2024-514750-67-00招募中3 期
“A Phase II, double-blinded, placebo-controlled clinical trial to evaluate the safety and efficacy of mesenchymal cells (MSV-ALLO®) in the treatment of lupus nephritis”
Hospital Universitario Rio Hortega1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年11月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary endpoint is the proportion of patients who have achieved complete response or partial response at week 24, relative to their baseline (treatment visit), in the treatment group compared to the placebo group.
研究概览
简要总结
General: The main objective of this trial is to evaluate the safety and efficacy of MSV-allo® compared to placebo in obtaining complete or partial remission in active LN. Principal: Proportion of patients achieving complete or partial response at week 24, relative to baseline, in the treatment group compared to the placebo group .
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Females or males aged ≥ 18 years who give written informed consent at the screening visit.
- •Systemic Lupus Erythematosus Diagnosis by meeting at least 4 criteria of the 11 included in ACR classification and/or SLICC criteria, at screening visit.
- •Lupus Nephritis Diagnosis according to 2003 International Society of Nephrology and Renal Pathology Society classification, by biopsy performed no more than 6 months prior to the screening visit if including from the induction period and performed no more than 1 year if including with moderate/severe recurrence.
- •No response, or partial response, to standard treatment, or moderate/severe recurrence of lupus nephritis
- •SLEDAI-2K # 10 during the screening period
- •Women of childbearing age must use effective methods of contraception to prevent pregnancy
- •Have been vaccinated against pneumococcus and influenza at vaccination campaign time
排除标准
- •Previous treatments related: 1.-Use of corticosteroids or mycophenolate above allowed doses for induction, according to Systemic Autoimmune Diseases Group of Internal Medicine Spanish Society and Nephrology Spanish Society Consensus Document.
- •Diagnosis of active or latent tuberculosis by a purified protein derivative TB skin test (induration # 5 mm) or a positive Quantiferon test result, at screening or 3 months prior to the screening visit. Patients who have completed adequate prior treatment or who are receiving treatment will not repeat the test. Patients who are receiving adequate TB treatment for at least 4 continuous weeks prior to the screening visit and who are expected to complete the treatment regimen will not be excluded
- •Presence of class 3 or 4 uncontrolled congestive heart failure according to the New York Heart Association
- •2.- Use of rituximab, belimumab, ocrelizumab or other biological therapies against B cells 6 months prior to screening
- •Active cancer
- •Major surgical intervention within 6 weeks prior to the screening visit or planned during the trial period, including follow-up.
- •Pregnant or lactating women
- •3.-Use of cyclophosphamide at any time during 6 months prior to selection.
- •4.- Use of any tumor necrosis factor inhibitor therapy at any time during 6 months prior to selection
- •5.- Central nervous system SLE active considered severe or progressive (recent or uncontrolled seizures, anticonvulsant therapy changes in the 3 months prior to the screening visit, or leading to significant cognitive impairment)
- •6.- Diagnosis of any demyelinating disease such as multiple sclerosis or optic neuritis
- •Active cardiac arrhythmia or significant ECG clinical abnormalities at screening visit or on randomization day which, according to investigator, sponsor, or designee opinion, constitute an inappropriate risk or contraindication to study participation.
- •7.- Comorbidities that require treatment with systemic corticosteroids (oral, rectal or injectable) such as asthma or inflammatory bowel disease
- •Medical conditions related 1.- Any medical condition, including an uncontrolled disease other than SLE, that, in investigator opinion, sponsor or designee, represents an inappropriate risk or trials participation contraindication or would interfere with trial objectives , conduct or evaluation.
- •Cardiac, peripheral or cerebrovascular cardiovascular episodes during 6 months prior to screening visit.
- •Laboratory abnormalities
- •Clinically significant abnormalities in laboratory tests not attributed to active SLE
- •Chest X-ray significant abnormalities indicating active TB. The chest x-ray must have been done within 3 months prior to the screening visit or during the screening period.
- •Legal incapacity
- •Thromboembolic episodes 12 months prior to or at screening visit, whether or not related to associated antiphospholipid syndrome, or inadequate anticoagulation testing 6 weeks immediately prior to or during the screening visit.
- •Central nervous system SLE active considered severe or progressive (recent or uncontrolled seizures, anticonvulsant therapy changes in the 3 months prior to the screening visit, or leading to significant cognitive impairment).
- •Diagnosis of any demyelinating disease such as multiple sclerosis or optic neuritis.
- •7.Comorbidities that require treatment with systemic corticosteroids (oral, rectal or injectable) such as asthma or inflammatory bowel disease
- •Previous or plans for organ transplantation
- •Active viral, bacterial or fungal infection clinically significant, or any major episode of infection which required hospitalization or parenteral treatment in 4 weeks prior to the screening visit, during the screening visit, or anti-infective treatment completion in the 2 weeks prior to or during the screening visit, or recurrent infections (three or more same type of infection cases in a period of 12 consecutive months). Vaginal candidiasis, onychomycosis and controlled genital or oral herpes simplex virus would not be reasons for exclusion.
- •History or positive result for human immunodeficiency virus (HIV) test, hepatitis C antibodies and/or polymerase chain reaction, hepatitis B surface antigen (HBsAg+), and/or total IgM antibodies to hepatitis B nuclear antigen at screening
结局指标
主要结局
The primary endpoint is the proportion of patients who have achieved complete response or partial response at week 24, relative to their baseline (treatment visit), in the treatment group compared to the placebo group.
The primary endpoint is the proportion of patients who have achieved complete response or partial response at week 24, relative to their baseline (treatment visit), in the treatment group compared to the placebo group.
次要结局
- Change from day 1 (treatment) in proteinuria levels
- Change from day 1 (treatment) in SF-36 and LupusQoL scores
- Proportion of patients at week 24 whose dose of prednisone-equivalent corticosteroids has been reduced relative to the screening visit by # 25% and to a dose # 7.5 mg/day and who have no exacerbation BILAG A or 2B . A BILAG A or 2B exacerbation is defined as at least one new BILAG A organic domain score or at least 2 new BILAG B organic domain scores compared to the screening visit.
- Proportion of patients at each visit whose prednisone-equivalent dose has been reduced relative to the screening visit by # 25% and at a dose # 7.5 mg/day, and who do not have any BILAG A or 2B exacerbations at the disease activity
- Proportion of patients at week 24 with a reduction relative to the screening visit in the daily dose of prednisone-equivalent corticosteroids of 0-<25%, 25%-50%, >50%.
- Cumulative dose of prednisone-equivalent corticosteroids from the screening visit to week 24
- Proportion of patients who before week 24 have reduced the dose of immunosuppressants and who do not present any BILAG A or 2B exacerbation
- Change from day 1 (treatment) in the SLEDAI-2K index.
研究者
Julia Barbado Ajo
Scientific
Hospital Universitario Rio Hortega
研究点 (1)
Loading locations...
相似试验
未知
不适用
A PHASE II RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO STUDY THE SAFETY AND IMMUNOGENICITY OF V212 IN ADULT PATIENTS WITH AUTOIMMUNE DISEASEPER-031-12MERCK SHARP & DOHME PERU S.R.L.,20
进行中（未招募）
不适用
Influenza Virus Challenge Study to Test Monoclonal Antibody TCN-032 as a Treatment for Influenza (Flu).Treatment of severe influenza A virus disease.MedDRA version: 14.1Level: PTClassification code 10070215Term: Influenza A virus test positiveSystem Organ Class: 10022891 - InvestigationsMedDRA version: 14.1Level: LLTClassification code 10022002Term: Influenza A virus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2012-000854-73-GBTHERACLONE SCIENCES, INC.
已完成
不适用
A 52-Week Study to Assess the Effects of MK0822 on Knee Osteoarthritis-M17M17PER-115-06MERCK SHARP & DOHME PERU S.R.L.,
已完成
不适用
A PHASE IIA, RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO STUDY THE EFFICACY AND SAFETY OF MK-0773 IN PATIENTS WITH SARCOPENIAPER-065-07MERCK SHARP & DOHME PERU S.R.L.,
已完成
不适用
Phase II, Randomized, Double-Blind ,Placebo-Controlled Study of Hangeshashinto for Prevention of Oral Mucositis in Gastric Cancer Patients Receiving Chemotherapy (HANGESHA-G Study).Gastric CancerJPRN-UMIN000004214PO Epidemiological and Clinical Research Information Network (ECRIN)90