A Study Evaluating The Efficacy And Safety Of CP-690,550 In Asian Subjects With Moderate To Severe 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 ASIAN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS

The primary objective of this study is to compare the efficacy of CP-690,550 (5 mg BID and 10 mg BID) versus placebo for the reduction in severity of plaque psoriasis after 16 weeks of treatment in Asian subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 266
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100034
    • Peking University First Hospital / The Department of Dermatology
  • Beijing, China, 100044
    • Peking University People's Hospital/Dermatology Department
  • Beijing, China, 100730
    • Beijing Hospital of the Ministry of Health/Department of Dermatology
  • Beijing, China, 100730
    • Peking Union Medical College Hospital/Department of Dermatology
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital, Dermatological Department
  • Beijing
    • Xicheng District, Beijing, China, 100050
      • Dept. Of dermatology &STD, Beijing Friendship Hospital, Capital Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 430022
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Jiangsu
    • Nanjing, Jiangsu, China, 210042
      • Hospital of Skin Diseases, Chinese Academy of Medical Sciences
  • Liaoning
    • Dalian, Liaoning, China, 116027
      • Department of Dermatology, The Second Affiliated Hospital of Dalian Medical University
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Huashan Hospital, Fudan University/Dermatology Department
    • Shanghai, Shanghai, China, 200433
      • Shanghai Changhai Hospital, Dermatology Department
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • Dermatology Department, The First Affiliated Hospital, The Fourth Military Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University
    • Chengdu, Sichuan, China, 610031
      • Sichuan Provincial People's Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology and STD Dept
    • Hangzhou, Zhejiang, China, 310009
      • The second Affiliated Hospital of College of Medicine, Zhejiang University
• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 120-452
    • Department of Dermatology,Severance Hospital, Yonsei University Health System
• Taiwan
  • Tainan, Taiwan, 704
    • National Cheng-Kung University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taoyuan, Taiwan, 333
    • Chang Gung Medical Foundation-Linkou Branch

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:

• Have had a diagnosis of plaque-type psoriasis (psoriasis vulgaris) for at least 12 months prior to the first screening procedure.
• Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe") at Baseline (Day 1).
• Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis (either naïve or history of previous treatment).

Exclusion Criteria:

• Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis, with the exception of nail psoriasis which is allowed.
• Have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or lithium.
• Subjects who cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA) for the study are excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo BID	Drug: placebo; placebo BID for 16 weeks and then re-randomized into active groups
Experimental: 5mg BID CP-690,550	Drug: CP-690,550; CP-690,550 5mg BID for 52 weeks; Drug: CP-690,550; CP-690,550 10mg BID for 52 weeks
Experimental: 10mg BID CP-690,550	Drug: CP-690,550; CP-690,550 5mg BID for 52 weeks; Drug: CP-690,550; CP-690,550 10mg BID for 52 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Physician's Global Assessment (PGA) 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 Achieving at Least a 75% Reduction in PASI (PASI75) 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. PASI75 response was defined as at least a 75% 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 to Week 16
Percentage of Participants Achieving at Least a 90% Reduction in PASI (PASI90) 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. PASI90 response was defined as at least a 90% reduction in PASI relative to Baseline.	Week 16
Change From Baseline in DLQI Total Score at Week 16	The DLQI is a 10 item general dermatology questionnaire that assesses 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 to Week 16
Percentage of Participants With PGA 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
Percentage of Participants Achieving PASI75 Response at Week 4	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% reduction in PASI relative to Baseline.	Week 4
Change From Baseline in DLQI Total Score at Week 4	The DLQI is a 10 item general dermatology questionnaire that assesses 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 to Week 4
Percent Change From Baseline in Nail Psorasis Severity Index (NAPSI) at Week 16 in Participants With Nail Psoriasis at Baseline	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 represent more severe psoriasis.	Baseline to Week 16
Percentage of Participants Maintaining PGA Score of "Clear" or "Almost Clear" at Week 52 Among Participants Achieving PGA Response 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). Maintenance of PGA response at Week 52 among patients achieving PGA response at Week 16 is reported. This is a key secondary endpoint. Percentage of participants maintaining the response and the 95% confidence interval (CI) were estimated based on the Kaplan-Meier method. Event is loss of response. Percentage of maintaining response is (1-probability of loss of response).	Week 16 to Week 52
Percentage of Participants Maintaining PASI75 Response at Week 52 Among Participants Achieving PASI75 Response at Week 16	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. PASI75 response=at least 75% reduction in PASI relative to Baseline. Maintenance of PASI75 response at Week 52 among patients achieving PASI75 response at Week 16 is reported. This is a key secondary endpoint. Probability and the 95% CI were estimated based on the Kaplan-Meier method. Event is loss of response. Percentage of maintaining response is (1-probability of loss of response).	Week 16 to Week 52
Percentage of Participants Maintaining PASI90 Response at Week 52 Among Participants Achieving PASI90 at Week 16	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. PASI90 response=at least 90% reduction in PASI relative to Baseline. Maintenance of PASI90 response at Week 52 among patients achieving PASI90 response at Week 16 is reported. This is a key secondary endpoint. Probability and the 95% CI were estimated based on the Kaplan-Meier method. Event is loss of response. Percentage of maintaining response is (1-probability of loss of response).	Week 16 to Week 52
Time to PGA Response up to 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). 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 less than 50% of participants had PGA response by Week 16.	Baseline to Week 16
Time to PASI75 Response up to Week 16	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. PASI75 response was defined as at least 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 less than 50% of participants had PASI50 response by Week 16.	Baseline up to Week 16
Time to PASI50 Response up to Week 16	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 PGA Response of 'Clear' or 'Almost Clear' Over Time Through 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).	Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Percentage of Participants in Each PGA Category Over Time Through 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). Percentage of participants with each PGA score is reported.	Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Percentage of Participants Achieving PASI75 Response Over Time Through Week 52	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 75 response was defined as at least 75% reduction in PASI relative to Baseline. Percentage of participants with PASI 75 response is reported.	Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Actual PASI Scores Over Time Through Week 52	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.	Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, 52
Change From Baseline in PASI Over Time Through Week 52	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.	Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
PASI Component Scores Over Time Through Week 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 and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Change From Baseline in PASI Component Scores Over Time Through Week 52	The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of body surface area (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 and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Percent Change From Baseline in PASI Scores Over Time Through Week 52	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.	Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Actual BSA Over Time Through Week 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 and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Percent Change From Baseline in BSA Over Time Through Week 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 and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Percentage of Participants With PASI50 Response Over Time Through Week 52	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. Percentage of participants with PASI50 response is reported.	Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Percentage of Participants With PASI90 Response Over Time Through Week 52	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 90 response was defined as at least 90% reduction in PASI relative to Baseline. Percentage of participants with PASI90 response up to Week 52 is reported.	Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Percentage of Participants With PASI125 Over Time Through Week 52	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. Percentage of participants with PASI score of at least 125% of baseline PASI score are reported.	Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Actual Nail Psoriasis Severity Index (NAPSI) Score Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline	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 represents more severe psoriasis.	Baseline and Weeks 8, 16, 20, 32, 40, and 52
Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline	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 was 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 represents more severe psoriasis.	Baseline and weeks 8, 16, 20, 32, 40, and 52
Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52	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 psoriasis affected nails (presence of psoriatic manifestations on the nail matrix/nail bed) were assessed and reported. The total number of affected FINGER nails was reported.	Baseline and Weeks 8, 16, 20, 32, 40, and 52
Percent Change From Baseline in NAPSI Over Time Through Week 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 represents more severe psoriasis.	Baseline and weeks 8, 16, 20, 32, 40, and 52
Percentage of Participants With NAPSI75 Response Over Time Through Week 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 represents 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.	Weeks 8, 16, 20, 32, 40, and 52
Percentage of Participants With NAPSI100 Response Over Time Through Week 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 represents 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.	Weeks 8, 16, 20, 32, 40, and 52
Actual Itch Severity Item (ISI) Score Over Time Through Week 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 for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment.	Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Change From Baseline in ISI Score Over Time Through Week 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 and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52	The DLQI is a 10 item general dermatology questionnaire that assesses 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 and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Change From Baseline in DLQI Score Over Time Through Week 52	The DLQI is a 10 item general dermatology questionnaire that assesses 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 and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Percentage of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Over Time Through Week 52	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). the percentage of participants with scores of 0 (clear) and 1 (almost clear) are reported.	Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52	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 worse health state.	Baseline, Weeks 16, 32, 40, 52
Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52	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 worse health state.	Baseline and weeks 16, 32, 40, and 52
Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52	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 and Weeks 16, 32, 40, and 52
Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52	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 and weeks 16, 32, 40, and 52

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-16	An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.	Baseline to Week 16
Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-52	An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.	Baseline to Week 52
Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16	Study drugs were to be discontinued and the participant withdrawn for: 2 sequential absolute neutrophil counts (ANC) <1.0 X 10^9/L (1000/mm^3); 2 sequential absolute lymphocyte counts <0.5 X 10^9/L; 2 sequential hemoglobin values <9.0 g/dL and/or decreases of >30% from baseline value; 2 sequential platelet counts <75 X 10^9/L; 2 sequential AST or ALT elevations ≥3X ULN with at least 1 total bilirubin value ≥2X ULN (reason #1); 2 sequential AST or ALT elevations ≥5X ULN regardless of total bilirubin or accompanying signs or symptoms (reason #2); 2 sequential increases in serum creatinine >50% and an increase in serum creatinine >0.5 mg/dL over the average of screening and baseline values; 2 sequential CK elevations >10X ULN.	Baseline to Week 16
Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52	Study drugs were to be discontinued and the participant withdrawn for: 2 sequential absolute neutrophil counts (ANC) <1.0 X 10^9/L (1000/mm^3); 2 sequential absolute lymphocyte counts <0.5 X 10^9/L; 2 sequential hemoglobin values <9.0 g/dL and/or decreases of >30% from baseline value; 2 sequential platelet counts <75 X 10^9/L; 2 sequential AST or ALT elevations ≥3X ULN with at least 1 total bilirubin value ≥2X ULN (reason #1); 2 sequential AST or ALT elevations ≥5X ULN regardless of total bilirubin or accompanying signs or symptoms (reason #2); 2 sequential increases in serum creatinine >50% and an increase in serum creatinine >0.5 mg/dL over the average of screening and baseline values; 2 sequential CK elevations >10X ULN.	Baseline up to Week 52
Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-16	Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: pulse rate less than (<)40 or greater than (>)120 beats per minute (bpm), heart rate less than (<)40 or greater than (>)120 bpm; sitting systolic blood pressure (SBP) of greater than or equal to (>=)30 millimeters of mercury (mmHg) change from baseline or sitting SBP <90 mmHg, sitting diastolic blood pressure (DBP) >=20 mmHg change from baseline or sitting DBP <50 mmHg.	Baseline to Week 16
Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-52	Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: pulse rate less than (<)40 or greater than (>)120 beats per minute (bpm), heart rate less than (<)40 or greater than (>)120 bpm; sitting systolic blood pressure (SBP) of greater than or equal to (>=)30 millimeters of mercury (mmHg) change from baseline or sitting SBP <90 mmHg, sitting diastolic blood pressure (DBP) >=20 mmHg change from baseline or sitting DBP <50 mmHg.	Baseline to Week 52
Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16	CV event categories included: cerebrovascular accident (CVA), coronary revascularization procedure (percutaneous transluminal coronary angioplasty [PTCA], percutaneous coronary intervention [PCI], coronary bypass grafting [CABG], heart failure, major adverse cardiac events (MACE), myocardial infarction (MI), new ischemic heart disease, peripheral vascular disease (first diagnosis). MACE included any MI, CVA (stroke or transient ischemic attack), or CV death.	Baseline to Week 16
Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52	CV event categories included: cerebrovascular accident (CVA), coronary revascularization procedure (percutaneous transluminal coronary angioplasty [PTCA], percutaneous coronary intervention [PCI], coronary bypass grafting [CABG], heart failure, major adverse cardiac events (MACE), myocardial infarction (MI), new ischemic heart disease, peripheral vascular disease (first diagnosis). MACE included any MI, CVA (stroke or transient ischemic attack), or CV death.	Baseline up to Week 52
Number of Participants With Adjudicated Malignancy Events Reported During Week 0-16	As part of AE monitoring, potential malignancy events were adjudicated and centrally reviewed by a safety committee.	Baseline to Week 16
Number of Participants With Adjudicated Malignancy Events Reported During Week 0-52	As part of AE monitoring, potential malignancy events were adjudicated and centrally reviewed by a safety committee.	Baseline to Week 52

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Zhang J, Tsai TF, Lee MG, Zheng M, Wang G, Jin H, Gu J, Li R, Liu Q, Chen J, Tu C, Qi C, Zhu H, Ports WC, Crook T. The efficacy and safety of tofacitinib in Asian patients with moderate to severe chronic plaque psoriasis: A Phase 3, randomized, double-blind, placebo-controlled study. J Dermatol Sci. 2017 Oct;88(1):36-45. doi: 10.1016/j.jdermsci.2017.05.004. Epub 2017 May 16.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: March 18, 2013
• First Submitted That Met QC Criteria: March 18, 2013
• First Posted (Estimate): March 21, 2013

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 4, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Itch; chronic; Oral Treatment; Xeljanz; Pruritus; DLQI; severe; moderate; Tofacitinib; Psoriasis vulgaris; plaque psoriasis; CP-690; 550; 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: A3921174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.