jRCT2071240068招募中不适用
A Phase 4, Multicenter, Prospective, Open-Label Study Describing the Efficacy and Safety of Belimumab Administered Subcutaneously in Adult Participants with Early Systemic Lupus Erythematosus (BE-EARLY)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •>=18 years of age at the time of signing the informed consent
- •Documented clinical diagnosis of SLE within 2 years of signing the informed consent according to the American College of Rheumatology (ACR) SLE classification criteria 2019
- •Have unequivocally positive autoantibody test results defined as an Anti-nuclear antibody (ANA) titer >=1:80 and/or a positive anti-dsDNA (>=30 IU/mL) serum antibody test from 2 independent
- •time points as follows:
- •Positive test results from 2 independent time points within the study screening
- •period. Screening results must be based on the study's central laboratory results
- •One positive historical test result and 1 positive test result during the screening
- •Disease Activity Inclusion Criteria Adjudication Group confirmation of active SLE defined as:
- •Clinical SLEDAI-2K (excluding anti-dsDNA and C3/C4) score greater than 4, OR
- •Clinical SLEDAI-2K (excluding anti-dsDNA and C3/C4) =< 4 and prednisone or equivalent dose >=10 mg/day
- •SDI = 0 at Screening
- •Incomplete response to stable, initial SLE therapy which includes any of the
- •following or combination of the following:
- •AMs started at least 12 weeks prior to Screening study visit and on a stable dose
- •for a minimum of 4 weeks prior to Day 1
- •Oral prednisone at a dose of =<20 mg/day. If a participant is not on oral
- •prednisone prior to the Screening study visit, oral prednisone at a dose of
- •=<20 mg/day may be introduced during Screening. No change in oral prednisone
- •dose may occur during the last 2 weeks during Screening prior to Day
- •Conventional IS treatment for least 12 weeks prior to Screening study visit, and
- •at a stable dose for a minimum of 4 weeks prior to Day 1
- •Male and/or female; a female participant is eligible to participate if she is not
- •pregnant, not breastfeeding, and at least one of the following conditions applies:
- •Not a WOCBP, OR
- •Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Contraceptive and Barrier Guidance during the study intervention period and for at least 4 months after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure in relationship to the first dose of study intervention.
- •A WOCBP must have a negative highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before the first dose of study intervention.
- •If a urine test cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- •The investigator is responsible for review of medical history, menstrual history,
- •and recent sexual activity to decrease the risk for inclusion of a woman with an
- •early undetected pregnancy.
- •A WOCBP who agrees to follow the contraceptive guidance during the
- •treatment period and for at least 16 weeks after the last dose of BEL
- •Capable of giving signed informed consent
排除标准
- •Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- •Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, GI, hepatic, renal, neurological, psychiatric, malignancy, or infectious diseases) and/or a planned surgical procedure, which, in the opinion of the PI, could confound the results of the clinical study or put the participant at undue risk.
- •Have an acute or chronic infection including requiring management as follows:
- •Currently on any suppressive therapy for a chronic infection such as pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria.
- •A serious infection requiring treatment with IV/IM antibiotics and/or hospitalization if the last dose of antibiotics or the hospital discharge date was within 60 days of the first day of dosing (Day 1). Prophylactic anti-infective treatment is allowed.
- •Evidence of active or latent TB as documented by medical history and examination, chest X-rays (posterior, anterior, and lateral), and TB testing: either a positive tuberculin skin test (TST; defined as a skin induration >=5 mm at 48 to 72 hours, regardless of Bacillus Calmette-Guerin (BCG) or other vaccination history) or a positive (not indeterminate) interferon gamma release assay TB test.
- •Confirmed PML or unexplained new-onset or deteriorating neurologic signs and symptoms.
- •Have severe active CNS lupus (including seizures, psychosis, organic brain syndrome, CVA, cerebritis, or CNS vasculitis) requiring therapeutic intervention within 60 days of Screening.
- •Lupus kidney disease defined by proteinuria >6 g/24 hour or equivalent using spot urine protein to creatinine ratio, or serum creatinine >2.5 mg/dL, or have active LN requiring induction therapy within 35 days of Screening.
- •Have evidence of serious suicide risk, defined as PHQ-9 score >=10, or any history of suicidal behavior in the last 6 months and/or any suicidal ideation in the last 2 months or who, in the investigator's opinion, pose a significant suicide risk.
- •Known to have titers of human anti-mouse antibody or history of hypersensitivity reactions when treated with diagnostic or therapeutic monoclonal antibodies.
- •Live or live-attenuated vaccine(s) within 35 days prior to Screening or plans to receive such vaccines during the Screening period or during the clinical study
- •Chronic oral steroid use for a non-SLE disorder at the Screening study visit (e.g., for asthma). Inhaled steroid use will be allowed.
- •Treatment at or prior to Screening study visit:
- •Treatment at Screening study visit with any of the following:
- •AZA >200 mg/day, MTX (any formulation) >25 mg/week, MMF (PO)/MMF hydrochloride (IV) >2 g/day, Mycophenolate acid/sodium (PO) >1.44 g/day, Oral cyclophosphamide >2.5 mg/kg/day, Tacrolimus >0.2 mg/kg/day, Cyclosporine (PO) >2.5 mg/kg/day
- •Treatment at any time prior to Screening with any of the following:
- •Second line use of conventional ISs or AMs, Commercially available BEL, Anifrolumab, Rituximab or other B cell depleting therapies, Anti-TNF therapy, Other treatments with effects on the immune system, IV cyclophosphamide, IV immunoglobulin, Plasmapheresis, Intra-articular, IM, or IV corticosteroids within 6 weeks of Day 1, Daily use of >1 NSAID within 2 weeks prior to Day 1
- •History of primary immunodeficiency, or hypogammaglobulinemia (IgG <400 mg/dL) or IgA deficiency (IgA <10 mg/dL)
- •Have a Grade 3 or greater neutropenia, defined as absolute neutrophil count <1000/mm3
- •(<1.0 x10^9/L) based on the CTCAE v5.0
- •Alanine aminotransferase >2 x ULN
- •Total bilirubin >1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- •Have any other clinically significant abnormal laboratory value, that in the opinion of the investigator, is capable of significantly altering the absorption, metabolism, or elimination of the clinical study intervention; or constitutes a risk when taking the clinical study intervention or interferes with the interpretation of the clinical study data.
- •Positive HIV antibody test
- •Presence of HBsAg or HBcAb at screening or within 3 months prior to first dose of study intervention.
- •Positive Hepatitis C antibody test result at screening or within 3 months prior to starting study intervention.
- •Positive Hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention.
结局指标
主要结局
-
Achieving LLDAS at Week 52
次要结局
- Achieving LLDAS(Day 1 to Week 52)
研究者
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