Evaluating SYHX1901 for treating non-segmental vitiligo

A Phase 2 Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of SYHX1901 Tablet in Non-segmental Vitiligo Patients

This study is testing a new tablet treatment called SYHX1901 to see if it can help adults with non-segmental vitiligo improve their skin over a year.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shijiazhuang)
• Trial ID: NCT06511739 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of SYHX1901, a tablet treatment for adults with non-segmental vitiligo. It will enroll approximately 144 participants aged 18-65, who will be divided into four treatment arms. Participants will receive either the study drug or a placebo once daily for the first 24 weeks, after which those on placebo will switch to the study drug for an additional 28 weeks. The study aims to assess the drug's effectiveness over a total duration of 52 weeks.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a clinical diagnosis of non-segmental vitiligo.

Not a fit: Patients with other active depigmentation diseases or uncontrolled thyroid function may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve skin pigmentation and quality of life for patients with non-segmental vitiligo.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in treating vitiligo with novel therapies.

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.

Where this trial is running

Shijiazhuang

• Clinical Trials Information Group — Shijiazhuang, China (Recruiting)

Conditions Non-segmental Vitiligo