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

• 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: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Study Director: Novartis Pharmaceuticals; Novartis

More Information

Additional Information:

A Plain Language Trial Summary is available on novartisclinicaltrials.com 

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02267135 History of Changes
• Other Study ID Numbers: CAIN457AUS01
• First Posted: October 17, 2014
• 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:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Antibodies, Monoclonal; Immunologic Factors; Physiological Effects of Drugs