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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group Study Followed by a Dose-Blind Period and Open-Label Follow-Up to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects with Moderate to Severe Chronic Plaque Psoriasis

    Summary
    EudraCT number
    2014-003486-14
    Trial protocol
    DK   AT  
    Global end of trial date
    12 Sep 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    04 Oct 2019
    First version publication date
    04 Oct 2019
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    PS0002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02326272
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Biopharma, SPRL
    Sponsor organisation address
    Allée de la Recherche 60, Brussels, Belgium, B-1070
    Public contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    Scientific contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.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
    02 Oct 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Sep 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the efficacy of Certolizumab Pegol (CZP) administered subcutaneous (sc) at the doses of CZP 400 mg every two weeks (Q2W) and CZP 200 mg Q2W after a loading dose of CZP 400 mg at Weeks 0, 2, and 4 in the treatment of moderate to severe chronic plaque psoriasis (PSO).
    Protection of trial subjects
    During the conduct of the study all participants were closely monitored.
    Background therapy
    Background therapy/concomitant medication was permitted as defined in the study protocol.
    Evidence for comparator
    Not applicable.
    Actual start date of recruitment
    15 Dec 2014
    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
    Austria: 7
    Country: Number of subjects enrolled
    Canada: 60
    Country: Number of subjects enrolled
    Poland: 63
    Country: Number of subjects enrolled
    United States: 97
    Worldwide total number of subjects
    227
    EEA total number of subjects
    70
    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)
    206
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    The study started to enroll patients in December 2014 and concluded in September 2018 from multiple sites in Europe and North America. 227 participants were included in the Randomized Set (RS) shown in the Participant Flow.

    Pre-assignment
    Screening details
    The study included a 5 Week Screening Period, a Double-blind Initial Treatment Period up to Week 16, a Dose-blind Maintenance Treatment Period up to Week 48, an Open-label Treatment Period up to Week 144 and a Post Study Safety Follow-up Period up to Week 152. Participant Flow refers to the Randomized Set, Open Label Set and Maintenance Set.

    Period 1
    Period 1 title
    Initial Period (Week 0 to Week 16)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Assessor, Subject, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo Q2W
    Arm description
    Placebo sc injection Q2W. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: •PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22. •PASI75 responders at Week 16 continued to receive Placebo. •PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. •PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the Open-label Extension (OLE) Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections Q2W, administered at separate injection sites: lateral abdominal wall and upper outer thigh.

    Arm title
    CZP 200 mg Q2W
    Arm description
    CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: •PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W. •PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. •PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg Q2W or 400 mg Q2W were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

    Arm title
    CZP 400 mg Q2W
    Arm description
    CZP 400 mg Q2W through Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: •PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W. •PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. •PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg Q2W or 400 mg Q2W were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

    Number of subjects in period 1
    Placebo Q2W CZP 200 mg Q2W CZP 400 mg Q2W
    Started
    49
    91
    87
    Completed Week 16
    45
    84
    83
    Finished Wk16 entered Maintenance Period
    45
    84
    81
    Completed
    45
    84
    81
    Not completed
    4
    7
    6
         Moved from the study area
    -
    -
    1
         Lost to follow-up after completing wk16
    -
    -
    1
         Consent withdrawn after completing wk16
    -
    -
    1
         Adverse event, non-fatal
    -
    3
    1
         Missed two doses
    -
    -
    1
         Consent withdrawn by subject
    3
    2
    1
         Lost to follow-up
    1
    2
    -
    Period 2
    Period 2 title
    Maintenance Period (Week 16 to Week 48)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Carer, Assessor, Investigator
    Blinding implementation details
    Participants who entered the escape arms of the study received open-label CZP 400 mg every two weeks.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo/Placebo Q2W
    Arm description
    This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI75 response at Week 16 and continued to receive Placebo in the Maintenance Period (Week 16 to Week 48).
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections Q2W, administered at separate injection sites: lateral abdominal wall and upper outer thigh.

    Arm title
    Placebo/CZP 200 mg Q2W
    Arm description
    This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI50 response at Week 16 but not a PASI75 response and received CZP 400 mg at Weeks 16, 18, and 20 (loading doses) followed by CZP 200 mg Q2W (starting at Week 22).
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections Q2W, administered at separate injection sites: lateral abdominal wall and upper outer thigh.

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg Q2W or 400 mg Q2W were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

    Arm title
    CZP 200 mg Q2W/CZP 200 mg Q2W
    Arm description
    This arm consisted of participants initially randomized in the CZP 200 mg Q2W arm, who achieved a PASI50 response at Week 16 and continued to receive CZP 200 mg Q2W.
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg Q2W or 400 mg Q2W were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

    Arm title
    CZP 400 mg Q2W/CZP 400 mg Q2W
    Arm description
    This arm consisted of participants initially randomized in the CZP 400 mg Q2W arm, who achieved a PASI50 response at Week 16 and continued to receive CZP 400 mg Q2W.
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg Q2W or 400 mg Q2W were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

    Arm title
    Placebo/Escape CZP 400 mg Q2W
    Arm description
    This arm consisted of participants initially randomized in the Placebo arm, who did not achieve a PASI50 response at Week 16 escaped from the blinded treatment and received unblinded CZP 400 mg Q2W, for 16 weeks. participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections Q2W, administered at separate injection sites: lateral abdominal wall and upper outer thigh.

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg Q2W or 400 mg Q2W were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

    Arm title
    CZP 200 mg Q2W/Escape CZP 400 mg Q2W
    Arm description
    This arm consisted of participants initially randomized in the CZP 200 mg Q2W arm, who did not achieve a PASI50 response at Week 16 escaped from the blinded treatment and received CZP unblinded 400 mg Q2W, for 16 weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg Q2W or 400 mg Q2W were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

    Arm title
    CZP 400 mg Q2W/Escape CZP 400 mg Q2W
    Arm description
    This arm consisted of participants initially randomized in the CZP 400 mg Q2W arm, who did not achieve a PASI50 response at Week 16 escaped from the blinded treatment and received unblinded CZP 400 mg Q2W, for 16 weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg Q2W or 400 mg Q2W were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

    Number of subjects in period 2
    Placebo/Placebo Q2W Placebo/CZP 200 mg Q2W CZP 200 mg Q2W/CZP 200 mg Q2W CZP 400 mg Q2W/CZP 400 mg Q2W Placebo/Escape CZP 400 mg Q2W CZP 200 mg Q2W/Escape CZP 400 mg Q2W CZP 400 mg Q2W/Escape CZP 400 mg Q2W
    Started
    6
    5
    76
    69
    34
    8
    12
    Completed Week 48
    5
    3
    64
    61
    27
    3
    10
    Finished Wk48 entered Open-label Period
    5
    3
    63
    60
    27
    3
    10
    Completed
    5
    3
    63
    60
    27
    3
    10
    Not completed
    1
    2
    13
    9
    7
    5
    2
         Did not achieve PASI50 after wk48
    -
    -
    -
    1
    -
    -
    -
         Non-compliance
    -
    -
    -
    -
    -
    1
    -
         Lack of efficacy
    -
    -
    2
    1
    -
    1
    1
         Pregnancy
    -
    -
    -
    1
    -
    -
    -
         Adverse event after completing wk48
    -
    -
    1
    -
    -
    -
    -
         Did not achieve PASI50
    -
    -
    2
    1
    1
    2
    -
         Adverse event, non-fatal
    -
    2
    3
    4
    2
    1
    -
         Consent withdrawn by subject
    1
    -
    3
    1
    1
    -
    1
         Subject moved out of state
    -
    -
    -
    -
    1
    -
    -
         Lost to follow-up
    -
    -
    2
    -
    2
    -
    -
    Period 3
    Period 3 title
    Open-label Period (Week 48 to Week 144)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo/CZP 200 mg Q2W OLE
    Arm description
    This arm consisted of participants who received dose-blind Placebo during the Maintenance Period, who achieved a PASI50 response at Week 48 and entered the OLE Period receiving CZP 200 mg Q2W.
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg Q2W or 400 mg Q2W were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections Q2W, administered at separate injection sites: lateral abdominal wall and upper outer thigh.

    Arm title
    CZP 200 mg Q2W/CZP 200 mg Q2W OLE
    Arm description
    This arm consisted of participants who received CZP 200mg Q2W in the Maintenance Period, who achieved a PASI50 response at Week 48 and entered OLE.
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg Q2W or 400 mg Q2W were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

    Arm title
    CZP 400 mg Q2W/CZP 200 mg Q2W OLE
    Arm description
    This arm consisted of participants who received blinded CZP 400mg Q2W in the Maintenance Period, who achieved a PASI50 response at Week 48, and entered OLE on the CZP 200mg Q2W dose.
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg Q2W or 400 mg Q2W were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

    Arm title
    CZP 400 mg Q2W/CZP 400 mg Q2W OLE
    Arm description
    This arm consisted of participants who received blinded CZP 400mg Q2W in the Maintenance Period and entered OLE on the CZP 400mg Q2W dose.
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg Q2W or 400 mg Q2W were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

    Arm title
    Escape CZP 400 mg Q2W/CZP 400 mg Q2W OLE
    Arm description
    This arm consisted of participants who received open-label CZP 400mg Q2W in the Maintenance Period and entered OLE.
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injections: 200 mg Q2W or 400 mg Q2W were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

    Number of subjects in period 3
    Placebo/CZP 200 mg Q2W OLE CZP 200 mg Q2W/CZP 200 mg Q2W OLE CZP 400 mg Q2W/CZP 200 mg Q2W OLE CZP 400 mg Q2W/CZP 400 mg Q2W OLE Escape CZP 400 mg Q2W/CZP 400 mg Q2W OLE
    Started
    5
    66
    59
    1
    40
    Completed
    2
    51
    48
    1
    31
    Not completed
    3
    15
    11
    0
    9
         Protocol deviation
    -
    1
    -
    -
    -
         Loss of efficacy
    -
    1
    -
    -
    -
         Lack of efficacy
    1
    -
    1
    -
    -
         Pregnancy
    -
    -
    1
    -
    -
         Adverse event, serious fatal
    -
    -
    1
    -
    -
         Did not achieve PASI50
    -
    1
    3
    -
    3
         Adverse event, non-fatal
    1
    8
    3
    -
    1
         Consent withdrawn by subject
    -
    4
    -
    -
    2
         Lost to follow-up
    1
    -
    2
    -
    3

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo Q2W
    Reporting group description
    Placebo sc injection Q2W. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: •PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22. •PASI75 responders at Week 16 continued to receive Placebo. •PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. •PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the Open-label Extension (OLE) Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.

    Reporting group title
    CZP 200 mg Q2W
    Reporting group description
    CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: •PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W. •PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. •PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.

    Reporting group title
    CZP 400 mg Q2W
    Reporting group description
    CZP 400 mg Q2W through Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: •PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W. •PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. •PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.

    Reporting group values
    Placebo Q2W CZP 200 mg Q2W CZP 400 mg Q2W Total
    Number of subjects
    49 91 87 227
    Age categorical
    Units: Subjects
        <=18 years
    0 0 0 0
        Between 18 and 65 years
    46 84 76 206
        >=65 years
    3 7 11 21
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    43.3 ± 14.5 46.7 ± 13.3 46.4 ± 13.5 -
    Gender categorical
    Units: Subjects
        Male
    26 58 43 127
        Female
    23 33 44 100
    Subject analysis sets

    Subject analysis set title
    Placebo Q2W (RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Placebo sc injection Q2W. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: •PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22. •PASI75 responders at Week 16 continued to receive Placebo. •PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. •PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants formed the Randomized Set (RS).

    Subject analysis set title
    CZP 200 mg Q2W (RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: •PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W. •PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. •PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study. Participants formed the RS.

    Subject analysis set title
    CZP 400 mg Q2W (RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    CZP 400 mg Q2W through Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: •PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W. •PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. •PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W. Participants formed the RS.

    Subject analysis set title
    CZP 200 mg Q2W (TCS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This arm consisted of all participants who received CZP 200 mg at any time during the study.

    Subject analysis set title
    CZP 400 mg Q2W (TCS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This arm consisted of all participants who received CZP 400 mg at any time during the study.

    Subject analysis sets values
    Placebo Q2W (RS) CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS) CZP 200 mg Q2W (TCS) CZP 400 mg Q2W (TCS)
    Number of subjects
    49
    91
    87
    170
    149
    Age categorical
    Units: Subjects
        <=18 years
    0
    0
    0
    0
    0
        Between 18 and 65 years
    46
    84
    76
    155
    132
        >=65 years
    3
    7
    11
    15
    17
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    43.3 ± 14.5
    46.7 ± 13.3
    46.4 ± 13.5
    45.7 ± 13.6
    46.3 ± 13.7
    Gender categorical
    Units: Subjects
        Male
    26
    58
    43
    100
    76
        Female
    23
    33
    44
    70
    73

    End points

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    End points reporting groups
    Reporting group title
    Placebo Q2W
    Reporting group description
    Placebo sc injection Q2W. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: •PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22. •PASI75 responders at Week 16 continued to receive Placebo. •PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. •PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the Open-label Extension (OLE) Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.

    Reporting group title
    CZP 200 mg Q2W
    Reporting group description
    CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: •PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W. •PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. •PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.

    Reporting group title
    CZP 400 mg Q2W
    Reporting group description
    CZP 400 mg Q2W through Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: •PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W. •PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. •PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.
    Reporting group title
    Placebo/Placebo Q2W
    Reporting group description
    This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI75 response at Week 16 and continued to receive Placebo in the Maintenance Period (Week 16 to Week 48).

    Reporting group title
    Placebo/CZP 200 mg Q2W
    Reporting group description
    This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI50 response at Week 16 but not a PASI75 response and received CZP 400 mg at Weeks 16, 18, and 20 (loading doses) followed by CZP 200 mg Q2W (starting at Week 22).

    Reporting group title
    CZP 200 mg Q2W/CZP 200 mg Q2W
    Reporting group description
    This arm consisted of participants initially randomized in the CZP 200 mg Q2W arm, who achieved a PASI50 response at Week 16 and continued to receive CZP 200 mg Q2W.

    Reporting group title
    CZP 400 mg Q2W/CZP 400 mg Q2W
    Reporting group description
    This arm consisted of participants initially randomized in the CZP 400 mg Q2W arm, who achieved a PASI50 response at Week 16 and continued to receive CZP 400 mg Q2W.

    Reporting group title
    Placebo/Escape CZP 400 mg Q2W
    Reporting group description
    This arm consisted of participants initially randomized in the Placebo arm, who did not achieve a PASI50 response at Week 16 escaped from the blinded treatment and received unblinded CZP 400 mg Q2W, for 16 weeks. participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.

    Reporting group title
    CZP 200 mg Q2W/Escape CZP 400 mg Q2W
    Reporting group description
    This arm consisted of participants initially randomized in the CZP 200 mg Q2W arm, who did not achieve a PASI50 response at Week 16 escaped from the blinded treatment and received CZP unblinded 400 mg Q2W, for 16 weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.

    Reporting group title
    CZP 400 mg Q2W/Escape CZP 400 mg Q2W
    Reporting group description
    This arm consisted of participants initially randomized in the CZP 400 mg Q2W arm, who did not achieve a PASI50 response at Week 16 escaped from the blinded treatment and received unblinded CZP 400 mg Q2W, for 16 weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.
    Reporting group title
    Placebo/CZP 200 mg Q2W OLE
    Reporting group description
    This arm consisted of participants who received dose-blind Placebo during the Maintenance Period, who achieved a PASI50 response at Week 48 and entered the OLE Period receiving CZP 200 mg Q2W.

    Reporting group title
    CZP 200 mg Q2W/CZP 200 mg Q2W OLE
    Reporting group description
    This arm consisted of participants who received CZP 200mg Q2W in the Maintenance Period, who achieved a PASI50 response at Week 48 and entered OLE.

    Reporting group title
    CZP 400 mg Q2W/CZP 200 mg Q2W OLE
    Reporting group description
    This arm consisted of participants who received blinded CZP 400mg Q2W in the Maintenance Period, who achieved a PASI50 response at Week 48, and entered OLE on the CZP 200mg Q2W dose.

    Reporting group title
    CZP 400 mg Q2W/CZP 400 mg Q2W OLE
    Reporting group description
    This arm consisted of participants who received blinded CZP 400mg Q2W in the Maintenance Period and entered OLE on the CZP 400mg Q2W dose.

    Reporting group title
    Escape CZP 400 mg Q2W/CZP 400 mg Q2W OLE
    Reporting group description
    This arm consisted of participants who received open-label CZP 400mg Q2W in the Maintenance Period and entered OLE.

    Subject analysis set title
    Placebo Q2W (RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Placebo sc injection Q2W. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: •PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22. •PASI75 responders at Week 16 continued to receive Placebo. •PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. •PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants formed the Randomized Set (RS).

    Subject analysis set title
    CZP 200 mg Q2W (RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: •PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W. •PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. •PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study. Participants formed the RS.

    Subject analysis set title
    CZP 400 mg Q2W (RS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    CZP 400 mg Q2W through Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: •PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W. •PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. •PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W. Participants formed the RS.

    Subject analysis set title
    CZP 200 mg Q2W (TCS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This arm consisted of all participants who received CZP 200 mg at any time during the study.

    Subject analysis set title
    CZP 400 mg Q2W (TCS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This arm consisted of all participants who received CZP 400 mg at any time during the study.

    Primary: Proportion of participants who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 16

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    End point title
    Proportion of participants who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 16
    End point description
    The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    Placebo Q2W (RS) CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
    Number of subjects analysed
    49
    91
    87
    Units: percentage of participants
        number (not applicable)
    11.6
    81.4
    82.6
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 200 mg Q2W (RS)
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [1]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    33.405
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    9.965
         upper limit
    111.983
    Notes
    [1] - The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose versus (vs) placebo (PBO).
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 200 mg Q2W (RS)
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Regression, Logistic
    Parameter type
    Estimated difference in responder rate
    Point estimate
    69.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    57.12
         upper limit
    82.36
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 400 mg Q2W (RS)
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [2]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    36.212
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    10.686
         upper limit
    122.713
    Notes
    [2] - The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.
    Statistical analysis title
    Statistical Analysis 4
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 400 mg Q2W (RS)
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Regression, Logistic
    Parameter type
    Estimated difference in responder rate
    Point estimate
    71
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    58.47
         upper limit
    83.43

    Primary: Proportion of participants who achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (with at least 2-category improvement) response at Week 16

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    End point title
    Proportion of participants who achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (with at least 2-category improvement) response at Week 16
    End point description
    The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    Placebo Q2W (RS) CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
    Number of subjects analysed
    49
    91
    87
    Units: percentage of participants
        number (not applicable)
    2.0
    66.8
    71.6
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 200 mg Q2W (RS)
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [3]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    106.225
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    9.572
         upper limit
    1178.843
    Notes
    [3] - The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 200 mg Q2W (RS)
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Regression, Logistic
    Parameter type
    Estimated difference in responder rate
    Point estimate
    64.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    52.16
         upper limit
    77.46
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 400 mg Q2W (RS)
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [4]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    133.163
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    11.904
         upper limit
    1489.578
    Notes
    [4] - The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.
    Statistical analysis title
    Statistical Analysis 4
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 400 mg Q2W (RS)
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Regression, Logistic
    Parameter type
    Estimated difference in responder rate
    Point estimate
    69.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    57.48
         upper limit
    81.77

    Secondary: Proportion of participants who achieve a Psoriasis Activity and Severity Index (PASI90) response at Week 16

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    End point title
    Proportion of participants who achieve a Psoriasis Activity and Severity Index (PASI90) response at Week 16
    End point description
    The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo Q2W (RS) CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
    Number of subjects analysed
    49
    91
    87
    Units: percentage of participants
        number (not applicable)
    4.5
    52.6
    55.4
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 200 mg Q2W (RS)
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [5]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    24.283
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    4.386
         upper limit
    134.432
    Notes
    [5] - The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 200 mg Q2W (RS)
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Regression, Logistic
    Parameter type
    Estimated difference in responder rate
    Point estimate
    48.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    35.04
         upper limit
    61.26
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 400 mg Q2W (RS)
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [6]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    27.204
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    4.895
         upper limit
    151.198
    Notes
    [6] - The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.
    Statistical analysis title
    Statistical Analysis 4
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 400 mg Q2W (RS)
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Regression, Logistic
    Parameter type
    Estimated difference in responder rate
    Point estimate
    51
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    37.75
         upper limit
    64.19

    Secondary: Proportion of participants who achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (with at least 2-category improvement) response at Week 48

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    End point title
    Proportion of participants who achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (with at least 2-category improvement) response at Week 48
    End point description
    The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
    Number of subjects analysed
    Units: percentage of participants
        number (confidence interval 95%)
    72.6 (61.22 to 83.92)
    66.6 (54.35 to 78.86)
    No statistical analyses for this end point

    Secondary: Proportion of participants who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 48

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    End point title
    Proportion of participants who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 48
    End point description
    The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
    Number of subjects analysed
    Units: percentage of participants
        number (confidence interval 95%)
    78.7 (68.93 to 88.45)
    81.3 (71.90 to 90.67)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16

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    End point title
    Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16
    End point description
    The DLQI is a subject-reported questionnaire designed for use in adult subjects with PSO. The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect patients’ health related quality of life (HRQoL). This instrument asks subjects about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has been shown to be valid and reproducible in PSO patients. The DLQI score ranges from 0 to 30 with higher scores indicating lower HRQoL. A higher than or equal to (>=) 4-point change in the DLQI score (DLQI response) has been reported to be meaningful for the patient (within-patient minimal important difference Basra et al, 2015) a DLQI absolute score of lower than or equal to (=<) 1 indicates DLQI remission (i.e., no or small impact of the disease on HRQoL).
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo Q2W (RS) CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
    Number of subjects analysed
    49
    90
    87
    Units: Scores on a scale
        least squares mean (standard error)
    -3.8 ± 0.84
    -10.4 ± 0.62
    -10.0 ± 0.64
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 200 mg Q2W (RS)
    Number of subjects included in analysis
    139
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [7]
    Method
    ANCOVA
    Parameter type
    Adjusted Mean Treatment Differences
    Point estimate
    -6.62
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    -8.88
         upper limit
    -4.36
    Notes
    [7] - The P-value was obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    Comparison groups
    Placebo Q2W (RS) v CZP 400 mg Q2W (RS)
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [8]
    Method
    ANCOVA
    Parameter type
    Adjusted Mean Treatment Differences
    Point estimate
    -6.19
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    -8.46
         upper limit
    -3.93
    Notes
    [8] - The P-value was obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
    Adverse event reporting additional description
    As per design, participants randomized to PBO either switched to CZP 200mg Q2W or escaped to CZP 400mg Q2W at Week 16, leading to a significantly lower exposure in PBO arm than in CZP arm. Considering the limitations of such comparison, AEs reported while the participants were on PBO are not included in this summary.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    CZP 200 mg Q2W (TCS)
    Reporting group description
    This arm consisted of all participants who received CZP 200 mg at any time during the study.

    Reporting group title
    CZP 400 mg Q2W (TCS)
    Reporting group description
    This arm consisted of all participants who received CZP 400 mg at any time during the study.

    Serious adverse events
    CZP 200 mg Q2W (TCS) CZP 400 mg Q2W (TCS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    24 / 170 (14.12%)
    12 / 149 (8.05%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    1
    0
    Vascular disorders
    Distributive shock
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign salivary gland neoplasm
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 170 (0.59%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected bite
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy with contraceptive device
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Penile swelling
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital haemorrhage
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal swelling
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood count abnormal
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest X-ray abnormal
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Laryngeal cyst
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillar cyst
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Disseminated intravascular coagulation
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple sclerosis
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    2 / 170 (1.18%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Tolosa-Hunt syndrome
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Haemorrhagic necrotic pancreatitis
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngo-oesophageal diverticulum
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic failure
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    2 / 170 (1.18%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriatic arthropathy
         subjects affected / exposed
    2 / 170 (1.18%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bartholin's abscess
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian abscess
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia legionella
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Chronic sinusitis
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 170 (0.59%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma infection
         subjects affected / exposed
    0 / 170 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    CZP 200 mg Q2W (TCS) CZP 400 mg Q2W (TCS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    76 / 170 (44.71%)
    75 / 149 (50.34%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    7 / 170 (4.12%)
    9 / 149 (6.04%)
         occurrences all number
    8
    9
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    8 / 170 (4.71%)
    5 / 149 (3.36%)
         occurrences all number
    8
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 170 (5.29%)
    6 / 149 (4.03%)
         occurrences all number
    10
    6
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    3 / 170 (1.76%)
    8 / 149 (5.37%)
         occurrences all number
    3
    8
    Psoriasis
         subjects affected / exposed
    9 / 170 (5.29%)
    12 / 149 (8.05%)
         occurrences all number
    10
    19
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 170 (3.53%)
    8 / 149 (5.37%)
         occurrences all number
    6
    8
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    33 / 170 (19.41%)
    35 / 149 (23.49%)
         occurrences all number
    55
    45
    Upper respiratory tract infection
         subjects affected / exposed
    19 / 170 (11.18%)
    18 / 149 (12.08%)
         occurrences all number
    20
    21
    Sinusitis
         subjects affected / exposed
    13 / 170 (7.65%)
    4 / 149 (2.68%)
         occurrences all number
    15
    4
    Pharyngitis
         subjects affected / exposed
    10 / 170 (5.88%)
    4 / 149 (2.68%)
         occurrences all number
    12
    4
    Urinary tract infection
         subjects affected / exposed
    11 / 170 (6.47%)
    10 / 149 (6.71%)
         occurrences all number
    15
    14

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Nov 2015
    The Global Protocol Amendment included the following changes: - CIMPASI-2 (name of the PS0002 protocol) was added. - Updated study contact information and serious adverse event (SAE) reporting contact information. - Added the secondary efficacy variable: at least 90% reduction from Baseline in PASI (PASI90). - Removed the other efficacy variables: absolute PASI score and absolute Body Surface Area (BSA) affected by PSO. - Corrected: the Subject Questionnaire for Tuberculosis (TB) was removed as a safety variable. - Clarified the responsibilities of the unblinded and blinded study personnel. - Provided additional details regarding breaking the treatment blind in an emergency situation - Revised Exclusion Criteria #21 to add secukinumab and require a 24-week washout period. - Allowed flexibility of self-administration of Certolizumab Pegol (CZP) during the Open label Treatment Period. - Corrected: subject treatment assignment was stratified by site.

    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.
    None reported

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/29660421
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