Chronic Scalp Psoriasis Clinical Trial
— SCALPOfficial 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
| Verified date | March 2019 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 102 |
| Est. completion date | December 7, 2015 |
| Est. primary completion date | December 7, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 ß-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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Novartis Investigative Site | Andover | Massachusetts |
| United States | Novartis Investigative Site | Arlington | Texas |
| United States | Novartis Investigative Site | Aurora | Colorado |
| United States | Novartis Investigative Site | Boston | Massachusetts |
| United States | Novartis Investigative Site | East Windsor | New Jersey |
| United States | Novartis Investigative Site | Gahanna | Ohio |
| United States | Novartis Investigative Site | Hershey | Pennsylvania |
| United States | Novartis Investigative Site | New York | New York |
| United States | Novartis Investigative Site | New York | New York |
| United States | Novartis Investigative Site | Pittsburgh | Pennsylvania |
| United States | Novartis Investigative Site | Rockville | Maryland |
| United States | Novartis Investigative Site | Sacramento | California |
| United States | Novartis Investigative Site | Salt Lake City | Utah |
| United States | Novartis Investigative Site | Troy | Michigan |
| United States | Novartis Investigative Site | Trumbull | Connecticut |
| United States | Novartis Investigative Site | West Jordan | Utah |
| United States | Novartis Investigative Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Secondary: Investigator's Global Assessment Model 2011 (IGA Mod 2011) Score of 0 or 1 (Scalp Only) | 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 | 12 weeks | |
| Secondary | Change From Baseline in PSSI Score | Change from baseline in Psoriasis Scalp Severity Index (PSSI) score. PSSI score ranges from 0-72 with 72 being severe | 12 weeks | |
| Secondary | Psoriasis Scalp Severity Index 75 (PSSI 75) Response | PSSI 75 response (yes) at Week 12 (non-responder imputation); PSSI 75 response means at least a 75% improvement in scalp psoriasis | 12 weeks | |
| Secondary | Psoriasis Scalp Severity Index 100 (PSSI 100) Response | PSSI 100 response (yes) at Week 12 (non-responder imputation); PSSI 100 response means no sign of scalp psoriasis | 12 weeks | |
| Secondary | Time to 50% Reduction in PSSI Score up to Week 12 | 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 |
12 weeks | |
| Secondary | Psoriasis Area and Severity Index 75 (PASI 75) | PASI 75 response (yes) at Week 12 (non-responder imputation); PASI 75 response means at least a 75% improvement in body psoriasis | 12 weeks | |
| Secondary | Psoriasis Area and Severity Index 90 (PASI 90) | PASI 90 response (yes) at Week 12 (non-responder imputation); PASI 90 response means at least a 90% improvement in body psoriasis | 12 weeks | |
| Secondary | Psoriasis Area and Severity Index 100 (PASI 100) | PASI 100 response (yes) at Week 12 (non-responder imputation); PASI 100 response means no sign of body psoriasis | 12 weeks | |
| Secondary | Investigator's Global Assessment Model 2011 (GA Mod 2011) Score of 0 or 1 (Entire Body Including Scalp) | 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 | 12 weeks | |
| Secondary | Change From Baseline in Subject Assessment of Pain | Change from baseline in the Subject Assessment of Pain
Scale of 0-10 with 10 being the most painful |
12 weeks | |
| Secondary | Change From Baseline in Subject Assessment of Itching | Change from baseline in the Subject Assessment of Itching
Scale of 0-10 with 10 being the most itchy |
12 weeks | |
| Secondary | Change From Baseline in Subject Assessment of Scaling (Scalp Only) | Change from baseline in the Subject Assessment of Scaling (scalp only)
Scale of 0-10 with 10 being the most scaling |
12 weeks |