A Phase 2/3 interventional study of Intervention1: FXS5626 Tablets and Intervention2: FXS5626 Tablets in Non-segmental Vitiligo, sponsored by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (part of Fosun Pharma) · Phase 2/3, Interventional, and Treatment
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.
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. The study consisted 2 periods: a phase 2 period and a phase 3 period.
Phase 2 design: This period is planned to enroll 120 patients with non-segmental vitiligo. Eligible participants will be randomized in a 2:2:1:1 ratio to the FXS5626 75 mg twice daily (BID) group, the FXS5626 50 mg BID group, the FXS5626 25 mg BID group, or the placebo group, with 40, 40, 20, and 20 participants enrolled in each group, respectively. The overall study duration consists of a 4-week screening period, a 24-week double-blind treatment period, and a 4-week safety follow-up period.
Phase 3 design: This period is planned to enroll 360 patients with non-segmental vitiligo. Eligible participants will be randomized in a 2:1 ratio to the FXS5626 group and the placebo group. The overall study duration consists of a 4-week screening period, a 52-week double-blind treatment period, and a 4-week safety follow-up period.
343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.
This study's planned enrollment of 480 is above the median of 36 across 265 interventional studies indexed under Vitiligo.
Browse Vitiligo studies →Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. is the lead sponsor of 34 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants must meet all of the following inclusion 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 (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:
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FXS5626 25 mg
Drug: Intervention1: FXS5626 Tablets
FXS5626 50 mg
Drug: Intervention2: FXS5626 Tablets
FXS5626 75 mg
Drug: Intervention3: FXS5626 Tablets
FXS5626 group (Dosage will be confirmed after Phase 2)
Drug: Intervention4: FXS5626 Tablets
Placebo
Drug: Intervention5: FXS5626 Placebo Tablets
Placebo
Drug: Intervention6: FXS5626 Placebo Tablets
FXS5626 tablets administered orally twice daily (BID) for 24 weeks.
FXS5626 tablets administered orally twice daily (BID) for 24 weeks.
FXS5626 tablets administered orally twice daily (BID) for 24 weeks.
FXS5626 tablets administered orally twice daily (BID) for 52 weeks.
FXS5626 placebo tablets administered orally twice daily (BID) for 24 weeks.
FXS5626 placebo tablets administered orally twice daily (BID) for 52 weeks.
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.
Time frame: 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).
Time frame: 52 weeks
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 24 weeks
Percent change from baseline in Total Vitiligo Area Scoring Index (T-VASI) at planned visits (Phase 2)
The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area \[BSA\]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100. Higher scores of T-VASI mean a worse outcome.
Time frame: 24 weeks
Proportion of participants achieving Total Vitiligo Area Scoring Index 50 (T-VASI 50, at least 50% improvement from baseline) at planned visits (Phase 2)
At least 50% improvement from baseline in Total Vitiligo Area Scoring Index. The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100. Higher scores of T-VASI mean a worse outcome.
Time frame: 24 weeks
Proportion of participants achieving Total Vitiligo Area Scoring Index 75 (T-VASI 75, at least 75% improvement from baseline) at planned visits (Phase 2)
At least 75% improvement from baseline in Total Vitiligo Area Scoring Index. The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100. Higher scores of T-VASI mean a worse outcome.
Time frame: 24 weeks
Change from baseline in the Facial Body Surface Area (F-BSA) affected by vitiligo at planned visits (Phase 2)
F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area "Face" was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area "Face" did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA.
Time frame: 24 weeks
Change from baseline in the Total Body Surface Area (T-BSA) affected by vitiligo at planned visits (Phase 2)
T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA.
Time frame: 24 weeks
Proportion of participants achieving a score of 0 or 1 on the Facial Physician's Global Vitiligo Assessment (F-PhGVA) at planned visits (Phase 2)
The F-PhGVA is an assessment tool used by physicians to evaluate the severity of facial vitiligo. It is rated on a 4-point scale: overall improvement: (0) no change, (1)limited extent, (2)moderate extent, (3)extensive, (4)very extensive. Higher score corresponds to worse evaluation.
Time frame: 24 weeks
Proportion of participants achieving a score of 0 or 1 on the Total Physician's Global Vitiligo Assessment (T-PhGVA) at planned visits (Phase 2)
The T-PhGVA is a assessment tool used by physicians to evaluate the severity of total body vitiligo. It is rated on a 4-point scale: overall improvement: (0) no change, (1)limited extent, (2)moderate extent, (3)extensive, (4)very extensive. Higher score corresponds to worse evaluation.
Time frame: 24 weeks
Proportion of participants achieving a score of 1 or 2 on the Facial Patient's Global Impression of Change-Vitiligo (F-PaGIC-V) at planned visits (Phase 2)
F-PaGIC-V is an assessment of improvement of vitiligo on the face by the participant. It is a 7-point scale ((1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, or (7) Very much worse）.
Time frame: 24 weeks
Proportion of participants achieving a score of 1 or 2 on the Total Body Patient's Global Impression of Change-Vitiligo (T-PaGIC-V) at planned visits (Phase 2)
T-PaGIC-V is an assessment of improvement of vitiligo on the total body by the participant. It is a 7-point scale ((1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, or (7) Very much worse).
Time frame: 24 weeks
Change from baseline in the Vitiligo-Specific Quality of Life (VitiQoL) at planned visits (Phase 2)
VitiQoL is a 15-item QoL assessment that asks participants to rate various aspects of their condition during the past month using a 7-point scale ("Not at all" to "All of the time")
Time frame: 24 weeks
Number of Participants with Adverse Events (AEs) (Phase 2)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. AE severity was assessed as mild, moderate and severe. Mild: Transient discomfort, no interference with daily activities, and/or no medical intervention required. Moderate: Mild to moderate limitation of daily activities, and/or minimal medical intervention required. Severe: Marked limitation of daily activities, requiring assistance with activities of daily living, and/or medical intervention required, possibly hospitalization.
Time frame: 24 weeks and 4 weeks
Plasma concentrations of FXS5626 and its metabolite TT-190 (Phase 2)
Time frame: 24 weeks
Proportion of participants achieving Total Vitiligo Area Scoring Index 50 (T-VASI 50) at Week 52 (Phase 3)
At least 50% improvement from baseline in total body Vitiligo Area Scoring Index. The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100. Higher scores of T-VASI mean a worse outcome.
Time frame: 52 weeks
Percent change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at planned visits (Phase 3)
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.
Time frame: 52 weeks
Proportion of participants achieving Facial Vitiligo Area Scoring Index 50 (F-VASI 50) at planned visits (Phase 3)
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.
Time frame: 52 weeks
Proportion of participants achieving Facial Vitiligo Area Scoring Index 75 (F-VASI 75) at planned visits other than Week 52 (Phase 3)
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.
Time frame: 52 weeks
Proportion of participants achieving Facial Vitiligo Area Scoring Index 90 (F-VASI 90) at planned visits (Phase 3)
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.
Time frame: 52 weeks
Percent change from baseline in Total Vitiligo Area Scoring Index (T-VASI) at planned visits (Phase 3)
The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area \[BSA\]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100. Higher scores of T-VASI mean a worse outcome.
Time frame: 52 weeks
Proportion of participants achieving Total Vitiligo Area Scoring Index 50 (T-VASI 50) at planned visits other than Week 52 (Phase 3)
At least 50% improvement from baseline in total body Vitiligo Area Scoring Index. The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100. Higher scores of T-VASI mean a worse outcome.
Time frame: 52 weeks
Proportion of participants achieving Total Vitiligo Area Scoring Index 75 (T-VASI 75) at planned visits (Phase 3)
At least 75% improvement from baseline in total body Vitiligo Area Scoring Index. The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100. Higher scores of T-VASI mean a worse outcome.
Time frame: 52 weeks
Proportion of participants achieving Total Vitiligo Area Scoring Index 90 (T-VASI 90) at planned visits (Phase 3)
At least 90% improvement from baseline in facial Vitiligo Area Scoring Index.The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100. Higher scores of T-VASI mean a worse outcome.
Time frame: 52 weeks
Change from baseline in the F-BSA affected by vitiligo at planned visits (Phase 3)
F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area "Face" was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area "Face" did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA.
Time frame: 52 weeks
Change from baseline in the T-BSA affected by vitiligo at planned visits (Phase 3)
T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA.
Time frame: 52 weeks
Proportion of participants achieving a score of 0 or 1 on the F-PhGVA at planned visits (Phase 3)
The F-PhGVA is an assessment tool used by physicians to evaluate the severity of facial vitiligo. It is rated on a 4-point scale: overall improvement: (0) no change, (1)limited extent, (2)moderate extent, (3)extensive, (4)very extensive. Higher score corresponds to worse evaluation.
Time frame: 52 weeks
Proportion of participants achieving a score of 0 or 1 on the T-PhGVA at planned visits (Phase 3)
The T-PhGVA is a assessment tool used by physicians to evaluate the severity of total body vitiligo. It is rated on a 4-point scale: overall improvement: (0) no change, (1)limited extent, (2)moderate extent, (3)extensive, (4)very extensive. Higher score corresponds to worse evaluation.
Time frame: 52 weeks
Proportion of participants achieving score of 1 or 2 on the a F-PaGIC-V at planned visits (Phase 3)
F-PaGIC-V is an assessment of improvement of vitiligo on the face by the participant. It is a 7-point scale ((1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, or (7) Very much worse).
Time frame: 52 weeks
Proportion of participants achieving a score of 1 or 2 on the T-PaGIC-V at planned visits (Phase 3)
T-PaGIC-V is an assessment of improvement of vitiligo on the total body by the participant. It is a 7-point scale ((1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, or (7) Very much worse).
Time frame: 52 weeks
Change from baseline in the VitiQoL at planned visits (Phase 3)
VitiQoL is a 15-item QoL assessment that asks participants to rate various aspects of their condition during the past month using a 7-point scale ("Not at all" to "All of the time")
Time frame: 52 weeks
Change from baseline in the Dermatology Life Quality Index (DLQI)) at planned visits (Phase 3)
DLQI is a 10-item instrument, each item scored from 0 to 3 where higher scores correspond to worse symptom impact, full range from 0 to 30.
Time frame: 52 weeks
Proportion of participants achieving a DLQI total score of "0" or "1"at planned visits (Phase 3)
DLQI is a 10-item instrument, each item scored from 0 to 3 where higher scores correspond to worse symptom impact, full range from 0 to 30.
Time frame: 52 weeks
Proportion of participants achieving a score of 4 or 5 on the Vitiligo Noticeability Scale (VNS) at planned visits (Phase 3)
The VNS is a patient-reported measure of vitiligo treatment success that is rated on a 5-point scale. The participant was asked to respond to the following query: Compared with before treatment, how noticeable is the vitiligo now? Responses: (1) more noticeable, (2) as noticeable, (3) slightly less noticeable, (4) a lot less noticeable, and (5) no longer noticeable. higher score corresponds to worse symptom impact.
Time frame: 52 weeks
Number of Participants with Adverse Events (AEs) (Phase 3)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. AE severity was assessed as mild, moderate and severe. Mild: Transient discomfort, no interference with daily activities, and/or no medical intervention required. Moderate: Mild to moderate limitation of daily activities, and/or minimal medical intervention required. Severe: Marked limitation of daily activities, requiring assistance with activities of daily living, and/or medical intervention required, possibly hospitalization.
Time frame: 52 weeks and 4 weeks
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: FXS5626
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. →