Status:
COMPLETED
Efficacy and Safety of Subcutaneous Secukinumab in Adults With Moderate to Severe Scalp Psoriasis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Scalp Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 treatment...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 29 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2015
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT02267135
Start Date
September 29 2014
End Date
December 7 2015
Last Update
January 5 2021
Active Locations (17)
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1
Novartis Investigative Site
Sacramento, California, United States, 95819
2
Novartis Investigative Site
Aurora, Colorado, United States, 80045
3
Novartis Investigative Site
Trumbull, Connecticut, United States, 06611
4
Novartis Investigative Site
Rockville, Maryland, United States, 20850