RecruitingPhase 2NCT06511739
A Study to Evaluate the Efficacy and Safety of SYHX1901 Tablet in Non-segmental Vitiligo Patients
A Phase 2 Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of SYHX1901 Tablet in Non-segmental Vitiligo Patients
Sponsor
CSPC Ouyi Pharmaceutical Co., Ltd.
Enrollment
144 participants
Start Date
May 27, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
A 52-Week Study of SYHX1901 tablet in Adults with non-segmental vitiligo.
Eligibility
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria5
- 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.
Exclusion Criteria9
- 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 Day1.
- 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.
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Interventions
DRUGSYHX1901
SYHX1901 tablet
DRUGplacebo
Oral tablet
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06511739
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