EUCTR2018-004142-42-GB进行中（未招募）1 期
A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 with Background Treatment in Subjects with Lupus Nephritis - BMS-986165 with background treatment in Lupus Nephritis
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 113
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. Signed Written Informed Consent
- •a. Willing to participate in the study and have the ability to give informed consent
- •b. Willing and able to complete all study-specific procedures and visits
- •2. SLE Disease Characteristics
- •a. Meets the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria for SLE
- •b. Renal biopsy confirming a histologic diagnosis of active LN ISN/RPS Classes III (A or A/C), IV-S (A or A/C), or IV-G (A or A/C); or Class V (in combination with Class III or IV)
- •c. UPCR = 1.5 mg/mg (for subjects with biopsies taken = 6 months prior to screening) or UPCR = 1 mg/mg (for subjects with biopsies taken = 3 months prior to screening) assessed with a 24-hour urine specimen
- •3. Medications for SLE/Concomitant Medications
- •a. If participants are taking an angiotensin converting enzyme inhibitor (ACE), angiotensin receptor blocker (ARB), or antimalarial drug, the dose must be stable for at least 4 weeks before randomisation into part B with no anticipated changes in dosage in Part B
- •b. Required discontinuation periods for other immunomodulatory drugs or biologic drugs must be met as outlined in the protocol. If a specific drug is not listed, consult the PRA medical monitor for guidance; usual discontinuation periods are 4 weeks or 5 half-lives, whichever is longer
- •c. It is allowed but not required for prospective subjects to have been taking MMF for = 24 weeks at the time of screening. The suggested target dose is 1.5 to 2.0 g/day (maximum 3.0 g/day) unless limited by toxicity or intolerance (refer to Section 6.1 for further details regarding individual target dose)
- •4. Age and Reproductive Status
- •a. Men and women aged 18 (or local age of majority) to 75 years inclusive at the time of screening
- •b. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta-human chorionic gonadotropin) at screening, within 24 hours before the first dose of MMF in Part A, and before the
- •first dose of blinded study treatment in Part B.
- •c. Women must not be breastfeeding
- •d. The contraception requirements for MMF are stricter than those for BMS-986165; therefore, the requirements for MMF must be followed throughout study participation and for a period of time after the final dose of MMF or blinded study treatment
- •a. Per the MMF prescribing information, participants taking MMF must use acceptable contraception throughout the study and continue for at least 6 weeks after the final dose of MMF
- •b. Participants must be counselled that MMF may reduce the effectiveness of oral contraceptives, and use of additional barrier contraceptive methods is required
- •2. Men who are sexually active with WOCBP:
- •a. Participants must inform any and all partners of their participation in the study and the need to use contraception during the man's study participation and for at least 90 days after his last dose of MMF
- •b. Per the MMF prescribing information, male participants taking MMF must continue to use effective contraception and should not donate sperm for at least 90 days after the final dose of MMF
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 113
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •Target Disease
- •a. Pure ISN/RPS Class V membranous LN
- •b. Screening estimated glomerular filtration rate (eGFR; calculated using the MDRD equation) = 30 mL/minute/1.73 m2
- •c. History of kidney transplantation or planned transplantation during the study
- •d. End-stage renal disease
- •e. Autoimmune diseases other than SLE, with the exception of secondary Sjögren's syndrome, celiac disease, and stable Hashimoto's thyroiditis
- •f. SLE overlap syndromes such as mixed connective tissue disease or coexisting scleroderma or rheumatoid arthritis
- •g. Antiphospholipid Syndrome (APS)
- •h. Active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition defined by British Isles Lupus Assessment Group (BILAG) A criteria, with the exception of participants with mononeuritis multiplex and polyneuropathy, which are allowed with the approval of CRS.
- •i. Dialysis within 12 months before screening or plans for dialysis after enrollment in the study
- •Other Medical Conditions and History
- •a. Women who are pregnant or breastfeeding
- •b. Screening systolic blood pressure > 150 and/or diastolic blood pressure > 90 mmHg
- •c. BMI = 40 kg/m2 at screening
- •d. Any major illness/condition, evidence of an unstable clinical condition, or symptoms of a severe, progressive, or uncontrolled condition or local active infection/infectious illness that might place the subject at unacceptable risk for participation in this study
- •e. Any major surgery within 30 days before the first dose of study treatment or any surgery planned during the course of the study
- •f. Cancer or history of cancer or lymphoproliferative disease within 5 years before screening
- •g. New York Heart Association (NYHA) Class III or IV congestive heart failure or any recent onset of heart failure resulting in NYHA Class III/IV symptoms
- •h. Acute coronary syndrome and/or any history of significant cerebrovascular disease within 24 weeks before screening
- •i. Serious thrombotic event(s) within 1 year before the screening visit
- •j. Current or recent gastrointestinal disease, including gastrointestinal surgery, that could impact the absorption of oral study treatment
- •k. Non-SLE concomitant illness that is likely to require additional systemic glucocorticosteroid therapy during the study
- •l. Severe, progressive, or uncontrolled kidney, liver, blood, stomach, lung, heart, or brain disease not due to active SLE
- •m. Comorbid conditions requiring systemic corticosteroid use in the 52 weeks before screening
- •n. Poorly controlled or advanced diabetes mellitus, as evidenced by a haemoglobin A1c of = 8.0% at screening, or by active diabetic complications such as diabetic nephropathy
- •o. Evidence of a degree of tubulointerstitial changes that suggest a significant and irreversible decrease in renal function
- •p. Renal disease unrelated to SLE including persistent, non-SLE-related pyuria or haematuria
- •q. Significant blood loss (> 500 mL) or blood transfusion within 4 weeks before randomisation
- •r. Inability to tolerate oral medication
- •s. Inability to tolerate venepuncture and/or inadequate venous access
- •t. Recent substance dependence or abuse
- •u. Any disease or medical condition that would make the participant unsuitable for this study, would interfere with the interpretation of participant safety or study results, or considered unsuitable by the investigator for any other reason
- •Findings Related to Possible Infection
- •a. Evidence of active or latent tuberculosis (TB)
- •b. Any of the following: hepatitis B (HBV), hepati
研究者
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