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

NCT06511739 | Recruiting Phase 2

• 1 other identifier: SYHX1902-004
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-segmental Vitiligo

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI)

  The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.5.

  At 24 weeks

Secondary Outcomes (7)

• Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline)

  At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks

• Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline)

  At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks

• Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline)

  At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks

• Percent Change From Baseline in F-VASI

  At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks

• Percent Change From Baseline in BSA

  At 4、8、12、16、20、24、28、32、36、40、44、48、52、56 weeks

Study Arms (4)

SYHX1901-A

EXPERIMENTAL

Participants in this group will receive dose A of SYHX1901 orally once daily (QD) for 52 weeks

Drug: SYHX1901

SYHX1901-B

EXPERIMENTAL

Participants in this group will receive dose B of SYHX1901 orally QD for 52 weeks

Drug: SYHX1901

SYHX1901-C

EXPERIMENTAL

articipants in this group will receive dose C of SYHX1901 orally QD for 52 weeks

Drug: SYHX1901

Placebo followed by dose C of SYHX1901

PLACEBO COMPARATOR

Participants in this group will receive placebo orally QD for 24 weeks followed by dose C of SYHX1901 orally QD for 28 weeks.

Drug: SYHX1901; Drug: placebo

Interventions

SYHX1901 DRUG

SYHX1901 tablet

Placebo followed by dose C of SYHX1901; SYHX1901-A; SYHX1901-B; SYHX1901-C

placebo DRUG

Oral tablet

Placebo followed by dose C of SYHX1901

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CSPC Ouyi Pharmaceutical Co., Ltd.: lead
• Zhongqi Pharmaceutical Technology (Shijiazhuang) Co. Ltd.: collaborator

Study Sites (1)

Clinical Trials Information Group

Shijiazhuang, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assigned

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 22, 2024
• Study Start: May 27, 2024
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 22, 2024

Record last verified: 2024-06

Locations

CN (1)