EUCTR2018-000305-23-BG进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 156
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. 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
- •b. Positive anti-dsDNA or anti-Smith (Sm) above the normal level asdetermined by the central laboratory
- •5. At screening, the total SLEDAI-2K score must be = 8, including points
- •from at least 1 of the following clinical components:
- •a. Arthritis, rash, myositis, mucosal ulcers, pleurisy, pericarditis, and
- •Note: Points from lupus headache and organic brain syndrome will also
- •be excluded from qualifying total and clinical SLEDAI-2K scores at
- •screening and Day 0.
- •6. A clinical SLEDAI-2K score of = 6 at screening at Day 0. Clinical
- •SLEDAI-2K score is defined as follows:
- •a. Contains points from arthritis, rash, myositis, mucosal ulcers, pleurisy,
- •pericarditis, or vasculitis
- •b. Excludes parameters which require central laboratory results:
- •hematuria, pyuria, urinary casts, proteinuria, positive anti-dsDNA,
- •decreased complement, thrombocytopenia, and leukopenia
- •Note: Points from lupus headache and organic brain syndrome will also
- •be excluded from qualifying total and clinical SLEDAI-2K scores at
- •screening and Day 0.
- •7. Patients must have at least 1 qualifying A or 2Bs from the following
- •manifestations of SLE, as defined by the BILAG criteria as modified for
- •use in this study, which must be confirmed by the central data reviewer:
- •a. BILAG A or B score in the mucocutaneous body system. If a BILAG B
- •score is due to BILAG number 6, mild skin eruption, the CLASI activity
- •score including erythema and scale/hypertrophy must be = 3 excluding
- •points from mucosal ulcers and alopecia.
- •b. BILAG A or B score in the musculoskeletal body system due to active
- •polyarthritis as defined in the protocol Section 4.4
- •Note: Hips, shoulders, back, neck, and temporomandibular joints do not
- •count towards the total number of joints with active synovitis.
- •If only one B and no A score is present in the mucocutaneous body
- •system or in the musculoskeletal body system due to arthritis, then at
- •least 1 B must be present in at least 1 other body system for a total of
- •2 B BILAG body system scores.
- •8. Patients must be currently receiving at least 1 of the following:
- •a. Administration for a minimum of 12 weeks, and a stable dose for at
- •least 56 days (8 weeks prior to Day 0) of the following permitted
- •steroid-sparing agents:
- •i. Azathioprine (AZA), mycophenolate mofetil or mycophenolic acid,
- 另有 6 项未显示
排除标准
- •1. Drug-induced SLE, rather than idiopathic SLE
- •2. Other systemic autoimmune disease (eg, erosive arthritis, rheumatoid
- •arthritis [RA], multiple sclerosis [MS], systemic sclerosis, or vasculitis
- •not related to SLE)
- •a. RA-Lupus overlap (Rupus), and secondary Sjögren syndrome are
- •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) -please see the details in the
- •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
- •6. Severe proliferative lupus nephritis, (WHO Class III, IV), which
- •requires or may require induction treatment with cytotoxic agents or
- •high dose CS
- •7. Concomitant illness that, in the opinion of the investigator or the
- •sponsor or their designee, is likely to require additional systemic
- •glucocorticosteroid therapy during the study, (eg, asthma), is
- •exclusionary
- •a. However, treatment for asthma with inhalational CS therapy is
- •8. Use or planned use of concomitant medication outside of standard of
- •baseline treatment for SLE from Day -1 or for any time during the study
- •9. Active and clinically significant infection (bacterial, fungal, viral, or
- •other) within 60 days prior to first dose of study drug. Clinically
- •significant is defined as requiring systemic parenteral antibiotics or
- •hospitalization
- •10. A history of opportunistic infection, or a history of recurrent or
- •severe disseminated herpes zoster or disseminated herpes simplex
- •within the last 3 years
- •11. Chronic viral hepatitis including hepatitis B (HBV) and hepatitis C
- •(HCV) unless patient received curative treatment for HCV and has a
- •documented negative viral load, known human immunodeficiency virus
- •(HIV), or acquired immunodeficiency syndrome (AIDS)-related illness
- •12. Cryptosporidium in the stool sample at screening
- •13. White blood cells (WBC) < 1,200/mm3 (1.2 × 109/L) at screening
- •14. Absolute neutrophil count (ANC) < 500/mm3 at screening
- •15. CD4+ count < 150/µL at screening
- •16. Platelets < 50,000/mm3 (50 × 109/L) or < 35,000/ mm3 (35 ×
- •109/L) if related to SLE, at screening
- •17. Hemoglobin < 8 g/dL or < 7 g/dL at screening if related to SLE
- •18. Proteinuria > 3.0 g/day (3000 mg/day) at screening or equivalent
- •level of proteinuria as assessed by protein/creatinine ratio (3 mg/mg or
- •339 mg/mmol)
- •19. Serum creatinine > 2.0 mg/dL at screening or creatinine clearance
- •(CrCL) < 40 ml/minute based on Cockcroft-Gault calculation
- •20. Serum alanine aminotransferase (ALT) and/or serum aspartate
- •aminotransferase (AST) > 2 × the upper limit of normal (ULN) at
- •screening, unless explicitly related to lupus based on the investigator's
- •21. Creatinine kinase (CK) > 3.0 × ULN at screening unless related to
- •lupus myositis
- •22. Total bilirubin > 1.5 × ULN at screening (unless related to Gilbert's
- 另有 6 项未显示
研究者
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