Study Evaluating Single Dose Of ILV-095 In Psoriasis Subjects

Plaque Psoriasis Clinical Trial

Official title:

A Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics And Clinical Activity Of ILV-095 Administered Subcutaneously To Subjects With Psoriasis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01010542
• Other study ID #: 3226K1-1002
• Secondary ID: B1991002
• Status: Terminated
• Phase: Phase 1
• First received: November 6, 2009
• Last updated: January 5, 2017
• Start date: December 2009
• Est. completion date: May 2011

Study information

• Verified date: January 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

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

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	St John's	Newfoundland and Labrador
Canada	Pfizer Investigational Site	Waterloo	Ontario
United States	Pfizer Investigational Site	Fort Gratiot	Michigan
United States	Pfizer Investigational Site	Greer	South Carolina
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Miami Gardens	Florida
United States	Pfizer Investigational Site	South Miami	Florida
United States	Pfizer Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		56 days for each treatment group	No
Secondary	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.		56 days for each treatment group	Yes

External Links

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