Secukinumab Study in PSOriasis Exploring pruRITUS Intensity and Lesional Biomarkers

Phase 3

Completed

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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Secukinumab	Secukinumab	300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 16, 20, 24, and 28
Placebo	Placebo	Inactive ingredients administered as a matching placebo at Weeks 16, 20, 24, and 28

Primary Outcome Measures

Name	Time	Method
Pruritus Intensity Visual Analogue Scale Score at Week 32	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.

Secondary Outcome Measures