Exploratory Study on the Kinetics of Psoriasis Symptoms, Pruritus Intensity and Lesional Biomarkers in Patients With Moderate to Severe Plaque-type Psoriasis Treated With Subcutaneous Secukinumab (300 mg) During a 16 Week Open-label run-in Phase Followed by a 16 Week Randomized, Double-blind, Placebo-controlled Withdrawal Phase
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Psoriasis
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- Pruritus Intensity Visual Analogue Scale Score at Week 32
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The study is designed to explore the kinetics of psoriasis symptoms, pruritus intensity and lesional biomarkers.
Detailed Description
All subjects will undergo a 16 week run-in phase (open label). At Week 16, an evaluation of the PASI response will be performed. Patients who achieve a PASI reduction of less than 98 percent will complete the study at Week 16 and be referred to routine clinical care for psoriasis by the investigator. Patients who achieve extensive remission (PASI reduction by 98-100 percent) at Week 16 will enter the randomized withdrawal phase (blinded) where they will be randomized to receive either secukinumab or matching placebo and will complete the study at Week 32.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Chronic moderate to severe plaque type psoriasis as diagnosed by a qualified physician at least 6 months prior to baseline and with a PASI score \> 10 at baseline.
- •Psoriasis patients with pruritus intensity of ≥ 30 on a 100-point VAS, with a recall period of 24h as part of the PGA-CP, both, at screening and at baseline.
Exclusion Criteria
- •Underlying conditions other than psoriasis which in the opinion of the investigator currently cause or influence pruritus of the skin (e.g. drug induced pruritus, renal insufficiency, diabetes).
- •Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and guttate) at screening or study start.
- •Ongoing use of prohibited psoriasis and non-psoriasis treatments. Washout periods have to be adhered to. If the use of any of the prohibited treatments is required, then the subject may not be included into the study.
- •Pregnancy, breast feeding or inadequate contraception (if necessary)
Outcomes
Primary Outcomes
Pruritus Intensity Visual Analogue Scale Score at Week 32
Time Frame: Week 32
On a 100-mm horizontal line, the patient placed a mark representing their perception of worst itching (pruritus) within a recall period of 24 hours, where 0 = no pruritus and 100 = most severe pruritus.