Plaque Psoriasis Efficacy and Safety With Secukinumab

Plaque Psoriasis Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02409667
• Other study ID #: CAIN457A3302
• Status: Completed
• Phase: Phase 3
• Start date: May 7, 2015
• Est. completion date: May 8, 2017

Study information

• Verified date: February 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16487
• Est. completion date: May 8, 2017
• Est. primary completion date: March 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Main Inclusion Criteria:

1. Chronic plaque-type psoriasis diagnosed for at least 6 months prior to Screening and candidate for systemic therapy.

2. 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:

1. 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.

2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.

3. Forms of psoriasis other than chronic plaque-type (eg, pustular, erythrodermic and guttate psoriasis).

4. Drug-induced psoriasis (ie, new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium).

5. Ongoing use of prohibited psoriasis treatments (eg, topical or systemic corticosteroids, ultraviolet (UV) therapy).

6. 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.

7. 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).

8. 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.

9. Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy.

10. 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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Biological:
• Secukinumab
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.

Locations

Country	Name	City	State
Austria	Novartis Investigative Site	Innsbruck
Austria	Novartis Investigative Site	Linz
Austria	Novartis Investigative Site	Wien
Austria	Novartis Investigative Site	Wien
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Jette	Brussel
Belgium	Novartis Investigative Site	Liege
Belgium	Novartis Investigative Site	Loverval
Bulgaria	Novartis Investigative Site	Pleven
Bulgaria	Novartis Investigative Site	Plovdiv
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia	BGR
Bulgaria	Novartis Investigative Site	Stara Zagora
Bulgaria	Novartis Investigative Site	Varna
Croatia	Novartis Investigative Site	Ivanic Grad
Croatia	Novartis Investigative Site	Osijek
Croatia	Novartis Investigative Site	Zagreb
Czechia	Novartis Investigative Site	Brno	Czech Republic
Czechia	Novartis Investigative Site	Olomouc
Czechia	Novartis Investigative Site	Ostrava Poruba	Czech Republic
Czechia	Novartis Investigative Site	Prague 8	Czech Republic
Czechia	Novartis Investigative Site	Praha
Czechia	Novartis Investigative Site	Praha 10
Denmark	Novartis Investigative Site	Arhus C
Denmark	Novartis Investigative Site	Hellerup
Finland	Novartis Investigative Site	Tampere
Finland	Novartis Investigative Site	Turku
France	Novartis Investigative Site	Bordeaux Cedex
France	Novartis Investigative Site	Dijon
France	Novartis Investigative Site	Grenoble
France	Novartis Investigative Site	Le Mans	Cedex 09
France	Novartis Investigative Site	Lille
France	Novartis Investigative Site	Montpellier cedex 5
France	Novartis Investigative Site	Nice
France	Novartis Investigative Site	Rouen
France	Novartis Investigative Site	Saint-Etienne
France	Novartis Investigative Site	Toulouse Cedex
France	Novartis Investigative Site	Trevenans
France	Novartis Investigative Site	Vandoeuvre Les Nancy
Germany	Novartis Investigative Site	Augsburg
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Braunschweig
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Duesseldorf
Germany	Novartis Investigative Site	Duesseldorf
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Goettingen
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hanau
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Lubeck
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Osnabrueck
Germany	Novartis Investigative Site	Pommelsbrunn
Germany	Novartis Investigative Site	Schwerin
Germany	Novartis Investigative Site	Stade
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Ulm
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Larissa	GR
Greece	Novartis Investigative Site	Thessaloniki	GR
Greece	Novartis Investigative Site	Thessaloniki
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Kaposvar
Hungary	Novartis Investigative Site	Kecskemet	Bacs Kiskun
Hungary	Novartis Investigative Site	Pecs
Hungary	Novartis Investigative Site	Szeged
Israel	Novartis Investigative Site	Afula
Israel	Novartis Investigative Site	Haifa
Israel	Novartis Investigative Site	Petach Tikva
Israel	Novartis Investigative Site	Ramat Gan
Israel	Novartis Investigative Site	Tel Aviv
Italy	Novartis Investigative Site	Bolzano	BZ
Italy	Novartis Investigative Site	Messina	ME
Italy	Novartis Investigative Site	Modena	MO
Italy	Novartis Investigative Site	Palermo	PA
Italy	Novartis Investigative Site	Roma	RM
Latvia	Novartis Investigative Site	Daugavpils	LVA
Latvia	Novartis Investigative Site	Riga	LVA
Latvia	Novartis Investigative Site	Riga
Latvia	Novartis Investigative Site	Riga
Latvia	Novartis Investigative Site	Ventspils	LVA
Lithuania	Novartis Investigative Site	Kaunas	LTU
Lithuania	Novartis Investigative Site	Kaunas	LT
Lithuania	Novartis Investigative Site	Klaipeda	LTU
Lithuania	Novartis Investigative Site	Vilnius
Lithuania	Novartis Investigative Site	Vilnius
Netherlands	Novartis Investigative Site	Alkmaar
Netherlands	Novartis Investigative Site	Almere
Netherlands	Novartis Investigative Site	Bergen op Zoom
Netherlands	Novartis Investigative Site	Breda	CK
Netherlands	Novartis Investigative Site	Geldrop
Netherlands	Novartis Investigative Site	Leiderdorp
Netherlands	Novartis Investigative Site	Sittard-Geleen
Netherlands	Novartis Investigative Site	Voorburg
Poland	Novartis Investigative Site	Kraków
Poland	Novartis Investigative Site	Lodz
Poland	Novartis Investigative Site	Lodz
Poland	Novartis Investigative Site	Lublin
Poland	Novartis Investigative Site	Olsztyn
Poland	Novartis Investigative Site	Ossy
Poland	Novartis Investigative Site	Poznan
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Wroclaw
Portugal	Novartis Investigative Site	Braga
Portugal	Novartis Investigative Site	Coimbra
Portugal	Novartis Investigative Site	Leiria
Portugal	Novartis Investigative Site	Porto
Portugal	Novartis Investigative Site	Porto
Portugal	Novartis Investigative Site	Vila Nova de Gaia
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Kazan
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Rostov on Don region
Russian Federation	Novartis Investigative Site	Saint-Petersburg
Russian Federation	Novartis Investigative Site	Saint-Petersburg
Slovakia	Novartis Investigative Site	Bojnice
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Kosice
Slovakia	Novartis Investigative Site	Povazska Bystrica
Slovakia	Novartis Investigative Site	Svidnik
Spain	Novartis Investigative Site	Alcorcon	Madrid
Spain	Novartis Investigative Site	Alicante	Comunidad Valenciana
Spain	Novartis Investigative Site	Alzira	Valencia
Spain	Novartis Investigative Site	Badalona	Catalunya
Spain	Novartis Investigative Site	Baracaldo	Vizcaya
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Bilbao	Pais Vasco
Spain	Novartis Investigative Site	Castellon	Comunidad Valenciana
Spain	Novartis Investigative Site	Cordoba	Andalucia
Spain	Novartis Investigative Site	Fuenlabrada	Madrid
Spain	Novartis Investigative Site	Granada	Andalucia
Spain	Novartis Investigative Site	Hospitalet de Llobregat	Barcelona
Spain	Novartis Investigative Site	Huesca
Spain	Novartis Investigative Site	La Coruna	Galicia
Spain	Novartis Investigative Site	La Laguna	Santa Cruz De Tenerife
Spain	Novartis Investigative Site	Las Palmas de Gran Canaria	Las Palmas De G.C
Spain	Novartis Investigative Site	Leon	Castilla Y Leon
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Mallorca
Spain	Novartis Investigative Site	Manises	Valencia
Spain	Novartis Investigative Site	Murcia
Spain	Novartis Investigative Site	Palma de Mallorca	Islas Baleares
Spain	Novartis Investigative Site	Pamplona	Navarra
Spain	Novartis Investigative Site	Pontevedra
Spain	Novartis Investigative Site	Sabadell	Barcelona
Spain	Novartis Investigative Site	Salamanca	Castilla Y Leon
Spain	Novartis Investigative Site	San Sebastian de los Reyes	Madrid
Spain	Novartis Investigative Site	Sant Joan Despi	Barcelona
Spain	Novartis Investigative Site	Santander	Cantabria
Spain	Novartis Investigative Site	Santiago de Compostela	Galicia
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Villajoyosa	Alicante
Spain	Novartis Investigative Site	Zaragoza
Sweden	Novartis Investigative Site	Falun
Sweden	Novartis Investigative Site	Malmo
Sweden	Novartis Investigative Site	Stockholm
Sweden	Novartis Investigative Site	Stockholm
Sweden	Novartis Investigative Site	Uppsala
Switzerland	Novartis Investigative Site	Basel
Switzerland	Novartis Investigative Site	Geneve
Switzerland	Novartis Investigative Site	Lausanne
Switzerland	Novartis Investigative Site	Zuerich
United Kingdom	Novartis Investigative Site	Cambridge
United Kingdom	Novartis Investigative Site	Cannock	Staffordshire
United Kingdom	Novartis Investigative Site	Canterbury	Kent
United Kingdom	Novartis Investigative Site	Cliftonville	Northampton
United Kingdom	Novartis Investigative Site	Dudley	West Midlands
United Kingdom	Novartis Investigative Site	Harrogate
United Kingdom	Novartis Investigative Site	Leeds	West Yorkshire
United Kingdom	Novartis Investigative Site	Salford	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Austria,  Belgium,  Bulgaria,  Croatia,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Latvia,  Lithuania,  Netherlands,  Poland,  Portugal,  Russian Federation,  Slovakia,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maintenance of PASI 90 Response 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).	Week 52
Secondary	Key Secondary: PASI 90 Response Rate at Week 52 in Participants With a PASI Response of =75 to <90 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).	Week 52
Secondary	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.	week 52
Secondary	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	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.	Week 52
Secondary	Change From Baseline in PASI 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). A negative change from baseline indicates improvement.	Baseline, Weeks 28, 32, 36, 40, 44, 48 and 52
Secondary	Change From Baseline in PASI in Participants With a PASI Response of =75 to <90 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). A negative change from baseline indicates improvement.	Baseline, Weeks 28, 32, 36, 40, 44, 48 and 52
Secondary	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.	Baseline, Week 52
Secondary	Change From Baseline in DLQI in Participants With a PASI Response of =75 to <90 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.	Baseline, Week 52
Secondary	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.	Baseline, Week 52
Secondary	Change From Baseline in WPAI-PSO Score in Participants With a PASI Response of =75 to <90 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.	Baseline, Week 52
Secondary	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	Baseline, Week 52
Secondary	Change From Baseline in Pain, Itching and Scaling Score in Participants With a PASI Response of =75 to <90 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	Baseline, Week 52
Secondary	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.	Baseline, Week 52
Secondary	Change From Baseline in the EQ-5D VAS in Participants With a PASI Response of =75 to <90 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").	Baseline, Week 52
Secondary	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).	Baseline, Week 52
Secondary	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").	Baseline, Week 52