Clinical trial NCT06511739: A Study to Evaluate the Efficacy and Safety of SYHX1901 Tablet in Non-segmental Vitiligo Patients
Official title: A Phase 2 Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of SYHX1901 Tablet in Non-segmental Vitiligo Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-segmental Vitiligo
Lead sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Zhongqi Pharmaceutical Technology (Shijiazhuang) Co. Ltd.
First posted: 2024-07-22
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assigned
Primary purpose: TREATMENT

Brief summary: A 52-Week Study of SYHX1901 tablet in Adults with non-segmental vitiligo.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Willing to sign an ICF, able to comprehend and comply with the study procedures.
2. Male or female subjects aged 18 to 65，inclusive.
3. Subjects with a clinical diagnosis of non-segmental vitiligo.
4. Agree to stop all other treatments for vitiligo during the study period.
5. Women of child-bearing potential must have a negative serum pregnancy test within 3 days prior to the first study agent administration.

Exclusion Criteria:

1. Diagnosed as other active depigmentation disease.
2. 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.
3. Uncontrolled thyroid function at screening as determined by the investigator.
4. Use of permanent depigmentation treatment or skin grafts.
5. Use of phototherapy, topical or systemic treatments within certain time frame prior to Day1.
6. Have active bacterial/virus/other pathogens infection or infestation that require medical intervention.
7. Have progressive or uncontrolled systemic disease, or other concomitant chronic disease that the investigators believe unsuitable to participate the study.
8. 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.
9. Have any other reasons determined by the investigator that the subject is not eligible for the study.

Primary outcomes:
measure: Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI)
timeFrame: At 24 weeks
Secondary outcomes:
measure: Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline)
timeFrame: At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks
measure: Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline)
timeFrame: At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks
measure: Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline)
timeFrame: At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks
measure: Percent Change From Baseline in F-VASI
timeFrame: At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks
measure: Percent Change From Baseline in BSA
timeFrame: At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks
measure: Change from baseline in Overall Dermatology Life Quality Index (DLQI) score
timeFrame: At 8、16、24、32、40、48、52、56 weeks
measure: Change from baseline in Hospital Anxiety and Depression Scale (HADS) score
timeFrame: At 8、16、24、32、40、48、52、56 weeks
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Clinical Trials Information Group
Study officials:
References: