Clinical trial NCT01537432: Multiple-dose Regimen Study to Assess Effect of 12 Months of Secukinumab Treatment on Skin Response and Biomarkers in Psoriasis Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis, Plaque-type Psoriasis
Keywords: Psoriasis, Plaque-type psoriasis
Plaque
Secukinumab
AIN457A
PASI
DLQI
IGA
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-02-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Achieving Skin Histology Response After Secukinumab Treatment From Baseline to Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving Skin Histological Disease Reversal at Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Pasadena
country: United States
facility: Novartis Investigative Site
state: California
city: Indianapolis
country: United States
facility: Novartis Investigative Site
state: Indiana
city: St. Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: East Windsor
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Verona
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Rochester
country: United States
facility: Novartis Investigative Site
state: New York
city: High Point
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Norfolk
country: United States
facility: Novartis Investigative Site
state: Virginia
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: