Study Evaluating The Safety And Tolerability Of ILV-094 In Subjects With Psoriasis

NCT00563524 | Completed Phase 1 Results

• 3 other identifiers: 3199K2-1105B19810022009-012554-20
• Study Type: interventional
• Target: 76
• Locations: 4 countries
• Sites: 24

Brief Summary

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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)

  An AE was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study (Day 126), that were absent before treatment or that worsened relative to pre-treatment state. AEs include both SAEs and all non-SAEs.

  Day 1 up to Day 126

• Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters

  Clinically significant ECG findings included: heart rate (HR): less than or equal to (\<=) 45 beats per minute (bpm) or greater than or equal to (\>=)120 bpm or decrease/increase of \>=15 bpm from baseline value, PR interval: \>=220 millisecond (msec) and change of \>=20 msec from baseline value and; QRS interval \>=120 msec; corrected QT (QTc) interval for men greater than (\>) 450 msec, QTc interval for women \>470 msec.

  Day 1 up to Day 126

• Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI)

  Criteria for identifying vital sign values of PCI: heart rate: increase of \>15 bpm from baseline value and \>=120 bpm and decrease of \>15 bpm from baseline value and \<=45 bpm; Sitting and Supine systolic blood pressure (SBP): increase of \>=20 millimeters of mercury (mm Hg) from baseline value and \>=160 mm Hg and decrease of \>=20 mm Hg from baseline value and \<=90 mm Hg; Sitting and Supine diastolic blood pressure (DBP): increase of \>=15 mm Hg from baseline value and \>=100 mm Hg and decrease of \>=15 mm Hg from baseline value and \<=50 mm Hg; Respiratory rate: \<10 or \>25 breaths/minute; Weight: \>=7 percent increase or decrease from baseline value; Oral temperature: \<35 degree Celsius (C) or \>38.3 degree C.

  Day 1 up to Day 126

• Number of Participants With Laboratory Test Values of Potential Clinical Importance

  Criteria:Hematocrit:5% decrease from baseline,Hemoglobin:decrease of \>=20 gram per liter(g/L) from baseline,WBC: \<3.0\*10\^9/L;neutrophils: \<1.5\*10\^9/L,platelet count:\<100\*10\^9/L,eosinophils: \>0.5\*10\^9/L;prothrombin time,partial thromboplastin time: \>1.5\*Upper limit of normal(ULN);sodium,potassium: \>5millimoles per liter(mmol/L)aboveULN/below lower limit of normal(LLN),creatinine: \>1.36\*ULN,urea: \>1.5\*ULN,glucose(fasting): \>0.83mmol/L above ULN/below ULN,glucose (non-fasting): \>5.0 mmol/L above ULN/\>0.56 mmol/L below LLN,calcium:change of \>=0.25 mmol/L from baseline,magnesium:change at \>=0.21mmol/L from baseline value,phosphorus:\>0.162 mmol/L above ULN/below LLN,total protein:change of \>=20 g/L from baseline,albumin:change of \>=10 g/L from baseline,uric acid:change of \>0.119mmol/L from baseline,creatine kinase: \>3\*ULN,cholesterol: \>7.77mmol/L,triglycerides:\>3.39mmol/L;ALT,AST,total bilirubin: \>2\*ULN,alkaline phosphatase: \>1.5\*ULN,Gamma-glutamyl transferase,lactate dehydrogenase: \>3\*ULN.

  Day 1 up to Day 126

Secondary Outcomes (20)

• Maximum Observed Plasma Concentration (Cmax) of ILV-094: Single Dose

  Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1

• Maximum Observed Plasma Concentration (Cmax) of ILV-094: Multiple Dose

  Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14

• Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Single Dose

  Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1

• Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Multiple Dose

  Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14

• Terminal-phase Disposition Rate Constant of ILV-094: Single Dose

  Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1

Other Outcomes (1)

• Number of Participants With Positive Anti-Drug Antibodies Response

  Day 1 up to Day 126

Study Arms (1)

1

PLACEBO COMPARATOR

Drug: ILV-094

Interventions

ILV-094 DRUG

SC and IV administration on days 1, 14, 28, and 42

Also known as: placebo

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (24)

David Stoll, MD

Beverly Hills, California, 90212, United States

Location

Dermatology Research

Santa Monica, California, 90404, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

MRA Clinical Research

South Miami, Florida, 33143, United States

Location

Hudson Dermatology

Evansville, Indiana, 47714, United States

Location

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, 46256, United States

Location

Dawes Fretzin Dermatology Group

Indianapolis, Indiana, 46256, United States

Location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

Location

Central Dermatology

St Louis, Missouri, 63117, United States

Location

New York University Medical Center

New York, New York, 10016, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Duke Clinical Reseach Unit

Durham, North Carolina, 27710, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635-0909, United States

Location

Baylor Research Institute

Dallas, Texas, 75246-1613, United States

Location

Stratical Medical

Edmonton, Alberta, T5K 1X3, Canada

Location

University of Alberta, Hospital Site Clinical Sciences Building

Edmonton, Alberta, T6G 2B7, Canada

Location

The Northern Alberta Clinical Trials and Research Centre (NACTRC)

Edmonton, Alberta, T6G 2C8, Canada

Location

Bio Pharma Services Inc

Toronto, Ontario, M9L 3A2, Canada

Location

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

Innovaderm Recherches Inc

Montreal, Quebec, H2K 4L5, Canada

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

FARMOVS Parexel (Pty) Ltd

Bloemfontein, Free State, 9301, South Africa

Location

Parexel George

George, Western Cape, 6529, South Africa

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Psoriasis

Interventions

fezakinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2007
• First Posted: November 26, 2007
• Study Start: December 20, 2007
• Primary Completion: June 14, 2010
• Study Completion: June 14, 2010
• Last Updated: August 23, 2024
• Results First Posted: August 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (2); CA (6); HK (1); US (15)