Non-segmental VitiligoPhase 2/3NCT07840820
Phase II/III Study of FXS5626 in Participants With Non-segmental Vitiligo
A Phase 2/3 study testing Intervention1: FXS5626 Tablets, Intervention2: FXS5626 Tablets and Intervention3: FXS5626 Tablets in people with Non-segmental Vitiligo, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Non-segmental Vitiligo
- What is being tested?
- Intervention1: FXS5626 Tablets, Intervention2: FXS5626 Tablets and Intervention3: FXS5626 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2026to 8 Dec 2027
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Guoying Cao, +86 021-52887892, Sherley_76@163.com
Yuran Cao, +86 021-52888041, yurancao@126.com
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Non-segmental Vitiligo
- Being tested
- Intervention1: FXS5626 Tablets, Intervention2: FXS5626 Tablets, Intervention3: FXS5626 Tablets, Intervention4: FXS5626 Tablets, Intervention5: FXS5626 Placebo Tablets
- Keywords
- Non-segmental vitiligo, FXS5626, JAK inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention1: FXS5626 TabletsDrug
FXS5626 tablets administered orally twice daily (BID) for 24 weeks.
Intervention2: FXS5626 TabletsDrug
FXS5626 tablets administered orally twice daily (BID) for 24 weeks.
Intervention3: FXS5626 TabletsDrug
FXS5626 tablets administered orally twice daily (BID) for 24 weeks.
Intervention4: FXS5626 TabletsDrug
FXS5626 tablets administered orally twice daily (BID) for 52 weeks.
Intervention5: FXS5626 Placebo TabletsDrug
FXS5626 placebo tablets administered orally twice daily (BID) for 24 weeks.
Intervention6: FXS5626 Placebo TabletsDrug
FXS5626 placebo tablets administered orally twice daily (BID) for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm1: FXS5626 25 mg (Phase 2) | Experimental | FXS5626 25 mg Receives: Drug: Intervention1: FXS5626 Tablets |
| Arm2: FXS5626 50 mg (Phase 2) | Experimental | FXS5626 50 mg Receives: Drug: Intervention2: FXS5626 Tablets |
| Arm3: FXS5626 75 mg (Phase 2) | Experimental | FXS5626 75 mg Receives: Drug: Intervention3: FXS5626 Tablets |
| Arm4: FXS5626 group (Phase 3) | Experimental | FXS5626 group (Dosage will be confirmed after Phase 2) Receives: Drug: Intervention4: FXS5626 Tablets |
| Arm5: Placebo (Phase 2) | Placebo comparator | Placebo Receives: Drug: Intervention5: FXS5626 Placebo Tablets |
| Arm6: Placebo (Phase 3) | Placebo comparator | Placebo Receives: Drug: Intervention6: FXS5626 Placebo Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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）.
Measured: 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).
Measured: 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")
Measured: 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.
Measured: 24 weeks and 4 weeks
Plasma concentrations of FXS5626 and its metabolite TT-190 (Phase 2)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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")
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 52 weeks and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start30 Oct 2026 (estimated)
- Primary completion10 Nov 2027 (estimated)
- Study completion8 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-segmental VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840820
- Sponsor's protocol ID
- FXS5626-VIT-301
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No