None listed
Conditions
Interventions
APPROXIMATELY 30 SITES IN THE WORLD WILL PARTICIPATE IN THE STUDY. A MINIMUM OF 42 SUBJECTS ARE PLANNED FOR THE STUDY, WITH 6 DOSE COHORTS OF SUBJECTS WITH SLE RECEIVING 1 OF 6 FIXED, SINGLE SC DOSES
Sponsors
ASTRAZENECA PERU S.A.,
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) AGE ≥ 18 AND ≤ 65 YEARS AT THE TIME OF SCREENING. 2) WRITTEN INFORMED CONSENT AND HIPAA AUTHORIZATION (APPLIES TO COVERED ENTITIES IN USA ONLY) OBTAINED FROM THE SUBJECT/LEGAL REPRESENTATIVE PRIOR TO PERFORMING ..... PROTOCOL-RELATED PROCEDURES, SCREENING EVALUATIONS. 3) MEET OR HAVE MET AT LEAST 4 OF THE 11 REVISED AMERICAN COLLEGE OF RHEUMATOLOGY (ACR) CLASSIFICATION CRITERIA FOR SLE (APPENDIX 2). 4) SCORE ≥ 6 POINTS ON THE SLEDAI-2K AT SCREENING. 5) HAVE POSITIVE ANTINUCLEAR ANTIBODY (ANA) TEST AT ≥ 1:80 SERUM DILUTION AT SCREENING. 6) A TARGET OF AT LEAST 5 SUBJECTS IN EACH DOSE COHORT (DOSE COHORT 3-6) WILL HAVE ACTIVE SKIN LESIONS DUE TO SLE IN AT LEAST ONE AREA SUITABLE FOR REPEAT SKIN BIOPSY, SUCH AS IN THE ARMS, LEGS OR TRUNK. 7) FEMALE SUBJECTS OF CHILDBEARING POTENTIAL WHO ARE SEXUALLY ACTIVE WITH NON-ESTERILIZED MALE PARTNER MUST USE ADEQUATE CONTRACEPTION FROM SCREENING THROUGH THE DAY 169/EARLY DISCONTINUATION VISIT. AN ACCEPTABLE METHOD OF CONTRACEPTION IS DEFINED AS ONE THAT HAS NO HIGHER THAN A 1% FAILURE RATE.
Exclusion criteria
Exclusion criteria: 1) PREGNANT OR LACTATING WOMAN 2) HISTORY OF ALCOHOL OR DRUG ABUSE ≤ 1 YEAR BEFORE SCREENING, AS JUDGED BY THE INVESTIGATOR, BEFORE RANDOMIZATION INTO THE STUDY. 3) ANY HISTORY OF CANCER EXCEPT BASAL ANS SQUAMOUS CELL CARCINOMA OF THE SKIN OR IN SITU CARCINOMA OF THE CERVIX TREATED AND CONSIDERED CURED. 4) ELECTIVE SURGERY PLANNED FROM THE TIME OF SIGNING OF THE INFORMED CONSENT THROUGH END OF STUDY UNLESS APPROVED BY THE MEDICAL MONITOR. 5) EVIDENCE OF CLINICALLY SIGNIFICANT LUNG PATHOLOGY BY CHEST X-RAY (OR CHEST COMPUTED TOMOGRAPHY [CT]). A CHEST X-RAY WILL BE PERFORMED AT SCREENING, IF ONE HAS NOT BEEN PERFORMED IN THE LAST 6 MONTHS. 6) EVIDENCE OF ACTIVE OR LATENT TUBERCULOSIS (TB). 7) HISTORY OF PRIMARY IMMUNODEFICIENCY. 8) HISTORY OF MIXED CONNECTIVE TISSUE DISEASE AND OVERLAP SYNDROMES OF SLE. 9) EVIDENCE OF INFECTION AT ANY TIME WITH HEPATITIS B OR C VIRUS OR HUMAN IMMUNODEFICIENCY VIRUS (HIV)-1 OR HIV-2, OR ACTIVE INFECTION WITH HEPATITIS A, AS DETERMINED BY RESULTS OF TESTING AT SCREENING. 10) ANY ACUTE ILLNESS OR EVIDENCE CLINICALLY SIGNIFICANT ACTIVE INFECTION BETWEEN THE SCREENING AND DAY 1.
Countries
Canada, Mexico, South Africa, United States
Contacts
Public ContactUrsula Rodriguez
ASTRAZENECA PERU S.A.
Outcome results
None listed