A RANDOMIZED DOUBLE-BLIND PHASE 1B/2 COMBINED STAGGERED MULTIPLE DOSE ESCALATION STUDY OF BOS161721 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS ON A BACKGROUND OF LIMITED STANDARD OF CARE

Boston Pharmaceuticals INC,0 个研究点目标入组 29 人开始时间: 2019年2月26日最近更新: 2023年11月13日

适应症

试验速览

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•Men and women, ages 18 to 70 years, inclusive
•2. Patients must be mentally capable of giving consent and there must be evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study
•3. Patients must have SLE as defined by meeting 4 of the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE (with at least 1 clinical and 1 immunologic criterion OR Lupus nephritis as the sole clinical criterion in the presence of antinuclear antibodies [ANA] or anti- double-stranded deoxyribonucleic acid [dsDNA] antibodies), either sequentially or simultaneously
•4. At screening, patients must have at least 1 of the following:
•a. Elevated ANA ≥ 1:80 via immunofluorescent assay at the central laboratory
•b. Positive anti-dsDNA or anti-Smith (Sm) above the normal level as determined by the central laboratory
•c. C3 or C4 below normal as determined by the central lab
•5. At screening, the SLEDAI-2K must be ≥ 6, including points from at least 1 of the following clinical components:

•Drug-induced SLE, rather than idiopathic” SLE
•2. Other systemic autoimmune disease (eg, erosive arthritis, rheumatoid arthritis [RA], multiple sclerosis [MS], systemic scleroderma, or vasculitis not related to SLE)
•a. RA-Lupus overlap (Rupus), and secondary Sjögren syndrome are allowed
•3. Any major surgery within 6 weeks of study drug administration, (Day 0), or any elective surgery planned during the course of the study
•4. Any history or risk for tuberculosis (TB), specifically those with:
•a. Current clinical, radiographic, or laboratory evidence of active TB
•b. History of active TB
•c. Latent TB defined as positive QuantiFERON-TB Gold In-Tube (QFT-G) or other diagnostic test in the absence of clinical manifestations. Latent TB is not excluded if the patient has documented completion of adequate course of prophylactic treatment with regimen recommended by local health authority guideline, or the patient has started treatment with isoniazid, or other regimen recommended by local health authority guidelines for at least 1 month before Day 0 and continues to receive the prophylactic treatment during study until the treatment course is completed
•5. Active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition defined by BILAG A criteria, with the exception of mononeuritis multiplex and polyneuropathy, which are allowed

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