukinumab 300 mg A1 (A1a+A1b) v Narrow-band ultraviolet B (nb-UVB) B1 (B1a+B1b)
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    16.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.9
         upper limit
    		 48.3

    Secondary: Number of participants who achieved PASI 90 at Week 104

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    End point title
    		 Number of participants who achieved PASI 90 at Week 104
    End point description
    The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of Body Surface Area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI composite score varies in increments of 0.1 and range from 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. PASI 90 response is a binary measure defined as at least a 90% improvement in PASI score at Week 104, relative to baseline PASI score.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 104
    End point values
    		 Secukinumab 300 mg A1 (A1a+A1b) Narrow-band ultraviolet B (nb-UVB) B1 (B1a+B1b)
    Number of subjects analysed
    77
    76
    Units: Participants
    23
    26
    Statistical analysis title
    		 Week 104 PASI 90
    Comparison groups
    Secukinumab 300 mg A1 (A1a+A1b) v Narrow-band ultraviolet B (nb-UVB) B1 (B1a+B1b)
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.653
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 2.1

    Secondary: Number of participants with IGA mod 2011 0/1 response at Week 52

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    End point title
    		 Number of participants with IGA mod 2011 0/1 response at Week 52
    End point description
    Investigators assessed the disease using the validated Investigator Global Assessment (IGA) mod 2011 and rated the disease from a score of 0 (clear skin) to 4 (severe disease). Response is defined as a score of 0 or 1 at Week 52.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Secukinumab 300 mg A1 (A1a+A1b) Narrow-band ultraviolet B (nb-UVB) B1 (B1a+B1b)
    Number of subjects analysed
    77
    76
    Units: Percentage of participants
        number (confidence interval 95%)
    85.7 (75.5 to 92.3)
    36.8 (26.3 to 48.7)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment emergent include AE from First dose to last dose plus 84 days. Follow-up phase include AE recorded after last dose plus 84 days.
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Treatment emergent@Secukinumab 300 mg@(A1a+A1b+A2+C1+C2)
    Reporting group description
    		 Treatment emergent@Secukinumab 300 mg@(A1a+A1b+A2+C1+C2)

    Reporting group title
    Follow-up@nb-UVB@(B1a+B1b)
    Reporting group description
    		 Follow-up@nb-UVB@(B1a+B1b)

    Reporting group title
    Follow-up@Secukinumab 300 mg@(A1a+A1b+A2)
    Reporting group description
    		 Follow-up@Secukinumab 300 mg@(A1a+A1b+A2)

    Reporting group title
    Treatment emergent@nb-UVB@(B1a+B1b)
    Reporting group description
    		 Treatment emergent@nb-UVB@(B1a+B1b)

    Serious adverse events
    		 Treatment emergent@Secukinumab 300 mg@(A1a+A1b+A2+C1+C2) Follow-up@nb-UVB@(B1a+B1b) Follow-up@Secukinumab 300 mg@(A1a+A1b+A2) Treatment emergent@nb-UVB@(B1a+B1b)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 112 (5.36%)
    1 / 76 (1.32%)
    0 / 88 (0.00%)
    1 / 76 (1.32%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 76 (0.00%)
    0 / 88 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 76 (0.00%)
    0 / 88 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 76 (0.00%)
    0 / 88 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Pancytopenia
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 76 (1.32%)
    0 / 88 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Umbilical hernia
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 76 (0.00%)
    0 / 88 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Vocal cord polyp
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 76 (0.00%)
    0 / 88 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 76 (0.00%)
    0 / 88 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Acute stress disorder
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 76 (0.00%)
    0 / 88 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment emergent@Secukinumab 300 mg@(A1a+A1b+A2+C1+C2) Follow-up@nb-UVB@(B1a+B1b) Follow-up@Secukinumab 300 mg@(A1a+A1b+A2) Treatment emergent@nb-UVB@(B1a+B1b)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 112 (25.89%)
    2 / 76 (2.63%)
    7 / 88 (7.95%)
    8 / 76 (10.53%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 112 (9.82%)
    0 / 76 (0.00%)
    1 / 88 (1.14%)
    1 / 76 (1.32%)
         occurrences all number
    27
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    7 / 112 (6.25%)
    1 / 76 (1.32%)
    5 / 88 (5.68%)
    0 / 76 (0.00%)
         occurrences all number
    8
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    11 / 112 (9.82%)
    1 / 76 (1.32%)
    3 / 88 (3.41%)
    5 / 76 (6.58%)
         occurrences all number
    17
    0
    0
    5
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 112 (7.14%)
    2 / 76 (2.63%)
    0 / 88 (0.00%)
    2 / 76 (2.63%)
         occurrences all number
    9
    0
    0
    3

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Apr 2017
    Amendment 1: • The IGA mod 2011 was included as additional secondary and exploratory objectives; • The assessment of epigenetic imprinting in skin biopsies was introduced as part of the exploratory objectives; • The upper limit of the age range for inclusion of subjects in the study was changed from 40 years to 50 years; • The risks-benefit section was updated with information on risks for secukinumab, biopsies and others; • The exclusion criterion involving barrier methods of contraception was modified to include applicable countries other than the UK; • The optional use of calcipotriol 50 µg/g and betamethasone 0.5 mg/g with nb UVB was further clarified; • The number of subjects per group in the Mechanistic Sub-study was reduced from 15 to 12; • The number of biopsies to be taken from lesional or resolved skin and from never-lesional skin was corrected
    23 Sep 2019
    Amendment 2: • Clarification was added that subjects who discontinued the study during the Follow-up Epoch would have all EOS assessments performed; • Inclusion criterion 3 was modified by allowing earlier episodes of mild psoriasis resolved spontaneously within 6 months; • Withdrawal of consent language was modified to align with the requirements of the General Data Protection Regulation; • Table 6-2 was updated to reflect that a biopsy had to be taken at Week 52 for Arm A2 and Arm C2 to ensure consistency with Table 6-1; • Table 6-3 was updated with the definition of EOS; • The hypothesis testing for the efficacy analyses was modified to 1-sided tests at 2.5% significance level instead of 2-sided at 5% significance level; • Age and BMI were included as covariates for the analyses; • The Wald’s test was replaced by the Fisher’s exact test, which is mainly used when the sample size is small or the proportions are extreme; • Clarification was added that missing data for the primary endpoint and the key secondary endpoint were to be imputed with modified multiple imputation method; • The power of the key secondary endpoint was re-assessed after considering dropout rates; • The assumptions for the sample size calculations were modified. The software for the calculation was modified from nQuery Advisor® 7.0 to PASS 11

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study ended early due to few patients left in the long-term extension phase, hindering significant conclusions. This early termination did not impact the study's main or secondary goals, and the decision was not related to any safety concerns.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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