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A Study Evaluating The Efficacy And Safety Of CP-690,550 In Asian Subjects With Moderate To Severe Plaque Psoriasis

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

placebo

CP-690,550

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Tofacitinib, CP-690, 550, Xeljanz, Jak-Inhibitor, Oral Treatment, Psoriasis vulgaris, Pruritus, Itch, DLQI, moderate, severe, chronic, plaque psoriasis

Eligibility Criteria

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

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.

Sites / Locations

Dept. Of dermatology &STD, Beijing Friendship Hospital, Capital Medical University
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hospital of Skin Diseases, Chinese Academy of Medical Sciences
Department of Dermatology, The Second Affiliated Hospital of Dalian Medical University
Huashan Hospital, Fudan University/Dermatology Department
Shanghai Changhai Hospital, Dermatology Department
Dermatology Department, The First Affiliated Hospital, The Fourth Military Medical University
Sichuan Provincial People's Hospital
West China Hospital of Sichuan University
The First Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology and STD Dept
The Second Affiliated Hospital of College of Medicine, Zhejiang University
Peking University First Hospital / The Department of Dermatology
Peking University People's Hospital/Dermatology Department
Beijing Hospital of the Ministry of Health/Department of Dermatology
Peking Union Medical College Hospital/Department of Dermatology
Tianjin Medical University General Hospital, Dermatological Department
Seoul National University Hospital
Department of Dermatology,Severance Hospital, Yonsei University Health System
Samsung Medical Center
National Cheng-Kung University Hospital
National Taiwan University Hospital
Chang Gung Medical Foundation-Linkou Branch

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo BID

5mg BID CP-690,550

10mg BID CP-690,550

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" at 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.

Secondary Outcome Measures

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.

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.

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.

Percentage of Participants With PGA Score of "Clear" or "Almost Clear" at 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.

Change From Baseline in DLQI Total Score at 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.

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).

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).

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).

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.

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.

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%.

Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52

Percentage of Participants in Each PGA Category Over Time Through Week 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.

Actual PASI Scores Over Time Through Week 52

Change From Baseline in PASI Over Time Through Week 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.

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.

Percent Change From Baseline in PASI Scores Over Time Through Week 52

Actual BSA Over Time Through Week 52

Percent Change From Baseline in BSA Over Time Through Week 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.

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.

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.

Actual Nail Psoriasis Severity Index (NAPSI) Score Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline

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.

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.

Percent Change From Baseline in NAPSI Over Time Through Week 52

Percentage of Participants With NAPSI75 Response Over Time Through Week 52

Percentage of Participants With NAPSI100 Response Over Time Through Week 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.

Change From Baseline in ISI Score Over Time Through Week 52

Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52

Change From Baseline in DLQI Score Over Time Through Week 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.

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.

Change From Baseline in EQ-5D - Utility Score Over Time Through Week 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.

Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52

Full Information

NCT ID

NCT01815424

First Posted

March 18, 2013

Last Updated

April 4, 2019

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01815424

Brief Title

A Study Evaluating The Efficacy And Safety Of CP-690,550 In Asian Subjects With Moderate To Severe Plaque Psoriasis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

December 2013 (Actual)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

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

Psoriasis

Keywords

Tofacitinib, CP-690, 550, Xeljanz, Jak-Inhibitor, Oral Treatment, Psoriasis vulgaris, Pruritus, Itch, DLQI, moderate, severe, chronic, plaque psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

266 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo BID

Arm Type

Placebo Comparator

Arm Title

5mg BID CP-690,550

Arm Type

Experimental

Arm Title

10mg BID CP-690,550

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo BID for 16 weeks and then re-randomized into active groups

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Intervention Description

CP-690,550 5mg BID for 52 weeks

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Intervention Description

CP-690,550 10mg BID for 52 weeks

Primary Outcome Measure Information:

Title

Percentage of Participants With Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" at Week 16

Description

Time Frame

Week 16

Title

Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at Week 16

Description

Time Frame

Week 16

Secondary Outcome Measure Information:

Title

Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16

Description

Time Frame

Baseline to Week 16

Title

Percentage of Participants Achieving at Least a 90% Reduction in PASI (PASI90) at Week 16

Description

Time Frame

Week 16

Title

Change From Baseline in DLQI Total Score at Week 16

Description

Time Frame

Baseline to Week 16

Title

Percentage of Participants With PGA Score of "Clear" or "Almost Clear" at Week 4

Description

Time Frame

Week 4

Title

Percentage of Participants Achieving PASI75 Response at Week 4

Description

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.

Time Frame

Week 4

Title

Change From Baseline in DLQI Total Score at Week 4

Description

Time Frame

Baseline to Week 4

Title

Percent Change From Baseline in Nail Psorasis Severity Index (NAPSI) at Week 16 in Participants With Nail Psoriasis at Baseline

Description

Time Frame

Baseline to Week 16

Title

Percentage of Participants Maintaining PGA Score of "Clear" or "Almost Clear" at Week 52 Among Participants Achieving PGA Response at Week 16

Description

Time Frame

Week 16 to Week 52

Title

Percentage of Participants Maintaining PASI75 Response at Week 52 Among Participants Achieving PASI75 Response at Week 16

Description

Time Frame

Week 16 to Week 52

Title

Percentage of Participants Maintaining PASI90 Response at Week 52 Among Participants Achieving PASI90 at Week 16

Description

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).

Time Frame

Week 16 to Week 52

Title

Time to PGA Response up to Week 16

Description

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.

Time Frame

Baseline to Week 16

Title

Time to PASI75 Response up to Week 16

Description

Time Frame

Baseline up to Week 16

Title

Time to PASI50 Response up to Week 16

Description

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%.

Time Frame

Baseline up to Week 16

Title

Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52

Description

Time Frame

Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Title

Percentage of Participants in Each PGA Category Over Time Through Week 52

Description

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Title

Percentage of Participants Achieving PASI75 Response Over Time Through Week 52

Description

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.

Time Frame

Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Title

Actual PASI Scores Over Time Through Week 52

Description

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, 52

Title

Change From Baseline in PASI Over Time Through Week 52

Description

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Title

PASI Component Scores Over Time Through Week 52

Description

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Title

Change From Baseline in PASI Component Scores Over Time Through Week 52

Description

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Title

Percent Change From Baseline in PASI Scores Over Time Through Week 52

Description

Time Frame

Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Title

Actual BSA Over Time Through Week 52

Description

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Title

Percent Change From Baseline in BSA Over Time Through Week 52

Description

Time Frame

Baseline and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Title

Percentage of Participants With PASI50 Response Over Time Through Week 52

Description

Time Frame

Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Title

Percentage of Participants With PASI90 Response Over Time Through Week 52

Description

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.

Time Frame

Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Title

Percentage of Participants With PASI125 Over Time Through Week 52

Description

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.

Time Frame

Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Title

Actual Nail Psoriasis Severity Index (NAPSI) Score Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline

Description

Time Frame

Baseline and Weeks 8, 16, 20, 32, 40, and 52

Title

Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline

Description

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.

Time Frame

Baseline and weeks 8, 16, 20, 32, 40, and 52

Title

Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52

Description

Time Frame

Baseline and Weeks 8, 16, 20, 32, 40, and 52

Title

Percent Change From Baseline in NAPSI Over Time Through Week 52

Description

Time Frame

Baseline and weeks 8, 16, 20, 32, 40, and 52

Title

Percentage of Participants With NAPSI75 Response Over Time Through Week 52

Description

Time Frame

Weeks 8, 16, 20, 32, 40, and 52

Title

Percentage of Participants With NAPSI100 Response Over Time Through Week 52

Description

Time Frame

Weeks 8, 16, 20, 32, 40, and 52

Title

Actual Itch Severity Item (ISI) Score Over Time Through Week 52

Description

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Title

Change From Baseline in ISI Score Over Time Through Week 52

Description

Time Frame

Baseline and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Title

Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52

Description

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Title

Change From Baseline in DLQI Score Over Time Through Week 52

Description

Time Frame

Baseline and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Title

Percentage of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Over Time Through Week 52

Description

Time Frame

Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52

Title

Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52

Description

Time Frame

Baseline, Weeks 16, 32, 40, 52

Title

Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52

Description

Time Frame

Baseline and weeks 16, 32, 40, and 52

Title

Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52

Description

Time Frame

Baseline and Weeks 16, 32, 40, and 52

Title

Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52

Description

Time Frame

Baseline and weeks 16, 32, 40, and 52

Other Pre-specified Outcome Measures:

Title

Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-16

Description

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.

Time Frame

Baseline to Week 16

Title

Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-52

Description

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.

Time Frame

Baseline to Week 52

Title

Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16

Description

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.

Time Frame

Baseline to Week 16

Title

Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52

Description

Time Frame

Baseline up to Week 52

Title

Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-16

Description

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.

Time Frame

Baseline to Week 16

Title

Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-52

Description

Time Frame

Baseline to Week 52

Title

Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16

Description

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.

Time Frame

Baseline to Week 16

Title

Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52

Description

Time Frame

Baseline up to Week 52

Title

Number of Participants With Adjudicated Malignancy Events Reported During Week 0-16

Description

As part of AE monitoring, potential malignancy events were adjudicated and centrally reviewed by a safety committee.

Time Frame

Baseline to Week 16

Title

Number of Participants With Adjudicated Malignancy Events Reported During Week 0-52

Description

As part of AE monitoring, potential malignancy events were adjudicated and centrally reviewed by a safety committee.

Time Frame

Baseline to Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Dept. Of dermatology &STD, Beijing Friendship Hospital, Capital Medical University

City

Xicheng District

State/Province

Beijing

ZIP/Postal Code

100050

Country

China

Facility Name

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

Facility Name

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430022

Country

China

Facility Name

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430030

Country

China

Facility Name

Hospital of Skin Diseases, Chinese Academy of Medical Sciences

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210042

Country

China

Facility Name

Department of Dermatology, The Second Affiliated Hospital of Dalian Medical University

City

Dalian

State/Province

Liaoning

ZIP/Postal Code

116027

Country

China

Facility Name

Huashan Hospital, Fudan University/Dermatology Department

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200040

Country

China

Facility Name

Shanghai Changhai Hospital, Dermatology Department

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200433

Country

China

Facility Name

Dermatology Department, The First Affiliated Hospital, The Fourth Military Medical University

City

Xi'an

State/Province

Shanxi

ZIP/Postal Code

710032

Country

China

Facility Name

Sichuan Provincial People's Hospital

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610031

Country

China

Facility Name

West China Hospital of Sichuan University

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Facility Name

The First Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology and STD Dept

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310003

Country

China

Facility Name

The Second Affiliated Hospital of College of Medicine, Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Facility Name

Peking University First Hospital / The Department of Dermatology

City

Beijing

ZIP/Postal Code

100034

Country

China

Facility Name

Peking University People's Hospital/Dermatology Department

City

Beijing

ZIP/Postal Code

100044

Country

China

Facility Name

Beijing Hospital of the Ministry of Health/Department of Dermatology

City

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

Peking Union Medical College Hospital/Department of Dermatology

City

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

Tianjin Medical University General Hospital, Dermatological Department

City

Tianjin

ZIP/Postal Code

300052

Country

China

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Department of Dermatology,Severance Hospital, Yonsei University Health System

City

Seoul

ZIP/Postal Code

120-452

Country

Korea, Republic of

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

National Cheng-Kung University Hospital

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Chang Gung Medical Foundation-Linkou Branch

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Citations:

PubMed Identifier

28558978

Citation

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.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921174&StudyName=A%20Study%20Evaluating%20The%20Efficacy%20And%20Safety%20oO%20CP-690%2C550%20In%20Asian%20Subjects%20With%20Moderate%20To%20Severe%20Plaque%20Psoriasis

Description

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Learn more about this trial

A Study Evaluating The Efficacy And Safety Of CP-690,550 In Asian Subjects With Moderate To Severe Plaque Psoriasis

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