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

NCT02267135 | Completed Phase 3 Results

• 1 other identifier: CAIN457AUS01
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 17

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.

Conditions

Chronic Scalp Psoriasis

Keywords

scalp psoriasis, plaque psoriasis, secukinumab, AIN457, biologic, monoclonal antibody, psoriasis, AIN457A

Outcome Measures

Primary Outcomes (1)

• Psoriasis Scalp Severity Index 90 (PSSI 90)

  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"

  12 weeks

Secondary Outcomes (12)

• Secondary: Investigator's Global Assessment Model 2011 (IGA Mod 2011) Score of 0 or 1 (Scalp Only)

  12 weeks

• Change From Baseline in PSSI Score

  12 weeks

• Psoriasis Scalp Severity Index 75 (PSSI 75) Response

  12 weeks

• Psoriasis Scalp Severity Index 100 (PSSI 100) Response

  12 weeks

• Time to 50% Reduction in PSSI Score up to Week 12

  12 weeks

Study Arms (2)

Secukinumab

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Secukinumab 300 mg BIOLOGICAL

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.

Also known as: AIN457 300 mg

Secukinumab

Placebo BIOLOGICAL

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (17)

Novartis Investigative Site

Sacramento, California, 95819, United States

Location

Novartis Investigative Site

Aurora, Colorado, 80045, United States

Location

Novartis Investigative Site

Trumbull, Connecticut, 06611, United States

Location

Novartis Investigative Site

Rockville, Maryland, 20850, United States

Location

Novartis Investigative Site

Andover, Massachusetts, 01810, United States

Location

Novartis Investigative Site

Boston, Massachusetts, 02114, United States

Location

Novartis Investigative Site

Troy, Michigan, 48084, United States

Location

Novartis Investigative Site

East Windsor, New Jersey, 08520, United States

Location

Novartis Investigative Site

New York, New York, 10025, United States

Location

Novartis Investigative Site

New York, New York, 10075, United States

Location

Novartis Investigative Site

Winston-Salem, North Carolina, 27157, United States

Location

Novartis Investigative Site

Gahanna, Ohio, 43230, United States

Location

Novartis Investigative Site

Hershey, Pennsylvania, 17033, United States

Location

Novartis Investigative Site

Pittsburgh, Pennsylvania, 15213-3403, United States

Location

Novartis Investigative Site

Arlington, Texas, 76011, United States

Location

Novartis Investigative Site

Salt Lake City, Utah, 84132, United States

Location

Novartis Investigative Site

West Jordan, Utah, 84088, United States

Location

Related Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com

MeSH Terms

Conditions

Psoriasis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

trialandresults.registries@novartis.com

+1 (800) 778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 17, 2014
• Study Start: September 29, 2014
• Primary Completion: December 7, 2015
• Study Completion: December 7, 2015
• Last Updated: January 5, 2021
• Results First Posted: February 28, 2018

Record last verified: 2019-03

Locations

US (17)