Dynamic Blood Inflammatory Profile in Atopic Dermatitis Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Compare the dynamic blood cytokines profile by stimulating blood with immune ligands
研究概览
简要总结
This is a prospective, single-center, class 2 study to better characterize the immune response in immune response in the blood of atopic dermatitis. Investigators are following in the referral center of Nice, 100 patients with atopic dermatitis. Investigators plan to include 30 patients. Blood samples will be collected to assess cytokine levels after non-specific immune stimulation. immune stimulation. Whole blood will be collected and stimulated with immune ligands (anti-CD3 T-cell stimulating ligands associated with Thymic Stromal LymphoPoietin (TSLP) or TLR agonist R848 7/8 agonist stimulating NK (natural killer) lymphocytes and promoting T cell response) on lyophilized freeze-dried spheres (LyoSphere, Qiagen) within 8 hours of blood collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged ≥ 18 years.
- •Patient with clinically diagnosed atopic dermatitis according to the criteria of Hanifin and Rajka.
- •Moderate to severe defined by an Investigator's Global Assessment ³3 and eligible to systemic treatment.
- •If the subject is a woman of childbearing potential, she has a negative urine pregnancy test.
- •Subject is non-pregnant, non-lactating and is not planning for pregnancy during the study period.
- •Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair his/her evaluation or which exposes the subject to an unacceptable risk by study participation.
- •Subject is able to comprehend and willing to sign an Informed Consent and/or Assent Form.
- •Affiliation to a social security scheme.
- •Signed informed consent
排除标准
- •Vulnerable person: pregnant or nursing woman, minor, adult under guardianship or deprived of liberty
- •Patient with an infection
- •Patient with other systemic inflammatory disease
- •Patient with anti-inflammatory or immunosuppressive therapy
- •Patient with a contraindication to JAK inhibitors
- •Participants in other clinical therapeutic studies involving a drug that may interfere with the present evaluation
研究组 & 干预措施
Main Cohort
干预措施: Blood sample (Other)
结局指标
主要结局
Compare the dynamic blood cytokines profile by stimulating blood with immune ligands
时间窗: After 3 months
Cytokines dosage, measured by ELISA, in blood sample before and after in vitro stimulation with immune ligands after 3 months of treatment. Responders are defined by an Investigator's Global Assessment score £ 1, and by 2 or more points improvement.
Compare the dynamic blood cytokines profile by stimulating blood with immune ligands
时间窗: At baseline
Cytokines dosage, measured by ELISA, in blood sample before and after in vitro stimulation with immune ligands at baseline. Responders are defined by an Investigator's Global Assessment score £ 1, and by 2 or more points improvement.
次要结局
- Compare cytokine dosage according to the different phenotypes of patients with atopic dermatitis.(6 months)