AbbVie (ABBV) announced Thursday that its Phase 2b study evaluating upadacitinib (RINVOQ) in adults with non-segmental vitiligo or NSV met the primary endpoint. Based on the data, the company is advancing its clinical program of upadacitinib in vitiligo to Phase 3.
NSV is the most common form of vitiligo, a chronic, immune condition, where white patches of depigmentation develop on the skin. RINVOQ is a JAK inhibitor with seven approved indications and is currently being studied in several immune-mediated diseases.
The 52-week, Phase 2b multicenter, randomized, double-blind, placebo-controlled study (NCT04927975) comprises two periods. In the trial, upadacitinib at week 24 met the primary endpoint of percent change from baseline in Facial Vitiligo Area Scoring Index or F-VASI with 11 mg and 22 mg doses versus placebo in adults with NSV.
F-VASI is a tool that measures re-pigmentation of the face and is used to assess the extent of re-pigmentation and treatment response in clinical trials.
The company noted that the percent reduction from baseline in F-VASI at week 52 was numerically greater than results at week 24 for all upadacitinib doses.
No new safety signals were identified beyond the known safety profile for upadacitinib.
The 24-week data and partial 52-week data are being presented as an oral presentation during the European Academy of Dermatology and Venerology (EADV) Congress in Berlin, Germany, on October 12.
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