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Palmoplantar Pustular Psoriasis Efficacy and Safety wIth Secukinumab

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02008890
First Posted: December 11, 2013
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
Was to demonstrate superiority of secukinumab compared to placebo in patients with moderate to severe chronic palmoplantar pustular psoriasis with respect to the palmoplantar pustulosis Psoriasis Area and Severity Index 75 response rate

Condition Intervention Phase
Palmoplantar Pustular Psoriasis Biological: Secucinumab Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 237
Actual Study Start Date: December 26, 2013
Study Completion Date: May 31, 2017
Primary Completion Date: May 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Secucinumab 300mg
70 patients with moderate to severe chronic palmoplantar pustular psoriasis will be treated with Secukinumab 300 mg subcutanous (s.c.) until Week 16. From Week 16 until Week 52 all patients and in addition half of the patients in the placebo arm that are non-responders to the placebo treatment are treated with Secucinumab 300 mg s.c. Efficacy and patient's safety will be compared separately in each group.
Biological: Secucinumab
Secucinumab will be used as 150 mg pre-filled syringes in a double-blinded fashion. Until Week 16 patients will perform a self-administration under the supervision of the investigator. After Week 16 patients will have regular office visits and apply the treatment under supervision of the investigator and in between office visits apply treatment at home. The investigator must emphazie compliance and instruct patients to take the treatment exactly as described.
Experimental: Secucinumab 150mg
70 patients with moderate to severe chronic palmoplantar pustular psoriasis will be treated with Secukinumab 150 mg subcutanous (s.c.) until Week 16. From Week 16 until Week 52 all patients and in addition half of the patients in the placebo arm that are non-responders to the placebo treatment are treated with Secucinumab 150 mg s.c. Efficacy and patient's safety will be compared separately in each group.
Biological: Secucinumab
Secucinumab will be used as 150 mg pre-filled syringes in a double-blinded fashion. Until Week 16 patients will perform a self-administration under the supervision of the investigator. After Week 16 patients will have regular office visits and apply the treatment under supervision of the investigator and in between office visits apply treatment at home. The investigator must emphazie compliance and instruct patients to take the treatment exactly as described.
Placebo Comparator: Placebo
70 patients with moderate to severe chronic palmoplantar pustular psoriasis will be treated with matching placebo subcutanous (s.c.) until Week 16. At week 16 non-responders to placebo treatment will be re-randomized 1:1 to both secukinumab treatment arms.
Drug: Placebo
matching placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02008890


  Show 68 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02008890     History of Changes
Other Study ID Numbers: CAIN457A3301
2013-003086-34 ( EudraCT Number )
First Submitted: December 8, 2013
First Posted: December 11, 2013
Last Update Posted: August 17, 2017
Last Verified: August 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
palmoplantar, pustular, psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs