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Study Evaluating Single Dose Of ILV-095 In Psoriasis Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01010542
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : November 10, 2009
Last Update Posted : January 6, 2017
Information provided by (Responsible Party):

Brief Summary:
The 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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: ILV-095 300 mg in a 4 to 1 ratio Phase 1

Detailed Description:
B1991002 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics And Clinical Activity Of ILV-095 Administered Subcutaneously To Subjects With Psoriasis
Study Start Date : December 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Active Comparator: ILV-095 Drug: ILV-095 300 mg in a 4 to 1 ratio
Single dose of ILV-095 300 mg

Placebo Comparator: placebo Drug: ILV-095 300 mg in a 4 to 1 ratio
Single dose of Placebo

Primary Outcome Measures :
  1. To assess the clinical activity of single SC (subcutaneous) dose of ILV-095 in subjects with psoriasis using the PASI (Psoriasis Area and Severity Index) score, the target lesion score and the PGA (Physician global assessment of psoriasis) score. [ Time Frame: 56 days for each treatment group ]

Secondary Outcome Measures :
  1. To provide safety, tolerability, PK, PD and immunogenicity profiles of a single dose of ILV-095 in subjects with psoriasis using, adverse event collection, injection site reaction, actual times of sample collection and IL-22 analysis. [ Time Frame: 56 days for each treatment group ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01010542

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United States, Florida
Pfizer Investigational Site
Miami Gardens, Florida, United States, 33169
Pfizer Investigational Site
South Miami, Florida, United States, 33143
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46256
United States, Michigan
Pfizer Investigational Site
Fort Gratiot, Michigan, United States, 48059
United States, North Carolina
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27157
United States, South Carolina
Pfizer Investigational Site
Greer, South Carolina, United States, 29651
Canada, Newfoundland and Labrador
Pfizer Investigational Site
St John's, Newfoundland and Labrador, Canada, A1C 2H5
Canada, Ontario
Pfizer Investigational Site
Waterloo, Ontario, Canada, N2J 1C4
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer Identifier: NCT01010542     History of Changes
Other Study ID Numbers: 3226K1-1002
First Posted: November 10, 2009    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017
Keywords provided by Pfizer:
Single dose psoriasis study
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases