KCT0004806尚未招募未知
A Randomized, Phase I/II Trial to Evaluate the Safety and Efficacy of SCM-AGH in Subjects with Moderate to Severe Atopic Dermatitis
SCM Lifescience0 个研究点目标入组 92 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1)Subjects who are males or females aged ? 19 years
- •2)Subjects who are diagnosed as AD based on the Eichenfield revised criteria of Hannifin and Rajka that
- •a.has been present for at least 1 year before the Screening visit, and
- •b.have chronic AD symptoms continually for at least 6 months before Screening visit, and
- •c.Prior screening visit, inadequate response to existing standard of treatment (topical medications of atopic dermatitis) within 6 months or topical treatment is medically not recommended (e.g., intolerance, important side effect or due to stability risks) and no other stem cell treatment has been administered.
- •a.inability to achieve good disease control defined as mild disease or better (e.g., IGA =2) after use of at least a moderate potency TCS for at least 28 days, or for the maximum duration recommended by the product prescribing information (e.g., 14 days for super-potent TCS), whichever is shorter.
- •b.Patients who failed systemic therapies intended to treat AD within 6 months preceding screening, such as cyclosporine, methotrexate, and corticosteroids will also be considered as a surrogate for having inadequate response to topical therapy.
- •3)Subjects who have moderate to severe AD (EASI =16) at the Screening and Baseline visit
- •4)Subjects who have IGA score = 3 at the Screening and Baseline visits
- •5)Subjects who have at least 10% of total body surface area affected by AD at the Screening visit and Baseline visit
- •6)Subjects who can give written informed consent
- •7)Subjects must have applied a stable dose of a bland emollient to affected areas for at least 7 days before the Baseline visit and be willing to continue for the duration of the study
- •8)Male subjects must abstain from heterosexual activities or agree to use a condom through 30 days after the final dose of study drug. Women of childbearing potential (WOCBP) must abstain from heterosexual activities or agree to use effective contraception through 30 days after the final dose of study drug.
- •Effective contraception for males and/or WOCBP includes:
- •-Blockage methods – spermicides and condoms/spermicides and vaginal diaphragm for contraception, vaginal sponges or cervical cap (where available)
- •-Oral contraceptives (the pill”) for at least 1 month
- •-Depot or injectable birth control or implantable contraception (e.g., Implanon)
- •-Intrauterine device
- •-Documented evidence of surgical sterilization at least 6 months prior to Screening visit i.e., tubal ligation or hysterectomy for women or vasectomy for men
- •-Women who are post-menopausal, as documented by measurement of follicle stimulating hormone
排除标准
- •1.Systemic infection or local infection requiring prohibited medications at screening
- •2.Subjects who underwent the following treatments within 4 weeks prior to Baseline visit or are scheduled to receive the following treatments within 4 weeks from Baseline at the discretion of investigator:
- •a.Use of immunosuppressive/ immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-?, Janus kinase inhibitors, azathioprine, methotrexate)
- •b.Phototherapy for AD
- •c.Any other systemic therapy used to treat AD or symptoms of AD (approved or off-label use)
- •3.Use of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within at least 2 weeks prior to baseline
- •4.History of anaphylaxis to any biologic therapy or vaccine
- •5.History of Guillain-Barré syndrome
- •6.Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained
- •7.Any allergen immunotherapy within 4 months prior to or throughout the study
- •8.A value outside the specified range of 90 mmHg – 140 mmHg for systolic blood pressure and 50 mmHg –90 mmHg for diastolic blood pressure (both inclusive) at Screening (can be repeated once at screening as per Principal Investigator’s [PI’s] discretion).
- •9.Receipt of live vaccines within 12 weeks prior to Baseline visit
- •10.Receipt of the following biologics:
- •a.Cell depleting agents such as rituximab: within 6 months prior to Baseline or within time to return of lymphocyte count to normal, whichever is longer
- •b.Other biologics: within 5 half-lives or within 16 weeks prior to Baseline, whichever is longer
- •11.Active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus (HCV)
- •12.Female subjects who are pregnant or lactating or female subjects of childbearing potential who have a pregnancy plan or do not agree to use acceptable methods of contraception, excluding females who are in post-menopausal or surgically infertile (bilateral tubal ligation, bilateral oophorectomy or complete hysterectomy)
- •13.Receipt of any investigational drugs within 8 weeks prior to Baseline, within 5 half lives of investigational drug or participated in any clinical trials of medical device
- •14.Diagnosed with either primary or recurrent malignancy within 5 years from Screening
- •15.Liver malfunctions with aspartate aminotransferase (AST) / alanine aminotransferase (ALT) level >2 x upper limit of normal (ULN) at Screening
- •16.Renal malfunctions with creatinine level >2 x ULN at Screening
- •17.QTc prolongation >470 msec or other significant electrocardiogram (ECG) abnormality noted within 14 days of treatment
- •18.History of hypersensitivity to antibiotics and antimicrobial agents
- •19.History of significant AEs during stem cell therapies
- •20.Allergic or hypersensitivity reaction to the IP, drug of similar class or ingredients [bovine serum, dimethyl sulfoxide (DMSO)]
- •21.Failure to comply with emollient application instructions prior to baseline, per diary
- •22.Subjects who, in the opinion of the investigator, have other unstable intercurrent diseases that confound safety and efficacy assessment
- •23.Planned or anticipated major surgical procedure during the subject's participation in this study
- •24.Subjects who, in the opinion of the investigator, would be non-compliant with the visit schedule of study procedures
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