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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Dept. Of dermatology &STD, Beijing Friendship Hospital, Capital Medical University
Xicheng District, Beijing, 100050 China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01815424
Pfizer
Completed
A Study Evaluating The Efficacy And Safety Of CP-690,550 In Asian Subjects With Moderate To Severe Plaque Psoriasis

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A Study Evaluating The Efficacy And Safety Of CP-690,550 In Asian Subjects With Moderate To Severe Plaque Psoriasis
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriasis
  • Drug: placebo
    placebo BID for 16 weeks and then re-randomized into active groups
  • Drug: CP-690,550
    CP-690,550 5mg BID for 52 weeks
  • Drug: CP-690,550
    CP-690,550 10mg BID for 52 weeks
  • Placebo Comparator: Placebo BID
    Intervention: Drug: placebo
  • Experimental: 5mg BID CP-690,550
    Intervention: Drug: CP-690,550
  • Experimental: 10mg BID CP-690,550
    Intervention: Drug: CP-690,550
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
266
July 2015
July 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China,   Korea, Republic of,   Taiwan
 
 
NCT01815424
A3921174
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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