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Starting soon Phase 2/3

Phase II/III Study of FXS5626 in Participants With Non-segmental Vitiligo

NCT07840820 · tracked via the Priya Life Science China tracker
Phase
Phase 2/3
Started
2026-10-30
Last updated
2026-09-25

Condition(s) studied

Non-segmental Vitiligo

Investigational drug(s) / intervention(s)

Intervention1: FXS5626 TabletsIntervention2: FXS5626 TabletsIntervention3: FXS5626 TabletsIntervention4: FXS5626 TabletsIntervention5: FXS5626 Placebo TabletsIntervention6: FXS5626 Placebo Tablets

Intervention1: FXS5626 Tablets: FXS5626 tablets administered orally twice daily (BID) for 24 weeks.

Intervention2: FXS5626 Tablets: FXS5626 tablets administered orally twice daily (BID) for 24 weeks.

Intervention3: FXS5626 Tablets: FXS5626 tablets administered orally twice daily (BID) for 24 weeks.

Intervention4: FXS5626 Tablets: FXS5626 tablets administered orally twice daily (BID) for 52 weeks.

Intervention5: FXS5626 Placebo Tablets: FXS5626 placebo tablets administered orally twice daily (BID) for 24 weeks.

Intervention6: FXS5626 Placebo Tablets: FXS5626 placebo tablets administered orally twice daily (BID) for 52 weeks.

Study summary

This is a multicenter, randomized, double-blind, placebo-controlled, adaptive seamless design, Phase II/III study evaluating the efficacy and safety of FXS5626 in participants with non-segmental vitiligo.

Eligibility

Sex
ALL
Min age
12 Years
Max age
75 Years
Healthy volunteers
No
Participants must meet all of the following inclusion criteria: 1. Understand the trial procedures and methods, voluntarily participate in this trial, be able to communicate well with the investigator, comply with the requirements of the entire study, and provide written informed consent; 2. Screening age must meet the following criteria: 1\) Age ≥18 years and ≤75 years, regardless sex (Phase 2); 2) Age ≥12 years and ≤75 years, regardless of sex (Phase 3); 3. At screening,participants must have a body mass index (BMI) ≥18 kg/m²; for adolescent participants in the Phase 3, baseline body weight must be ≥40 kg; 4. Clinically diagnosed with non-segmental vitiligo, either active or stable, with a disease history ≥3 months; 5. At the screening and baseline visits, vitiligo lesions must satisfy all of the following criteria: 1. The percentage of vitiligo lesion area relative to the total body surface area (BSA) is ≥3%, excluding involvement of the palms, dorsa of the hands (fingers), soles, and dorsa of the feet; 2. Facial involvement BSA (F-BSA) ≥0.5%; 3. T-VASI ≥0.5 and 3 ≤ T-VASI ≤50; 6. Participants must ensure and agree that, from 28 days before signing the informed consent form to 28 days after the last dose, female participants of childbearing potential, male participants, and their spouses will use effective contraceptive methods other than oral medications (such as condoms or intrauterine devices), and will not donate sperm or ova during this study. Exclusion Criteria 1. Presence of vitiligo-related medical conditions and other skin diseases at screening, as assessed by the investigator; 2. Presence of \>33% leukotrichia in areas of vitiligo on the face or \> 33% leukotrichia in areas of vitiligo on the body (including the face); 3. As assessed by the investigator, accompanied by active infection or history of infection; 4. Patients with a history of severe herpes simplex and herpes zoster infections, or with active/current herpes simplex or herpes zoster infection; 5. Participants with any other clinically significant medical history, or other conditions that, as assessed by the investigator, may affect the participant's safety or compliance, or result in the participant's inability to complete the study.

Primary outcome measure(s)

  • Percent change from baseline in facial vitiligo area scoring index (F-VASI) at week 24 in Phase 2 study. — 24 weeks
    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. Higher scores of F-VASI mean a worse outcome.
  • Proportion of participants achieving Facial Vitiligo Area Scoring Index 75 (F-VASI 75, at least 75% improvement from baseline) at Week 52 in Phase 3 study. — 52 weeks
    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. Higher scores of F-VASI mean a worse outcome. F-VASI 75 denotes a at least 75% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI).

Trial sites (1)

FacilityCityRegionStatus
Huashan Hospital, Fudan University Shanghai Shanghai Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07840820 on ClinicalTrials.gov ↗ ← All trials in China