Clinical trial NCT00563524: Study Evaluating The Safety And Tolerability Of ILV-094 In Subjects With Psoriasis
Official title: AN ASCENDING MULTIPLE DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND CLINICAL EFFICACY OF ILV-094 ADMINISTERED SUBCUTANEOUSLY OR INTRAVENOUSLY TO SUBJECTS WITH PSORIASIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-11-26
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess safety, and tolerability of multiple doses of ILV-094 administered to subjects with psoriasis


Eligibility criteria: Inclusion Criteria:

* Men and Women of nonchildbearing potential 18 years or older.
* Physician Area and Severity Index (PASI) greater than 11.
* Physician Global Assessment (PGA) greater than 3.

Exclusion Criteria:

* Use of any investigational small -molecule drug within 30 days before the first dose of test article administration, and use of any investigational biologic agents within 5 half lives before study day 1, or 90 days for investigational biologics that may have a long clinical duration of effect.
* Live vaccines within 3 months before test article administration or during the study.
* Use of any biologic therapy within approximately 5 half-lives before test article administration. Approximate half-lives of biologic therapies approved for psoriasis are as follows: Enbrel, 5 days; Humira, 14 days; Remicade, 9 days; Amevive, 12 days; Raptiva, 6 days. It is recommended that Amevive be discontinued for at least 90 days because of its long clinical duration of action.
* Psoralen plus ultraviolet A radiation (PUVA) therapy within 4 weeks before study day 1.
* Ultraviolet B (UVB) therapy within 2 weeks before study day 1.
* Receipt of systemic psoriasis therapy (eg, oral retinoids, methotrexate, hydroxyurea, cyclosporine, or azathioprine) or systemic corticosteroids within 4 weeks before study day 1.
* Topical steroids, topical vitamin A or D analog preparations, or anthralin within 2 weeks before study day 1. (Exception: topical therapies, including steroids at no higher than mild strength \[class 6 or 7 topical corticosteroids\], are permitted on the scalp, axillae, face, and groin, but the dose of the medication must be kept stable throughout the trial.)

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
timeFrame: Day 1 up to Day 126
measure: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
timeFrame: Day 1 up to Day 126
measure: Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI)
timeFrame: Day 1 up to Day 126
measure: Number of Participants With Laboratory Test Values of Potential Clinical Importance
timeFrame: Day 1 up to Day 126
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of ILV-094: Single Dose
timeFrame: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
measure: Maximum Observed Plasma Concentration (Cmax) of ILV-094: Multiple Dose
timeFrame: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Single Dose
timeFrame: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Multiple Dose
timeFrame: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
measure: Terminal-phase Disposition Rate Constant of ILV-094: Single Dose
timeFrame: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
measure: Terminal-phase Disposition Rate Constant of ILV-094: Multiple Dose
timeFrame: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
measure: Terminal Half-Life (t1/2) of ILV-094: Single Dose
timeFrame: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
measure: Terminal Half-Life (t1/2) of ILV-094: Multiple Dose
timeFrame: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
measure: Area Under the Curve From Time Zero to The Time of Last Quantifiable Concentration (AUClast) of ILV-094: Single Dose
timeFrame: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
measure: Area Under the Curve From Time Zero to 312 Hours [AUC (0-312)] Postdose of ILV-094: Multiple Dose
timeFrame: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312 hours post-dose
measure: Apparent Clearance of ILV-094: Multiple Dose
timeFrame: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
measure: Apparent Volume of Distribution of ILV-094: Multiple Dose
timeFrame: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
measure: Average Observed Plasma Concentration (Cavg) of ILV-094: Multiple Dose
timeFrame: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
measure: Accumulation Ratio (Rac) of ILV-094
timeFrame: Day 1: pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose; Day 42: pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312 hours post-dose
measure: Serum C-Reactive Protein (CRP) Levels
timeFrame: Day 1, 14, 28, 42, 56
measure: Serum Interleukin-6 (IL-6) Levels
timeFrame: Day 1, 14, 28, 42, 56
measure: Serum Amyloid-A Levels
timeFrame: Day 1, 14, 28, 42, 56
measure: Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12
timeFrame: Baseline, Week 2, 4, 6, 8, 12
measure: Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12
timeFrame: Baseline, Week 2, 4, 6, 8, 12
measure: Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12
timeFrame: Baseline, Week 2, 4, 6, 8, 12
Other outcomes:
measure: Number of Participants With Positive Anti-Drug Antibodies Response
timeFrame: Day 1 up to Day 126
Locations:
city: Beverly Hills
country: United States
facility: David Stoll, MD
state: California
city: Santa Monica
country: United States
facility: Dermatology Research
state: California
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: South Miami
country: United States
facility: MRA Clinical Research
state: Florida
city: Evansville
country: United States
facility: Hudson Dermatology
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Dermatology Group
state: Indiana
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Saint Louis
country: United States
facility: Central Dermatology
state: Missouri
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Durham
country: United States
facility: Duke Clinical Reseach Unit
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Edmonton
country: Canada
facility: Stratical Medical
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta, Hospital Site Clinical Sciences Building
state: Alberta
city: Edmonton
country: Canada
facility: The Northern Alberta Clinical Trials and Research Centre (NACTRC)
state: Alberta
city: Toronto
country: Canada
facility: Bio Pharma Services Inc
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Recherches Inc
state: Quebec
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Bloemfontein
country: South Africa
facility: FARMOVS Parexel (Pty) Ltd
state: Free State
city: George
country: South Africa
facility: Parexel George
state: Western Cape
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: