NCT06386744已完成2 期
Pilot Study of SGX945 (Dusquetide) in the Treatment of Aphthous Ulcers in Behcet's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Soligenix
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Number of Genital Ulcers
研究概览
简要总结
This is a clinical study to see if dusquetide can treat flares of oral and genital ulcers caused by Behcet's Disease. Study participants will receive an infusion of dusquetide twice a week for 4 weeks (8 treatments total), with weekly follow-up visits for an additional 4 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have a clinical diagnosis of Behcet's Disease meeting the International Study Group criteria.
- •Participants must have at least two oral ulcers and/or one genital ulcer on the day of randomization.
- •Participants willing to follow the clinical protocol and voluntarily give their written informed consent.
- •Female participants not pregnant or nursing and willing to undergo a pregnancy test prior to treatment initiation and at the end of the treatment period.
排除标准
- •Pregnancy or mothers who are breast-feeding.
- •All women of childbearing potential (WOCBP) and males with female partners who are WOCBP not willing to agree to the use of effective contraception during the trial.
- •Evidence of significant renal, hepatic, hematologic or immunologic disease.
- •Use of any investigational medication within 4 weeks prior to enrollment or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer).
- •Having received concomitant immune modulating therapy (except colchicine) within:
- •Ten days prior to enrollment for azathioprine and mycophenolate mofetil,
- •Four weeks (28 days) prior to enrollment for cyclosporine, methotrexate, cyclophosphamide, thalidomide and dapsone
- •Oral and topical corticosteroids must have been tapered as appropriate and discontinued 3 days prior to day of enrollment
- •At least 5 terminal half-lives for all biologics including, but not limited to, those listed below; within: i. Four weeks prior to enrollment for etanercept; ii. Eight weeks prior to enrollment for infliximab; iii. Ten weeks prior to enrollment for adalimumab, golimumab, certolizumab, abatacept, and tocilizumab; iv. Six months prior to enrollment for secukinumab.
- •Having received oral or parenteral corticosteroids within 6 weeks (42 days) prior to enrollment.
- •Having received apremilast (Otezla) within 4 weeks prior to enrollment.
- •Presence of non- Behcet's Disease related genital ulcers, including both infectious and non-infectious etiologies.
- •Active organ involvement requiring immunosuppressive treatment.
研究组 & 干预措施
SGX945
Experimental
This is an open-label study and all participants will receive SGX945.
干预措施: Dusquetide (Drug)
结局指标
主要结局
Number of Genital Ulcers
时间窗: 4 weeks
The number of genital ulcers will be counted at baseline and each visit during the treatment period.
Number of Oral Ulcers
时间窗: 4 weeks
The number of oral ulcers were counted at baseline and each visit during the treatment period.
次要结局
- Pain of Oral Ulcers(4 weeks)
- Pain of Genital Ulcers(4 weeks)
- Change in Pain of Oral Ulcers From Baseline to End of Treatment(4 weeks)
- Change in Pain of Genital Ulcers From Baseline to End of Treatment(4 weeks)
研究者
研究点 (1)
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