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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01815424
First received: March 18, 2013
Last updated: August 30, 2015
Last verified: August 2015
  Purpose
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.

Condition Intervention Phase
Psoriasis
Drug: placebo
Drug: CP-690,550
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Physician Global Assessment (PGA) of Psoriasis Score [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and "Almost clear' includes all participants who were scored as a 0 or 1

  • Psoriasis Area and Severity Index 75 (PASI75) response, the proportion of participants achieving at least 75% reduction in PASI relative to baseline at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dermatology Life Quality Index (DLQI) Total Score [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).

  • Physician Global Assessment (PGA) of Psoriasis Score [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and "Almost clear' includes all participants who were scored as a 0 or 1.

  • Dermatology Life Quality Index (DLQI) Total Score [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).


Enrollment: 266
Study Start Date: December 2013
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: 10mg BID CP-690,550 Drug: CP-690,550
CP-690,550 10mg BID for 52 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01815424

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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01815424     History of Changes
Other Study ID Numbers: A3921174 
Study First Received: March 18, 2013
Last Updated: August 30, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Tofacitinib
CP-690
550
Xeljanz
Jak-Inhibitor
Oral Treatment
Psoriasis vulgaris
Pruritus
Itch
DLQI
moderate
severe
chronic
plaque psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 21, 2016