Secukinumab Study in PSOriasis Exploring pruRITUS Intensity and Lesional Biomarkers

Study 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.

Official Title
-----------------
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

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Biological: Secukinumab
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key 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. Key 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Secukinumab<br>300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 16, 20, 24, and 28 | Biological: Secukinumab<br>* 150 mg secukinumab in 1 ml solution for subcutaneous injection (pre-filled syringe)<br>|
| Placebo Comparator: Placebo<br>Inactive ingredients administered as a matching placebo at Weeks 16, 20, 24, and 28 | Biological: Placebo<br>* Matching placebo in 1 ml solution for subcutaneous injection (pre-filled syringe)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pruritus Intensity Visual Analogue Scale Score at 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. | Week 32 |