Clinical trial NCT02267135: Efficacy and Safety of Subcutaneous Secukinumab in Adults With Moderate to Severe Scalp Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Scalp Psoriasis
Keywords: scalp psoriasis, plaque psoriasis, secukinumab, AIN457, biologic, monoclonal antibody, psoriasis, AIN457A
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-10-17
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Psoriasis Scalp Severity Index 90 (PSSI 90)
timeFrame: 12 weeks
Secondary outcomes:
measure: Secondary: Investigator's Global Assessment Model 2011 (IGA Mod 2011) Score of 0 or 1 (Scalp Only)
timeFrame: 12 weeks
measure: Change From Baseline in PSSI Score
timeFrame: 12 weeks
measure: Psoriasis Scalp Severity Index 75 (PSSI 75) Response
timeFrame: 12 weeks
measure: Psoriasis Scalp Severity Index 100 (PSSI 100) Response
timeFrame: 12 weeks
measure: Time to 50% Reduction in PSSI Score up to Week 12
timeFrame: 12 weeks
measure: Psoriasis Area and Severity Index 75 (PASI 75)
timeFrame: 12 weeks
measure: Psoriasis Area and Severity Index 90 (PASI 90)
timeFrame: 12 weeks
measure: Psoriasis Area and Severity Index 100 (PASI 100)
timeFrame: 12 weeks
measure: Investigator's Global Assessment Model 2011 (GA Mod 2011) Score of 0 or 1 (Entire Body Including Scalp)
timeFrame: 12 weeks
measure: Change From Baseline in Subject Assessment of Pain
timeFrame: 12 weeks
measure: Change From Baseline in Subject Assessment of Itching
timeFrame: 12 weeks
measure: Change From Baseline in Subject Assessment of Scaling (Scalp Only)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Novartis Investigative Site
state: California
city: Aurora
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Trumbull
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Rockville
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Andover
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Boston
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Troy
country: United States
facility: Novartis Investigative Site
state: Michigan
city: East Windsor
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Winston-Salem
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Gahanna
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Hershey
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Arlington
country: United States
facility: Novartis Investigative Site
state: Texas
city: Salt Lake City
country: United States
facility: Novartis Investigative Site
state: Utah
city: West Jordan
country: United States
facility: Novartis Investigative Site
state: Utah
Study officials:
affiliation: Novartis
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: