NCT06625177进行中（未招募）1 期
A Phase 1b, Open-Label Trial to Assess Safety and Exploratory Efficacy of TEV-53408 in Participants With Vitiligo
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 66
- 试验地点
- 19
- 主要终点
- Number of Participants With at Least One Serious Treatment-Emergent Adverse Event
研究概览
简要总结
The purpose of the trial is to evaluate the safety of TEV-53408 when given as an under the skin injection to adults with vitiligo. Vitiligo is a condition where patches of skin lose color (pigment) and turn white.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •The participant has a diagnosis of active or stable vitiligo for at least 3 months.
- •The participant has a body mass index (BMI) within the range of 18.5 to 40.0 kg/m2
- •A female participant is eligible if she is not pregnant or breastfeeding AND is a woman of nonchildbearing potential OR is a women of childbearing potential using a contraceptive method that is highly effective AND agrees not to donate eggs for the purpose of reproduction for the required period
- •A male participant is eligible if he agrees to refrain from donating sperm PLUS remain abstinent from heterosexual intercourse OR use a male condom with a female partner for the required period
- •The participant is capable of giving signed, informed consent
- •The participant agrees to discontinue all agents and procedures used to treat vitiligo during the treatment period in the trial
- •If receiving permitted concomitant medications for any reason other than vitiligo, the participant must be on a stable regimen,
- •The participant must agree to avoid prolonged exposure to the sun, must use sunscreen, and must not use tanning booths, sun lamps, or other ultraviolet light sources
- •NOTE - Additional criteria apply, please contact the investigator for more information
排除标准
- •The participant suffers from vitiligo induced by exposure to chemicals or immunotherapy known to induce vitiligo
- •The participant has other autoimmune diseases for which systemic immunotherapy is or may be warranted
- •The participant has current or history of malignancy or treatment of malignancy in the last 5 years, excluding fully-treated basal cell carcinoma
- •Infectious disease
- •The participant has used skin bleaching treatments for past treatment of vitiligo or other pigmented areas
- •The participant has a history of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo. After 2 or more years since last melanocyte-keratinocyte transplantation procedure, the participants may be included in the trial.
- •The participant has donated or received any blood or blood products (white blood cells, platelets, etc) within the 60 days prior to screening or has donated blood or blood products on 2 or more occasions within the 6 months prior to IMP administration, or has donated plasma within 7 days before the screening visit, or has planned donations during the trial
- •The participant has current or history of alcohol or other substance abuse
- •NOTE- Additional criteria apply, please contact the investigator for more information
研究组 & 干预措施
Cohort 1
Experimental
Dose A
干预措施: TEV-53408 (Drug)
Cohort 2
Experimental
Dose A
干预措施: TEV-53408 (Drug)
Cohort 3
Experimental
Dose B
干预措施: TEV-53408 (Drug)
结局指标
主要结局
Number of Participants With at Least One Serious Treatment-Emergent Adverse Event
时间窗: Up to Week 40
Number of Participants With at Least One Treatment-Emergent Adverse Event
时间窗: Up to Week 40
Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest
时间窗: Up to Week 40
Number of Participants With at Least One Treatment-Related Adverse Event
时间窗: Up to Week 40
Number of Participants who Discontinued Treatment due to an Adverse Event
时间窗: Up to Week 40
次要结局
- Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest(Week 40 to Week 80)
研究者
研究点 (19)
Loading locations...
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