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

NCT07840820 | Not Yet Recruiting Phase 2

• 1 other identifier: FXS5626-VIT-301
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-segmental Vitiligo

Keywords

Non-segmental vitiligo; FXS5626; JAK inhibitor

Outcome Measures

Primary Outcomes (2)

• 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.

  24 weeks

• 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).

  52 weeks

Secondary Outcomes (36)

• Percent change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at planned visits other than Week 24（Phase 2)

  24 weeks

• Proportion of participants achieving Facial Vitiligo Area Scoring Index 75 (F-VASI 75, at least 75% improvement from baseline) at planned visits (Phase 2)

  24 weeks

• Proportion of participants achieving Facial Vitiligo Area Scoring Index 50 (F-VASI 50, at least 50% improvement from baseline) at planned visits (Phase 2)

  24 weeks

• Proportion of participants achieving Facial Vitiligo Area Scoring Index 90 (F-VASI 90, at least 90% improvement from baseline) at planned visits (Phase 2)

  24 weeks

• Percent change from baseline in Total Vitiligo Area Scoring Index (T-VASI) at planned visits (Phase 2)

  24 weeks

Study Arms (6)

Arm1: FXS5626 25 mg (Phase 2)

EXPERIMENTAL

FXS5626 25 mg

Drug: Intervention1: FXS5626 Tablets

Arm2: FXS5626 50 mg (Phase 2)

EXPERIMENTAL

FXS5626 50 mg

Drug: Intervention2: FXS5626 Tablets

Arm3: FXS5626 75 mg (Phase 2)

EXPERIMENTAL

FXS5626 75 mg

Drug: Intervention3: FXS5626 Tablets

Arm4: FXS5626 group (Phase 3)

EXPERIMENTAL

FXS5626 group (Dosage will be confirmed after Phase 2)

Drug: Intervention4: FXS5626 Tablets

Arm5: Placebo (Phase 2)

PLACEBO COMPARATOR

Placebo

Drug: Intervention5: FXS5626 Placebo Tablets

Arm6: Placebo (Phase 3)

PLACEBO COMPARATOR

Placebo

Drug: Intervention6: FXS5626 Placebo Tablets

Interventions

Intervention1: FXS5626 Tablets DRUG

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

Arm1: FXS5626 25 mg (Phase 2)

Intervention2: FXS5626 Tablets DRUG

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

Arm2: FXS5626 50 mg (Phase 2)

Intervention3: FXS5626 Tablets DRUG

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

Arm3: FXS5626 75 mg (Phase 2)

Intervention4: FXS5626 Tablets DRUG

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

Arm4: FXS5626 group (Phase 3)

Intervention5: FXS5626 Placebo Tablets DRUG

FXS5626 placebo tablets administered orally twice daily (BID) for 24 weeks.

Arm5: Placebo (Phase 2)

Intervention6: FXS5626 Placebo Tablets DRUG

FXS5626 placebo tablets administered orally twice daily (BID) for 52 weeks.

Arm6: Placebo (Phase 3)

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Screening age must meet the following criteria:
• \) 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:
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.: lead

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Central Study Contacts

Wenyu Wu

CONTACT

+86 021-52887783; wwylcsy@163.com

Jian Li

CONTACT

+86 021-52887783; lil3579_nn@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 25, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): November 10, 2027
• Study Completion (Estimated): December 8, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

CN (1)