PER-085-11Unknown未知
A PHASE 1, DOUBLE-BLIND, RANDOMIZED, SINGLE ASCENDING DOSE STUDY OF THE SAFETY AND TOLERABILITY OF MEDI-570 IN SYSTEMIC LUPUS ERYTHEMATOSUS
Trial Snapshot
- Phase
- 未知
- Sponsor
- ASTRAZENECA PERU S.A.,
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 65 (—)
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
- •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.
Investigators
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