Palmoplantar Pustular Psoriasis Efficacy and Safety wIth Secukinumab

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT02008890
First received: December 8, 2013
Last updated: June 18, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

Primary Outcome Measures:
  • palmoplantar pustulosis Psoriasis Area and Severity Index 75 response rate (ppPASI 75) [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 210
Study Start Date: December 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02008890

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

  Show 89 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02008890     History of Changes
Other Study ID Numbers: CAIN457A3301, 2013-003086-34
Study First Received: December 8, 2013
Last Updated: June 18, 2014
Health Authority: European Union: European Medicines Agency
Germany: Paul-Ehrlich-Institut
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
France: National Agency for the Safety of Medicines and Health Products (MSNA)
Italy: The Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Russia: Ministry of Health of the Russian Federation

Keywords provided by Novartis:
palmoplantar, pustular, psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 29, 2014