A Multicenter, Randomized, Single-Blind, Phase Ⅱ Clinical Trial and Open Label Long-term Observation Study of ADSTEM Inj. to Evaluate the Safety and Efficacy in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 118
- 试验地点
- 12
- 主要终点
- EASI-50
研究概览
简要总结
A Multicenter, Randomized, Single-Blind, Phase Ⅱ Clinical Trial and Open Label Long-term Observation Study of ADSTEM Inj. to Evaluate the Safety and Efficacy in Patients with Moderate to Severe Subacute and Chronic Atopic Dermatitis.
The aim of this study is to evaluate the safety and efficacy of ADSTEM Inj. against Placebo in the treatment of atopic dermatitis in patients with moderate to severe acute and chronic atopic.
详细描述
This clinical trial is designed with multi-organization, random assignment, single-blind, second-phase clinical trials and open long-term follow up studies, and is intended for patients with secondary or above subacuteal and chronic atopic dermatitis. If the test subjects voluntarily agree in writing to participate in this clinical trial, they shall conduct the examination and examination required for four weeks prior to administration of the investigational product (visit 1) in accordance with the clinical trial plan. As a result of the suitability assessment of the test subjects, those who comply with the inclusion/exclusion criteria, adipose tissue will be collected through the liposuction method and randomly assigned to each arms. Subjects who are eligible for administration of the investigational product on the day of administration (visit 2) under the investigator's judgment are given intravenous administration of the clinical trial medication once at the date of administration (visit 2, visit 3) and follow-up inspection is conducted at 4 weeks, 8 weeks, 12 weeks, and 16 weeks after the first administration of the investigational product and safety and efficacy assessments are conducted for a total of 16 weeks. The test subjects assigned to the placebo group shall be compensated by administering a experimental drug on demand after the visit 6. It is a principle to administer the test drug prepared from the previously obtained adipose tissue, and it is possible to carry out further adipose tissue collection if necessary. However, no safety and efficacy assessments of compensatory treatments will be collected. Safety and efficacy will be analyzed after all the subjects has completed visit 6. For the experimental group only, long-term observation study for safety assessment is conducted at the point of 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months, and 60 months after the second administration of the investigational product for a total of 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and efficacy outcome assessor will be blinded
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At the time of visit 1, only men and women aged between 19 and 70
- •Patients with atopic dermatitis meeting the Hanifin and Rajka diagnostic criteria
- •Subacute and chronic patients with symptoms of atopic dermatitis lasting at least 6 months
- •Patients with moderate to severe atopic dermatitis who meet all of the following criteria
- •SCORAD score ≥ 20points
- •EASI score ≥ 12points
- •Patients with inadequate response to the stable use of topical atopic dermatitis treatment within 24 weeks prior to study initiation, or those who are unable to administer topical atopic dermatitis treatment due to safety reasons
- •Patients who voluntarily agreed in writing to participate in this clinical trial
排除标准
- •Patients with systemic infection symptoms at the time of clinical trials
- •Patients with HIV, HBV, HCV, Syphilis test positive
- •Patients with uncontrolled asthma disease at the time of clinical trial participation
- •Patients who were considered inevitable to receive the medication from 1 month prior to administration of the clinical trial drug to visit 6 such as Immune function modifier(tacrolimus, pimecrolimus, cyclosporine, etc.), and high-frequency topical steroids in Groups 1 to 5, systemic steroids, systemic photochemotherapy, medication that are thought to affect other immune functions (such as immunoglobulin therapy like dupilumab, tralloquinap and desensitization therapy, etc.)
- •Women who are pregnant, breastfeeding or have a pregnancy plan up to visit 6 or who do not use available contraceptive methods (women of childbearing age must be negative in screening pregnancy test)
- •If patients are the male subject, Those who do not agree to have a contraception during the clinical trial (If the male subject or female partner is infertile, the above-mentioned contravention method is unnecessary)
- •Patients participating in other clinical trials or participating in other clinical trials within the last 30 days
- •Patients who have experienced significant adverse events during treatment with stem cell therapies
- •Patients with stem cell therapy doses or history of participating in clinical trials
- •Patients with a history of hypersensitivity to antibiotics and antifungal agents used in the manufacture of medicines for clinical trials
- •Patients with renal dysfunction whose creatinine level is more than twice the normal upper limit in the screening test
- •Patients with hepatic dysfunction whose AST (Aspartate Amino Transaminase) and ALT (Alanine Amino Transaminase) levels are more than three times the normal upper limit
- •Patients who are not suitable for this clinical trial under the judgment of the other examiners
研究组 & 干预措施
ADSTEM Inj.
ADSTEM Inj. hAD-MSC 1.0x10^8 cells
干预措施: ADSTEM Inj. (Biological)
Placebo
0.9% Normal Saline Inj.
干预措施: Placebo (Other)
结局指标
主要结局
EASI-50
时间窗: 16 weeks
Percentage of subjects whose EASI score decreased by 50% or more at 16 weeks compared to baseline
次要结局
- SCORAD score(4, 8, 12, 16 weeks)
- SCORAD-75(4, 8, 12, 16 weeks)
- Severity(4, 8, 12, 16 weeks)
- IGA -1 or more grade(4, 8, 12, 16 weeks)
- EASI-75(4, 8, 12, 16 weeks)
- EASI-50(4, 8, 12 weeks)
- SCORAD subgroup(4, 8, 12, 16 weeks)
- IGA -2 or more grade(4, 8, 12, 16 weeks)
- EASI score(4, 8, 12, 16 weeks)
- SCORAD-50(4, 8, 12, 16 weeks)
- IGA grade(4, 8, 12, 16 weeks)
- Total IgE(4, 8, 12, 16 weeks)
- PGE2 and ECP(4, 8, 12, 16 weeks)
- Remedy used subjects(4, 8, 12, 16 weeks)
- Immune cytokine(4, 8, 12, 16 weeks)
- Remedy used days and frequency(4, 8, 12, 16 weeks)