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Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab

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ClinicalTrials.gov Identifier: NCT02008890
Recruitment Status : Completed
First Posted : December 11, 2013
Results First Posted : January 4, 2019
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE December 8, 2013
First Posted Date  ICMJE December 11, 2013
Results First Submitted Date  ICMJE May 31, 2018
Results First Posted Date  ICMJE January 4, 2019
Last Update Posted Date January 4, 2019
Actual Study Start Date  ICMJE December 26, 2013
Actual Primary Completion Date November 24, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 1, 2019)
Percentage of Participants With ppPASI 75 Response at Week 16 (Period 1) [ Time Frame: Baseline to Week 16 ]
The primary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Original Primary Outcome Measures  ICMJE
 (submitted: December 8, 2013)
palmoplantar pustulosis Psoriasis Area and Severity Index 75 response rate (ppPASI 75) [ Time Frame: Baseline to Week 16 ]
Primary endpoint is assessed by a Patient Related Outcome as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who archieve a 75% reduction in ppPASI score from Baseline to Week 16 is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total maximum score is 72.
Change History Complete list of historical versions of study NCT02008890 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 1, 2019)
  • ppPASI: Absolute Change From Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
    A secondary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI). The mean change of ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
  • Percentage of Participants With ppPASI 75 Response Over Time (Period 1) [ Time Frame: Baseline to Week 16 ]
    A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
  • Percentage of Participants With ppPASI 75 Response Over Time (Period 2) [ Time Frame: Week 16 to Week 52 ]
    A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
  • Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) [ Time Frame: Week 52 to Week 148 ]
    A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to each post-baseline visit was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
  • Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) [ Time Frame: Baseline to Week 16 (Period 1) ]
    Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
  • Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) [ Time Frame: Week 16 to Week 52 (Period 2) ]
    Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
  • Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety) [ Time Frame: Week 52 to Week 148 (extension period) ]
    Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
Original Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2013)
  • palmoplantar pustulosis Psoriasis Area and Severity Index response rate (ppPASI) [ Time Frame: Baseline to Week 16 ]
    A secondary endpoint is assessed by a Patient Related Outcome as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI). The mean change of ppPASI score from Baseline to Week 16 is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total maximum score is 72.
  • palmoplantar pustulosis Psoriasis Area and Severity Index response rate (ppPASI) [ Time Frame: Baseline to Week 52 ]
    A secondary endpoint is assessed by a Patient Related Outcome as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI). The mean change of ppPASI score from Baseline to Week 52 is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total maximum score is 72.
  • patient's safety [ Time Frame: Baseline to Week 60 ]
    Clinical safety and tolerability of secukinumab treatment regimens as assessed by vital signs, clinical laboratory variables, electrocardiograms (ECGs), and adverse events monitoring are measured as number of events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab
Official Title  ICMJE A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab to Demonstrate Efficacy as Assessed by Palmoplantar Pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 Weeks of Treatment, Compared to Placebo, and to Assess Long-term Safety, Tolerability, and Efficacy in Subjects With Moderate to Severe Chronic Palmoplantar Pustular Psoriasis - Amended With an Optional Extension Treatment Period of up to a Total of 148 Weeks
Brief Summary A one year study assessing the efficacy and safety of secukinumab compared with placebo in adult patients with moderate to severe palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Palmoplantar Pustular Psoriasis
Intervention  ICMJE
  • Biological: Secukinumab 300mg
    Secukinumab was used as 150 mg pre-filled syringes (PFS) in a double-blinded fashion. Secukinumab 300 mg s.c. (two PFS injections of the 150 mg dose) self-administered
  • Biological: Secukinumab 150mg
    secukinumab 150 mg s.c. (one PFS injection of the 150 mg dose + one PFS injection of placebo) self-administered
  • Biological: Placebo
    secukinumab placebo s.c. (two PFS injections of placebo) self-administered
Study Arms  ICMJE
  • Experimental: Secukinumab 300mg

    Secukinumab 300mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48.

    In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19.

    For extension period: Secukinumab 300mg at 4-weekly intervals starting Week 52 up to Week 148.

    Interventions:
    • Biological: Secukinumab 300mg
    • Biological: Placebo
  • Experimental: Secukinumab 150mg

    Secukinumab 150mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48.

    In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19.

    For extension period: Secukinumab 150mg at 4-weekly intervals starting Week 52 up to Week 148.

    Interventions:
    • Biological: Secukinumab 150mg
    • Biological: Placebo
  • Placebo Comparator: Placebo
    Placebo once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 12. Patients who achieved ppPASI 75 at Week 16 remained on placebo treatment Until week 48 and were not eligible to enter the extension. Patients who did not achieve ppPASI 75 at Week 16 were re-randomized to receive Secukinumab 150mg or Secukinumab 300mg from Week 16 onwards up to Week 148.
    Interventions:
    • Biological: Secukinumab 300mg
    • Biological: Secukinumab 150mg
    • Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 1, 2019)
237
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2013)
210
Actual Study Completion Date  ICMJE May 31, 2017
Actual Primary Completion Date November 24, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Palmoplantar pustular psoriasis for at least 6 months before Randomization
  • Moderate to severe palmoplantar pustular psoriasis as defined at Baseline by:

    • ppPASI score of ≥ 12 and
    • DLQI ≥ 10
  • Candidate for systemic therapy, defined as having palmoplantar pustular psoriasis inadequately controlled by:

    • Topical treatment, and/or
    • Phototherapy, and/or
    • Previous systemic therapy

Exclusion Criteria:

  • Forms of psoriasis other than chronic plaque psoriasis and pustular palmoplantar psoriasis (e.g., erythrodermic, guttate, or generalized pustular psoriasis)
  • Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors, or lithium) or history of proven contact dermatitis
  • Patients not willing to limit UV light exposure (e.g. sunbathing and/or the use of tanning devices) during the course of the study
  • Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy). Washout periods detailed in the protocol have to be adhered to
  • Previous exposure to any biologic drug directly targeting IL-17 or IL-17 Receptor (e.g., secukinumab, ixekizumab, or brodalumab)
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment and for 16 weeks after stopping treatment
  • Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy
  • Use of any other investigational drugs within 4 weeks of study drug initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer

Other protocol-defined inclusion/exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   France,   Germany,   Italy,   Poland,   Russian Federation,   Spain,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02008890
Other Study ID Numbers  ICMJE CAIN457A3301
2013-003086-34 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP