NCT02362789

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2016

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

December 28, 2018

Completed
Last Updated

December 28, 2018

Status Verified

June 1, 2018

Enrollment Period

1.5 years

First QC Date

February 9, 2015

Results QC Date

July 12, 2017

Last Update Submit

June 25, 2018

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Secukinumab

EXPERIMENTAL

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

Biological: Secukinumab

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

SecukinumabBIOLOGICAL

150 mg secukinumab in 1 ml solution for subcutaneous injection (pre-filled syringe)

Secukinumab
PlaceboBIOLOGICAL

Matching placebo in 1 ml solution for subcutaneous injection (pre-filled syringe)

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Novartis Investigative Site

Bad Bentheim, 48455, Germany

Location

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Bielefeld, 33647, Germany

Location

Novartis Investigative Site

Bochum, 44803, Germany

Location

Novartis Investigative Site

Dippoldiswalde-Schmiedeberg, 01744, Germany

Location

Novartis Investigative Site

Erlangen, 91054, Germany

Location

Novartis Investigative Site

Frankfurt, 60590, Germany

Location

Novartis Investigative Site

Gelsenkirchen, 45883, Germany

Location

Novartis Investigative Site

Gera, 07548, Germany

Location

Novartis Investigative Site

Hamburg, 22391, Germany

Location

Novartis Investigative Site

Hanover, 30625, Germany

Location

Novartis Investigative Site

Leipzig, 04105, Germany

Location

Novartis Investigative Site

Mannheim, 68167, Germany

Location

Novartis Investigative Site

München, 81675, Germany

Location

Novartis Investigative Site

Münster, 48149, Germany

Location

Novartis Investigative Site

Osnabrück, 49074, Germany

Location

Novartis Investigative Site

Selters, 56242, Germany

Location

Novartis Investigative Site

Stuttgart, 70176, Germany

Location

Novartis Investigative Site

Stuttgart, 70178, Germany

Location

MeSH Terms

Conditions

Psoriasis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Clinical Disclosure Office
Organization
Novartis Pharmaceuticals
Novartis.email@novartis.com
(862) 778-8300

Study Officials

  • Study Lead

    Muenster

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 13, 2015

Study Start

January 4, 2015

Primary Completion

July 15, 2016

Study Completion

July 15, 2016

Last Updated

December 28, 2018

Results First Posted

December 28, 2018

Record last verified: 2018-06

Locations

DE(19)