Clinical trial NCT01010542: Study Evaluating Single Dose Of ILV-095 In Psoriasis Subjects
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Plaque Psoriasis
Keywords: Single dose psoriasis study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-11-10
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 2
timeFrame: Baseline, Week 2
measure: Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 4
timeFrame: Baseline, Week 4
measure: Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 6
timeFrame: Baseline, Week 6
measure: Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 8
timeFrame: Baseline, Week 8
Secondary outcomes:
Other outcomes:
measure: Target Lesion Score (TLS)
timeFrame: Pre-treatment (Day -1), Week 2, 4, 6, 8
measure: Physician Global Assessment (PGA) Score of Psoriasis
timeFrame: Pre-treatment (Day -1), Week 2, 4, 6, 8
measure: Number of Participants With Laboratory Abnormalities of Potential Clinical Importance
timeFrame: Baseline (Day 1) up to Week 16
measure: Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance
timeFrame: Baseline (Day 1) up to Week 16
measure: Number of Participants With Electrocardiograms (ECG) Abnormalities of Potential Clinical Importance
timeFrame: Baseline (Day 1) up to Week 16
measure: Maximum Observed Serum Concentration (Cmax) of ILV-095
timeFrame: Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose
measure: Time to Reach Maximum Observed Serum Concentration (Tmax) of ILV-095
timeFrame: Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose
measure: Serum Terminal Half-Life (t1/2) of ILV-095
timeFrame: Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose
measure: Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of ILV-095
timeFrame: Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose
measure: Area Under the Serum Concentration-Time Curve From Time Zero to Time of The Last Quantifiable Concentration (AUClast) of ILV-095
timeFrame: Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose
measure: Apparent Clearance (CL/F) of ILV-095
timeFrame: Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose
measure: Apparent Volume of Distribution (Vz/F) of ILV-095
timeFrame: Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose
measure: Serum Amyloid-A Levels
timeFrame: Baseline, Day 14, 56,112
measure: Plasma Interleukin-6 (IL-6) Levels
timeFrame: Baseline, Day 14, 56,112
measure: Plasma Interleukin-22 (IL-22) Levels
timeFrame: Baseline, Day 14, 56,112
measure: Serum C-Reactive Protein (CRP) Levels
timeFrame: Baseline, Day 14, 56,112
measure: Number of Participants With Positive Anti-Drug Antibodies of ILV-095
timeFrame: Baseline up to Week 16
measure: Number of Participants With Injection-Site Reactions
timeFrame: Baseline up to Week 16
Locations:
city: Miami Gardens
country: United States
facility: Cetero Research
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates, Inc.
state: Florida
city: South Miami
country: United States
facility: MRA Clinical Research
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Greer
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: St John's
country: Canada
facility: NewLab Clinical Research Inc
state: Newfoundland and Labrador
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: