RecruitingPhase 2NCT06511739

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


Sponsor

CSPC Ouyi Pharmaceutical Co., Ltd.

Enrollment

144 participants

Start Date

May 27, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

A 52-Week Study of SYHX1901 tablet in Adults with non-segmental vitiligo.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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 Criteria9

  • 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.

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Interventions

DRUGSYHX1901

SYHX1901 tablet

DRUGplacebo

Oral tablet


Locations(1)

Clinical Trials Information Group

Shijiazhuang, China

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NCT06511739


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