Upadacitinib Regulatory Applications Submitted for Adults, Adolescents with Vitiligo

Regulatory applications to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have been submitted by AbbVie seeking approval of upadacitinib (Rinvoq) 15 mg once daily for adult and adolescent patients with non-segmental vitiligo (NSV).1

The February 3 announcement of these submissions followed previously disclosed results from the Viti-Up clinical trial program, evaluating the safety and efficacy of upadacitinib in those with NSV. Vitiligo itself is a chronic autoimmune condition impacting patients’ appearance, and non-segmental vitiligo accounts for approximately 84% of all vitiligo cases.

"Many patients experience ongoing frustration due to the unpredictability of non-segmental vitiligo spread and the lack of systemic treatment options that can stabilize disease progression and achieve skin re-pigmentation," said Kori Wallace, MD, PhD, vice president and global head of immunology clinical development at AbbVie, said in a statement.1

NSV is characterized by symmetrical, bilateral areas of depigmentation and can progress in patients with the condition unpredictably, even following extended periods of disease stability. Current strategies for management focus on stabilizing vitiligo activity, restoring skin pigmentation, and preserving re-pigmentation once attained. Currently, there are no systemic drugs are approved to address such treatment aims in vitiligo.

Upadacitinib is an oral Janus kinase (JAK) inhibitor investigated across an array of immune-mediated inflammatory diseases. In enzymatic and cellular studies, the medication led to greater inhibitory activity against JAK1 compared with JAK2, JAK3, and TYK2. However, the clinical significance of selectively inhibiting specific JAK enzymes regarding efficacy and safety has not been fully established.

In the phase 3 M19-044 program, investigators implemented a single overarching protocol and used 2 replicate studies, referred to as Study 1 and Study 2. Each of these 2 analyses had independent randomization, data collection, investigative sites, analysis, and reporting. Together, the studies evaluated the safety, efficacy, and tolerability of upadacitinib in individuals aged 12 years and older with NSV who were also candidates for systemic drugs.

During Period A, those involved in each trial were randomized in a 2:1 ratio to be given either upadacitinib 15 mg once-per-day or placebo for a course of 48 weeks. Those who completed this period were then eligible to take part in Period B, a 112-week open-label extension in which all subjects were treated with once-daily upadacitinib 15 mg. Periods A and B together spanned a total of 160 weeks. In both studies, 614 individuals with NSV were recruited at 90 sites worldwide. The co-primary endpoints assessed the proportion of patients achieving at least a 50% reduction from the point of baseline in Total Vitiligo Area Scoring Index (T-VASI 50) at the 48-week mark and a minimum of 75% reduction from baseline in Facial Vitiligo Area Scoring Index (F-VASI 75) at the same time point.

Among the key secondary endpoints evaluated by the investigators, examples included attainment of F-VASI 50 at the 48-week mark and F-VASI 75 at the 24-week mark, measures intended to assess both the extent and timing of facial re-pigmentation. This outcome is known as 1 of particular importance, in light of the visibility and psychosocial effects of facial involvement in NSV.

"The Viti-Up clinical studies explored these treatment gaps in vitiligo care and reinforced AbbVie's dedication to providing the first systemic treatment for patients, aiming to evolve the vitiligo treatment landscape,” Wallace said in her statement.1

Results from the phase 3 Viti-Up clinical trials demonstrating upadacitinib therapy led to achievement of the studies’ co-primary endpoints of T-VASI 50 and F-VASI 75 from baseline at Week 48. Beyond vitiligo, upadacitinib is currently being assessed in phase 3 research for several additional conditions, including hidradenitis suppurativa, alopecia areata, and systemic lupus erythematosus. The medication has not yet been approved for the treatment of those living with NSV, and its safety and efficacy have not yet been reviewed by the required regulatory authorities.

References

1. AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) in Adults and Adolescents With Vitiligo. Abbvie. February 3, 2026. https://news.abbvie.com/2026-02-03-AbbVie-Submits-Regulatory-Applications-to-FDA-and-EMA-for-Upadacitinib-RINVOQ-R-in-Adults-and-Adolescents-With-Vitiligo.

2. Kunzmann K. Oral Upadacitinib Significantly Reduces Facial, Total Nonsegmental Vitiligo Through 52 Weeks. HCPLive. March 10, 2024. Accessed February 3, 2026. https://www.hcplive.com/view/oral-upadacitinib-facial-total-nonsegmental-vitiligo-52-weeks.