A One-Year Study To Evaluate The Efficacy And Safety Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis

A Phase 3, Multi-Site, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: CP-690,550; Drug: CP-690,550; Drug: Placebo/CP-690,550; Drug: Placebo/CP-690,550

• Study Type: Interventional
• Enrollment (Actual): 960
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2S 3B3
      • Kirk Barber Research
    • Calgary, Alberta, Canada, T3G 0B4
      • Northwest Dermatology & Laser Centre
    • Edmonton, Alberta, Canada, T5K 1X3
      • Stratica Medical
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Guildford Dermatology Specialists
    • Victoria, British Columbia, Canada, V8V 3P9
      • Percuro Clinical Research Ltd
    • Victoria, British Columbia, Canada, V8V 3M9
      • Practice office of John D. Amiss MD
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1C 2H5
      • NewLab Clinical Research Inc.
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1Z4
      • Eastern Canada Cutaneous Research Associates Ltd.
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Queen Elizabeth II Health Sciences Centre
  • Ontario
    • Ajax, Ontario, Canada, L1S 7K8
      • CCA Medical Research Corporation
    • Courtice, Ontario, Canada, L1E 3C3
      • Co-Medica Research Network Inc.
    • London, Ontario, Canada, N6A 3H7
      • The Guenther Dermatology Research Centre
    • Oshawa, Ontario, Canada, L1H 1B9
      • Oshawa Clinic
    • Peterborough, Ontario, Canada, K9J 1Z2
      • SKiN Centre for Dermatology
    • Waterloo, Ontario, Canada, N2J 1C4
      • K.Papp Clinical Research Inc.
    • Windsor, Ontario, Canada, N8W 1E6
      • XLR8 Medical Research Inc.
  • Quebec
    • Montreal, Quebec, Canada, H3Z 2S6
      • Siena Medical Research
    • Sherbrooke, Quebec, Canada, J1H 1Z1
      • Diex Research Sherbrooke Inc.
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia, 0000
      • Hospital Pablo Tobón Uribe
• Germany
  • Berlin, Germany, 13125
    • Klinische Forschung Berlin-Buch GmbH
  • Berlin, Germany, 10435
    • Facharzt fuer Dermatologie und Allergologie
  • Buchholz, Germany, 21244
    • Dres.Kirsten Prepeneit und Volker Streit
  • Frankfurt/Main, Germany, 60590
    • Klinikum der Johann Wolfgang Goethe Universitaet
  • Halle, Germany, 06120
    • Universitaetsklinik Und Poliklinik Fuer Dermatologie Und Venerologie
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg-Eppendorf
  • Hanau, Germany, 63450
    • Gemeinschaftspraxis Dres.Michael Ockenfels und Christoph Sauter
  • Luebeck, Germany, 23538
    • Universitaetsklinikum, Schleswig-Holstein, Klinik fuer Dermatologie
  • Mahlow, Germany, 15831
    • Hautarztpraxis Dres. Scholz, Sebastian, Schilling
  • Wiesbaden/ Bierstadt, Germany, 65191
    • Wilhelm Fresenius Klinik
  • Witten, Germany, 58453
    • Facharzt fuer Dermatologie, Venerologie, Allergologie, Naturheilverfahren, Lasermedizin
• Hungary
  • Szekszard, Hungary, 7100
    • Tolna Megyei Onkormanyzat Balassa Janos Korhaza, Borgyogyaszati Osztaly
  • Szombathely, Hungary, 9700
    • Vas Megyei Markusovszky Korhaz, Borgyogyaszati Osztaly
  • Veszprem, Hungary, 8200
    • Veszprem Megyei Csolnoky Ferenc Korhaz, Borgyogyaszat
• Mexico
  • D.f.
    • Mexico, D.f., Mexico, 06700
      • Instituto Mexicano de Investigación Clínica, S.A. de C.V
  • Jalisco
    • Zapopan, Jalisco, Mexico, 45190
      • Instituto Dermatologico de Jalisco Dr. Jose Barba Rubio
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64710
      • Centro Medico San Lucas
• Poland
  • Lodz, Poland, 90-265
    • Specjalistyczne Gabinety Lekarskie "Dermed�
  • Warszawa, Poland, 02-106
    • MTZ Clinical Research Sp. z o.o.
  • Warszawa, Poland, 04-141
    • Klinika Dermatologii Wojskowy Instytut Medyczny
• Puerto Rico
  • Carolina, Puerto Rico, 00985
    • The Office of Dr. Alma M. Cruz, MD.
• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy
• Taiwan
  • New Taipei City, Taiwan, 235
    • Taipei Medical University-Shuang Ho Hospital
  • Taichung, Taiwan, 402
    • Chung Shan Medical University Hospital
  • Kaohsiung County
    • Niao-Sung Hsiang, Kaohsiung County, Taiwan, 833
      • Chang Gung Memorial Hospital Kaohsiung Branch
  • Taoyuan
    • Kwei-Shan, Taoyuan, Taiwan, 333
      • Chang Gung Medical Foundation, Linkou Branch
• Ukraine
  • Kharkiv, Ukraine, 61038
    • MIHC Kharkiv City Dermatovenerologic Dispensary #2
  • Kyiv, Ukraine, 01032
    • Dept of Dermatology and Venereology of National Medical University n.a. O.O. Bogomolets
  • Lugansk, Ukraine, 91047
    • Lugansk Regional Dermatovenerologic Dispensary
  • Lviv, Ukraine, 79013
    • Lviv regional municipal dermatovenerologic dispensary,
  • Odessa, Ukraine, 65006
    • Department of dermatology and venereology of Odessa National Medical University
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Burke Pharmaceutical Research
  • California
    • Bakersfield, California, United States, 93309
      • Bakersfield Dermatology and Skin Cancer Medical Group
    • La Jolla, California, United States, 92037
      • University of California San Diego
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • Los Angeles, California, United States, 90045
      • Expresscare Medical (X-Rays only)
    • San Diego, California, United States, 92103
      • MedDerm Associates
    • San Diego, California, United States, 92122
      • University of California San Diego
    • Torrance, California, United States, 90503
      • HealthCare Partners Medical Group
  • Florida
    • Jacksonville, Florida, United States, 32204
      • North Florida Dermatology Associates, PA
  • Georgia
    • Macon, Georgia, United States, 31217
      • Dermatologic Surgery Specialists, PC
  • Illinois
    • Algonquin, Illinois, United States, 60102
      • Sherman Immediate Care Center (Imaging Only)
    • Schaumburg, Illinois, United States, 60194
      • Schaumburg Dermatology
    • Skokie, Illinois, United States, 60077
      • NorthShore University HealthSystem - Division of Dermatology
    • West Dundee, Illinois, United States, 60118
      • Dundee Dermatology
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Hudson Dermatology
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital
  • Michigan
    • Fort Gratiot, Michigan, United States, 48059
      • Hamzavi Dermatology
    • Troy, Michigan, United States, 48084
      • Somerset Skin Centre - Dermcenter
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota - Department of Dermatology
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • Saint Louis University - Department of Dermatology
    • St. Louis, Missouri, United States, 63117
      • Central Dermatology, PC
  • Nevada
    • Henderson, Nevada, United States, 89074
      • Bettencourt Skin Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center - Section of Dermatology
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Comprehensive Clinical Research
  • New York
    • New York, New York, United States, 10065
      • The Rockefeller University
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • University of North Carolina at Chapel Hill
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina at Chapel Hill Hospital
    • Winston-Salem, North Carolina, United States, 27104
      • Wake Forest University Health Sciences
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Radiant Research, Inc.
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Research Center, Inc.
    • Austin, Texas, United States, 78705
      • Austin Dermatology Associates
    • Dallas, Texas, United States, 75230
      • Dermatology Treatment & Research Center, PA
    • Dallas, Texas, United States, 75243
      • InSight Diagnostic Center
    • Houston, Texas, United States, 77030
      • Center For Clinical Studies
    • Houston, Texas, United States, 77056
      • Suzanne Bruce and Associates, PA
    • San Antonio, Texas, United States, 78229
      • Progressive Clinical Research, PA
    • San Antonio, Texas, United States, 78229
      • Office of Mark S. Lee, MD
    • Webster, Texas, United States, 77598
      • Center For Clinical Studies
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years or older with diagnosis for at least 12 months of moderate to severe plaque psoriasis covering at least 10% of body surface area
• A Psoriasis Area and Severity Index (PASI) score of 12 or greater
• Are considered to be candidates for systemic or light therapy
• Have no evidence of active or latent tuberculosis

Exclusion Criteria:

• Non-plaque or drug-induced forms of psoriasis
• Cannot discontinue current oral, injectible or topical therapy for psoriasis or cannot discontinue phototherapy (PUVA or UVB)
• Any uncontrolled significant medical condition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Active Treatment 10 mg BID	Drug: CP-690,550; 10 mg oral BID, Continuous treatment for 52 Weeks; Drug: CP-690,550; 5 mg oral BID, Continuous treatment for 52 Weeks
EXPERIMENTAL: Active Treatment 5 mg BID	Drug: CP-690,550; 10 mg oral BID, Continuous treatment for 52 Weeks; Drug: CP-690,550; 5 mg oral BID, Continuous treatment for 52 Weeks
PLACEBO_COMPARATOR: Placebo Treatment	Drug: Placebo/CP-690,550; 0 mg oral BID, Continuous Treatment for 16 Weeks; 10 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo); Drug: Placebo/CP-690,550; 0 mg oral BID, Continuous Treatment for 16 Weeks; 5 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16	The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).	Week 16
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16	Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.	Baseline, Week 16
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 4	The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).	Week 4
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16	The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.	Baseline, Week 16
Percent Probability of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 52	The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported. Percent probability and 95% confidence interval (CI) were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).	Week 52
Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52	The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response = at least 75% reduction in PASI relative to Baseline. Maintenance of PASI 75 response at Week 52 among participants achieving PASI 75 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).	Week 52
Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 52	The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response = at least 90% reduction in PASI relative to Baseline. Maintenance of PASI 90 response at Week 52 among participants achieving PASI 90 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).	Week 52
Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'	The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 1). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.	Baseline up to Week 16
Time to Achieve Psoriasis Area and Severity Index 50 (PASI 50) Response	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 26). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.	Baseline up to Week 16
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'	The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).	Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score	The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). Percentage of participants with each PGA score is reported.	Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52	Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.	Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
36-Item Short-Form Health Survey Version 2, Acute (SF-36)	36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).	Baseline, Week 16, 28, 52
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response	The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from "very dissatisfied" to "very satisfied" with the study treatment.	Week 16, 28, 52
Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.	Baseline, Week 16, 28, 40, 52
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status	The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Percentage of participants reporting healthcare resource use events and employment status, work impacted events due to psoriasis, and absence or sick leave for work due to psoriasis at Week 16 are reported. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.	Week 16
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline.	Week 16
Dermatology Life Quality Index (DLQI) Total Score	The DLQI is a 10-item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.	Baseline
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16	The DLQI is a 10-item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.	Baseline, Week 4,16
Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 4	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline.	Week 4
Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 2). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.	Baseline up to Week 16
Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline. Percentage of participants with PASI 75 response is reported.	Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Psoriasis Area and Severity Index (PASI) Score	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.	Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.	Baseline, Week 2, 4, 8,12, 16, 20, 28, 40, 52
Psoriasis Area and Severity Index (PASI) Component Scores	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4 and where higher scores indicate greater severity of psoriatic lesions.	Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4 where higher scores indicate greater severity of psoriatic lesions.	Baseline, Week 2, 4, 8,12, 16, 20, 28, 40, 52
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.	Baseline, Week 2, 4, 8, 12,16, 20, 28, 40, 52
Total Body Surface Area (BSA) With Psoriasis	Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.	Baseline, Week 2, 4, 8,16, 20, 28, 40, 52
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least a 50% reduction in PASI relative to Baseline. Percentage of participants with PASI 50 response is reported.	Week 2, 4, 8,12,16, 20, 28, 40, 52
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline. Percentage of participants with PASI 90 response is reported.	Week 2, 4, 8,12,16, 20, 28, 40, 52
Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked).	Week 2, 4, 8,12,16, 20, 28, 40, 52
Nail Psoriasis Severity Index (NAPSI) Score	The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.'n' signifies participants evaluable at specified time point for each arm.	Baseline, Week 8, 16, 20, 28, 40, 52
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52	The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. 'n' signifies participants evaluable at specified time point for each arm.	Baseline,Week 8, 16, 20, 28, 40, 52
Number of Affected Nails	Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Total number of psoriasis affected nails (presence of psoriatic manifestations on the nail matrix / nail bed) were assessed and reported. 'N' (number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure.	Baseline, Week 8, 16, 20, 28, 40, 52
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52	The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. 'N' (number of participants analyzed) signifies participants with baseline nail psoriasis and who were unique in longitudinal model.	Baseline,Week 8,16, 20, 28, 40, 52
Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response	The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. NAPSI 75 response was defined as at least a 75% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 75 response is reported. N(number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure.	Week 8, 16, 20, 28, 40, 52
Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response	The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. NAPSI 100 response was defined as at least a 100% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 100 response is reported. N(number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure.	Week 8,16, 20, 28, 40, 52
Itch Severity Item (ISI) Score	ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment.	Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52
Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52	ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.	Baseline, Week 2, 4, 8,12,16, 20, 28 , 40, 52
Dermatology Life Quality Index (DLQI) Score	The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.	Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52	The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. Here 'N' (number of participants analyzed) signifies the unique participants in the longitudinal model.	Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Hospital Anxiety and Depression Scale (HADS) Score	HADS: 14-item questionnaire that screens for the presence of anxiety and depression symptoms. There are 7 items comprising the anxiety subscale and 7 items comprising the depression subscale. Each item has response options ranging from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total HADS score ranges from 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.	Baseline, Week 8, 16, 28, 52
Work Limitation Questionnaire (WLQ) Index Score	WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands Scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 [no loss] to 100 [complete loss of work]).	Baseline, Week 8, 16, 28, 52
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response	The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear [no psoriasis]; 1=almost clear; 2=mild; 3=moderate; 4=severe).	Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52
Joint Pain Assessment (JPA) Score	The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to "select the number that best describes any joint pain that participant may have experienced over the past 24 hours" with response options ranging from "0-no joint pain" to "10-worst possible joint pain".	Baseline, Week 8,16, 28, 52
Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS)	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.	Baseline,Week 16, 28, 40, 52
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional	The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use (interactions with healthcare providers such as general practitioners, Dermatologist and Rheumatologist. Baseline is the latest pre-dose measurement. Week 16 includes all reported log data to Week 16 (excluding Baseline). Participants may have response in more than 1 category. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.	Baseline, Week 16
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work	The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Participants (currently employed [Emp]) answered (Yes/No [Y/N]): "Were you absent or on sick leave from work due to psoriasis today?", and participants (unemployed [UEmp]) answered (Yes/No): "Are you unemployed due to your psoriasis?" Baseline is the latest pre-dose measurement. Week 16 includes all reported log up to Week 16 (excluding Baseline). Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.	Baseline, Week 16
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours	The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.	Baseline, Week 16
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours	The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Percent absent hours = (hours absent from work/hours scheduled to work) multiplied by 100. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.	Baseline, Week 16
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work	The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work.The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants rate how much psoriasis affected their ability to work by reporting a number from 0 to 10, where 0 means "ability to work was not affected by psoriasis", and 10 means "ability to work was completely affected by psoriasis". Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.	Baseline, Week 16
Family Dermatology Life Quality Index (FDLQI) Score	The FDLQI is a 10-item questionnaire that examine the impact of health-related quality of life issues associated with living with a person with a skin condition (example, emotional distress, personal relationships, reactions of other people, social life, caregiving) over the last month. The FDLQI need to be completed by a family member (for example, spouse or partner, parent) who currently lives with the participant. Each question is scored on a scale from 0 (Not at all/ Not relevant) to 3 (Very much). Total score is calculated by summing the score of each item resulting in a maximum score of '30' and a minimum score of '0'. Higher scores indicate greater impairment to quality of life. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.	Baseline, Week 16, 52

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:
• Merola JF, Elewski B, Tatulych S, Lan S, Tallman A, Kaur M. Efficacy of tofacitinib for the treatment of nail psoriasis: Two 52-week, randomized, controlled phase 3 studies in patients with moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2017 Jul;77(1):79-87.e1. doi: 10.1016/j.jaad.2017.01.053. Epub 2017 Apr 7.
• Papp KA, Menter MA, Abe M, Elewski B, Feldman SR, Gottlieb AB, Langley R, Luger T, Thaci D, Buonanno M, Gupta P, Proulx J, Lan S, Wolk R; OPT Pivotal 1 and OPT Pivotal 2 investigators. Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: results from two randomized, placebo-controlled, phase III trials. Br J Dermatol. 2015 Oct;173(4):949-61. doi: 10.1111/bjd.14018.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: March 4, 2011
• First Submitted That Met QC Criteria: March 4, 2011
• First Posted (ESTIMATE): March 7, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): September 19, 2014
• Last Update Submitted That Met QC Criteria: September 18, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: treatment; safety; efficacy; Plaque Psoriasis; Itch; chronic; tofacitinib; Xeljanz; Pruritus; DLQI; severe; moderate; CP-690,550; Psoriasis Vulgaris; oral treatment; Jak-inhibitor
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Tofacitinib
• Other Study ID Numbers: A3921079