A Multicenter Study to Evaluate the Safety and Tolerability of Single-Dose for MEDI-545 (CP145)

Tracking Information
First Submitted Date ICMJE	May 11, 2007
First Posted Date ICMJE	May 14, 2007
Last Update Posted Date	November 17, 2011
Study Start Date ICMJE	February 2007
Actual Primary Completion Date	February 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 11, 2007)	Safety and tolerability of MEDI-545 will be assessed through the collection of AEs and SAEs from study drug administration through Study Day 126. [ Time Frame: Through day 26 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00472758 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 11, 2007)	Secondary endpoints are the PK and IM of single-dose IV MEDI-545. [ Time Frame: determination not stated ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Multicenter Study to Evaluate the Safety and Tolerability of Single-Dose for MEDI-545
Official Title ICMJE	A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation, Multicenter Study to Evaluate the Safety and Tolerability of Single-Dose, Intravenously Administered MEDI-545, a Fully Human Anti-Interferon-Alpha Monoclonal Antibody, in Patients With Chronic Plaque Psoriasis
Brief Summary	-To evaluate the safety and tolerability of a multiple doses of this drug in adult patients.
Detailed Description	-The primary objective of the study is to evaluate the safety and tolerability of escalating single IV doses of MEDI-545 in adult patients with chronic plaque psoriasis.
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Chronic Plaque Psoriasis
Intervention ICMJE	Biological: MEDI 545 IV dosed at 1.0 mg/kg, 3.0,g/kg, 10.0mg/kg and 30.0mg/kg; Other: Placebo IV Placebo dosed at 1.0 mg/kg, 3.0,g/kg, 10.0mg/kg and 30.0mg/kg
Study Arms	Active Comparator: 1 MEDI 545 Intervention: Biological: MEDI 545; Placebo Comparator: 2 Placebo IV Intervention: Other: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 11, 2007)	40
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	March 2008
Actual Primary Completion Date	February 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Male or female adults, age 18 through 70 years of age at time of screening;; Written informed consent obtained from the patient prior to receipt of any study medication or beginning study procedures;; Documented clinical history of chronic plaque psoriasis;; ≥ 3% body surface area (BSA) involvement in affected skin other than the face and scalp;; Have at least two target plaques that are suitable for serial photographic assessments, one of which is of a size and location to allow serial biopsies;; No significant changes in regular psoriasis treatment from at least 28 days from screening through the time of study drug administration;; Sexually active women, unless surgically sterile or at least 1 year post-menopausal, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of a condom with spermicide by the sexual partner or sterile sexual partner) for 21 days prior to study drug administration, and must agree to continue using such precautions through Study Day 126. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active men, unless surgically sterile, must likewise use an effective method of birth control (condom with spermicide) and must agree to continue using such precautions through Study Day 126;; Willing to forego other forms of experimental treatment and study procedures during the study; and; Ability to complete the study period, including follow-up period through Study Day 126. Exclusion Criteria: Receipt of MEDI-545 in any previous clinical study;; History of allergy or reaction to any component of the MEDI-545 formulation;; Pustular, guttate, or erythrodermic psoriasis as the predominant disease type;; Current use of potent topical corticosteroids, tacrolimus, or calcipotriol from 28 days prior to screening through study drug administration;; Current use of phototherapy including tanning beds, Goeckerman or modified Goeckerman regimen, systemic corticosteroids, cyclosporin A, azathioprine, mycophenolate mofetil, methotrexate, or any other systemic treatment for psoriasis within 28 days prior to screening up through study drug administration;; Current use of biologic agents such as alefacept or tumor necrosis factor-α inhibitors within 90 days prior to screening up through study drug administration;; Any disease or illness, other than chronic plaque psoriasis, that may require the use of systemic corticosteroids during the study period;; Acute illnesses or evidence of significant active infection, such as fever ≥ 38.0°C (≥ 100.5°F) from screening through study drug administration;; Receipt of any investigational drug therapy or attenuated live vaccine therapy (other than vaccination against influenza) within 30 days or 5 half-life periods (whichever is longer) prior to study drug administration through the end of study;; Pregnancy (sexually active women, unless surgically sterile or at least 1 year post-menopausal, must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to study drug administration on Study Day 0);; Breastfeeding or lactating women;; Evidence of infection with hepatitis B or C virus, or human immunodeficiency virus (HIV)-1 or -2, or active infection with hepatitis A, as determined by results of testing at screening;; A history of severe infection with cytomegalovirus or viruses of the herpes family including Epstein-Barr virus requiring hospitalization, disseminated herpes, herpes encephalitis, or ophthalmic herpes;; Herpes zoster within 3 months prior to screening;; Current suppressive antiviral therapy for herpes or other viral infections;; A history of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy ≥ 1 year prior to randomization;; Elective surgery planned during the study period through end of study;; Clinically significant abnormality, as determined by the investigator, on 12-lead electrocardiogram (ECG) or chest radiograph at screening;; A history of coagulation disorders;; History of primary immunodeficiency;; History of stroke, or any cerebrovascular disease requiring current medication/treatment;; In the opinion of the investigator, clinically significant active cardiac disease, including: unstable angina; myocardial infarction within 6 months; congestive heart failure; or arrhythmia requiring active therapy;; Ongoing, clinically significant (in the opinion of the investigator) chronic infectious disease;; History of active tuberculosis or positive tuberculosis (TB) test (defined as a reaction ≥ 10 mm in diameter) without a completed course of appropriate medical treatment;; At the time of screening, any of the following: clinically significant abnormalities of hemoglobin, total white blood cell count, or platelet count; aspartate transaminase (AST) or alanine transaminase (ALT) > 1.5 times the upper limits of normal (ULN), serum creatinine, and prothrombin time (PT) or partial thromboplastin time (PTT) > ULN;; Any other abnormal laboratory values in the screening panel that, in the opinion of the investigator, are clinically significant. Abnormal results on screening laboratory tests may be repeated once at the discretion of the site investigator(s) or qualified designee, prior to Study Day 0, to determine eligibility; or; Evidence of any systemic disease or skin disease (other than chronic plaque psoriasis), any finding upon physical examination or history of any disease that, in the opinion of the investigator, designated health care provider, or medical monitor, may compromise the safety of the patient in the study or confound the analysis of the study.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 70 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Canada
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00472758
Other Study ID Numbers ICMJE	MI-CP145
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	MedImmune LLC
Study Sponsor ICMJE	MedImmune LLC
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Barbara White, M.D. MedImmune LLC
PRS Account	MedImmune LLC
Verification Date	November 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP