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Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis (GESTURE)

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ClinicalTrials.gov Identifier: NCT01806597
Recruitment Status : Completed
First Posted : March 7, 2013
Results First Posted : February 22, 2018
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE January 23, 2013
First Posted Date  ICMJE March 7, 2013
Results First Submitted Date  ICMJE October 31, 2017
Results First Posted Date  ICMJE February 22, 2018
Last Update Posted Date February 22, 2018
Actual Study Start Date  ICMJE June 19, 2013
Actual Primary Completion Date November 2, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2018)
Percentages of Participants With Palmoplantar Investigator Global Assessmnet (ppIGA) 0 or 1 Response After 16 Weeks of Treatment [ Time Frame: Week 16 ]
palmoplantar Investigator's Global Assessment (ppIGA) response after 16 weeks of treatment. To be considered a ppIGA responder at Week 16, a subject must have ppIGA of 0 or 1 at Week 16 and a reduction of at least 2 points on the ppIGA scale from baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: March 5, 2013)
Efficacy:palmoplantar Investigator Global Assessmnet (ppIGA) response after 16 weeks of treatment. Each of the treatment group will be compared to placebo. [ Time Frame: Baseline, 16 weeks ]
The primary endpoint is the palmoplantar Investigator Global Assessment (ppIGA) response after 16 weeks of treatment. To be considered a ppIGA responder at Week 16, a subject must have a ppIGA of 0 or 1 at Week 16 and a reduction of at least 2 points on the ppIGA scale from baseline.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2018)
  • Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I [ Time Frame: Week 1, week 2, week 4, week, 8, week 12, week 16 ]
    ppIGA: Palmoplantar Ivestigator's Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline).
  • Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II [ Time Frame: Week 16, Week 20, Week 28, Week 32, Week 64, Week 132 ]
    ppIGA: Palmoplantar Ivestigator's Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline).
  • Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period [ Time Frame: Week 16, Week 24, Week 28, Week 80 ]
    ppIGA: Palmoplantar Ivestigator's Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline).
  • Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I [ Time Frame: Week 1, Week 2, Week 4, Week 8, Week 12, Week 16 ]
    Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease).
  • Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set [ Time Frame: Week 16, Week 32, Week 80, Week 132 ]
    Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease).
  • Number of Participants Developing Anti-secukinumab Antibodies [ Time Frame: Over time up to week 132 ]
    To investigate the development of immunogenicity against secukinumab
Original Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2013)
  • Efficacy: palmoplantar Investigator Global Assessment (ppIGA) response over time up to Week 16 compared to placebo, and over time up to Week 80 [ Time Frame: 16 weeks, 80 weeks ]
    The ppIGA score for signs of plaque psoriasis on the palms and soles. A subject will be considered a ppIGA responder at a specific time, if the ppIGA score at that time of assessment is 0 or 1 AND if there is a reduction of at least 2 points on the ppIGA scale at that time from baseline. Each secukinumab dose regimen will be compared with placebo in terms of treatment response at each visit up to Week 16 and over time up to Week 80.
  • Efficacy: palmoplantar Psoriasis Area and Severity Index (ppPASI) over time up to Week 16 compared to placebo, and over time up to Week 80 [ Time Frame: 16 weeks, 80 weeks ]
    The ppPASI score evaluates erythema, induration and desquamation, as well as the area affected with the disease on the palms and soles. Percentage change from baseline in ppPASI score from randomization to Week 16 and over time up to Week 80 will be analyzed. Each of the secukinumab groups will be compared with the placebo group.
  • Number of subjects in treatment groups 150mg and 300mg with adverse events, safety labs, ECG, and vital signs as a measure of safety and tolerability [ Time Frame: Baseline, up to 88 weeks ]
    Adverse events, safety labs, ECG, and vital signs will be used to measure and evaluate safety and tolerability of subjects who took at least one dose of study treatment.
  • Number and percentage of subjects who develop immunogenicity against secukinumab [ Time Frame: Baseline, 32 weeks, 80 weeks, 88 weeks ]
    Overall statistical data will be used as a measure of the development of immunogenicity against secukinumab.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Demonstrate the Efficacy at 16 Weeks of Secukinumab 150 and 300 mg s.c. and to Assess Safety, Tolerability and Long-term Efficacy up to 132 Weeks in Subjects With Moderate to Severe Palmoplantar Psoriasis
Brief Summary Purpose of the study was to demonstrate the efficacy of secukinumab versus placebo on palmoplantar psoriasis and to assess the long term efficacy, safety and tolerability of secukinumab.
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 Moderate to Severe Palmoplantar Psoriasis
Intervention  ICMJE
  • Biological: secukinumab 150 mg
    Study treatment were provided in pre-filled syringes of secukinumab 150 mg in 1 mL. Each dosing consiseds of one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection and took place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then once every four weeks starting at Week 8 until Week 128 inclusive. In order to maintain the blinding, patients also received two placebo injections at Weeks 17, 18 and 19. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.
    Other Name: AIN457 150 mg
  • Biological: secukinumab 300 mg
    Study treatment were provided in pre-filled syringes of secukinumab 150 mg in 1 mL. Each dosing consisted of two secukinumab 150 mg s.c. injections and took ke place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then once every four weeks starting at Week 8 until Week 128 inclusive. In order to maintain the blinding, patients also receives two placebo injections at Weeks 17, 18 and 19. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.
    Other Name: AIN457 300 mg
  • Biological: Placebo
    Placebo were provided in 1 mL pre-filled syringes. Each dosing consisted of two s.c. injections and took place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then at Week 8 and at Week 12. At Week 16, ppIGA responders continued on placebo with dosing at Weeks 16, 17, 18, 19 and 20, then once every four weeks from Week 24 until Week 76 inclusive. At Week 80, ppIGA responders ended their participation in the study while ppIGA non-responders were re-randomized, to receive 150 mg or 300 mg secukinumab once every four weeks starting at Week 80 until Week 128 inclusive. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.
Study Arms  ICMJE
  • Experimental: secukinumab 150mg
    201 subjects were randomized in a 1:1:1 ratio to secukinumab either 150 mg or 300 mg, or placebo. Subjects assigned to secukinumab 150 mg were dosed weekly for the first five weeks, then every four weeks up to and including Week 128. To maintain blinding, subjects received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
    Intervention: Biological: secukinumab 150 mg
  • Experimental: secukinumab 300 mg
    201 subjects were randomized in a 1:1:1 ratio to secukinumab either 150 mg or 300 mg, or placebo. Subjects assigned to secukinumab 300 mg were dosed weekly for the first five weeks and then every four weeks up to and including Week 128. In order to maintain the blinding, subjects received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.
    Intervention: Biological: secukinumab 300 mg
  • Placebo Comparator: Placebo
    201 subjects were randomized in a 1:1:1 ratio to secukinumab either 150 mg or 300 mg, or placebo. Subjects on placebo were dosed weekly for 5 weeks then once every 4 weeks. At Week 16, ppIGA responders continued to receive placebo weekly for 5 weeks starting at Week 16, then every 4 weeks up to and including Week 76 while ppIGA non-responders were randomized in a 1:1 ratio to secukinumab either 150 mg or 300mg weekly for 5 weeks, starting at Week 16, then every 4 weeks up to and including Week 128. At Week 80, subjects on placebo were either terminated their participation, if ppIGA responders, or randomized in a 1:1 ratio to secukinumab either 150 mg or 300 mg once every 4 weeks until Week 128 inclusive. All doses of study treatment were administered by sub-cutaneous injections.
    Intervention: 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: November 20, 2014)
205
Original Estimated Enrollment  ICMJE
 (submitted: March 5, 2013)
201
Actual Study Completion Date  ICMJE November 2, 2016
Actual Primary Completion Date November 2, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with chronic, moderate to severe plaque type psoriasis for at least 6 months prior to randomization and significant involvement of the palms and soles at baseline, defined as palmoplantar Investigator's Global Assessment (ppIGA) score of ≥ 3 on a 5-point scale, as well as at least one skin plaque at baseline which is not in the palmoplantar area
  • Candidates for systemic therapy, i.e. psoriasis inadequately controlled by topical treatment (including super potent topical corticosteroids) and/or phototherapy and/or previous systemic therapy

Exclusion Criteria:

  • Forms of psoriasis other than chronic plaque type psoriasis (e.g., pustular psoriasis, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic and guttate psoriasis)
  • Drug-induced psoriasis (e.g. new onset or current exacerbation from β-blockers, calcium channel inhibitors or lithium)
  • Ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (CS), UV therapy). Washout periods do apply.
  • Prior exposure to secukinumab (AIN457) or any other biological drug directly targeting IL-17 or the IL-17 receptor
  • Use of any investigational drugs within 4 weeks prior to study treatment initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer
  • Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy
  • History of hypersensitivity to constituents of the study treatment
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 Australia,   Belgium,   Canada,   Finland,   Hungary,   Israel,   Netherlands,   Norway,   Portugal,   Russian Federation,   Slovakia,   Spain,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01806597
Other Study ID Numbers  ICMJE CAIN457A2312
2012-005412-25 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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 2018

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