Non-Segmental VitiligoPhase 3Ph3 Peds VitiNCT07896434
A Study to Learn How Effective, Safe, and Tolerable Upadacitinib is for Young Participants With Non-segmental Vitiligo
A Phase 3 study testing Upadacitinib in people with Non-Segmental Vitiligo, run by AbbVie.
Trial summary
Vitiligo is a common, long-lasting disease that happens when the immune system attacks melanocytes (skin cells that produce the skin-coloring pigment melanin) in the skin leading to loss of color. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Non-Segmental Vitiligo
- What is being tested?
- Upadacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- 28 Jan 2027to Aug 2032
- Phase
- Phase 3
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric participants 6 to < 12 years of age at Screening and Baseline who have a documented clinical diagnosis of Non-Segmental Vitiligo (NSV).
- Must satisfy at least 1 of the following criteria at Screening and Baseline:
- >= 0.5 Facial Vitiligo Area Scoring Index (F-VASI) and 5 <= Total Vitiligo Area Scoring Index (T-VASI) < 50 AND have failed to adequately respond to at least 1 topical corticosteroid and/or at least 1 topical calcineurin inhibitor for NSV or
- >= 0.5 F-VASI and 5 <= T-VASI < 50 AND have active NSV or
- >= 0.5 F-VASI and 10 <=T-VASI < 50
- Must have no segmental or localized vitiligo
- Must have no history of active skin disease other than NSV that could interfere with the assessment of NSV
- Must not have > 33% leukotrichia in areas of NSV on the face or > 33% leukotrichia in areas of NSV on the total body (including the face).
Who cannot join
- Participant has segmental or localized vitiligo
- History of active skin disease other than NSV that could interfere with the assessment of NSV
- Participant has > 33% leukotrichia in areas of NSV on the face or > 33% leukotrichia in areas of NSV on the total body (including the face).
- Screening laboratory values that meet the following criteria at the most recent testing prior to the first dose of study treatment:
- Serum AST > 2 × ULN; Serum ALT > 2 × ULN; Estimated glomerular filtration rate (eGFR) by modified Schwartz equation < 60 mL/min/1.73 m2 Total WBC count < 3,000/μL; ANC < 1,500/μL; Platelet count < 100,000/μL; ALC < 800/μL; Hemoglobin < 10 g/dL
- History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months prior to Baseline.
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 Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Tolerability of Upadacitinib in Pediatric Subjects 6 to <12 Years Old With Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy
Vitiligo is a common, long-lasting disease that happens when the immune system attacks melanocytes (skin cells that produce the skin-coloring pigment melanin) in the skin leading to loss of color. Non-segmental vitiligo (NSV) occurs when patches of color loss appear on both sides of the body, such as both knees or both hands. This study is to evaluate how effective, safe and tolerable upadacitinib is for the treatment of non-segmental vitiligo in pediatric participants ages 6 to 11 years old.
This study will have two periods: Period A and Period B. In Period A, participants are placed in 1 of 2 groups called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will receive placebo. Participants who complete Period A will continue into Period B and remain on blinded treatment.
Read more
In Studies 1 and 2: Period A, participants will receive oral tablets (or oral solution) of upadacitinib or placebo once a day for 48 weeks. In Period B,participants who complete Period A will continue into Period B and remain on blinded treatment for 112 weeks. Participants will be followed up for 30 days. This study will enroll approximately 154 pediatric participants at 110 sites worldwide.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
- Conditions
- Non-Segmental Vitiligo
- Being tested
- Upadacitinib, Placebo for Upadacitinib
- Keywords
- Non-Segmental Vitiligo, Upadacitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UpadacitinibDrug
Also called ABT-494, Rinvoq
Oral Tablet or Oral Solution
Placebo for UpadacitinibDrug
Oral Tablet or Oral Solution
| Study group | Role | What they receive |
|---|---|---|
| Period A: Double-Blind Treatment Period | Experimental | Pediatric participants will receive an adult-equivalent dose of upadacitinib or a matching placebo dose Receives: Drug: Upadacitinib; Drug: Placebo for Upadacitinib |
| Period B: Blinded Extension Period | Experimental | Pediatric participants who complete Period A will continue into Period B and remain on blinded treatment.
Pediatric participants initially randomized to blinded placebo (Period A) who have not achieved F-VASI 75 at Week 48 (nonresponders) will receive a blinded upadacitinib adult dose equivalent in Period B. Receives: Drug: Upadacitinib; Drug: Placebo for Upadacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Facial-Vitiligo Area Scoring Index (F-VASI) 75 (>= 75% Improvement in F-VASI From Baseline)
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.
Measured: At Week 48
Number of Participants with Adverse Events (AEs)
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.
Measured: Up to Approximately Day 1150
Secondary outcomes (3)
Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (>= 50% Improvement in T-VASI From Baseline)
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.
Measured: At Week 48
Percentage of Participants Achieving Facial-Vitiligo Area Scoring Index (F-VASI) 75 (>= 75% Improvement in F-VASI From Baseline)
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.
Measured: At Week 24
Percentage of Participants with a Change in Baseline Cartoon Children's Dermatology Life Quality Index (CDLQI) score
The Cartoon CDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatological disease symptoms and treatment on quality of life. The Cartoon CDLQI has been validated for use in participants 4 to 16 years of age. It consists of 10 questions assessing impact of skin diseases on different aspects of quality of life over the prior week. The Cartoon CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale: 0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of quality of life.
Measured: At Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start28 Jan 2027 (estimated)
- Primary completionAug 2032 (estimated)
- Study completionAug 2032 (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.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896434
- Sponsor's protocol ID
- M25-264
- Other IDs
- 2025-524537-40-00, 2025
- Acronym
- Ph3 Peds Viti
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Tolerability of Upadacitinib in Pediatric Subjects 6 to <12 Years Old With Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy
- ClinicalTrials.gov ID
- NCT07896434
- Acronym / sponsor ID
- Ph3 Peds Viti / M25-264
- Conditions
- Non-Segmental Vitiligo
- Keywords
- Non-Segmental Vitiligo, Upadacitinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2027 (estimated)
- Primary completion
- Aug 2032 (estimated)
- Study completion
- Aug 2032 (estimated)
- First posted
- 27 Oct 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.
Vitiligo is a common, long-lasting disease that happens when the immune system attacks melanocytes (skin cells that produce the skin-coloring pigment melanin) in the skin leading to loss of color. Non-segmental vitiligo (NSV) occurs when patches of color loss appear on both sides of the body, such as both knees or both hands. This study is to evaluate how effective, safe and tolerable upadacitinib is for the treatment of non-segmental vitiligo in pediatric participants ages 6 to 11 years old.
This study will have two periods: Period A and Period B. In Period A, participants are placed in 1 of 2 groups called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will receive placebo. Participants who complete Period A will continue into Period B and remain on blinded treatment.
In Studies 1 and 2: Period A, participants will receive oral tablets (or oral solution) of upadacitinib or placebo once a day for 48 weeks. In Period B,participants who complete Period A will continue into Period B and remain on blinded treatment for 112 weeks. Participants will be followed up for 30 days. This study will enroll approximately 154 pediatric participants at 110 sites worldwide.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period A: Double-Blind Treatment Period | Experimental | Drug: Upadacitinib, Drug: Placebo for UpadacitinibPediatric participants will receive an adult-equivalent dose of upadacitinib or a matching placebo dose |
| Period B: Blinded Extension Period | Experimental | Drug: Upadacitinib, Drug: Placebo for UpadacitinibPediatric participants who complete Period A will continue into Period B and remain on blinded treatment. Pediatric participants initially randomized to blinded placebo (Period A) who have not achieved F-VASI 75 at Week 48 (nonresponders) will receive a blinded upadacitinib adult dose equivalent in Period B. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Pediatric participants 6 to < 12 years of age at Screening and Baseline who have a documented clinical diagnosis of Non-Segmental Vitiligo (NSV).
- Must satisfy at least 1 of the following criteria at Screening and Baseline:
- Must have no segmental or localized vitiligo
- Must have no history of active skin disease other than NSV that could interfere with the assessment of NSV
- Must not have > 33% leukotrichia in areas of NSV on the face or > 33% leukotrichia in areas of NSV on the total body (including the face).
Key exclusion criteria (6 listed)
- Participant has segmental or localized vitiligo
- History of active skin disease other than NSV that could interfere with the assessment of NSV
- Participant has > 33% leukotrichia in areas of NSV on the face or > 33% leukotrichia in areas of NSV on the total body (including the face).
- Screening laboratory values that meet the following criteria at the most recent testing prior to the first dose of study treatment:
- Serum AST > 2 × ULN; Serum ALT > 2 × ULN; Estimated glomerular filtration rate (eGFR) by modified Schwartz equation < 60 mL/min/1.73 m2 Total WBC count < 3,000/μL; ANC < 1,500/μL; Platelet count < 100,000/μL; ALC < 800/μL; Hemoglobin < 10 g/dL
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 |
|---|---|---|
| UpadacitinibAlso: ABT-494, RinvoqOral Tablet or Oral Solution | Drug | Period A: Double-Blind Treatment Period, Period B: Blinded Extension Period |
| Placebo for UpadacitinibOral Tablet or Oral Solution | Drug | Period A: Double-Blind Treatment Period, Period B: Blinded Extension Period |
Primary outcome
Percentage of Participants Achieving Facial-Vitiligo Area Scoring Index (F-VASI) 75 (>= 75% Improvement in F-VASI From Baseline)
Time frame: At Week 48
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.
Number of Participants with Adverse Events (AEs)
Time frame: Up to Approximately Day 1150
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.
3 secondary outcomes
Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (>= 50% Improvement in T-VASI From Baseline)
Time frame: At Week 48
Percentage of Participants Achieving Facial-Vitiligo Area Scoring Index (F-VASI) 75 (>= 75% Improvement in F-VASI From Baseline)
Time frame: At Week 24
Percentage of Participants with a Change in Baseline Cartoon Children's Dermatology Life Quality Index (CDLQI) score
Time frame: At Week 48
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 27 Oct 2026.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Related trials for Non-Segmental Vitiligo
RecruitingPhase 2
A Study of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo
Non-Segmental Vitiligo (NSV)
Active, not recruitingPhase 1
A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-segmental Vitiligo
Vitiligo
RecruitingPhase 2
A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo
Non-segmental Vitiligo
RecruitingPhase 2
A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
Vitiligo, Non-Segmental Vitiligo (NSV)
Not yet recruitingPhase 2/3
Phase II/III Study of FXS5626 in Participants With Non-segmental Vitiligo
Non-segmental Vitiligo
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.
ABBVIE INC. study director
AbbVie
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Upadacitinib in people with Non-Segmental Vitiligo, run by AbbVie.
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 8 inclusion and 6 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 27 Oct 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Facial-Vitiligo Area Scoring Index (F-VASI) 75 (>= 75% Improvement in F-VASI From Baseline) (time frame: At Week 48). The study lists 2 primary outcomes in all. 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 27 Oct 2026.