Status:
RECRUITING
A Study to Evaluate the Efficacy and Safety of SYHX1901 Tablet in Non-segmental Vitiligo Patients
Lead Sponsor:
CSPC Ouyi Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Zhongqi Pharmaceutical Technology (Shijiazhuang) Co. Ltd.
Conditions:
Non-segmental Vitiligo
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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. Partici...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06511739
Start Date
May 27 2024
End Date
October 1 2025
Last Update
July 22 2024
Active Locations (1)
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1
Clinical Trials Information Group
Shijiazhuang, China