2025-523133-26-00招募中4 期
The effect of anifrolumab on cutaneous lupus erythematosus characterized by the change of the inflammatory infiltrate analyzed by immunohistochemistry, spatial transcriptomics and single-cell RNA- and TCR-sequencing as well as on the clinical outcome - an open label, single arm phase IV pilot study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- changes in inflammatory cell composition and gene expression profiles in skin and blood samples.
研究概览
简要总结
To investigate the impact of anifriolumab therapy on inflammatory cells in skin and blood of patients with cutaneous lupus erythematosus
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Active lesions of histology proven cutaneous lupus erythematosus
- •age18 years or older
- •ability to understand and sign informed consent
- •adequate contraception: females of childbearing potential must use 2 effective methods of avoiding pregnancy, one of which is a barrier method, from screening until 12 weeks after the final dose of investigational product unless the subject is surgically sterile (ie bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy).Sustained abstinence is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception
- •Meets all of the following TB criteria: (a) No history of active TB prior to any Screening visit (b) No history of latent TB prior to initial Screening visit, with the exception of latent TB with documented completion of appropriate treatment Note: Subjects with no history of latent TB prior to the initial Screening visit, but who are diagnosed with latent TB during screening, may be considered eligible if appropriate treatment is initiated prior to randomisation. Such subjects may be re-screened if necessary to allow for local guidelines on latent TB treatment initiation.
排除标准
- •Patients under legal protection
- •Prior receipt of anifrolumab shorter than 12 weeks before first dosage of the IP.
- •Positive test for HIV
- •Positive test for hepatitis C
- •Confirmed positive test for hepatitis B serology for: (a) Hepatitis B surface antigen (HBsAg), OR (b) Hepatitis B core antibody (HBcAb) AND hepatitis B virus (HBV) DNA detected above the lower limit of quantitation
- •Any severe herpesviridae infection at any time prior to Week 0 Any infection requiring oral anti-infectives (including antivirals) within 2 weeks prior to Day 1
- •Active malignancy (except local non-melanoma skin-cancer)
- •Concurrent enrolment in another clinical study with an investigational product
- •A known history of allergy or reaction to any component of the investigational product formulation or history of anaphylaxis to any human gamma globulin therapy
结局指标
主要结局
changes in inflammatory cell composition and gene expression profiles in skin and blood samples.
changes in inflammatory cell composition and gene expression profiles in skin and blood samples.
次要结局
- the impact of anifriolumab therapy on the clinical course of patients with cutaneous lupus erythematosus.
研究者
Department of Dermatology
Scientific
Medical University Of Vienna
研究点 (1)
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