NCT07251595招募中2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR0302 Tablets as Single Therapy or in Combination With SHR0302 Base Gel in the Treatment of Patients With Non-segmental Vitiligo
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- The percentage change in the facial vitiligo area score index (F-VASI) from the baseline.
研究概览
简要总结
The study is being conducted to evaluate the efficacy, and safety of SHR0302 tablets as single therapy or in combination with SHR0302 Base gel for patients with non-segmental vitiligo.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent form before the clinical trial.
- •On the day of signing the informed consent form, the age must be between 18 and 75 years old (inclusive), and it can be either male or female.
- •The subjects and their partners had no intention of having children during the study period and within one month after the administration of the drug, did not donate sperm or eggs, and voluntarily adopted effective contraceptive measures. The serum pregnancy test results of the female subjects must be negative and they must not be in the lactation period.
- •During the screening process, it was clinically diagnosed as non-segmental vitiligo.
- •Throughout the entire research process, the participants agreed to stop using all treatments related to vitiligo as well as any cosmetic products with therapeutic effects.
排除标准
- •Subjects diagnosed with segmental, mixed or undifferentiated vitiligo; or subjects previously diagnosed with other skin pigmentation disorders.
- •When the facial skin lesions caused by vitiligo cover more than 33% of the area with white hair.
- •During the screening period or at the baseline, there were other active skin lesions or skin infections that might interfere with the use of the study drug or the evaluation of the drug's efficacy.
- •Subjects with a history of related infections/communicable diseases or infection/contagion history.
- •Known or suspected history of immunosuppression.
- •Tuberculosis (TB) or latent tuberculosis infection.
- •Positive for human immunodeficiency virus antibody HIV-Ab, positive for syphilis-specific antibody, positive for hepatitis C virus antibody HCV-Ab, or hepatitis B virus (HBV) infection.
- •Subjects who have malignant tumors or have a history of malignant tumors.
- •Abnormal thyroid function, with a history of thrombotic diseases within the previous 12 months, and having experienced a cardiovascular or cerebrovascular event that required hospitalization within the previous 12 months.
- •There are serious abnormalities in the cardiovascular, mental, renal, liver, immune, gastrointestinal, urogenital, nervous, skeletal-muscular, skin, sensory, endocrine or hematological systems.
- •Pregnant women, lactating women, or female participants who plan to become pregnant during the study period.
- •Those who are known to be allergic to the test drug or any component of the test drug.
研究组 & 干预措施
SHR0302 tablets in low dose group
Experimental
干预措施: SHR0302 Tablets (Drug)
SHR0302 tablets in low dose group
Experimental
干预措施: SHR0302 Base Placebo Gel (Drug)
SHR0302 tablets in high dose group
Experimental
干预措施: SHR0302 Tablets (Drug)
SHR0302 tablets in high dose group
Experimental
干预措施: SHR0302 Base Placebo Gel (Drug)
SHR0302 tablets + SHR0302 Base gel group
Experimental
干预措施: SHR0302 Tablets (Drug)
SHR0302 tablets + SHR0302 Base gel group
Experimental
干预措施: SHR0302 Base Gel (Drug)
SHR0302 placebo tablets + SHR0302 Base placebo gel group
Placebo Comparator
干预措施: SHR0302 Placebo Tablets (Drug)
SHR0302 placebo tablets + SHR0302 Base placebo gel group
Placebo Comparator
干预措施: SHR0302 Base Placebo Gel (Drug)
结局指标
主要结局
The percentage change in the facial vitiligo area score index (F-VASI) from the baseline.
时间窗: At Week 24.
次要结局
- The proportion of subjects who achieved a moderate improvement (2) in the overall impression (T-PaGIC-V) of generalized vitiligo.(Up to 48 weeks.)
- The percentage change in F-VASI compared to the baseline.(Up to 48 weeks.)
- The percentage change in the total body vitiligo area score index (T-VASI) compared to the baseline.(Up to 48 weeks.)
- The proportion of subjects who achieved an improvement of at least 50%/75%/90% compared to the baseline on the F-VASI (F-VASI 50/75/90 response).(Up to 48 weeks.)
- The proportion of subjects who achieved at least a 50%/75%/90% improvement in T-VASI compared to the baseline (T-VASI 50/75/90 response).(Up to 48 weeks.)
- The absolute change in facial vitiligo area (F-BSA) compared to the baseline.(Up to 48 weeks.)
- The percentage change in facial vitiligo area (F-BSA) compared to the baseline.(Up to 48 weeks.)
- The percentage change the total body vitiligo area (T-BSA) compared to the baseline.(Up to 48 weeks.)
- The absolute change the total body vitiligo area (T-BSA) compared to the baseline.(Up to 48 weeks.)
- The proportion of subjects who achieved a significant improvement (4) on the Vitiligo Visual Scale (VNS).(Up to 48 weeks.)
- The proportion of subjects who achieved a complete improvement (5) on the Vitiligo Visual Scale (VNS).(Up to 48 weeks.)
- The absolute values of the changes in the vitiligo-specific quality of life scale (VitiQoL) compared to the baseline.(Up to 48 weeks.)
- The percentages of the changes in the vitiligo-specific quality of life scale (VitiQoL) compared to the baseline.(Up to 48 weeks.)
- The proportion of subjects who achieved the facial - vitiligo physician global assessment (F-PhGVA) of no depigmentation (0).(Up to 48 weeks.)
- The proportion of subjects who achieved the facial - vitiligo physician global assessment (F-PhGVA) of almost no depigmentation (1).(Up to 48 weeks.)
- The proportion of subjects who achieved the overall assessment of vitiligo by dermatologists (T-PhGVA) as no depigmentation (0).(Up to 48 weeks.)
- The proportion of subjects who achieved the overall assessment of vitiligo by dermatologists (T-PhGVA) as almost no depigmentation (1).(Up to 48 weeks.)
- The proportion of subjects who achieved a significant improvement (1) in the facial vitiligo condition as perceived by the overall impression (F-PaGIC-V).(Up to 48 weeks.)
- The proportion of subjects who achieved a moderate improvement (2) in the facial vitiligo condition as perceived by the overall impression (F-PaGIC-V).(Up to 48 weeks.)
- The proportion of subjects who achieved a significant improvement (1) in the overall impression (T-PaGIC-V) of generalized vitiligo.(Up to 48 weeks.)
- The plasma concentration of SHR0302.(Week 12 and Week 24.)
- The relative change in serum CXCL-9 level before administration compared to the baseline value.(At Week 4, 12, 24, 32, and 48.)
- The relative change in serum CXCL-10 level before administration compared to the baseline value.(At Week 4, 12, 24, 32, and 48.)
研究者
研究点 (1)
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