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

• Sponsor: MedImmune LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00192517
• Collaborator: (none)
• Enrollment: 44
• Locations: 20
• Arms: 2
• Duration (Months): 9
• Patients Per Site: 2.2
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: MEDI-522; Other: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of MEDI-522, a Humanized Monoclonal Antibody to Integrin Alpha V Beta 3, Administered by Subcutaneous Injection to Adults With Plaque Psoriasis
• Study Start Date: Dec 1, 2003
• Actual Primary Completion Date: Aug 1, 2004
• Actual Study Completion Date: Sep 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 MEDI-522	Drug: MEDI-522; 4 mg/kg (for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0)
Placebo Comparator: 2 Placebo	Other: Placebo; 4 mg/kg(for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. Incidence of adverse events and serious adverse events [through Study Day 167]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Clinical manifestations of significant end organ dysfunction or failure that may compromise the safety of the patient in the study

• History of gastrointestinal bleeding (i.e., stool positive for occult blood or overt bleeding) within the previous 6 months

• Known bleeding disorder or significant risk of clinically important abnormal bleeding due to anticoagulant therapy with warfarin or heparin

• Insulin-dependent diabetes mellitus that is recent-onset or unstable

• Elective surgery planned during the study period through Study Day 167

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bressinck, Gibson, Parker, Dinehart, Sanster Dermatology, PA	Little Rock	Arkansas	United States	72205
2	Associates In Research, Inc.	Fresno	California	United States	93710
3	Solano Dermatology Associates	Vallejo	California	United States	94589
4	Dermatology Specialists	Vista	California	United States	92083
5	The Savin Center, P.C.	New Haven	Connecticut	United States	06511-4808
6	North Florida Dermatology Associates, P.A.	Jacksonville	Florida	United States	32204
7	Atlanta Dermatology, Vein & Research Center, LLC	Alpharetta	Georgia	United States	30005
8	South Bend Clinic	South Bend	Indiana	United States	46617
9	FutureCare Studies, INC	Springfield	Massachusetts	United States	01107
10	Midwest Cutaneous Research, Corp.	Clinton Township	Michigan	United States	48038
11	Central Dermatology	St. Louis	Missouri	United States	63117
12	Karen Harkaway, M.D., LLC	Delran	New Jersey	United States	08075
13	University of Cincinnati	Cincinnati	Ohio	United States	45219
14	NorthEast Clinical Research Centers, Inc	Allentown	Pennsylvania	United States	18103
15	Clincial Partners, LLC	Johnston	Rhode Island	United States	02919
16	Harmony Clinical Research	Johnson City	Tennessee	United States	37601
17	Tenn. Clinical Research Center, INC	Nashville	Tennessee	United States	37215
18	Derm. Clinical Research Center of San Antonio	San Antonio	Texas	United States	78229
19	North Bay Dermatology Center	North Bay	Ontario	Canada	P1B 2T6
20	Probity Medical Research, Inc.	Waterloo	Ontario	Canada	N2J 1C4

Sponsors and Collaborators

• MedImmune LLC

Investigators

• Study Director: Barbara White, M.D., MedImmune LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00192517
• Other Study ID Numbers: MI-CP102
• First Posted: Sep 19, 2005
• Last Update Posted: Apr 3, 2009
• Last Verified: Apr 1, 2009

• Additional relevant MeSH terms: Psoriasis

Study Results

No Results Posted as of Apr 3, 2009