The Phase 3 study (NCT06118411) investigating upadacitinib (Rinvoq) oral tablets for adult and adolescent participants with vitiligo reached primary completion on 2025-09-23. This milestone indicates the trial has concluded its primary data collection period for its main objectives.
Background
Upadacitinib, also known as Rinvoq, is an approved drug for various immune-mediated inflammatory diseases. This study is evaluating its safety and effectiveness in participants with non-segmental vitiligo (NSV), a common chronic autoimmune disease where the body's immune system attacks its own pigment-producing skin cells.
Trial design
The study, titled "A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo" (NCT06118411), is a Phase 3 trial. It has an enrollment of 614 participants and is investigating upadacitinib oral tablets in adult and adolescent participants with vitiligo. The trial includes intervention arms for upadacitinib and placebo, with the aim to assess adverse events and changes in disease activity.
What this means
The primary completion of this Phase 3 trial for upadacitinib in vitiligo marks a significant step towards potentially expanding treatment options for this chronic autoimmune condition. With primary data collection concluded, the focus will now shift to data analysis and the eventual reporting of results, which will provide crucial insights into the drug's safety and effectiveness for vitiligo patients.
Source
The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT06118411, titled "A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo," was updated to reflect primary completion on 2025-09-23 on clinicaltrials.gov.