Clinical trial NCT01815424: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Tofacitinib
CP-690
550
Xeljanz
Jak-Inhibitor
Oral Treatment
Psoriasis vulgaris
Pruritus
Itch
DLQI
moderate
severe
chronic
plaque psoriasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-03-21
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16
timeFrame: Baseline to Week 16
measure: Percentage of Participants Achieving at Least a 90% Reduction in PASI (PASI90) at Week 16
timeFrame: Week 16
measure: Change From Baseline in DLQI Total Score at Week 16
timeFrame: Baseline to Week 16
measure: Percentage of Participants With PGA Score of "Clear" or "Almost Clear" at Week 4
timeFrame: Week 4
measure: Percentage of Participants Achieving PASI75 Response at Week 4
timeFrame: Week 4
measure: Change From Baseline in DLQI Total Score at Week 4
timeFrame: Baseline to Week 4
measure: Percent Change From Baseline in Nail Psorasis Severity Index (NAPSI) at Week 16 in Participants With Nail Psoriasis at Baseline
timeFrame: Baseline to Week 16
measure: Percentage of Participants Maintaining PGA Score of "Clear" or "Almost Clear" at Week 52 Among Participants Achieving PGA Response at Week 16
timeFrame: Week 16 to Week 52
measure: Percentage of Participants Maintaining PASI75 Response at Week 52 Among Participants Achieving PASI75 Response at Week 16
timeFrame: Week 16 to Week 52
measure: Percentage of Participants Maintaining PASI90 Response at Week 52 Among Participants Achieving PASI90 at Week 16
timeFrame: Week 16 to Week 52
measure: Time to PGA Response up to Week 16
timeFrame: Baseline to Week 16
measure: Time to PASI75 Response up to Week 16
timeFrame: Baseline up to Week 16
measure: Time to PASI50 Response up to Week 16
timeFrame: Baseline up to Week 16
measure: Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52
timeFrame: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
measure: Percentage of Participants in Each PGA Category Over Time Through Week 52
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
measure: Percentage of Participants Achieving PASI75 Response Over Time Through Week 52
timeFrame: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
measure: Actual PASI Scores Over Time Through Week 52
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, 52
measure: Change From Baseline in PASI Over Time Through Week 52
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
measure: PASI Component Scores Over Time Through Week 52
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
measure: Change From Baseline in PASI Component Scores Over Time Through Week 52
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
measure: Percent Change From Baseline in PASI Scores Over Time Through Week 52
timeFrame: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
measure: Actual BSA Over Time Through Week 52
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
measure: Percent Change From Baseline in BSA Over Time Through Week 52
timeFrame: Baseline and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
measure: Percentage of Participants With PASI50 Response Over Time Through Week 52
timeFrame: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
measure: Percentage of Participants With PASI90 Response Over Time Through Week 52
timeFrame: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
measure: Percentage of Participants With PASI125 Over Time Through Week 52
timeFrame: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
measure: Actual Nail Psoriasis Severity Index (NAPSI) Score Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline
timeFrame: Baseline and Weeks 8, 16, 20, 32, 40, and 52
measure: Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline
timeFrame: Baseline and weeks 8, 16, 20, 32, 40, and 52
measure: Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52
timeFrame: Baseline and Weeks 8, 16, 20, 32, 40, and 52
measure: Percent Change From Baseline in NAPSI Over Time Through Week 52
timeFrame: Baseline and weeks 8, 16, 20, 32, 40, and 52
measure: Percentage of Participants With NAPSI75 Response Over Time Through Week 52
timeFrame: Weeks 8, 16, 20, 32, 40, and 52
measure: Percentage of Participants With NAPSI100 Response Over Time Through Week 52
timeFrame: Weeks 8, 16, 20, 32, 40, and 52
measure: Actual Itch Severity Item (ISI) Score Over Time Through Week 52
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
measure: Change From Baseline in ISI Score Over Time Through Week 52
timeFrame: Baseline and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
measure: Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
measure: Change From Baseline in DLQI Score Over Time Through Week 52
timeFrame: Baseline and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
measure: Percentage of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Over Time Through Week 52
timeFrame: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52
measure: Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52
timeFrame: Baseline, Weeks 16, 32, 40, 52
measure: Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52
timeFrame: Baseline and weeks 16, 32, 40, and 52
measure: Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52
timeFrame: Baseline and Weeks 16, 32, 40, and 52
measure: Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52
timeFrame: Baseline and weeks 16, 32, 40, and 52
Other outcomes:
measure: Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-16
timeFrame: Baseline to Week 16
measure: Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-52
timeFrame: Baseline to Week 52
measure: Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16
timeFrame: Baseline to Week 16
measure: Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52
timeFrame: Baseline up to Week 52
measure: Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-16
timeFrame: Baseline to Week 16
measure: Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-52
timeFrame: Baseline to Week 52
measure: Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16
timeFrame: Baseline to Week 16
measure: Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52
timeFrame: Baseline up to Week 52
measure: Number of Participants With Adjudicated Malignancy Events Reported During Week 0-16
timeFrame: Baseline to Week 16
measure: Number of Participants With Adjudicated Malignancy Events Reported During Week 0-52
timeFrame: Baseline to Week 52
Locations:
city: Xicheng District
country: China
facility: Dept. Of dermatology &STD, Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Nanjing
country: China
facility: Hospital of Skin Diseases, Chinese Academy of Medical Sciences
state: Jiangsu
city: Dalian
country: China
facility: Department of Dermatology, The Second Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University/Dermatology Department
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changhai Hospital, Dermatology Department
state: Shanghai
city: Xi'an
country: China
facility: Dermatology Department, The First Affiliated Hospital, The Fourth Military Medical University
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology and STD Dept
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of College of Medicine, Zhejiang University
state: Zhejiang
city: Beijing
country: China
facility: Peking University First Hospital / The Department of Dermatology
city: Beijing
country: China
facility: Peking University People's Hospital/Dermatology Department
city: Beijing
country: China
facility: Beijing Hospital of the Ministry of Health/Department of Dermatology
city: Beijing
country: China
facility: Peking Union Medical College Hospital/Department of Dermatology
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital, Dermatological Department
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Department of Dermatology,Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.