None listed
Conditions
Interventions
300 SUBJECTS WILL BE RANDOMIZED IN A 1:1:1 RATIO TO RECEIVE A FIXED IV DOSE OF MEDI-546 (300 OR 1000 MG) OR PLACEBO Q4WKS FOR 48 WEEKS AS FOLLOWS:
• TREATMENT ARM 1 (N = 100): IV MEDI-546 (300 MG)
Sponsors
MedImmune, LLC, miembro del Grupo de Compañias de AstraZeneca,
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) IN THE OPINION OF THE INVESTIGATOR, MUST HAVE ADEQUATE READING AND WRITING ABILITIES (IN THEIR NATIVE LANGUAGE) SUCH THAT THE SUBJECT CAN COMPREHEND AND COMPLETE THE INFORMED CONSENT, AND ALL PROTOCOL-RELATED SUBJECT ASSESSMENTS 2) AGE 18-65 YEARS AT THE TIME OF SCREENING 3) WRITTEN INFORMED CONSENT AND ANY LOCALLY REQUIRED AUTHORIZATION (EG, HIPAA IN THE USA, EU DATA PRIVACY DIRECTIVE IN THE EU) OBTAINED FROM THE SUBJECT PRIOR TO PERFORMING ANY PROTOCOL-RELATED PROCEDURES, INCLUDING SCREENING EVALUATIONS 4) FULFILLS AT LEAST 4 OF THE 11 AMERICAN COLLEGE OF RHEUMATOLOGY (ACR) CLASSIFICATION CRITERIA FOR SLE (SEE APPENDIX 2), ONE OF WHICH MUST BE: A. POSITIVE ANTINUCLEAR ANTIBODY (ANA) TEST ≥ 1:80 AT SCREENING BY IMMUNOFLUORESCENT ASSAY AT CENTRAL LABORATORY; OR B. ELEVATED ANTI-DSDNA OR ANTI-SM ANTIBODY AT SCREENING AS DETERMINED BY CENTRAL LABORATORY 5) WEIGHT ≥ 40.0 KG AT SCREENING
Exclusion criteria
Exclusion criteria: 1) ANY CONDITION THAT, IN THE OPINION OF THE INVESTIGATOR, WOULD INTERFERE WITH EVALUATION OF THE INVESTIGATIONAL PRODUCT OR INTERPRETATION OF SUBJECT SAFETY OR STUDY RESULTS 2) CONCURRENT ENROLLMENT IN ANOTHER CLINICAL STUDY WITH AN INVESTIGATIONAL PRODUCT WITHIN 4 WEEKS PRIOR TO DAY 1 OR WITHIN 5 HALF-LIVES OF THE INVESTIGATIONAL PRODUCT USED IN THAT CLINICAL STUDY, WHICHEVER IS LONGER 3) EMPLOYEES OF THE CLINICAL STUDY SITE OR ANY OTHER INDIVIDUALS INVOLVED WITH THE CONDUCT OF THE STUDY, OR IMMEDIATE FAMILY MEMBERS OF SUCH INDIVIDUALS 4) LACTATING OR PREGNANT FEMALES OR FEMALES WHO INTEND TO BECOME PREGNANT ANYTIME FROM INITIATION OF SCREENING THROUGH THE 85-DAY SAFETY FOLLOW-UP PERIOD FOLLOWING LAST DOSE OF INVESTIGATIONAL PRODUCT 5) CURRENT SUGGESTION OF ALCOHOL, DRUG OR CHEMICAL ABUSE, OR A RECENT HISTORY OF SUCH ABUSE < 1 YEAR BEFORE RANDOMIZATION INTO THE STUDY 6) MAJOR SURGERY WITHIN 8 WEEKS BEFORE SIGNING THE INFORMED CONSENT FORM OR ELECTIVE MAJOR SURGERY PLANNED DURING THE STUDY PERIOD (SEE APPENDIX 5 FOR GUIDANCE ON MAJOR SURGERY)
Countries
Colombia, Czech Republic, Hungary, India, Korea North, Mexico, Peru, Taiwan, Ukraine, United States
Contacts
Public ContactMarcela Toledo
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed