A Phase II Study of MEDI-507, Administered by Injection to Adults With Psoriasis

• Sponsor: MedImmune LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00540618
• Collaborator: (none)
• Enrollment: 420
• Locations: 43
• Arms: 4
• Duration (Months): 21.9
• Patients Per Site: 9.8
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

To compare disease activity, as measured by PASI score, of three MEDI-507 dosing (injection)regimens vs. placebo.

Condition or Disease	Intervention/Treatment	Phase
Plaque Psoriasis	Drug: MEDI-507; Other: Placebo; Drug: MEDI-507; Drug: MEDI-507	Phase 2

Detailed Description

The primary objective of this study is to compare disease activity, as measured by PASI score, of three MEDI-507 dosing regimens (5 mg for 12 weeks, 5 mg for 6 weeks, 7 mg for 4 weeks) versus placebo administered weekly by SC injection.

Study Design

• Study Type: Interventional
• Actual Enrollment: 420 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Phase II Randomized, Placebo-Controlled, Double-Blind Study of MEDI-507, A Humanized Monoclonal Antibody That Binds to the CD2 Receptor, Administered by Subcutaneous Injection to Adults With Plaque Psoriasis.
• Study Start Date: Sep 1, 2001
• Actual Study Completion Date: Jul 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 MEDI-507	Drug: MEDI-507; Compare in a placebo controlled manner, the disease activity of three dosing regimens of MEDI-507 (Monoclonal Antibody)
Placebo Comparator: 2	Other: Placebo
Active Comparator: 3 MEDI-507	Drug: MEDI-507; Monoclonal Antibody (5 mg for 12 weeks and 5 mg for 6 weeks)
Active Comparator: 4 MEDI-507	Drug: MEDI-507; Administered 7 mg for 4 weeks by injection (Monoclonal Antibody)

Outcome Measures

Primary Outcome Measures

1. Biological activity will be assessed primarily by the Psoriasis Activity and Severity Index (PASI) [Days 14, 28, 42, 56, 70, 91, 107, and 167]

Secondary Outcome Measures

1. Observe adverse and serious adverse events [Day 107 and 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

• 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

• Currently receiving no therapy for psoriasis except emollients (certain other over-the-counter products may be allowed with prior approval of the sponsor)

• 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

• PASI score <8

• At screening (must be within 21 days before study entry) any of the following: lymphocyte count under 1,200 cells/mm3, WBC under 4,000 cells/mm3, hematocrit below 32%, platelets below 110,000 cells/mm3, creatinine, AST, ALT over 1.5 times upper limit of normal

• At screening (must be within 21 days before study entry) any clinical evidence of HIV, hepatitis B, hepatitis C or active hepatitis A infection

• 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)

• Any documented immunodeficiency

• A history of prior administration of monoclonal antibodies or related proteins

• Receipt of systemic retinoids, corticosteroids, cyclosporin A, methotrexate, phototherapy or coal tar treatment in the past 4 weeks

• Use of topical therapy (except emollients) for psoriasis in the past 2 weeks (certain other over-the-counter products may be allowed with prior approval of the sponsor)

• Receipt of any investigational drug therapy within 6 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

• Nursing mother

• Acute illness including infections 15. Clinical manifestations of significant end organ dysfunction or failure that may compromise the safety of the volunteer in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MDS Pharma Services (US) Inc.	Phoenix	Arizona	United States	85040
2	Bressinck-Parker-Dinehart-Sangster Dermatology, PA	Little Rock	Arkansas	United States	72205
3	Associates in Research, Inc.	Fresno	California	United States	93710
4	nTouch Research Corporation	San Diego	California	United States	92103
5	Solano Clinical Research	Vallejo	California	United States	94589
6	Dermatology Specialists, Inc.	Vista	California	United States	92083
7	Colorado Medical Research Center, Inc.	Denver	Colorado	United States	80210
8	Cherry Creek Dermatology	Denver	Colorado	United States	80246
9	The Savin Center, PC	New Haven	Connecticut	United States	06511
10	North Florida Dermatology Associates, PA	Jacksonville	Florida	United States	32204
11	ICSL-Clinical Studies	Sarasota	Florida	United States	34232
12	Comprehensive Research Institute	Tampa	Florida	United States	33607
13	Atlanta Dermatology, Vein & Research Center, LLC	Alpharetta	Georgia	United States	30005
14	Northwestern University Medical School	Chicago	Illinois	United States	60611-2923
15	Research Solutions, LLC	Evansville	Indiana	United States	47714
16	The South Bend Clinic	South Bend	Indiana	United States	46617
17	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
18	FutureCare Studies	Springfield	Massachusetts	United States	01107
19	Washington University School of Medicine	St. Louis	Missouri	United States	63110
20	Probe Inc.	Delran	New Jersey	United States	08075
21	University of Medicine & Dentistry of New Jersey Robert Wood Johnson Medical School and Clinical Research Center	New Brunswick	New Jersey	United States	08903-0019
22	Associates in Dermatology Research	Rutherford	New Jersey	United States	07070
23	Sadick Research Group	New York	New York	United States	10021
24	Mount Sinai School of Medicine	New York	New York	United States	10029
25	Wake Forest University School of Medicine	Winston-Salem	North Carolina	United States	27157
26	University Dermatology Consultants, Inc.	Cincinnatti	Ohio	United States	45219
27	Oregon Medical Research Center, PC	Portland	Oregon	United States	97223
28	Northeast Clinical Research Center	Allentown	Pennsylvania	United States	18104
29	Paddington Testing Company	Philadelphia	Pennsylvania	United States	19103
30	Radiant Research	Philadelphia	Pennsylvania	United States	19115
31	Clinicalm Partners-LLC	Johnston	Rhode Island	United States	02919
32	Harmony Clinical Research, Inc.	Johnson City	Tennessee	United States	37601
33	Dermatology Consultants, PC	Nashville	Tennessee	United States	37205
34	Veteran's Administration Medical Center	Nashville	Tennessee	United States	37212-2637
35	Breco Research, Ltd.	Houston	Texas	United States	77024
36	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas	United States	78229
37	The Dermatology Centre	Calgary	Alberta	Canada	T2S 3B3
38	NewLab Clinical Research	St. Johns	Newfoundland and Labrador	Canada	A1B 3E1
39	Queen Elizabeth II Health Sciences Center	Halifax	Nova Scotia	Canada	B3H 1V8
40	Probity Medical Research	Waterloo	Ontario	Canada	N2J 1B7
41	Probity Medical Research	Windsor	Ontario	Canada	N8X 3V6
42	Innovaderm Research Inc.	Montreal	Quebec	Canada	H2K 4L5
43	International Dermatology Research	Montreal	Quebec	Canada	H3H 1V4

Sponsors and Collaborators

• MedImmune LLC

Investigators

• Study Director: Christine A Dingivan, M.D., MedImmune LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00540618
• Other Study ID Numbers: MI-CP082
• First Posted: Oct 8, 2007
• Last Update Posted: Nov 28, 2007
• Last Verified: Nov 1, 2007

• Additional relevant MeSH terms: Psoriasis

Study Results

No Results Posted as of Nov 28, 2007