Secukinumab Study in PSOriasis Exploring pruRITUS Intensity and Lesional Biomarkers (PSORITUS)

Novartis

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Biological: Placebo; Biological: Secukinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02362789

CAIN457ADE03

Details and patient eligibility

About

The study is designed to explore the kinetics of psoriasis symptoms, pruritus intensity and lesional biomarkers.

Full 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.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 2 patient groups, including a placebo group

Secukinumab

Experimental group

Description:

300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 16, 20, 24, and 28

Treatment:

Biological: Secukinumab

Placebo

Placebo Comparator group

Description:

Inactive ingredients administered as a matching placebo at Weeks 16, 20, 24, and 28

Treatment:

Biological: Placebo