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RECRUITINGPHASE2

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

NCT06511739•CSPC Ouyi Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Clinical Trials Information Group

Shijiazhuang, China

Key Dates

Start Date

May 27, 2024

Primary Completion Date

August 1, 2025

Completion Date

October 1, 2025

Last Updated

July 22, 2024

Enrollment

144

ESTIMATED participants

Conditions

Non-segmental Vitiligo

Interventions

SYHX1901

DRUG

placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Efficacy and Safety of SYHX1901 Tablet in Non-segmental Vitiligo Patients

Inclusion Criteria

Exclusion Criteria

A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo

Comparison of Needling and Microneedling Plus Phototherapy in Localized Vitiligo Patients

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VYN201 Gel in Subjects With Non-segmental Vitiligo.

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Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2)