EUCTR2014-005526-35-PL进行中（未招募）1 期
A Prospective, Double-blind, Randomized, Placebo-controlled, Repeated dose, Multicentre Phase IIa Proof-of-Concept Study with BT063 in Subjects with Systemic Lupus Erythematosus (BT063 in SLE)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Biotest AG
- 入组人数
- 36
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
- •Eligible male and female subjects, Age = 18 and = 75 years with Body mass index = 18 and = 35 kg/m2 at screening visit
- •Diagnosed SLE (defined by = 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE) for at least 3 months before screening
- •Moderate to severe SLE disease activity demonstrated by SLEDAI-2K total score = 6, including skin and joint involvement
- •CLASI Activity score = 5 or at least 5 of 66/68 joints with pain and signs of inflammation
- •Positive anti-nuclear antibodies (ANA) test at screening
- •No change in concomitant medication for SLE activity maintenance and symptom control regarding type of medication and dose level for at least 8 weeks prior to baseline (for steroids and NSAIDs/pain medication 2 weeks)
- •Normal electrocardiogram (ECG)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •Active, severe neuropsychiatric SLE defined as any neuropsychiatric element scoring BILAG level A disease or lupus nephritis
- •Diagnosed psoriasis
- •Presence or history of malignancy within the previous 5 years
- •Systemic antibiotic treatment within 2 weeks before baseline visit
- •A positive diagnosis for viral hepatitis B or hepatitis C or Human immunodeficiency virus (HIV) or tested positive for tuberculosis as assessed or recent infection with Herpes Zoster or Herpes Simplex (Type 1 and Type 2), Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection or reactivation at screening
- •Clinically significant hematologic abnormalities attributed to SLE:
- •- Haemoglobin < 8 g/dL
- •- Platelets < 50 × 109/L
- •- Leucocytes < 2.0 × 109/L
- •Active or history of inflammatory bowel disease (including active or history of colitis)
- •Received the following medications:
- •- Rituximab within the last 48 weeks before screening
- •- Belimumab within the last 12 weeks before screening
- •- IV immunoglobulin (Ig) within the last 12 weeks before screening
- •- Intramuscular (IM) or intra-articular glucocorticosteroids within the last 4 weeks before screening
- •- IV cyclophosphamide within the last 6 months before screening
- •- IV glucocorticosteroids (pulse therapy) within the last 6 months before screening
- •Pregnant or nursing women or women who intend to become pregnant
- •Known intolerance to immunoglobulins or comparable substances (e.g., significant vaccination reaction)
- •Known intolerance to proteins of human origin
- •History of clinically significant drug or alcohol abuse within the last 12 months
研究者
相似试验
已完成
不适用
A clinical trial to study the effectiveness of Dermacyte® A clinical trial to study the effectiveness of Dermacyte® Cosmetic Cream in reducing itching, redness and swelling due to Histamine.CTRI/2012/01/002360Oxygen Biotherapeutics Inc30
已完成
2 期
Phase II Clinical Study to Evaluate Safety and Efficacy of Azelastine 0.1% Nasal Spray in Non-hospitalized Patients with Mild COVID-19 InfectioCTRI/2022/09/045465rsapharm Arzneimittel GmbH294
进行中（未招募）
不适用
A Prospective, Randomised, Double-blind, Placebo-controlled, Parallel-group, International Multicentre Phase III Trial of PI-88 in the Adjuvant Treatment of Post-resection Hepatocellular Carcinoma (PATHWAY) - PATHWAYpost-resection hepatocellular carcinomaMedDRA version: 6.1Level: PTClassification code 10019701EUCTR2007-005011-25-ITPROGEN PHARMACEUTICALS LIMITED600
尚未招募
4 期
A clinical trial to study the effect of Ashwagandha on Transient InsomniaCTRI/2020/12/029647International Institute of Sleep Sciences
尚未招募
Unknown
Effect of GLUBLOC™ on blood glucose level after consumption of food among healthy individuals.CTRI/2023/07/055757Vidya Herbs Pvt Ltd