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.
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;
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;
Facial involvement BSA (F-BSA) ≥0.5%;
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.
Presence of vitiligo-related medical conditions and other skin diseases at screening, as assessed by the investigator;
Presence of >33% leukotrichia in areas of vitiligo on the face or > 33% leukotrichia in areas of vitiligo on the body (including the face);
As assessed by the investigator, accompanied by active infection or history of infection;
Patients with a history of severe herpes simplex and herpes zoster infections, or with active/current herpes simplex or herpes zoster infection;
Parallel
Intervention1: FXS5626 Tablets
DrugFXS5626 tablets administered orally twice daily (BID) for 24 weeks.
Intervention2: FXS5626 Tablets
DrugFXS5626 tablets administered orally twice daily (BID) for 24 weeks.
Intervention3: FXS5626 Tablets
DrugFXS5626 tablets administered orally twice daily (BID) for 24 weeks.
Intervention4: FXS5626 Tablets
DrugFXS5626 tablets administered orally twice daily (BID) for 52 weeks.
Intervention5: FXS5626 Placebo Tablets
DrugFXS5626 placebo tablets administered orally twice daily (BID) for 24 weeks.
Intervention6: FXS5626 Placebo Tablets
DrugFXS5626 placebo tablets administered orally twice daily (BID) for 52 weeks.
6
Treatment groupsSee each treatment group below.
Percent change from baseline in facial vitiligo area scoring index (F-VASI) at week 24 in Phase 2 study.
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.
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).
Percent change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at planned visits other than Week 24（Phase 2)
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 planned visits (Phase 2)
At least 75% improvement from baseline in facial Vitiligo Area Scoring Index. 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 50 (F-VASI 50, at least 50% improvement from baseline) at planned visits (Phase 2)
At least 50% improvement from baseline in facial Vitiligo Area Scoring Index. 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 90 (F-VASI 90, at least 90% improvement from baseline) at planned visits (Phase 2)
At least 90% improvement from baseline in facial Vitiligo Area Scoring Index. 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.
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