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Efficacy and Safety of Subcutaneous Secukinumab in Adults With Moderate to Severe Scalp Psoriasis (SCALP)

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ClinicalTrials.gov Identifier: NCT02267135
Recruitment Status : Completed
First Posted : October 17, 2014
Results First Posted : February 28, 2018
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will assess the efficacy and safety of secukinumab compared to placebo in adult patients who have moderate to severe scalp psoriasis that is poorly controlled by current psoriasis treatments.

Condition or disease Intervention/treatment Phase
Chronic Scalp Psoriasis Biological: Secukinumab 300 mg Biological: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Efficacy of Subcutaneous Secukinumab [300 mg] as Assessed by the Psoriasis Scalp Severity Index (PSSI) at 12 Weeks of Treatment, Compared to Placebo, and to Assess Safety and Tolerability up to 24 Weeks in Adult Subjects With Moderate to Severe Scalp Psoriasis
Actual Study Start Date : September 29, 2014
Actual Primary Completion Date : December 7, 2015
Actual Study Completion Date : December 7, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Secukinumab

Arm Intervention/treatment
Experimental: Secukinumab
Eligible patients will receive secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
Biological: Secukinumab 300 mg
Secukinumab 300 mg will be provided in 1 mL prefilled syringes of 150 mg. Each dose of 300 mg secukinumab will consist of two secukinumab 150 mg injections once weekly for 5 weeks (Baseline, Weeks 1, 2, 3 and 4), followed by dosing every four weeks starting at Week 8 through Week 20 inclusive. In order to maintain the blinding, patients will receive additional placebo injections at Weeks 13, 14 and 15. The patients (or caregivers) will self-inject each dose at the study site under the supervision of site personnel when injections occur of days of study visits. The injections not occurring during a study visit will be done by the patients (or caregivers) at home.
Other Name: AIN457 300 mg

Placebo Comparator: Placebo
Eligible patients will receive placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, the patient will be assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the subject is a responder, the subject will continue on placebo dosing weekly at Weeks 12, 13, 14, 15 and 16 and then after four weeks at Week 20. Subjects who are not responders will be switched to treatment with secukinumab 300 mg and will dose once weekly at Weeks 12, 13, 14, 15 and 16 and then after four weeks at Week 20.
Biological: Placebo
Placebo will be provided in 1 mL prefilled syringe. Each placebo dose will consist of two placebo injections once weekly for five weeks (Baseline, Weeks 1, 2, 3 and 4), then after four weeks at Week 8. At Week 12, PSSI responders will continue on placebo and receive their injections once weekly for five weeks (Weeks 12, 13, 14, 15 and 16), then followed by dosing after four weeks at Week 20. PSSI non-responders will be switched to receive 300 mg secukinumab at Weeks 12, 13, 14, 15 and 16, then after four weeks at Week 20. The patients (or caregivers) will self-inject each dose at the study site under the supervision of site personnel when injections occur on days of study visits. The injections not occurring during a study visit will be done by the patients (or caregivers) at home.




Primary Outcome Measures :
  1. Psoriasis Scalp Severity Index 90 (PSSI 90) [ Time Frame: 12 weeks ]

    PSSI 90 response (yes) at Week 12; PSSI 90 response means at least a 90% improvement in scalp psoriasis

    Percentage of participants with Psoriasis Scalp Severity Index 90 (PSSI 90) response of "yes"



Secondary Outcome Measures :
  1. Secondary: Investigator's Global Assessment Model 2011 (IGA Mod 2011) Score of 0 or 1 (Scalp Only) [ Time Frame: 12 weeks ]
    IGA mod 2011 score of 0 or 1 (scalp only) response at Week 12 (non-responder imputation); IGA mod 2011 score of 0 means no sign of scalp psoriasis, and IGA score of 1 means almost no scalp psoriasis

  2. Change From Baseline in PSSI Score [ Time Frame: 12 weeks ]
    Change from baseline in Psoriasis Scalp Severity Index (PSSI) score. PSSI score ranges from 0-72 with 72 being severe

  3. Psoriasis Scalp Severity Index 75 (PSSI 75) Response [ Time Frame: 12 weeks ]
    PSSI 75 response (yes) at Week 12 (non-responder imputation); PSSI 75 response means at least a 75% improvement in scalp psoriasis

  4. Psoriasis Scalp Severity Index 100 (PSSI 100) Response [ Time Frame: 12 weeks ]
    PSSI 100 response (yes) at Week 12 (non-responder imputation); PSSI 100 response means no sign of scalp psoriasis

  5. Time to 50% Reduction in PSSI Score up to Week 12 [ Time Frame: 12 weeks ]

    Time to 50% reduction in PSSI score up to week 12 was estimated for drug arm

    The median time to reduction was not estimable for placebo because a 50% reduction in PSSI score was not achieved by enough participants receiving placebo


  6. Psoriasis Area and Severity Index 75 (PASI 75) [ Time Frame: 12 weeks ]
    PASI 75 response (yes) at Week 12 (non-responder imputation); PASI 75 response means at least a 75% improvement in body psoriasis

  7. Psoriasis Area and Severity Index 90 (PASI 90) [ Time Frame: 12 weeks ]
    PASI 90 response (yes) at Week 12 (non-responder imputation); PASI 90 response means at least a 90% improvement in body psoriasis

  8. Psoriasis Area and Severity Index 100 (PASI 100) [ Time Frame: 12 weeks ]
    PASI 100 response (yes) at Week 12 (non-responder imputation); PASI 100 response means no sign of body psoriasis

  9. Investigator's Global Assessment Model 2011 (GA Mod 2011) Score of 0 or 1 (Entire Body Including Scalp) [ Time Frame: 12 weeks ]
    IGA mod 2011 score of 0 or 1 (entire body including scalp); IGA mod 2011 score of 0 means no sign of psoriasis, and IGA mod 2011 score of 1 means almost no psoriasis

  10. Change From Baseline in Subject Assessment of Pain [ Time Frame: 12 weeks ]

    Change from baseline in the Subject Assessment of Pain

    Scale of 0-10 with 10 being the most painful


  11. Change From Baseline in Subject Assessment of Itching [ Time Frame: 12 weeks ]

    Change from baseline in the Subject Assessment of Itching

    Scale of 0-10 with 10 being the most itchy


  12. Change From Baseline in Subject Assessment of Scaling (Scalp Only) [ Time Frame: 12 weeks ]

    Change from baseline in the Subject Assessment of Scaling (scalp only)

    Scale of 0-10 with 10 being the most scaling




Information from the National Library of Medicine

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

Inclusion Criteria:

  • Chronic scalp psoriasis for at least the previous six months
  • Moderate to severe scalp psoriasis as defined by a PSSI score of ≥12 and 30% or higher of scalp surface area affected
  • Must be candidates for systemic therapy, which means having scalp psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy.

Exclusion Criteria:

  • Forms of psoriasis other than chronic plaque
  • Drug-induced psoriasis (e.g., new onset or current exacerbation from β-blockers, calcium channel inhibitors)
  • Ongoing use of prohibited treatments (e.g., topical or systemic corticosteroids, UV therapy)
  • Prior exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL17A or IL-17RA receptors
  • Use of other investigational drugs within 30 days prior to study entry, 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
  • Active system infections (with the exception of the common cold) during the two weeks prior to starting study treatment
  • Other protocol-defined inclusion/exclusion criteria may apply

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): NCT02267135


Locations
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United States, California
Novartis Investigative Site
Sacramento, California, United States, 95819
United States, Colorado
Novartis Investigative Site
Aurora, Colorado, United States, 80045
United States, Connecticut
Novartis Investigative Site
Trumbull, Connecticut, United States, 06611
United States, Maryland
Novartis Investigative Site
Rockville, Maryland, United States, 20850
United States, Massachusetts
Novartis Investigative Site
Andover, Massachusetts, United States, 01810
Novartis Investigative Site
Boston, Massachusetts, United States, 02114
United States, Michigan
Novartis Investigative Site
Troy, Michigan, United States, 48084
United States, New Jersey
Novartis Investigative Site
East Windsor, New Jersey, United States, 08520
United States, New York
Novartis Investigative Site
New York, New York, United States, 10025
Novartis Investigative Site
New York, New York, United States, 10075
United States, North Carolina
Novartis Investigative Site
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Novartis Investigative Site
Gahanna, Ohio, United States, 43230
United States, Pennsylvania
Novartis Investigative Site
Hershey, Pennsylvania, United States, 17033
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States, 15213-3403
United States, Texas
Novartis Investigative Site
Arlington, Texas, United States, 76011
United States, Utah
Novartis Investigative Site
Salt Lake City, Utah, United States, 84132
Novartis Investigative Site
West Jordan, Utah, United States, 84088
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis

Additional Information:
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02267135     History of Changes
Other Study ID Numbers: CAIN457AUS01
First Posted: October 17, 2014    Key Record Dates
Results First Posted: February 28, 2018
Last Update Posted: April 10, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
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

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
scalp psoriasis, plaque psoriasis, secukinumab, AIN457, biologic, monoclonal antibody, psoriasis, AIN457A
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs