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

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Secukinumab
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Secukinumab

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 9, 2015
Last Updated
June 25, 2018
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02362789
Brief Title
Secukinumab Study in PSOriasis Exploring pruRITUS Intensity and Lesional Biomarkers
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 4, 2015 (Actual)
Primary Completion Date
July 15, 2016 (Actual)
Study Completion Date
July 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Secukinumab
Arm Type
Experimental
Arm Description
300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 16, 20, 24, and 28
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Inactive ingredients administered as a matching placebo at Weeks 16, 20, 24, and 28
Intervention Type
Biological
Intervention Name(s)
Secukinumab
Intervention Description
150 mg secukinumab in 1 ml solution for subcutaneous injection (pre-filled syringe)
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Matching placebo in 1 ml solution for subcutaneous injection (pre-filled syringe)
Primary Outcome Measure Information:
Title
Pruritus Intensity Visual Analogue Scale Score at Week 32
Description
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.
Time Frame
Week 32

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Lead
Organizational Affiliation
Muenster
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigative Site
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Novartis Investigative Site
City
Bielefeld
ZIP/Postal Code
33647
Country
Germany
Facility Name
Novartis Investigative Site
City
Bochum
ZIP/Postal Code
44803
Country
Germany
Facility Name
Novartis Investigative Site
City
Dippoldiswalde-Schmiedeberg
ZIP/Postal Code
01744
Country
Germany
Facility Name
Novartis Investigative Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Novartis Investigative Site
City
Gelsenkirchen
ZIP/Postal Code
45883
Country
Germany
Facility Name
Novartis Investigative Site
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04105
Country
Germany
Facility Name
Novartis Investigative Site
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Novartis Investigative Site
City
Osnabrueck
ZIP/Postal Code
49074
Country
Germany
Facility Name
Novartis Investigative Site
City
Selters
ZIP/Postal Code
56242
Country
Germany
Facility Name
Novartis Investigative Site
City
Stuttgart
ZIP/Postal Code
70176
Country
Germany
Facility Name
Novartis Investigative Site
City
Stuttgart
ZIP/Postal Code
70178
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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Secukinumab Study in PSOriasis Exploring pruRITUS Intensity and Lesional Biomarkers

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