None listed
Conditions
Interventions
APPROXIMATELY 1140 PATIENTS WILL BE RANDOMIZED 1:1:1 TO 1 OF 2 DOSE GROUPS OF LY2127399 OR PLACEBO (APPROXIMATELY 380 PER TREATMENT GROUP). PATIENTS WILL BE STRATIFIED AT RANDOMIZATION ACCORDING TO AN
Sponsors
ELI LILLY AND COMPANY,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: [1] ARE MALES OR FEMALES ≥ 18 YEARS OF AGE. [2] HAVE A CLINICAL DIAGNOSIS OF SLE DEFINED AS MEETING 4 OF THE 11 AMERICAN COLLEGE OF RHEUMATOLOGY (ACR) CRITERIA (PROTOCOL BCDS AMERICAN COLLEGE OF RHEUMATOLOGY (ACR) CRITERIA FOR LUPUS, ATTACHMENT 3). [3] HAVE A POSITIVE ANA (HEp-2 ANA TITER ≥ 1:80) AS ASSESSED BY A CENTRAL LABORATORY AT SCREENING. PATIENTS WITH A NEGATIVE ANA TEST RESULT BUT POSITIVE ANTI-dsDNA TEST RESULT AT SCREENING WILL HAVE ANA REPEAT 1 TIME DURING THE SCREENING PERIOD. IF THE REPEAT ANA IS ALSO NEGATIVE, THE PATIENT WILL BE EXCLUDED FROM THE STUDY. [4] HAVE A SCREENING SELENA-SLEDAI SCORE ≥ 6. (THE PATIENT MUST BE ACTIVELY EXHIBITING ALL THE SYMPTOMS SCORE ON THE SCREENING SELENA-SLEDAI ON THE DAY OF SCREENING.) [5A] FOR FEMALE PATIENTS OF CHILDBEARING POTENTIAL, MUST TEST NEGATIVE FOR PREGNANCY AT THE TIME OF ENROLLMENT AND AGREE TO USE A RELIABLE METHOD OF BIRTH CONTROL OR REMAIN ABSTINENT DURING THE STUDY OR FOR AT LEAST 8 WEEKS FOLLOWING THE LAST DOSE OF STUDY DRUG, WHICHEVER IS LONGER, OR [5B] FOR FEMALE PATIENTS OF NON-CHILDBEARING POTENTIAL, DEFINED AS: • WOMEN WHO HAVE HAD SURGICAL STERILIZATION (HYSTERECTOMY OR BILATERAL OOPHORECTOMY
Exclusion criteria
Exclusion criteria: [7] HAVE ACTIVE LUPUS NEPHRITIS AS ASSESSED BY THE INVESTIGATOR OR URINE PROTEIN/CREATININE RATIO OF > 200 MG/MM0L OR ESTIMATED CREATININE CLEARANCE 40 MG OF PREDNISONE OR ITS EQUIVALENT (INCLUDING IV EQUIVALENT) WITHIN 30 DAYS PRIOR TO BASELINE. [1O] HAVE ADJUSTED THEIR DOSE OF ORAL ANTIMALARIAL DRUGS, SUCH AS CHLOROQUINE, HYDROXYCHLOROQUINE, OR QUINACRINE, WITHIN 30 DAYS PRIOR TO THE BASELINE. [11] HAVE INITIATED TREATMENT OF IMMUNOSUPPRESSANT DRUGS, SUCH AS AZATHIOPRINE, LEFLUNOMIDE, MTX, MYCOFENOLATE MOFETIL, MYCOFENOLATE SODIUM, CYCLOPHOSPHAMIDE, OR CYCLOSPORINE, WITHIN 90 DAYS PRIOR TO BASELINE.
Countries
Argentina, Austria, Belarus, Bulgaria, Canada, Chile, Colombia, Croatia, Egypt, Germany, Guatemala, Italy, Japan, Korea North, Macedonia, Peru, Philippines, Poland, Singapore, Thailand, Turkey, Ukraine, United States, Yugoslavia
Contacts
Public ContactYngrid Saldarriaga
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed