A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis

Psoriasis Clinical Trial

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Official title:

A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03090100
• Other study ID #: CR108278
• Secondary ID: 2016-002995-29CN
• Status: Completed
• Phase: Phase 3
• Start date: April 27, 2017
• Est. completion date: September 20, 2018

Study information

• Verified date: September 2019
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab for the treatment of participants with moderate to severe plaque-type psoriasis.

Description:

The study consists of Screening Phase(4 weeks before administration of study drug),Active Treatment Phase(Week 0-Week 44),Follow Up Phase(Week 44-Week 56).During various study periods,safety assessments(example[e.g] recording of adverse events,Vital signs,Tuberculosis evaluation,Chest radiograph,Urine pregnancy Test);Efficacy assessments(e.g IGA,PASI);Clinical Laboratory Assessments(e.g haematology,chemistry);Biomarkers/Genetic evaluations,will be performed per the study procedures.The primary hypotheses are that guselkumab treatment is non-inferior to secukinumab as assessed by proportion of participants achieving PASI 90 response at Week 48 with noninferiority margin of 10% and,once non-inferiority is established,that guselkumab is superior to secukinumab as assessed by proportion of participants achieving PASI 90 response at Week 48.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1048
• Est. completion date: September 20, 2018
• Est. primary completion date: August 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have a diagnosis of plaque-type psoriasis (with or without [Psoriatic Arthritis]PsA) for at least 6 months before the first administration of study drug

• A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0 and agree to urine pregnancy testing before receiving injections

• Agree not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug

• Agree not to receive a Bacille Calmette-Guérin (BCG) vaccination during the study, or within 12 months after the last administration of study drug

• Agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during study

Exclusion Criteria:

• Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances

• Has previously received guselkumab or secukinumab

• Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers

• Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly

• Is unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Guselkumab
Participants will receive 1 injection of active guselkumab at Weeks 0, 4, 12, 20, 28, 36, and 44.
• Placebo
Participants will receive 1 injection of placebo at Weeks 0, 4, 12, 20, 28, 36, and 44 and 2 injections of placebo at Weeks 1, 2, 3, 8, 16, 24, 32, and 40.
• Secukinumab
Participants will receive 2 injections of active secukinumab at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44.

Locations

Country	Name	City	State
Australia	The Skin Centre	Benowa
Australia	Sinclair Dermatology	East Melbourne
Australia	Fremantle Dermatology	Fremantle
Australia	Clinical Trials SA Pty Ltd	Hectorville
Australia	Premier Specialists	Kogarah
Australia	St George Dermatology & Skin Cancer Centre	Kogarah
Australia	Skin&Cancer Foundation Inc	Melbourne
Australia	Royal Melbourne Hospital	Parkville
Australia	Westmead Hospital	Westmead
Australia	Woden Dermatology	Woden
Australia	Veracity Clinical Research	Woolloongabba
Canada	CCA Medical Research Corporation	Ajax
Canada	Stratica Medical	Edmonton
Canada	Eastern Canada Research Associates	Halifax
Canada	Dermatrials Research	Hamilton	Ontario
Canada	Guenther Dermatology Research Centre	London	Ontario
Canada	DermEdge Research	Mississauga
Canada	Innovaderm Research	Montreal
Canada	North Bay Dermatology Centre	North Bay	Ontario
Canada	Skin Centre for Dermatology	Peterborough	Ontario
Canada	Centre Dermatologique	Quebec
Canada	Dr. Chih-ho Hong Medical	Surrey
Canada	Toronto Research Centre	Toronto	Ontario
Canada	K. Papp Clinical Research	Waterloo
Canada	XLR8 Medical Research	Windsor
Czechia	Nemocnice Jihlava	Jihlava
Czechia	Kozni ambulance Kutna Hora, s.r.o.	Kutna Hora
Czechia	DERMAMEDICA s.r.o.	Nachod
Czechia	Nemocnice Novy Jicin a.s.	Novy Jicin
Czechia	Fakultni nemocnice Ostrava	Ostrava- Poruba
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha
Czechia	Dermatologicka ambulance	Svitavy
Czechia	Masarykova nemocnice v Usti nad Labem	Usti Nad Labem
France	CHU Bordeaux - Hopital St Andre	Bordeaux
France	ICH Hopital A. Morvan	Brest
France	Groupe Hospitalier La Rochelle - Re - Aunis	La Rochelle
France	Le Bateau Blanc	Martigues
France	CHU Nantes - Hotel Dieu	Nantes
France	CHU de Nice Hopital de l Archet	Nice
France	Hopital Charles Nicolle	Rouen
France	Hopital Larrey CHU de Toulouse	Toulouse
Germany	Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center	Berlin
Germany	ISA GmbH	Berlin
Germany	Universitatsklinikum Bonn	Bonn
Germany	Klinische Forschung Dresden GmbH	Dresden
Germany	University Hospital Dresden	Dresden
Germany	Universitatsklinikum Essen	Essen
Germany	Universitatsklinikum Frankfurt	Frankfurt am Main
Germany	MensingDerma research GmbH	Hamburg
Germany	SCIderm GmbH	Hamburg
Germany	Universitaetsklinik Hamburg-Eppendorf	Hamburg
Germany	Universitatsklinikum Schleswig-Holstein - Kiel	Kiel
Germany	Universitaetsklinik Luebeck	Luebeck
Germany	Hautarztpraxis	Mahlow
Germany	Technische Universitaet Muenchen	Muenchen
Germany	Universitaetsklinikum Muenster	Muenster
Germany	Universitaetsklinik Tuebingen	Tuebingen
Germany	Centrovital	Witten
Hungary	Semmelweis Egyetem	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Somogy Megyei Kaposi Mor Oktatokorhaz	Kaposvar
Hungary	Bacs-kiskun Megyei Korhaz	Kecskemet
Hungary	Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz	Miskolc
Hungary	Pecsi Tudomanyegyetem	Pecs
Hungary	Szegedi Tudomanyegyetem	Szeged
Hungary	Markusovszky Egyetemi Oktatokorhaz	Szombathely
Hungary	Medmare Egeszsegugyi Es Szolgaltato Bt.	Veszprem
Poland	NZOZ Osteo-Medic S.C. Artur Racewicz i Jerzy Supronik	Bialystok
Poland	Specderm Poznanska sp. j.	Bialystok
Poland	Szpital Uniwersytecki nr 1 im. Dr A. Jurasza	Bydgoszcz
Poland	Centrum Kliniczno Badawcze	Elblag
Poland	Copernicus Podmiot Leczniczy Sp. z o.o	Gdansk
Poland	Malopolskie Centrum Medyczne	Krakow
Poland	Centrum Badawcze Wspolczesnej Terapii	Lodz
Poland	Dermed Centrum Medyczne Sp. z o.o	Lodz
Poland	CRC Sp. z o.o.	Poznan
Poland	Solumed S.C.	Poznan
Poland	Lubelskie Centrum Diagnostyczne	Swidnik
Poland	NZOZ Poradnia Dermatologiczno-Wenerologiczna Mediderm	Torun
Poland	Przychodnia Specjalistyczna High-Med	Warszawa
Poland	Wojskowy Instytut Medyczny	Warszawa
Poland	Centrum Medyczne WroMedica	Wroclaw
Poland	DermMedica Sp. z o.o.	Wroclaw
Spain	Hosp. Univ. Fundacion Alcorcon	Alcorcon
Spain	Hosp. Gral. Univ. de Alicante	Alicante
Spain	Hosp. Univ. Germans Trias I Pujol	Badalona
Spain	Hosp. Univ. de Cruces	Barakaldo
Spain	Hosp. de La Santa Creu I Sant Pau	Barcelona
Spain	Hosp. Del Mar	Barcelona
Spain	Hosp. Univ. de Basurto	Bilbao Vizcaya
Spain	Hosp. Reina Sofia	Cordoba
Spain	Hosp. Univ. 12 de Octubre	Madrid
Spain	Hosp. Univ. de Torrejon	Madrid
Spain	Hosp. Univ. Infanta Leonor	Madrid
Spain	Hosp. Univ. La Paz	Madrid
Spain	Hosp. de Manises	Manises
Spain	Hosp. Provincial de Pontevedra	Pontevedra
Spain	Hosp. Univ. I Politecni La Fe	Valencia
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	Atlanta Dermatology, Vein & Research Center	Alpharetta	Georgia
United States	Advanced Medical Research	Atlanta	Georgia
United States	Austin Dermatology Associates	Austin	Texas
United States	Great Lakes Research Group	Bay City	Michigan
United States	Dermatologists of Greater Columbus	Bexley	Ohio
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	Olympian Clinical Research	Clearwater	Florida
United States	Florida Academic Dermatology Centers	Coral Gables	Florida
United States	Menter Dermatology Research Institute	Dallas	Texas
United States	Modern Research Associates	Dallas	Texas
United States	Clinical Research Center of Connecticut	Danbury	Connecticut
United States	Henry Ford Medical Center	Detroit	Michigan
United States	Windsor Dermatology	East Windsor	New Jersey
United States	Hamzavi Dermatology	Fort Gratiot	Michigan
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	The Ohio State University	Gahanna	Ohio
United States	Dermatology Consulting Services, PLLC	High Point	North Carolina
United States	Suzanne Bruce and Associates - The Center for Skin Research	Houston	Texas
United States	Dawes Fretzin Clinical Research Group	Indianapolis	Indiana
United States	Clinical Partners	Johnston	Rhode Island
United States	Southern California Permanente Medical Group	Los Angeles	California
United States	Dermatology Specialists	Louisville	Kentucky
United States	Marietta Dermatology Clinical Research	Marietta	Georgia
United States	Virginia Clinical Research	Norfolk	Virginia
United States	Central Sooner Research	Norman	Oklahoma
United States	Renstar Medical Research	Ocala	Florida
United States	Dermatology Specialists	Oceanside	California
United States	Park Avenue Dermatology	Orange Park	Florida
United States	University of Pittsburgh Department of Dermatology	Pittsburgh	Pennsylvania
United States	Indiana Clinical Trial Center	Plainfield	Indiana
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Oregon Medical Research Center	Portland	Oregon
United States	DermAssociates, PC	Rockville	Maryland
United States	Arlington Dermatology	Rolling Meadows	Illinois
United States	Central Dermatology	Saint Louis	Missouri
United States	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	Progressive Clinical Research	San Antonio	Texas
United States	MedDerm Associates	San Diego	California
United States	San Luis Dermatology & Laser Clinic, Inc	San Luis Obispo	California
United States	Southern California Dermatology	Santa Ana	California
United States	Dermatology Associates of Seattle	Seattle	Washington
United States	Northshore Universite Healthsystem	Skokie	Illinois
United States	Somerset Skin Centre	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czechia,  France,  Germany,  Hungary,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48	The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.	Week 48
Secondary	Percentage of Participants Who Achieved a PASI-75 Response at Both Week 12 and 48	Percentage of participants who achieved PASI-75 response at both Week 12 and 48 was reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.	Week 12 and 48
Secondary	Percentage of Participants Who Achieved a PASI-90 Response at Week 12	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Due to failing to achieve superiority of prior secondary endpoint, no formal statistical testing was performed for endpoints from this point onwards.	Week 12
Secondary	Percentage of Participants Who Achieved a PASI-75 Response at Week 12	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.	Week 12
Secondary	Percentage of Participants Who Achieved a PASI-100 Response at Week 48	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 100 response was defined as 100% reduction in PASI relative to baseline.	Week 48
Secondary	Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) at Week 48	The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).	Week 48
Secondary	Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 48	The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).	Week 48
Secondary	Percentage of Participants Who Achieved a PASI-90 Response at Both Week 16 and 48	Percentage of participants who achieved PASI-90 response at both Week 16 and 48 was reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline.	Week 16 and 48
Secondary	Percentage of Participants Who Achieved a PASI-75 Response at Week 16	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.	Week 16
Secondary	Percentage of Participants Who Achieved a PASI-90 Response at Week 16	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline.	Week 16
Secondary	Percentage of Participants Who Achieved a PASI-90 Response at All 7 Visits From Week 24 Through Week 48	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Percentage of participants who achieved a PASI-90 response at all 7 visits from Week 24 to 48 (Week 24, 28, 32, 36, 40, 44 and 48) was reported.	Week 24 up to Week 48
Secondary	Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 16	The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).	Week 16
Secondary	Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 12	The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).	Week 12
Secondary	Percentage of Participants Who Achieved PASI-75 Response at Week 48 Among PASI-75 Responders at Week 12	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.	Week 48
Secondary	Percentage of Participants Who Achieved PASI-90 Response at Week 48 Among PASI-90 Responders at Week 16	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90 percent (%) reduction in PASI relative to baseline.	Week 48
Secondary	Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56	PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. PASI produces a numeric score that can range from 0 (no psoriasis) to 72.Participants with >=50%, >= 75%, >=90% and 100% improvement in PASI from baseline were considered PASI 50, 75, 90 and PASI 100 responders, respectively.	Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56
Secondary	Percentage of Participants With IGA Responses Through Week 56	The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).	Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56
Secondary	Percent Improvement From Baseline in PASI Through Week 56	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.	Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 56