Study of MEDI-522 Administered by Subcutaneous Injection to Adults With Plaque Psoriasis

NCT00192517 | Completed Phase 2

• 1 other identifier: MI-CP102
• Study Type: interventional
• Target: 44
• Locations: 2 countries
• Sites: 20

Brief Summary

The primary objective of this study is to compare the effects on disease activity, in the absence of systemic psoriasis therapy, of 4 mg/kg MEDI-522 versus placebo administered weekly by SC injection for 12 weeks.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects achieving at least a 50% or 75% improvement of PASI

  PASI score at Study Days 28, 56, 77, 91, 107, 137, and 167.

Secondary Outcomes (1)

• Incidence of adverse events and serious adverse events

  through Study Day 167

Study Arms (2)

1

ACTIVE COMPARATOR

MEDI-522

Drug: MEDI-522

2

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

MEDI-522 DRUG

4 mg/kg (for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0)

1

Placebo OTHER

4 mg/kg(for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0)

2

Eligibility Criteria

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

You may qualify if:

• Plaque psoriasis involving at least 10% of body surface area (Appendix A)
• PASI score greater than 12
• Age 18 through 65 years at the time of the first dose of study drug
• Both males and females are eligible. However, sexually active females, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 30 days prior to the first dose of study drug and must agree to continue using such precautions for 60 days after the final dose of study drug
• Prior to randomization (must be within 21 days of the first administration of the study drug), all of the following: WBC less than or equal to 3,800/mm3; hematocrit above 32%, platelet count less than or equal to 140,000/mm3; AST, ALT, BUN, or creatinine\<1.5 x ULN; and stool negative for occult blood
• Currently receiving no therapy for psoriasis except emollients
• Written informed consent obtained from the patient
• Ability to complete follow-up period of 167 days as required by the protocol

You may not qualify if:

• Pustular, guttate, or erythrodermic psoriasis as the predominant disease type
• Evidence of active hepatitis A, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, such as positive HBsAg or positive anti-hepatitis C antibody
• Pregnancy (must have a negative serum pregnancy test within 21 days prior to the first dose of study drug, and urine pregnancy test must be negative on Study Day 0 before study entry)
• History of cancer (except excision of basal cell carcinoma)
• Evidence of significant active infection, such as fever less than or greater to 38.0°C (100.5°F), or chronic systemic infection
• Known or suspected infection with human immunodeficiency virus (HIV) or other evidence of clinically significant immune deficiencies
• Diagnosis of psoriatic arthritis or rheumatoid arthritis requiring active treatment
• History of hematuria due to chronic cystitis, recurrent kidney stones, or nephritis, history of CVA, poorly controlled hypertension, angina, stable abdominal aneurysm, recent superficial phlebitis, or recent myocardial infarction (within past 1 year without definitive corrective surgery such as coronary bypass graft or angioplasty)
• Receipt of systemic therapy for psoriasis or immunosuppressive medication in the past 4 weeks, including systemic retinoids, systemic steroids (oral, IM, or IV), cyclosporine A,methotrexate, azathioprine, anti-TNF agents, anti-T-cell agents, phototherapy (PUVA, UVB,tanning bed use), coal tar treatment (Goeckerman or modified Goeckerman regimen), tacrolimus, or mycophenolate
• Use of topical therapy for psoriasis in the past 2 weeks, such as steroid containing creams, Vitamin D analog creams and coal tar shampoos
• Receipt of any investigational drug therapy within 4 weeks before the first dose of study drug in this protocol (use of licensed agents for indications not listed in the package insert is permitted)
• Current or planned participation in a research protocol in which an investigational agent or therapy may be administered
• History of allergic disease or reactions likely to be exacerbated by any component of MEDI-522
• Nursing mother
• Evidence of acute illness

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (20)

Bressinck, Gibson, Parker, Dinehart, Sanster Dermatology, PA

Little Rock, Arkansas, 72205, United States

Location

Associates In Research, Inc.

Fresno, California, 93710, United States

Location

Solano Dermatology Associates

Vallejo, California, 94589, United States

Location

Dermatology Specialists

Vista, California, 92083, United States

Location

The Savin Center, P.C.

New Haven, Connecticut, 06511-4808, United States

Location

North Florida Dermatology Associates, P.A.

Jacksonville, Florida, 32204, United States

Location

Atlanta Dermatology, Vein & Research Center, LLC

Alpharetta, Georgia, 30005, United States

Location

South Bend Clinic

South Bend, Indiana, 46617, United States

Location

FutureCare Studies, INC

Springfield, Massachusetts, 01107, United States

Location

Midwest Cutaneous Research, Corp.

Clinton Township, Michigan, 48038, United States

Location

Central Dermatology

St Louis, Missouri, 63117, United States

Location

Karen Harkaway, M.D., LLC

Riverside Park, New Jersey, 08075, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

NorthEast Clinical Research Centers, Inc

Allentown, Pennsylvania, 18103, United States

Location

Clincial Partners, LLC

Johnston, Rhode Island, 02919, United States

Location

Harmony Clinical Research

Johnson City, Tennessee, 37601, United States

Location

Tenn. Clinical Research Center, INC

Nashville, Tennessee, 37215, United States

Location

Derm. Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

North Bay Dermatology Center

North Bay, Ontario, P1B 2T6, Canada

Location

Probity Medical Research, Inc.

Waterloo, Ontario, N2J 1C4, Canada

Location

MeSH Terms

Conditions

Psoriasis

Interventions

etaracizumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Barbara White, M.D.

  MedImmune LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: December 1, 2003
• Primary Completion: August 1, 2004
• Study Completion: September 1, 2004
• Last Updated: April 3, 2009

Record last verified: 2009-04

Locations

US (18); CA (2)