Secukinumab Study in PSOriasis Exploring pruRITUS Intensity and Lesional Biomarkers

Psoriasis Clinical Trial

— PSORITUS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02362789
• Other study ID #: CAIN457ADE03
• Status: Completed
• Phase: Phase 3
• Start date: January 4, 2015
• Est. completion date: July 15, 2016

Study information

• Verified date: June 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: July 15, 2016
• Est. primary completion date: July 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pruritus
• Psoriasis

Intervention

Biological:
• Secukinumab
150 mg secukinumab in 1 ml solution for subcutaneous injection (pre-filled syringe)
• Placebo
Matching placebo in 1 ml solution for subcutaneous injection (pre-filled syringe)

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Bad Bentheim
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bielefeld
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Dippoldiswalde-Schmiedeberg
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Gelsenkirchen
Germany	Novartis Investigative Site	Gera
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Mannheim
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Osnabrueck
Germany	Novartis Investigative Site	Selters
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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