A Phase 3 interventional study of Upadacitinib and Placebo for Upadacitinib in Non-Segmental Vitiligo, sponsored by AbbVie. Not yet recruiting. Open to participants aged 6 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
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.
343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.
This study's planned enrollment of 154 is above the median of 36 across 265 interventional studies indexed under Vitiligo.
Browse Vitiligo studies →AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Must satisfy at least 1 of the following criteria at Screening and Baseline:
Exclusion Criteria:
Serum > 2 × ; Serum ALT > 2 × ULN; Estimated (eGFR) by modified Schwartz equation \< 60 mL/min/1.73 m2 Total WBC count \< 3,000/μL; ANC \< 1,500/μL; count \< 100,000/μL; ALC \< 800/μL; \< 10 g/dL
- History of (per investigator's judgment) drug or alcohol abuse within the last 6 months prior to Baseline.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
Pediatric participants will receive an adult-equivalent dose of upadacitinib or a matching placebo dose
Drug: Upadacitinib · Drug: Placebo for Upadacitinib
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.
Drug: Upadacitinib · Drug: Placebo for Upadacitinib
Oral Tablet or Oral Solution
Also known as: ABT-494, Rinvoq
Oral Tablet or Oral Solution
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.
Time frame: 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.
Time frame: Up to Approximately Day 1150
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.
Time frame: 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.
Time frame: 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.
Time frame: At Week 48
No study locations are listed for this record.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Access criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
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 ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Upadacitinib