Study Evaluating Single Dose Of ILV-095 In Psoriasis Subjects

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01010542
First received: November 6, 2009
Last updated: July 5, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Plaque Psoriasis
Drug: ILV-095 300 mg in a 4 to 1 ratio
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: December 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  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: NCT01010542

Locations
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT01010542     History of Changes
Other Study ID Numbers: 3226K1-1002, B1991002
Study First Received: November 6, 2009
Last Updated: July 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Single dose psoriasis study

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014