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

NCT ID: NCT01815424

Last Updated: 2019-04-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo BID

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

5mg BID CP-690,550

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

CP-690,550 5mg BID for 52 weeks

10mg BID CP-690,550

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

CP-690,550 10mg BID for 52 weeks

Interventions

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placebo

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

Intervention Type DRUG

CP-690,550

CP-690,550 5mg BID for 52 weeks

Intervention Type DRUG

CP-690,550

CP-690,550 10mg BID for 52 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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

Xicheng District, Beijing Municipality, China

Site Status

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

Guangzhou, Guangdong, China

Site Status

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

Wuhan, Hubei, China

Site Status

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

Wuhan, Hubei, China

Site Status

Hospital of Skin Diseases, Chinese Academy of Medical Sciences

Nanjing, Jiangsu, China

Site Status

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

Dalian, Liaoning, China

Site Status

Huashan Hospital, Fudan University/Dermatology Department

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Changhai Hospital, Dermatology Department

Shanghai, Shanghai Municipality, China

Site Status

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

Xi’an, Shanxi, China

Site Status

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Site Status

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status

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

Hangzhou, Zhejiang, China

Site Status

The Second Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Peking University First Hospital / The Department of Dermatology

Beijing, , China

Site Status

Peking University People's Hospital/Dermatology Department

Beijing, , China

Site Status

Beijing Hospital of the Ministry of Health/Department of Dermatology

Beijing, , China

Site Status

Peking Union Medical College Hospital/Department of Dermatology

Beijing, , China

Site Status

Tianjin Medical University General Hospital, Dermatological Department

Tianjin, , China

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Department of Dermatology,Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

National Cheng-Kung University Hospital

Tainan City, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, , Taiwan

Site Status

Countries

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China South Korea Taiwan

References

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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.

Reference Type DERIVED
PMID: 28558978 (View on PubMed)

Related Links

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Other Identifiers

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A3921174

Identifier Type: -

Identifier Source: org_study_id

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