You are here

Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Little Rock, Arkansas, 72202 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis, Immunomodulation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and/or female subjects between the ages of 18 and 65 years, inclusive, with
active psoriasis lesion(s).

- Subjects should be healthy with the exception of psoriasis, where healthy is defined
as no clinically relevant abnormalities identified by a detailed medical history,
full physical examination. Blood pressure must be between 18-36 kg/m2, inclusive; and a total body weight >50 kg (110 lbs)

- The following laboratory variables must be no more than 10% below the lower limit of
the normal reference range: RBC, hemoglobin, hematocrit, WBC, absolute neutrophil
count. The absolute lymphocyte count must be greater than or equal to the lower limit
of the reference range. Values for AST, ALT, bilirubin and alkaline phosphatase must
be no more than 10% above the upper limit of the normal reference range. Values for
total cholesterol and LDL must be no more than 20% above the upper limit of the
normal reference range except for subjects being treated for hyperlipidemia. Normal
glomerular filtration rate (> 80 mL/min).

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

- Subjects with evidence or history of clinically significant hematological, renal,
urological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic,
psychiatric, neurologic disorder.

- Subjects with controlled essential hypertension and/or hyperlipidemia may be eligible
for the study provided that any medications that are administered.

- Screening 12-lead ECG demonstrating at least one of the following: heart rate > 100
bpm, QRS >120 msec, QTc > 430 msec (males), QTc > 450 msec (females) or PR > 220
msec.

- Abnormal chest radiographs including, but not limited to, evidence of past or present
tuberculosis infection. History of tuberculosis without treatment and/or positive
tuberculin reaction without known vaccination with BCG.

- Subjects with a history of tumors with the exception of adequately treated basal cell
carcinoma of the skin.

NCT01736696
Pfizer
Completed
Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, Erythrodermic Psoriasis
NCT03885089
All Genders
0+
Years
Tokyo,
Descriptive Information
Brief Title  ICMJE Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis
Official Title  ICMJE Phase 1, Investigator-Blind, Subject-Blind, Sponsor-Open, Placebo-Controlled, Two-Week, Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of CP-690,550
Brief SummaryThis study was conducted in subjects with psoriasis to evaluate drug activity in this patient population by analysis of changes in psoriatic lesion biopsy characteristics. This subject population was selected to evaluate potentially relevant biological activity of CP-690,550 as well as assessing safety and pharmacokinetics.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Psoriasis
  • Immunomodulation
Intervention  ICMJE
  • Drug: tofacitinib
    5 mg BID For 13 days and once on Day 14
  • Drug: tofacitinib
    10 mg BID for 13 days and once on Day 14*
  • Drug: tofacitinib
    20 mg BID for 13 days and once on Day 14
  • Drug: tofacitinib
    30 mg BID for 13 days and once on Day 14
  • Drug: tofacitinib
    60 mg tablet once a day (QD) for 14 days
  • Drug: tofacitinib
    50 mg tablets two times a day (BID) for 13 days and once on day 14
Study Arms  ICMJE
  • Experimental: 5 mg BID
    5 mg BID for 13 days and once on Day 14
    Intervention: Drug: tofacitinib
  • Experimental: 10 mg BID
    10 mg BID for13 days and once on Day 14*
    Intervention: Drug: tofacitinib
  • Experimental: 20 mg BID
    20 mg BID for 13 days and once on Day 14
    Intervention: Drug: tofacitinib
  • Experimental: 30 mg BID
    30 mg BID for 13 days and once on Day 14
    Intervention: Drug: tofacitinib
  • Experimental: 60 mg QD
    60 mg QD for 14 days
    Intervention: Drug: tofacitinib
  • Experimental: 50 mg BID
    50 mg BID x 13 days and once on day 14
    Intervention: Drug: tofacitinib
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 26, 2012)
59
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2004
Actual Primary Completion DateApril 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and/or female subjects between the ages of 18 and 65 years, inclusive, with active psoriasis lesion(s).
  • Subjects should be healthy with the exception of psoriasis, where healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination. Blood pressure must be < 140/89. Body Mass Index (BMI) between 18-36 kg/m2, inclusive; and a total body weight >50 kg (110 lbs)
  • The following laboratory variables must be no more than 10% below the lower limit of the normal reference range: RBC, hemoglobin, hematocrit, WBC, absolute neutrophil count. The absolute lymphocyte count must be greater than or equal to the lower limit of the reference range. Values for AST, ALT, bilirubin and alkaline phosphatase must be no more than 10% above the upper limit of the normal reference range. Values for total cholesterol and LDL must be no more than 20% above the upper limit of the normal reference range except for subjects being treated for hyperlipidemia. Normal glomerular filtration rate (> 80 mL/min).

Exclusion Criteria:

  • Subjects with evidence or history of clinically significant hematological, renal, urological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic disorder.
  • Subjects with controlled essential hypertension and/or hyperlipidemia may be eligible for the study provided that any medications that are administered.
  • Screening 12-lead ECG demonstrating at least one of the following: heart rate > 100 bpm, QRS >120 msec, QTc > 430 msec (males), QTc > 450 msec (females) or PR > 220 msec.
  • Abnormal chest radiographs including, but not limited to, evidence of past or present tuberculosis infection. History of tuberculosis without treatment and/or positive tuberculin reaction without known vaccination with BCG.
  • Subjects with a history of tumors with the exception of adequately treated basal cell carcinoma of the skin.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01736696
Other Study ID Numbers  ICMJE A3921003
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2013

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now