NCT07734415Enrolling By Invitation2 期
A Long-term Extension Study to Evaluate the Safety and Efficacy of Subcutaneous IMG-007 in Participants of a Previous IMG-007 Moderate-To-Severe Atopic Dermatitis Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- Inmagene LLC
- 入组人数
- 400
- 试验地点
- 23
- 主要终点
- Evaluate the safety of long-term treatment with IMG-007 in participants with moderate-to-severe atopic dermatitis
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of long-term treatment with IMG-007 in participants with moderate-to-severe atopic dermatitis (AD)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolling by invitation participants with moderate to severe AD who have completed IMG-007-203
排除标准
- 未提供
研究组 & 干预措施
IMG-007 Dose
Experimental
Subcutaneous injection as per protocol.
干预措施: IMG-007 (Drug)
结局指标
主要结局
Evaluate the safety of long-term treatment with IMG-007 in participants with moderate-to-severe atopic dermatitis
时间窗: Baseline, Week 44
Incidence and severity of TEAEs, including treatment-emergent SAEs, AESIs, and AEs leading to discontinuation
次要结局
- Characterize the safety of long-term treatment with IMG-007 based on pulse rate (beats per minute)(Baseline, Week 44)
- Characterize the safety of long-term treatment with IMG-007 based on body temperature (Celsius)(Baseline, Week 44)
- Characterize the safety of long-term treatment with IMG-007 based on respiratory rate (breaths per minute)(Baseline, Week 44)
- Characterize the safety of long-term treatment with IMG-007 based on blood pressure (systolic and diastolic) (mmHg)(Baseline, Week 44)
- Number of Participants With Clinically Significant Abnormal (defined by rate, rhythm, morphology, and conduction abnormalities) ECG Findings (unit is number of participants).(Baseline, Week 44)
- Characterize the safety of long-term treatment with IMG-007, as assessed by hematology(Baseline, Week 44)
- Characterize the safety of long-term treatment with IMG-007, as assessed by blood chemistry(Baseline, Week 44)
- Characterize the safety of long-term treatment with IMG-007, as assessed by urinalysis(Baseline, Week 44)
- Evaluate the effect of long-term treatment with IMG-007 on disease activity as assessed by Eczema Area and Severity Index (EASI)(Baseline, Week 44)
- Evaluate the effect of long-term treatment with IMG-007 on disease activity as assessed by Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)(Baseline, Week 44)
研究者
研究点 (23)
Loading locations...
相似试验
Enrolling By Invitation
不适用
"Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDNHypertensionNCT07273877Shanghai Golden Leaf MedTec Co. Ltd1,000
Enrolling By Invitation
2 期
Open-Label, Long-Term, Extension Study of Infigratinib in Children With HypochondroplasiaHypochondroplasiaNCT07393373QED Therapeutics, a BridgeBio company135
尚未招募
2 期
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African ChildrenNCT07320716GlaxoSmithKline528
招募中
1 期
A Study in Adults with Parkinson's Disease and a Lack of Interest or Motivation to Test How Different Doses of IRL757 Given for Multiple Days are Tolerated in the Body2025-523612-37-00Integrative Research Laboratories Sweden AB55
招募中
3 期
An Open-Label Extension Study of Fazirsiran2023-503497-21-00Takeda Development Center Americas Inc.18