Non-Segmental Vitiligo (NSV)Phase 2NCT07556471
Evaluation of the Efficacy and Safety of LW402 Tablets in Patients With Non-Segmental Vitiligo
A Phase 2 study testing Experimental LW402 Tablet in people with Non-Segmental Vitiligo (NSV), run by Shanghai Longwood Biopharmaceuticals Co., Ltd..
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to assess the efficacy, safety, and tolerability of LW402 tablets in participants with non-segmental vitiligo. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Segmental Vitiligo (NSV)
- What is being tested?
- Experimental LW402 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2026to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years (inclusive), with no restriction on gender;
- Clinically diagnosed with non-segmental vitiligo at screening;
- At the screening visit and baseline visit, the Facial Vitiligo Area Scoring Index (F-VASI) is ≥ 0.5 and the Total Vitiligo Area Scoring Index (T-VASI) is ≥ 3;
- At the screening visit and baseline visit, the disease is in the progressive stage or stable stage;
Who cannot join
- Individuals with a known allergy to Janus kinase inhibitors；
- Segmental vitiligo, mixed vitiligo, or undetermined vitiligo；
- White hair is present in more than 33% of facial skin lesions due to vitiligo, or in more than 33% of total skin lesions due to vitiligo;
- Skin lesions due to vitiligo are restricted to hairless areas, or hairless regions account for ≥30% of the lesion sites (e.g., lips, palms, fingers, labia);
- Individuals with other active hypopigmentary conditions during the screening period (including but not limited to Vogt-Koyanagi-Harada syndrome, hypopigmentation associated with malignant tumors [melanoma and mycosis fungoides], post-inflammatory hypopigmentation, pityriasis alba [a mild manifestation of atopic dermatitis], senile leukoderma [age-related depigmentation], chemical/drug-induced leukoderma, ataxia-telangiectasia, tuberous sclerosis complex, melasma, and congenital hypopigmentary disorders [including piebaldism, Waardenburg syndrome, hypomelanosis of Ito, incontinentia pigmenti, hereditary symmetrical dyschromatosis, xeroderma pigmentosum, and nevus depigmentosus]) are excluded. Note: Coexisting halo nevus (also referred to as Sutton nevus) is permitted;
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of LW402 Tablets in Patients With Non-Segmental Vitiligo
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to assess the efficacy, safety, and tolerability of LW402 tablets in participants with non-segmental vitiligo.
Drawing on the prior/preclinical data of LW402 tablets, this clinical trial will incorporate three dose groups: 50 mg twice daily (BID), 100 mg BID, and 150 mg BID. The trial will be structured into a screening period (maximum 5 weeks), a treatment period (52 weeks, encompassing a 24-week main trial phase and a 28-week extension phase), and a safety follow-up period (4 weeks). The maximum duration of participation in this study will be 61 weeks.
Following the completion of 24-week data collection for all trial participants, unblinding will be performed in accordance with the pre-specified procedure. Subsequently, based on the unblinded data results, regulatory communication will be conducted with the Center for Drug Evaluation (CDE) regarding the initiation of the Phase III confirmatory clinical trial. Participants who have undergone unblinding will continue to attend scheduled study visits to complete the trial.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to assess the efficacy, safety, and tolerability of LW402 tablets in participants with non-segmental vitiligo.
Drawing on the prior/preclinical data of LW402 tablets, this clinical trial will incorporate three dose groups: 50 mg twice daily (BID), 100 mg BID, and 150 mg BID. The trial will be structured into a screening period (maximum 5 weeks), a treatment period (52 weeks, encompassing a 24-week main trial phase and a 28-week extension phase), and a safety follow-up period (4 weeks). The maximum duration of participation in this study will be 61 weeks.
Following the completion of 24-week data collection for all trial participants, unblinding will be performed in accordance with the pre-specified procedure. Subsequently, based on the unblinded data results, regulatory communication will be conducted with the Center for Drug Evaluation (CDE) regarding the initiation of the Phase III confirmatory clinical trial. Participants who have undergone unblinding will continue to attend scheduled study visits to complete the trial.
Eligible trial participants will be stratified by disease severity (T-VASI < 15 vs. ≥ 15) and randomly allocated in a 1:1:1:1 ratio to three active treatment groups (50 mg BID, 100 mg BID, and 150 mg BID) and one placebo group. The planned sample size is 45 participants per group, with a total of 180 participants expected to be enrolled. Following 24 weeks of continuous dosing, participants in the placebo group will be re-randomized in a 1:1:1 ratio to the 50 mg BID, 100 mg BID, and 150 mg BID treatment groups for continued dosing until Week 52.
- Conditions
- Non-Segmental Vitiligo (NSV)
- Being tested
- Experimental LW402 Tablet, Placebo
- Keywords
- LW402 Tablets,Phase II,Non-segmental Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental LW402 TabletDrug
LW402 Tablets
PlaceboDrug
LW402 Placebo Tablets
| Study group | Role | What they receive |
|---|---|---|
| LW402 50mg,PO.BID | Experimental | LW402 Tablet,50mg,BID Receives: Drug: Experimental LW402 Tablet |
| LW402 100mg,PO.BID | Experimental | LW402 Tablet,100mg,BID Receives: Drug: Experimental LW402 Tablet |
| LW402 150mg,PO.BID | Experimental | LW402 Tablet,150mg,BID Receives: Drug: Experimental LW402 Tablet |
| LW402 Placebo | Placebo comparator | LW402 Placebo Tablet,BID Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in F-VASI at Week 24 relative to baseline
Evaluation of the efficacy of LW402 tablets in the treatment of non-segmental vitiligo in trial participants at 24 weeks
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start31 May 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Segmental Vitiligo (NSV)Studies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible trial participants will be stratified by disease severity (T-VASI \< 15 vs. ≥ 15) and randomly allocated in a 1:1:1:1 ratio to three active treatment groups (50 mg BID（ twice daily）, 100 mg BID, and 150 mg BID) and one placebo group. The planned sample size is 45 participants per group, with a total of 180 participants expected to be enrolled. Following 24 weeks of continuous dosing, participants in the placebo group will be re-randomized in a 1:1:1 ratio to the 50 mg BID, 100 mg BID, and 150 mg BID treatment groups for continued dosing until Week 52.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Longwood Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Service, China
- Responsible party
- Sponsor
- Investigators
- Leihong Xiang, Doctor, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556471
- Sponsor's protocol ID
- LW402-II-03
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of LW402 Tablets in Patients With Non-Segmental Vitiligo
- ClinicalTrials.gov ID
- NCT07556471
- Acronym / sponsor ID
- LW402-II-03
- Conditions
- Non-Segmental Vitiligo (NSV)
- Keywords
- LW402 Tablets,Phase II,Non-segmental Vitiligo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shanghai Longwood Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Clinical Service, China
- Study start
- 31 May 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to assess the efficacy, safety, and tolerability of LW402 tablets in participants with non-segmental vitiligo.
Drawing on the prior/preclinical data of LW402 tablets, this clinical trial will incorporate three dose groups: 50 mg twice daily (BID), 100 mg BID, and 150 mg BID. The trial will be structured into a screening period (maximum 5 weeks), a treatment period (52 weeks, encompassing a 24-week main trial phase and a 28-week extension phase), and a safety follow-up period (4 weeks). The maximum duration of participation in this study will be 61 weeks.
Following the completion of 24-week data collection for all trial participants, unblinding will be performed in accordance with the pre-specified procedure. Subsequently, based on the unblinded data results, regulatory communication will be conducted with the Center for Drug Evaluation (CDE) regarding the initiation of the Phase III confirmatory clinical trial. Participants who have undergone unblinding will continue to attend scheduled study visits to complete the trial.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to assess the efficacy, safety, and tolerability of LW402 tablets in participants with non-segmental vitiligo.
Drawing on the prior/preclinical data of LW402 tablets, this clinical trial will incorporate three dose groups: 50 mg twice daily (BID), 100 mg BID, and 150 mg BID. The trial will be structured into a screening period (maximum 5 weeks), a treatment period (52 weeks, encompassing a 24-week main trial phase and a 28-week extension phase), and a safety follow-up period (4 weeks). The maximum duration of participation in this study will be 61 weeks.
Following the completion of 24-week data collection for all trial participants, unblinding will be performed in accordance with the pre-specified procedure. Subsequently, based on the unblinded data results, regulatory communication will be conducted with the Center for Drug Evaluation (CDE) regarding the initiation of the Phase III confirmatory clinical trial. Participants who have undergone unblinding will continue to attend scheduled study visits to complete the trial.
Eligible trial participants will be stratified by disease severity (T-VASI < 15 vs. ≥ 15) and randomly allocated in a 1:1:1:1 ratio to three active treatment groups (50 mg BID, 100 mg BID, and 150 mg BID) and one placebo group. The planned sample size is 45 participants per group, with a total of 180 participants expected to be enrolled. Following 24 weeks of continuous dosing, participants in the placebo group will be re-randomized in a 1:1:1 ratio to the 50 mg BID, 100 mg BID, and 150 mg BID treatment groups for continued dosing until Week 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Eligible trial participants will be stratified by disease severity (T-VASI < 15 vs. ≥ 15) and randomly allocated in a 1:1:1:1 ratio to three active treatment groups (50 mg BID（ twice daily）, 100 mg BID, and 150 mg BID) and one placebo group. The planned sample size is 45 participants per group, with a total of 180 participants expected to be enrolled. Following 24 weeks of continuous dosing, participants in the placebo group will be re-randomized in a 1:1:1 ratio to the 50 mg BID, 100 mg BID, and 150 mg BID treatment groups for continued dosing until Week 52.
| Arm | Type | Receives |
|---|---|---|
| LW402 50mg,PO.BID | Experimental | Drug: Experimental LW402 TabletLW402 Tablet,50mg,BID |
| LW402 100mg,PO.BID | Experimental | Drug: Experimental LW402 TabletLW402 Tablet,100mg,BID |
| LW402 150mg,PO.BID | Experimental | Drug: Experimental LW402 TabletLW402 Tablet,150mg,BID |
| LW402 Placebo | Placebo comparator | Drug: PlaceboLW402 Placebo Tablet,BID |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 to 75 years (inclusive), with no restriction on gender;
- Clinically diagnosed with non-segmental vitiligo at screening;
- At the screening visit and baseline visit, the Facial Vitiligo Area Scoring Index (F-VASI) is ≥ 0.5 and the Total Vitiligo Area Scoring Index (T-VASI) is ≥ 3;
- At the screening visit and baseline visit, the disease is in the progressive stage or stable stage;
Key exclusion criteria (5 listed)
- Individuals with a known allergy to Janus kinase inhibitors；
- Segmental vitiligo, mixed vitiligo, or undetermined vitiligo；
- White hair is present in more than 33% of facial skin lesions due to vitiligo, or in more than 33% of total skin lesions due to vitiligo;
- Skin lesions due to vitiligo are restricted to hairless areas, or hairless regions account for ≥30% of the lesion sites (e.g., lips, palms, fingers, labia);
- Individuals with other active hypopigmentary conditions during the screening period (including but not limited to Vogt-Koyanagi-Harada syndrome, hypopigmentation associated with malignant tumors [melanoma and mycosis fungoides], post-inflammatory hypopigmentation, pityriasis alba [a mild manifestation of atopic dermatitis], senile leukoderma [age-related depigmentation], chemical/drug-induced leukoderma, ataxia-telangiectasia, tuberous sclerosis complex, melasma, and congenital hypopigmentary disorders [including piebaldism, Waardenburg syndrome, hypomelanosis of Ito, incontinentia pigmenti, hereditary symmetrical dyschromatosis, xeroderma pigmentosum, and nevus depigmentosus]) are excluded. Note: Coexisting halo nevus (also referred to as Sutton nevus) is permitted;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental LW402 TabletLW402 Tablets | Drug | LW402 100mg,PO.BID, LW402 150mg,PO.BID, LW402 50mg,PO.BID |
| PlaceboLW402 Placebo Tablets | Drug | LW402 Placebo |
Primary outcome
Percentage change in F-VASI at Week 24 relative to baseline
Time frame: Baseline to Week 24
Evaluation of the efficacy of LW402 tablets in the treatment of non-segmental vitiligo in trial participants at 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leihong Xiang, Doctor principal investigator
Huashan Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Experimental LW402 Tablet in people with Non-Segmental Vitiligo (NSV), run by Shanghai Longwood Biopharmaceuticals Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara Chen (+86-21-63634910, barbara@lwbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in F-VASI at Week 24 relative to baseline (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.