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Study Evaluating Single Dose Of ILV-095 In Psoriasis Subjects

Last updated on November 16, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Miami Gardens, Florida, 33169 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Plaque 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

- Sexually active men or women must agree to use a medically acceptable form of
contraception during the study and continue it for 16 weeks after investigational
product administration.

- Negative urine pregnancy test result for all women.

- Body mass index (BMI) >=18 kg/m2 and body weight >=50 kg. BMI is calculated by taking
the subject's weight, in kilograms, divided by the square of the subject's height, in
meters, at screening: BMI = weight (kg)/(height [m]).

- Must meet the following criteria for disease activity, at screening and/or at study
entry (subjects who washout from prior therapy may not meet this level of disease
activity at screening but must before being entered into the study).

- Must have stable moderate to severe chronic plaque psoriasis covering >=15% of body
surface area and be a candidate for systemic therapy or phototherapy.

- Psoriasis Area Severity Index (PASI) score of >11.

- Physician Global Assessment (PGA) of psoriasis score >=3.

- Target lesion score >=6 based on the physician rating of selected sites for erythema,
plaque elevation and scaling, with a minimum of 2 on the plaque elevation score.
A-12-point score will be used with a 1-4 scale for each domain. Target lesions should
not be on the scalp, axillae, face, or groin.

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

- Presence or history of any disorder that may prevent the successful completion of the
study.

- Evidence of unstable clinically significant disease (eg, unstable cardiovascular,
renal, respiratory, or psychiatric disease or any serious disorder that currently
requires physician care).

- Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before
study day 1.

- Evidence of skin conditions (eg, eczema) other than psoriasis that would interfere
with evaluations of the effect of study medication on psoriasis.

- Presence of guttate, erythrodermic, or pustular psoriasis.

- Active severe infections within 4 weeks before study day 1.

- Systemic malignancy within the past 5 years including melanoma. Treated skin cancer
(basal cell carcinoma or squamous cell carcinoma) is excluded.

Evidence of latent tuberculosis by purified protein derivative (PPD) screening. PPD
screening should be performed according to local standards using the tuberculin skin test
(TST). Any result >5mm is considered positive. Prior Bacillus Calmette-Guerin (BCG) should
not be taken into account when interpreting a TST result. TST must be performed during the
screening period unless one has been performed within the previous 3 months and the results
are available.

NCT01010542
Pfizer
Terminated
Study Evaluating Single Dose Of ILV-095 In Psoriasis Subjects

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Descriptive Information
Brief Title  ICMJE Study Evaluating Single Dose Of ILV-095 In Psoriasis Subjects
Official Title  ICMJE A Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics And Clinical Activity Of ILV-095 Administered Subcutaneously To Subjects With Psoriasis
Brief SummaryThe purpose of this research study is to evaluate the safety and tolerability of ILV-095 when it is given to individuals with moderate to severe chronic plaque psoriasis. Another purpose of the study is to observe how the drug enters the blood and tissues over time, how the body breaks down the drug and whether or not the body will develop an immune reaction (sensitivity) to the drug.
Detailed DescriptionB1991002 study is a phase 1 adaptive design study which terminated on 14Mar2011. Regular analyzes of psoriasis assessments conducted per the statistical plan indicate that even if every patient enrolled for the rest of the study respond (up to 23 additional subjects), the study can not meet its primary efficacy endpoint. Pfizer Inc. has terminated the trial and clinical team is asking all clinical investigators to continue collecting safety, pharmacokinetics and pharmacodynamics data until the last subject last visit for all subjects who received test article. Last Subject Last Visit occurred 20May2011.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Plaque Psoriasis
Intervention  ICMJE
  • Drug: ILV-095 300 mg in a 4 to 1 ratio
    Single dose of ILV-095 300 mg
  • Drug: ILV-095 300 mg in a 4 to 1 ratio
    Single dose of Placebo
Study Arms  ICMJE
  • Active Comparator: ILV-095
    Intervention: Drug: ILV-095 300 mg in a 4 to 1 ratio
  • Placebo Comparator: placebo
    Intervention: Drug: ILV-095 300 mg in a 4 to 1 ratio
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 Terminated
Actual Enrollment  ICMJE
 (submitted: January 5, 2017)
39
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2009)
0
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion DateMay 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Sexually active men or women must agree to use a medically acceptable form of contraception during the study and continue it for 16 weeks after investigational product administration.
  • Negative urine pregnancy test result for all women.
  • Body mass index (BMI) >=18 kg/m2 and body weight >=50 kg. BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's height, in meters, at screening: BMI = weight (kg)/(height [m]).
  • Must meet the following criteria for disease activity, at screening and/or at study entry (subjects who washout from prior therapy may not meet this level of disease activity at screening but must before being entered into the study).
  • Must have stable moderate to severe chronic plaque psoriasis covering >=15% of body surface area and be a candidate for systemic therapy or phototherapy.
  • Psoriasis Area Severity Index (PASI) score of >11.
  • Physician Global Assessment (PGA) of psoriasis score >=3.
  • Target lesion score >=6 based on the physician rating of selected sites for erythema, plaque elevation and scaling, with a minimum of 2 on the plaque elevation score. A-12-point score will be used with a 1-4 scale for each domain. Target lesions should not be on the scalp, axillae, face, or groin.

Exclusion Criteria:

  • Presence or history of any disorder that may prevent the successful completion of the study.
  • Evidence of unstable clinically significant disease (eg, unstable cardiovascular, renal, respiratory, or psychiatric disease or any serious disorder that currently requires physician care).
  • Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.
  • Evidence of skin conditions (eg, eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
  • Presence of guttate, erythrodermic, or pustular psoriasis.
  • Active severe infections within 4 weeks before study day 1.
  • Systemic malignancy within the past 5 years including melanoma. Treated skin cancer (basal cell carcinoma or squamous cell carcinoma) is excluded.

Evidence of latent tuberculosis by purified protein derivative (PPD) screening. PPD screening should be performed according to local standards using the tuberculin skin test (TST). Any result >5mm is considered positive. Prior Bacillus Calmette-Guerin (BCG) should not be taken into account when interpreting a TST result. TST must be performed during the screening period unless one has been performed within the previous 3 months and the results are available.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01010542
Other Study ID Numbers  ICMJE 3226K1-1002
B1991002
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 2017

ICMJE     Data element required by the

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

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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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