A Long-Term Safety Follow-Up Study of SCM AGH in Subjects Who Participated in the ADT2002 Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Long-term concomitant medication assessment of SCM-AGH in subjects with moderate to severe Atopic Dermatitis(AD)
研究概览
简要总结
This is a long-term safety follow-up study of the Phase I/II multicenter study of SCM-AGH in subjects with moderate to severe atopic dermatitis. subjects will be followed up for a maximum period of 240 weeks after the first dose of investigational product. Only subjects previously enrolled in protocol ADT2002 (ClinicalTrials.gov ID: NCT04179760) will be eligible for this long-term follow-up protocol.
详细描述
Subjects who meet all eligibility criteria for Long Term Follow Up(LTFU) study participation at the ADT2002 End of Treatment(EOT) visit may continue LTFU for a maximum period of up to 240 weeks post first dose of investigational product. No additional dosing will be administered on this LTFU protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who provide written informed consent
- •Subjects who have received at least 1 dose of SCM-AGH in the ADT2002 study
- •Subjects who are willing to comply with the visit schedule and study requirements for reporting relevant information to the site.
排除标准
- •Subjects who are unable to comply with the visit schedule prior to Week 240 after first dose of SCM AGH
结局指标
主要结局
Long-term concomitant medication assessment of SCM-AGH in subjects with moderate to severe Atopic Dermatitis(AD)
时间窗: Up to 5 Years
Number of occurrence of use of medications related to adverse events
Long-term safety assessment of SCM-AGH in subjects with moderate to severe Atopic Dermatitis(AD)
时间窗: Up to 5 Years
Number of occurrence of treatment-related adverse events (≥ Grade 3 in severity (NCI-CTCAE, v5.0))
次要结局
- Outcome of unresolved Adverse Events(AEs) from ADT2002 study(Up to 5 Years)
- Number of occurrence of Abnormal, clinically significant in hematology laboratory results(Up to 5 Years)
- Number of occurrence of Abnormal, clinically significant in chemistry laboratory results(Up to 5 Years)
- Number of occurrence of Abnormal, clinically significant in urinalysis laboratory results(Up to 5 Years)
- Clinically important physical examination findings(Up to 5 Years)