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Plaque Psoriasis Efficacy and Safety With Secukinumab (OPTIMISE)

Primary Purpose

Plaque Psoriasis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Secukinumab

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring plaque, psoriasis

Eligibility Criteria

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

Main Inclusion Criteria:

Chronic plaque-type psoriasis diagnosed for at least 6 months prior to Screening and candidate for systemic therapy.
Moderate to severe psoriasis at Baseline as evidenced by:
- PASI ≥ 10 and
- IGA mod 2011 score of 3 or higher (based on a scale of 0 to 4) and
- BSA affected by plaque-type psoriasis of ≥ 10%.

Main Exclusion Criteria:

History of exposure to any biologic drug taken for the treatment of chronic plaque psoriasis or any other indication including but not limited to anti-tumor necrosis factor (TNF) alpha, anti interleukin (IL)12/23, or any anti-IL 17A or IL 17A receptor (IL 17AR) antibody.
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
Forms of psoriasis other than chronic plaque-type (eg, pustular, erythrodermic and guttate psoriasis).
Drug-induced psoriasis (ie, new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium).
Ongoing use of prohibited psoriasis treatments (eg, topical or systemic corticosteroids, ultraviolet (UV) therapy).
Ongoing use of other non-psoriasis prohibited treatments. Washout periods detailed in the protocol have to be adhered to. All other prior non-psoriasis concomitant treatments must be at a stable dose as detailed in the protocol before initiation of study drug.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL).
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study drug and for 16 weeks after stopping study drug.
Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy.
Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions) which, in the opinion of the Investigator, significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Secukinumab 300mg in PASI 90 responders (every 4 weeks)

Secukinumab 300mg in PASI 90 responders (longer intervals)

Secukinumab 300mg in PASI 75-90 responders (every 4 weeks)

Secukinumab 300mg in PASI 75-90 responders (shorter intervals)

Arm Description

Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks were treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 4 weeks.

Participants with moderate to severe plaque psoriasis who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks will be treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 4 weeks.

Participants with moderate to severe plaque psoriasis who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks were treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 2 weeks.

Outcomes

Primary Outcome Measures

Maintenance of PASI 90 Response at Week 52 in Participants With a PASI 90 Response at Week 24

Secondary Outcome Measures

Key Secondary: PASI 90 Response Rate at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24

PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI 90 Response at Week 24

PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.

PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24

Change From Baseline in PASI in Participants With a PASI 90 Response at Week 24

Change From Baseline in PASI in Participants With a PASI Response of ≥75 to <90 at Week 24

Change From Baseline in DLQI in Participants With a PASI 90 Response at Week 24

The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.

Change From Baseline in DLQI in Participants With a PASI Response of ≥75 to <90 at Week 24

Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Psoriasis (WPAI-PSO) Score in Participants With a PASI 90 Response at Week 24

The WPAI-PSO is a self-administered questionnaire comprised of 6 questions about effects of psoriasis on the patient's ability to work and perform regular activities based on the previous 7 days. The questionnaire quantifies the number of hours the respondent was unable to work and evaluates how much the respondent's psoriasis affected productivity while working. For respondents who were not in paid employment, the questionnaire evaluated how much the respondent's psoriasis affects their ability to perform regular daily activities. Four outcomes were generated from the WPAI-PSO: % Absenteeism: percent work time missed due to health; % Presenteism: percent impairment while working due to health; % Total work productivity impairment: percent overall work impairment due to health; % Total activity impairment: percent activity impairment due to health for all respondents. First 3 outcomes applied to employed participants only. A negative change from baseline indicates improvement.

Change From Baseline in WPAI-PSO Score in Participants With a PASI Response of ≥75 to <90 at Week 24

Change From Baseline in Pain, Itching and Scaling Score in Participants With a PASI 90 Response at Week 24

Self-administered, 11-point numeric rating scales (NRS, 0-10) were used to evaluate the patients' assessment of their current pain, itching and scaling. Respondents answered the following questions for the assessment: Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours?; Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours?; and Scaling: Overall, how severe was your psoriasis-related scaling over the past 24 hours? Patients had to rate their pain, itching, and scaling from 0 to 10 (11-point scale), with the understanding that the 0 represents the absence or null end of the pain, itching, or scale intensity (i.e. no pain, itching or scaling) and the 10 represents the other extreme of pain, itching, or scaling intensity (i.e. pain, itching or scaling as bad as it could be). The number that the patient selected represents his or her intensity score in the respective category. A negative change from baseline indicates improvement

Change From Baseline in Pain, Itching and Scaling Score in Participants With a PASI Response of ≥75 to <90 at Week 24

Change From Baseline in the European Quality of Life - 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) in Participants With a PASI 90 Response at Week 24

A visual analogue scale (VAS) was used within the EQ-5D. This scale recorded the respondent's self-rated health on a vertical 20-cm VAS where the endpoints were labeled "best imaginable health state" and "worst imaginable health state." This resulted in a numeric value set ranging from 0 (="worst imaginable health state") up to 100 (="best imaginable health state"). A positive change from baseline indicates improvement.

Change From Baseline in the EQ-5D VAS in Participants With a PASI Response of ≥75 to <90 at Week 24

Change From Baseline in the EQ-5D Utility Index (Germany, United Kingdom (UK)) in Participants With a PASI 90 Response at Week 24

The EQ-5D quantifies the health state of a patient for the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort & anxiety/depression. In this study the EQ-5D-5L version has been used which evaluates each of these dimensions using the following 5 labels: no problems, slight problems, moderate problems, severe problems & unable to/extreme problems. Based on the 5 dimensions, a summary score (utility index) was derived using country specific value sets evaluating the patient condition described by the outcome in the single dimensions. The EQ-5D-5L (in this trail) utility index based on the crosswalk value sets available from the EuroQol for Germany & UK (https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/) was calculated. A positive change from baseline indicates improvement. A visual analogue scale was used within the EQ-5D measuring the health state of the patients, ranging from 0 (worst imaginable health state) up to 100 (best imaginable health state).

Change From Baseline in the EQ-5D Utility Index (Germany, UK) in Participants With a PASI Response of ≥75 to <90 at Week 24

The EQ-5D quantifies the health state of a patient for the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. In the current study the EQ-5D-5L version has been used which evaluates each of these dimensions using the following five labels: "no problems", "slight problems", "moderate problems", "severe problems" and "unable to/extreme problems". Based on the five dimensions, a summary score (utility index) was derived using country specific value sets evaluating the patient condition described by the outcome in the single dimensions. For this trial, the EQ-5D-5L utility index based on the crosswalk value sets available from the EuroQol for Germany and for UK (https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/) was calculated. A visual analogue scale (VAS) was used within the EQ-5D measuring the health state of the patients, ranging from 0 (="worst imaginable health state") up to 100 (="best imaginable health state").

Full Information

NCT ID

NCT02409667

First Posted

March 31, 2015

Last Updated

February 12, 2019

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02409667

Brief Title

Plaque Psoriasis Efficacy and Safety With Secukinumab

Acronym

OPTIMISE

Official Title

Long Term Clear Skin Maintenance Treatment Optimization in Patients With Moderate to Severe Chronic Plaque Psoriasis: A Randomized, Multicenter, Open-label With Blinded-assessment, Comparative, 52 Week Study to Evaluate the Efficacy, Safety and Tolerability of Secukinumab 300 mg s.c.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

May 7, 2015 (Actual)

Primary Completion Date

March 14, 2017 (Actual)

Study Completion Date

May 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

To demonstrate in the patient pool of PASI 90 responders at Week 24 that secukinumab 300 mg s.c. when administered at a longer dosing interval is non-inferior to secukinumab 300 mg s.c. every 4 weeks treatment with respect to maintaining a PASI 90 response rate at Week 52.

6. Conditions and Keywords

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

Plaque Psoriasis

Keywords

plaque, psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

16487 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Secukinumab 300mg in PASI 90 responders (every 4 weeks)

Arm Type

Active Comparator

Arm Description

Arm Title

Secukinumab 300mg in PASI 90 responders (longer intervals)

Arm Type

Experimental

Arm Description

Arm Title

Secukinumab 300mg in PASI 75-90 responders (every 4 weeks)

Arm Type

Experimental

Arm Description

Arm Title

Secukinumab 300mg in PASI 75-90 responders (shorter intervals)

Arm Type

Active Comparator

Arm Description

Participants with moderate to severe plaque psoriasis who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks were treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 2 weeks.

Intervention Type

Biological

Intervention Name(s)

Secukinumab

Intervention Description

Secukinumab for s.c. injection was supplied in single boxes each containing 2 pre-filled syringes (PFS) of 150 mg secukinumab in a 1 mL liquid formulation. Each 300 mg dose was administered as 2 PFS injections of 150 mg secukinumab.

Primary Outcome Measure Information:

Title

Maintenance of PASI 90 Response at Week 52 in Participants With a PASI 90 Response at Week 24

Description

Time Frame

Week 52

Secondary Outcome Measure Information:

Title

Key Secondary: PASI 90 Response Rate at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24

Description

Time Frame

Week 52

Title

PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI 90 Response at Week 24

Description

Time Frame

week 52

Title

PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24

Description

Time Frame

Week 52

Title

Change From Baseline in PASI in Participants With a PASI 90 Response at Week 24

Description

Time Frame

Baseline, Weeks 28, 32, 36, 40, 44, 48 and 52

Title

Change From Baseline in PASI in Participants With a PASI Response of ≥75 to <90 at Week 24

Description

Time Frame

Baseline, Weeks 28, 32, 36, 40, 44, 48 and 52

Title

Change From Baseline in DLQI in Participants With a PASI 90 Response at Week 24

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline in DLQI in Participants With a PASI Response of ≥75 to <90 at Week 24

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Psoriasis (WPAI-PSO) Score in Participants With a PASI 90 Response at Week 24

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline in WPAI-PSO Score in Participants With a PASI Response of ≥75 to <90 at Week 24

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline in Pain, Itching and Scaling Score in Participants With a PASI 90 Response at Week 24

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline in Pain, Itching and Scaling Score in Participants With a PASI Response of ≥75 to <90 at Week 24

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline in the European Quality of Life - 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) in Participants With a PASI 90 Response at Week 24

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline in the EQ-5D VAS in Participants With a PASI Response of ≥75 to <90 at Week 24

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline in the EQ-5D Utility Index (Germany, United Kingdom (UK)) in Participants With a PASI 90 Response at Week 24

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline in the EQ-5D Utility Index (Germany, UK) in Participants With a PASI Response of ≥75 to <90 at Week 24

Description

Time Frame

Baseline, Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Main Inclusion Criteria: Chronic plaque-type psoriasis diagnosed for at least 6 months prior to Screening and candidate for systemic therapy. Moderate to severe psoriasis at Baseline as evidenced by: PASI ≥ 10 and IGA mod 2011 score of 3 or higher (based on a scale of 0 to 4) and BSA affected by plaque-type psoriasis of ≥ 10%. Main Exclusion Criteria: History of exposure to any biologic drug taken for the treatment of chronic plaque psoriasis or any other indication including but not limited to anti-tumor necrosis factor (TNF) alpha, anti interleukin (IL)12/23, or any anti-IL 17A or IL 17A receptor (IL 17AR) antibody. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. Forms of psoriasis other than chronic plaque-type (eg, pustular, erythrodermic and guttate psoriasis). Drug-induced psoriasis (ie, new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium). Ongoing use of prohibited psoriasis treatments (eg, topical or systemic corticosteroids, ultraviolet (UV) therapy). Ongoing use of other non-psoriasis prohibited treatments. Washout periods detailed in the protocol have to be adhered to. All other prior non-psoriasis concomitant treatments must be at a stable dose as detailed in the protocol before initiation of study drug. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL). Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study drug and for 16 weeks after stopping study drug. Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy. Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions) which, in the opinion of the Investigator, significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Novartis Investigative Site

City

Linz

ZIP/Postal Code

A-4020

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

A 1090

Country

Austria

Facility Name

Novartis Investigative Site

City

Jette

State/Province

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Loverval

ZIP/Postal Code

6280

Country

Belgium

Facility Name

Novartis Investigative Site

City

Sofia

State/Province

BGR

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1404

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Ivanic Grad

ZIP/Postal Code

10310

Country

Croatia

Facility Name

Novartis Investigative Site

City

Osijek

ZIP/Postal Code

31000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Brno

State/Province

Czech Republic

ZIP/Postal Code

656 91

Country

Czechia

Facility Name

Novartis Investigative Site

City

Ostrava Poruba

State/Province

Czech Republic

ZIP/Postal Code

708 52

Country

Czechia

Facility Name

Novartis Investigative Site

City

Prague 8

State/Province

Czech Republic

ZIP/Postal Code

180 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Olomouc

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha

ZIP/Postal Code

12808

Country

Czechia

Facility Name

Novartis Investigative Site

City

Arhus C

ZIP/Postal Code

DK-8000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Hellerup

ZIP/Postal Code

DK-2900

Country

Denmark

Facility Name

Novartis Investigative Site

City

Tampere

ZIP/Postal Code

33100

Country

Finland

Facility Name

Novartis Investigative Site

City

Turku

ZIP/Postal Code

FIN-20100

Country

Finland

Facility Name

Novartis Investigative Site

City

Le Mans

State/Province

Cedex 09

ZIP/Postal Code

72037

Country

France

Facility Name

Novartis Investigative Site

City

Bordeaux Cedex

ZIP/Postal Code

33075

Country

France

Facility Name

Novartis Investigative Site

City

Dijon

ZIP/Postal Code

21079

Country

France

Facility Name

Novartis Investigative Site

City

Grenoble

ZIP/Postal Code

38043

Country

France

Facility Name

Novartis Investigative Site

City

Lille

ZIP/Postal Code

59000

Country

France

Facility Name

Novartis Investigative Site

City

Montpellier cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

Novartis Investigative Site

City

Nice

ZIP/Postal Code

06202

Country

France

Facility Name

Novartis Investigative Site

City

Rouen

ZIP/Postal Code

76031

Country

France

Facility Name

Novartis Investigative Site

City

Saint-Etienne

ZIP/Postal Code

42055

Country

France

Facility Name

Novartis Investigative Site

City

Toulouse Cedex

ZIP/Postal Code

31400

Country

France

Facility Name

Novartis Investigative Site

City

Trevenans

ZIP/Postal Code

90400

Country

France

Facility Name

Novartis Investigative Site

City

Vandoeuvre Les Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

Novartis Investigative Site

City

Augsburg

ZIP/Postal Code

86179

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10783

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44793

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53105

Country

Germany

Facility Name

Novartis Investigative Site

City

Braunschweig

ZIP/Postal Code

38100

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01069

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Duesseldorf

ZIP/Postal Code

40212

Country

Germany

Facility Name

Novartis Investigative Site

City

Duesseldorf

ZIP/Postal Code

D 40225

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Novartis Investigative Site

City

Goettingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22391

Country

Germany

Facility Name

Novartis Investigative Site

City

Hanau

ZIP/Postal Code

63450

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Lubeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81377

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

Pommelsbrunn

ZIP/Postal Code

91224

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwerin

ZIP/Postal Code

19055

Country

Germany

Facility Name

Novartis Investigative Site

City

Stade

ZIP/Postal Code

21682

Country

Germany

Facility Name

Novartis Investigative Site

City

Stuttgart

ZIP/Postal Code

70178

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Novartis Investigative Site

City

Larissa

State/Province

ZIP/Postal Code

411 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

546 29

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

161 21

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

ZIP/Postal Code

546 43

Country

Greece

Facility Name

Novartis Investigative Site

City

Kecskemet

State/Province

Bacs Kiskun

ZIP/Postal Code

6000

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1085

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Novartis Investigative Site

City

Kaposvar

ZIP/Postal Code

7400

Country

Hungary

Facility Name

Novartis Investigative Site

City

Pecs

ZIP/Postal Code

7632

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

6725

Country

Hungary

Facility Name

Novartis Investigative Site

City

Afula

ZIP/Postal Code

1834111

Country

Israel

Facility Name

Novartis Investigative Site

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

Novartis Investigative Site

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Novartis Investigative Site

City

Ramat Gan

ZIP/Postal Code

5265601

Country

Israel

Facility Name

Novartis Investigative Site

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Novartis Investigative Site

City

Bolzano

State/Province

ZIP/Postal Code

39100

Country

Italy

Facility Name

Novartis Investigative Site

City

Messina

State/Province

ZIP/Postal Code

98125

Country

Italy

Facility Name

Novartis Investigative Site

City

Modena

State/Province

ZIP/Postal Code

41124

Country

Italy

Facility Name

Novartis Investigative Site

City

Palermo

State/Province

ZIP/Postal Code

90127

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00189

Country

Italy

Facility Name

Novartis Investigative Site

City

Daugavpils

State/Province

LVA

ZIP/Postal Code

LV-5404

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

State/Province

LVA

ZIP/Postal Code

LV-1003

Country

Latvia

Facility Name

Novartis Investigative Site

City

Ventspils

State/Province

LVA

ZIP/Postal Code

LV-3601

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

1012

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV-1001

Country

Latvia

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

LTU

ZIP/Postal Code

LT 50161

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Klaipeda

State/Province

LTU

ZIP/Postal Code

92304

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

ZIP/Postal Code

47144

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

LT-07195

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Breda

State/Province

ZIP/Postal Code

4818

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Alkmaar

ZIP/Postal Code

1817 MS

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Almere

ZIP/Postal Code

1315 RA

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Bergen op Zoom

ZIP/Postal Code

4624 VT

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Geldrop

ZIP/Postal Code

5664 EH

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Leiderdorp

ZIP/Postal Code

2353 GA

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Sittard-Geleen

ZIP/Postal Code

6162 BG

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Voorburg

ZIP/Postal Code

2275 CX

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Kraków

ZIP/Postal Code

31-501

Country

Poland

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

90-265

Country

Poland

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

90-436

Country

Poland

Facility Name

Novartis Investigative Site

City

Lublin

ZIP/Postal Code

20-079

Country

Poland

Facility Name

Novartis Investigative Site

City

Olsztyn

ZIP/Postal Code

10-045

Country

Poland

Facility Name

Novartis Investigative Site

City

Ossy

ZIP/Postal Code

42 624

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60 529

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

04141

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

50-368

Country

Poland

Facility Name

Novartis Investigative Site

City

Braga

ZIP/Postal Code

4710243

Country

Portugal

Facility Name

Novartis Investigative Site

City

Coimbra

ZIP/Postal Code

3000 075

Country

Portugal

Facility Name

Novartis Investigative Site

City

Leiria

ZIP/Postal Code

2410-187

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4099-001

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4200 319

Country

Portugal

Facility Name

Novartis Investigative Site

City

Vila Nova de Gaia

ZIP/Postal Code

4434 502

Country

Portugal

Facility Name

Novartis Investigative Site

City

Chelyabinsk

ZIP/Postal Code

454092

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kazan

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

107076

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Rostov on Don region

ZIP/Postal Code

346880

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint-Petersburg

ZIP/Postal Code

194021

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint-Petersburg

ZIP/Postal Code

194044

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Bojnice

ZIP/Postal Code

972 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

841 04

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kosice

ZIP/Postal Code

04001

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Povazska Bystrica

ZIP/Postal Code

017 26

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Svidnik

ZIP/Postal Code

08901

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Villajoyosa

State/Province

Alicante

ZIP/Postal Code

703570

Country

Spain

Facility Name

Novartis Investigative Site

City

Cordoba

State/Province

Andalucia

ZIP/Postal Code

14004

Country

Spain

Facility Name

Novartis Investigative Site

City

Granada

State/Province

Andalucia

ZIP/Postal Code

18016

Country

Spain

Facility Name

Novartis Investigative Site

City

Malaga

State/Province

Andalucia

ZIP/Postal Code

29009

Country

Spain

Facility Name

Novartis Investigative Site

City

Malaga

State/Province

Andalucia

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41009

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41013

Country

Spain

Facility Name

Novartis Investigative Site

City

Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Novartis Investigative Site

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

Novartis Investigative Site

City

Sant Joan Despi

State/Province

Barcelona

ZIP/Postal Code

08970

Country

Spain

Facility Name

Novartis Investigative Site

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Novartis Investigative Site

City

Leon

State/Province

Castilla Y Leon

ZIP/Postal Code

24071

Country

Spain

Facility Name

Novartis Investigative Site

City

Salamanca

State/Province

Castilla Y Leon

ZIP/Postal Code

37007

Country

Spain

Facility Name

Novartis Investigative Site

City

Badalona

State/Province

Catalunya

ZIP/Postal Code

08916

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08003

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novartis Investigative Site

City

Alicante

State/Province

Comunidad Valenciana

ZIP/Postal Code

03010

Country

Spain

Facility Name

Novartis Investigative Site

City

Castellon

State/Province

Comunidad Valenciana

ZIP/Postal Code

12005

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46014

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46015

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46017

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46026

Country

Spain

Facility Name

Novartis Investigative Site

City

La Coruna

State/Province

Galicia

ZIP/Postal Code

15006

Country

Spain

Facility Name

Novartis Investigative Site

City

Santiago de Compostela

State/Province

Galicia

ZIP/Postal Code

15706

Country

Spain

Facility Name

Novartis Investigative Site

City

Palma de Mallorca

State/Province

Islas Baleares

ZIP/Postal Code

07014

Country

Spain

Facility Name

Novartis Investigative Site

City

Las Palmas de Gran Canaria

State/Province

Las Palmas De G.C

ZIP/Postal Code

35010

Country

Spain

Facility Name

Novartis Investigative Site

City

Alcorcon

State/Province

Madrid

ZIP/Postal Code

28922

Country

Spain

Facility Name

Novartis Investigative Site

City

Fuenlabrada

State/Province

Madrid

ZIP/Postal Code

28942

Country

Spain

Facility Name

Novartis Investigative Site

City

San Sebastian de los Reyes

State/Province

Madrid

ZIP/Postal Code

28702

Country

Spain

Facility Name

Novartis Investigative Site

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Facility Name

Novartis Investigative Site

City

Bilbao

State/Province

Pais Vasco

ZIP/Postal Code

48013

Country

Spain

Facility Name

Novartis Investigative Site

City

La Laguna

State/Province

Santa Cruz De Tenerife

ZIP/Postal Code

38320

Country

Spain

Facility Name

Novartis Investigative Site

City

Alzira

State/Province

Valencia

ZIP/Postal Code

46600

Country

Spain

Facility Name

Novartis Investigative Site

City

Manises

State/Province

Valencia

ZIP/Postal Code

46940

Country

Spain

Facility Name

Novartis Investigative Site

City

Baracaldo

State/Province

Vizcaya

ZIP/Postal Code

48903

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Novartis Investigative Site

City

Huesca

ZIP/Postal Code

22004

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28031

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28222

Country

Spain

Facility Name

Novartis Investigative Site

City

Mallorca

ZIP/Postal Code

07500

Country

Spain

Facility Name

Novartis Investigative Site

City

Murcia

ZIP/Postal Code

30003

Country

Spain

Facility Name

Novartis Investigative Site

City

Pontevedra

ZIP/Postal Code

36003

Country

Spain

Facility Name

Novartis Investigative Site

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Novartis Investigative Site

City

Falun

ZIP/Postal Code

791 82

Country

Sweden

Facility Name

Novartis Investigative Site

City

Malmo

ZIP/Postal Code

SE-205 02

Country

Sweden

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

171 76

Country

Sweden

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

SE-118 83

Country

Sweden

Facility Name

Novartis Investigative Site

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Geneve

ZIP/Postal Code

1211

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Zuerich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Canterbury

State/Province

Kent

ZIP/Postal Code

CT1 3NG

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Salford

State/Province

Manchester

ZIP/Postal Code

M6 8HD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Cliftonville

State/Province

Northampton

ZIP/Postal Code

NN1 5BD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Cannock

State/Province

Staffordshire

ZIP/Postal Code

WS11 2XY

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Dudley

State/Province

West Midlands

ZIP/Postal Code

DY1 2HQ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Leeds

State/Province

West Yorkshire

ZIP/Postal Code

LS7 4SA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Cambridge

ZIP/Postal Code

CB7 5JD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Harrogate

ZIP/Postal Code

HG2 7SX

Country

United Kingdom

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

Learn more about this trial

Plaque Psoriasis Efficacy and Safety With Secukinumab

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Plaque Psoriasis Efficacy and Safety With Secukinumab (OPTIMISE)

Plaque Psoriasis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial