A Phase 2 Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of SYHX1901 Tablet in Non-segmental Vitiligo Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI)
研究概览
简要总结
A 52-Week Study of SYHX1901 tablet in Adults with non-segmental vitiligo.
详细描述
SYHX1901 tablet is being evaluated for the treatment of non-segmental vitiligo. The study will enroll approximately 144 participants aged 18-65 with non-segmental vitiligo in 4 treatment arms. Participants will either receive study drug vs placebo oral tablets once daily (QD) for 24 weeks (Period A). In Period B (up to 52 weeks), participants who received placebo during the first 24 weeks will switch to study drug. Participants who received study drug during the first 24 weeks, will continue to receive study drug.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to sign an ICF, able to comprehend and comply with the study procedures.
- •Male or female subjects aged 18 to 65，inclusive.
- •Subjects with a clinical diagnosis of non-segmental vitiligo.
- •Agree to stop all other treatments for vitiligo during the study period.
- •Women of child-bearing potential must have a negative serum pregnancy test within 3 days prior to the first study agent administration.
排除标准
- •Diagnosed as other active depigmentation disease.
- •At screening or baseline visits, subject exhibits active inflammatory dermatologic disease or symptoms that in the opinion of investigators would interfere of vitiligo evaluation or response to treatment.
- •Uncontrolled thyroid function at screening as determined by the investigator.
- •Use of permanent depigmentation treatment or skin grafts.
- •Use of phototherapy, topical or systemic treatments within certain time frame prior to Day
- •Have active bacterial/virus/other pathogens infection or infestation that require medical intervention.
- •Have progressive or uncontrolled systemic disease, or other concomitant chronic disease that the investigators believe unsuitable to participate the study.
- •History of alcohol and drug abuse within one year prior to screening; History of neurological or mental disorders with diagnosis records, such as severe depression, suicidal tendencies, epilepsy, dementia, etc.
- •Have any other reasons determined by the investigator that the subject is not eligible for the study.
研究组 & 干预措施
Placebo followed by dose C of SYHX1901
Participants in this group will receive placebo orally QD for 24 weeks followed by dose C of SYHX1901 orally QD for 28 weeks.
干预措施: SYHX1901 (Drug)
SYHX1901-A
Participants in this group will receive dose A of SYHX1901 orally once daily (QD) for 52 weeks
干预措施: SYHX1901 (Drug)
SYHX1901-B
Participants in this group will receive dose B of SYHX1901 orally QD for 52 weeks
干预措施: SYHX1901 (Drug)
SYHX1901-C
articipants in this group will receive dose C of SYHX1901 orally QD for 52 weeks
干预措施: SYHX1901 (Drug)
Placebo followed by dose C of SYHX1901
Participants in this group will receive placebo orally QD for 24 weeks followed by dose C of SYHX1901 orally QD for 28 weeks.
干预措施: placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI)
时间窗: At 24 weeks
The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.5.
次要结局
- Percent Change From Baseline in F-VASI(At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks)
- Percent Change From Baseline in BSA(At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks)
- Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline)(At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks)
- Change from baseline in Overall Dermatology Life Quality Index (DLQI) score(At 8、16、24、32、40、48、52、56 weeks)
- Change from baseline in Hospital Anxiety and Depression Scale (HADS) score(At 8、16、24、32、40、48、52、56 weeks)
- Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline)(At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks)
- Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline)(At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks)