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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01815424
First received: March 18, 2013
Last updated: September 10, 2014
Last verified: September 2014
  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).


Estimated Enrollment: 264
Study Start Date: December 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 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
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

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
China, Beijing
Dept. Of dermatology &STD, Beijing Friendship Hospital, Capital Medical University Recruiting
Xicheng District, Beijing, China, 100050
China, Guangdong
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510120
China, Hubei
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430022
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
China, Jiangsu
Hospital of Skin Diseases, Chinese Academy of Medical Sciences Recruiting
Nanjing, Jiangsu, China, 210042
China, Liaoning
Department of Dermatology, The Second Affiliated Hospital of Dalian Medical University Recruiting
Dalian, Liaoning, China, 116027
China, Shanghai
Huashan Hospital, Fudan University/Dermatology Department Recruiting
Shanghai, Shanghai, China, 200040
Shanghai Changhai Hospital, Dermatology Department Recruiting
Shanghai, Shanghai, China, 200433
China, Shanxi
Dermatology Department, The First Affiliated Hospital, The Fourth Military Medical University Recruiting
Xi'an, Shanxi, China, 710032
China, Sichuan
Sichuan Provincial People's Hospital Active, not recruiting
Chengdu, Sichuan, China, 610031
West China Hospital of Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
China, Zhejiang
The First Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology and STD Dept Recruiting
Hangzhou, Zhejiang, China, 310003
The Second Affiliated Hospital of College of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310009
China
Peking Union Medical College Hospital/Department of Dermatology Recruiting
Beijing, China, 100730
Peking University First Hospital / The Department of Dermatology Recruiting
Beijing, China, 100034
Peking University People's Hospital/Dermatology Department Recruiting
Beijing, China, 100044
Beijing Hospital of the Ministry of Health/Department of Dermatology Recruiting
Beijing, China, 100730
Tianjin Medical University General Hospital, Dermatological Department Recruiting
Tianjin, China, 300052
Korea, Republic of
Samsung Medical Center Active, not recruiting
Seoul, Korea, Republic of, 135-710
Seoul National University Hospital Active, not recruiting
Seoul, Korea, Republic of, 110-744
Department of Dermatology,Severance Hospital, Yonsei University Health System Active, not recruiting
Seoul, Korea, Republic of, 120-452
Taiwan
National Cheng-Kung University Hospital Active, not recruiting
Tainan, Taiwan, 704
National Taiwan University Hospital Active, not recruiting
Taipei, Taiwan, 100
Chang Gung Medical Foundation-Linkou Branch Active, not recruiting
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01815424     History of Changes
Other Study ID Numbers: A3921174
Study First Received: March 18, 2013
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 11, 2014