Actively Recruiting
A Phase 2 Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of SYHX1901 Tablet in Non-segmental Vitiligo Patients
Led by CSPC Ouyi Pharmaceutical Co., Ltd. · Updated on 2024-07-22
144
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
C
CSPC Ouyi Pharmaceutical Co., Ltd.
Lead Sponsor
Z
Zhongqi Pharmaceutical Technology (Shijiazhuang) Co. Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating SYHX1901 tablet for treating adults aged 18 to 65 with non-segmental vitiligo. This phase 2 randomized, double-blind, placebo-controlled study aims to assess the efficacy and safety of SYHX1901 compared to a placebo. The trial is sponsored by CSPC Ouyi Pharmaceutical Co., Ltd. and involves approximately 144 participants divided into four treatment groups. Participants will be assigned to receive either one of three different doses of SYHX1901 tablets or a placebo once daily for 24 weeks (Period A). After this, in Period B lasting up to 52 weeks, those who initially took the placebo will switch to the highest dose of SYHX1901, while participants already receiving SYHX1901 will continue their assigned dose. The study involves oral administration of the study drug daily throughout the trial. During the study, participants will undergo regular assessments including measurements of facial vitiligo area using the Facial-Vitiligo Area Scoring Index (F-VASI) at 24 weeks and other time points up to 56 weeks. Additional evaluations include total vitiligo area scoring, body surface area affected, and quality of life questionnaires such as the Dermatology Life Quality Index and Hospital Anxiety and Depression Scale. Safety and adherence will be monitored throughout the 52-week treatment period.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of SYHX1901 Tablet in Non-segmental Vitiligo Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to sign an informed consent form and able to follow study procedures
- Male or female aged 18 to 65 years inclusive
- Clinical diagnosis of non-segmental vitiligo
- Agree to stop all other vitiligo treatments during the study
- Women of child-bearing potential must have a negative pregnancy test within 3 days before first study drug dose
You will not qualify if you...
- Diagnosed with other active depigmentation diseases
- Active inflammatory skin disease or symptoms interfering with vitiligo evaluation
- Uncontrolled thyroid function at screening
- Previous use of permanent depigmentation treatment or skin grafts
- Recent use of phototherapy, topical, or systemic treatments as specified
- Active infections requiring medical treatment
- Progressive or uncontrolled systemic or chronic diseases unsuitable for study participation
- History of alcohol or drug abuse within one year prior to screening
- History of severe neurological or mental disorders
- Any other reason deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants receive SYHX1901 tablet or placebo orally once daily. After 24 weeks, participants initially receiving placebo switch to SYHX1901 tablet, continuing treatment up to 52 weeks.
Regular visits scheduled throughout treatment period
Trial Site Locations
Total: 1 location
1
Clinical Trials Information Group
Shijiazhuang, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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