Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2026-03-05 @ 7:20 PM
Study NCT ID:
NCT00540618
Status:
COMPLETED
Last Update Posted:
2007-11-28
First Post:
2007-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Study of MEDI-507, Administered by Injection to Adults With Psoriasis
Sponsor:
Organization:
Raw JSON
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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\n* Currently receiving no therapy for psoriasis except emollients (certain other over-the-counter products may be allowed with prior approval of the sponsor)\n* Written informed consent obtained from the patient\n* Ability to complete follow-up period of 167 days as required by the protocol\n\nExclusion Criteria:\n\n* Pustular, guttate, or erythrodermic psoriasis as the predominant disease type\n* PASI score \\<8\n* 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\n* At screening (must be within 21 days before study entry) any clinical evidence of HIV, hepatitis B, hepatitis C or active hepatitis A infection\n* 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)\n* History of cancer (except excision of basal cell carcinoma)\n* Any documented immunodeficiency\n* A history of prior administration of monoclonal antibodies or related proteins\n* Receipt of systemic retinoids, corticosteroids, cyclosporin A, methotrexate, phototherapy or coal tar treatment in the past 4 weeks\n* 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)\n* 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)\n* Current or planned participation in a research protocol in which an investigational agent or therapy may be administered\n* Nursing mother\n* 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'}, 'identificationModule': {'nctId': 'NCT00540618', 'briefTitle': 'A Phase II Study of MEDI-507, Administered by Injection to Adults With Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'MI-CP082'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'MEDI-507', 'interventionNames': ['Drug: MEDI-507']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'MEDI-507', 'interventionNames': ['Drug: MEDI-507']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'MEDI-507', 'interventionNames': ['Drug: MEDI-507']}], 'interventions': [{'name': 'MEDI-507', 'type': 'DRUG', 'description': 'Compare in a placebo controlled manner, the disease activity of three dosing regimens of MEDI-507 (Monoclonal Antibody)', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['2']}, {'name': 'MEDI-507', 'type': 'DRUG', 'description': 'Monoclonal Antibody (5 mg for 12 weeks and 5 mg for 6 weeks)', 'armGroupLabels': ['3']}, {'name': 'MEDI-507', 'type': 'DRUG', 'description': 'Administered 7 mg for 4 weeks by injection (Monoclonal Antibody)', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85040', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'MDS Pharma Services (US) Inc.', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 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