NCT06511739

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-segmental Vitiligo

Interventions

Type	Name	Description
DRUG	SYHX1901	SYHX1901 tablet
DRUG	placebo	Oral tablet

Timeline

• Start date: 2024-05-27
• Primary completion: 2025-08-01
• Completion: 2025-10-01
• First posted: 2024-07-22
• Last updated: 2024-07-22

Locations

1 site across 1 country: China