Psoriasis, Plaque-type Psoriasis Clinical Trial
Official title:
Phase II Randomized Double Blinded Placebo Controlled, Multiple-dose Regimen Study to Assess the Rate of Histological Clearance and Effect on Molecular Pathways as Well as on Biomarkers of 12 Months Secukinumab 300 mg s.c. Treated Patients With Chronic Plaque-type Psoriasis
| Verified date | November 2015 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This study is designed to evaluate the proportion of patients achieving reversal of chronic plaque psoriasis at week 4 and 12 following multiple doses of secukinumab administered subcutaneously (sc) compared to placebo. Starting from week 13, all patients will receive multiple doses of secukinumab up to week 52 to study long term effects of secukinumab. Clinical endpoints including biomarker assessments, PASI, IGA and DLQI will be compared to better understand, why secukinumab may be effective in psoriasis patients.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion criteria: - Chronic plaque-type psoriasis diagnosed for at least 6 months - Moderate to severe psoriasis as defined by: PASI score of =12, IGA score of =3, BSA (body surface area) affected by plaque-type psoriasis of =10% - Chronic plaque-type psoriasis considered inadequately controlled by: topical treatment and/or; phototherapy and/or previous systemic therapy Exclusion criteria: - Forms of psoriasis other than chronic plaque-type - Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis - History or evidence of active tuberculosis or evidence of latent tuberculosis (or other infections like Hepatitis-C/B), malignancy; active or known use of other immunosuppressive drugs (for eg: AIDs, RA, organ rejection etc.) at the screening visit - Pregnant or nursing (lactating) women |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Novartis Investigative Site | Birmingham | Alabama |
| United States | Novartis Investigative Site | Dallas | Texas |
| United States | Novartis Investigative Site | East Windsor | New Jersey |
| United States | Novartis Investigative Site | High Point | North Carolina |
| United States | Novartis Investigative Site | Houston | Texas |
| United States | Novartis Investigative Site | Indianapolis | Indiana |
| United States | Novartis Investigative Site | New York | New York |
| United States | Novartis Investigative Site | Norfolk | Virginia |
| United States | Novartis Investigative Site | Pasadena | California |
| United States | Novartis Investigative Site | Rochester | New York |
| United States | Novartis Investigative Site | St. Louis | Missouri |
| United States | Novartis Investigative Site | Verona | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Skin Histology Response After Secukinumab Treatment From Baseline to Week 12 | Histological sections of lesional and nonlesional skin biopsies at baseline and at Week 12 were examined. For each visit, each patient's lesional skin biopsy was scored for the degree of histological improvement compared to that patient's baseline disease on a five point scale; - 1 (worse) to +3 (excellent). Histological disease reversal or "excellent improvement" (histological disease reversal score = 3) was declared at the endpoint when all of the following four criteria were met. |
Baseline, Week 12 | No |
| Secondary | Percentage of Participants Achieving Skin Histological Disease Reversal at Week 52 | Histological sections of lesional and nonlesional skin biopsies at Week 52 were examined. For each visit, each patient's lesional skin biopsy was scored for the degree of histological improvement compared to that patient's baseline disease on a five point scale; - 1 (worse) to +3 (excellent). Histological disease reversal or "excellent improvement" (histological disease reversal score = 3) was declared at the endpoint when all of the following four criteria were met. |
Week 52 | No |