NCT06454461招募中不适用
Efficacy of Upadacitinib After Autologous Non-cultured Epidermal Cell Suspension Transplantation in Vitiligo Participants -- a Pilot, Random, Observer Blinded, Comparative Study
Jilin University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- T-VASI
研究概览
简要总结
The goal of this clinical trial is to investigate the efficacy of upadacitinib after NECS in participants with vitiligo. The main question it aims to answer is: whether the short time use of upadacitinib after NECS will improve NECS efficacy. Participants in the experimental group will receive upadacitinib after NECS, while Participants in the control group will receive NECS only.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who can sign the informed consent.
- •Participants aged 18-60 years (both men and women) at the time of signing the informed consent.
- •Non-segmented vitiligo
- •Vitiligo affected area should meet the following two criteria:
- •(1) containing the target area (relatively flat vitiligo lesions except of the hands and feet, perineum, lips, joints, perianal); (2) total BSA involvement ≤30%
- •Clinically stable for more than one year (stable refers to the original lesion no longer expanding and no new lesions appearing).
- •All fertile women had to be willing to use at least one highly effective method of contraception from the time they signed informed consent through the final follow-up visit.
- •Participants must be willing and able to adhere to scheduled visits and scheduled treatments, laboratory tests, and other study procedures.
排除标准
- •Any active skin lesions (e.g. psoriasis, dermatitis, skin ulceration, etc.) or skin infections (bacterial, fungal, viral, etc.) which may interfere with the assessment of vitiligo at screening.
- •Participants had a clinically significant infection (requiring hospitalization and parenteral treatment with antibiotics, antiviral agents, or antifungal agents for more than 3 days) within one month of the screening period or an active infection for which they were receiving treatment during the screening period.
- •Infected with HBV or HCV or HIV or syphilis.
- •Participants had active Tuberculosis or were receiving anti-Tuberculosis treatment, or had received anti-Tuberculosis treatment within 1 year.
- •Hepatic dysfunction (Total bilirubin ≥ 2 × ULN, AST≥2 × ULN, ALT ≥ 2 × ULN) at screening.
- •Renal impairment ( eGFR of <45 mL/min or receiving dialysis) at screening
- •Participants with malignancy or with a history of malignancy other than adequately treated or resected nonmetastatic basal cell carcinoma or squamous cell carcinoma.
- •Participants with current thyroid disease or undergoing thyroid replacement therapy.
- •Participants with a history of mental illness, such as anxiety or depression, who were assessed by the investigator to be unfit to participate in the study.
- •Pregnant or lactating female participants.
- •Participants who received any laser or phototherapy for vitiligo within 4 weeks before baseline.
- •Participants who received oral or systemic medications (e.g., glucocorticoids, cyclosporine, methotrexate, tacrolimus, Chinese medicine, etc.) aimed at controlling/improving vitiligo symptoms within 4 weeks before baseline.
- •Participants who had received JAK inhibitor therapy (including, but not limited to Ruxolitinib, Tofacitinib, Baricitinib, Upadacinib, etc.) within 12 weeks or 5 half-lives before baseline, whichever was longer.
- •Participants who had used any biologic agent within 12 weeks or 5 half-lives before baseline, whichever was longer.
- •Participants who had been enrolled in another intervention clinical trial within 4 weeks before the baseline visit or who were within 5 half-lives of the last dose of the intervention drug at baseline.
- •Any other condition that the investigator considered might render the subject ineligible for inclusion in the study.
研究组 & 干预措施
A
Experimental
upadacitinib after autologous non-cultured epidermal cell suspension transplantation
干预措施: Upadacitinib 15 MG (Drug)
结局指标
主要结局
T-VASI
时间窗: 6 months
Percentage of change from baseline in target lesion Vitiligo Area Scoring Index (T-VASI) at 6 months
次要结局
未报告次要终点
研究者
Shanshan Li
Dr.
Jilin University
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Tucatinib in Patients With Locally Advanced or Metastatic HER2-positive Breast Cancer Who Received at Least Two Prior Anti-HER2 Treatment Regimens.HER2-positive Breast CancerNCT05253911iOMEDICO AG49
已完成
2 期
N-Acetyl Cysteine Plus Naltrexone in Methamphetamine DependenceMethamphetamine DependenceNCT00332605University of Chicago45
已完成
2 期
N-Acetyl Cysteine in Pathologic Skin PickingPathologic Skin PickingPsychogenic ExcoriationDermatillomaniaNeurotic ExcoriationNCT01063348University of Chicago66
已完成
不适用
Acetylated Natural Nucleotides in Treating Hand-foot SyndromeHand-foot SyndromeNCT04592731Nan xu21
终止
2 期
Clinical Trial of N-acetylcysteine Versus Placebo Efficacy in the Cannabis WithdrawalCannabis DependenceCannabis AbuseNCT01439828Assistance Publique - Hôpitaux de Paris6