Povorcitinib for nonsegmental vitiligo: two randomized, controlled, phase 3 STOP-V trials

There is an unmet need for repigmentation therapies for patients with nonsegmental vitiligo (NSV) who are candidates for systemic therapy. Here, 52-week primary results are reported from two parallel phase 3, randomized, double-blind, placebo-controlled trials of once-daily povorcitinib (oral, highly selective JAK1 inhibitor) 30 mg in adults with moderate-to-severe NSV (STOP-V1 and STOP-V2). STOP-V1 and STOP-V2 enrolled 467 and 449 patients, respectively. In both studies, the primary endpoint of ≥75% improvement in the facial Vitiligo Area Scoring Index (F-VASI75) at week 52 was met, demonstrating statistically significant and clinically meaningful repigmentation with povorcitinib versus placebo (STOP-V1: 18.9% versus 6.8%; odds ratio, 3.1; 95% confidence interval 1.6-5.9; P = 0.0003; STOP-V2: 18.9% versus 3.1%; odds ratio, 7.5; 95% confidence interval 3.0-18.6; P < 0.0001). Povorcitinib was well tolerated; the percentage of patients with any treatment-emergent adverse event (TEAE) was similar between the povorcitinib and placebo groups in both studies (STOP-V1/STOP-V2, 68.7%/66.7% versus 63.7%/62.7%). The most common TEAEs with povorcitinib were nasopharyngitis (STOP-V1/STOP-V2, 11.2%/11.3% versus placebo, 9.8%/11.1%), acne (10.7%/10.8% versus 3.0%/2.2%) and upper respiratory tract infection (6.9%/14.0% versus 9.0%/10.7%). Serious TEAEs were generally single events, and Janus kinase inhibitor class-specific TEAEs were absent or rare. These results support once-daily povorcitinib as an effective and well-tolerated systemic treatment for adults with moderate-to-severe NSV. ClinicalTrials.gov identifiers: NCT06113445 , NCT06113471 .

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Journal
Nature Medicine
Published
2026-11-02
DOI
https://doi.org/10.1038/s41591-026-04739-2
Primary Topic
melanin and skin pigmentation
Type
article
Field-Weighted Citation Impact
0.00

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article

Povorcitinib for nonsegmental vitiligo: two randomized, controlled, phase 3 STOP-V trials

Deanna Kornacki, David M. Rosmarin, Julien Ringuet, Matthias Augustin et al.
6 links
Nature Medicine
melanin and skin pigmentation
article

Povorcitinib for nonsegmental vitiligo: two randomized, controlled, phase 3 STOP-V trials

Deanna Kornacki, David M. Rosmarin, Julien Ringuet, Matthias Augustin, Harvey Lui, Charles W Lynde, Albert Wolkerstorfer, José Luis López-Estebaranz, Viktoria Eleftheriadou, Thierry Passeron, Nanja van Geel, Seemal R. Desai, Khaled Ezzedine, Pearl Grimes, Amit G. Pandya, Kurt A. Brown, Shaoceng Wei, Sunanda Karanam
article en

Abstract

There is an unmet need for repigmentation therapies for patients with nonsegmental vitiligo (NSV) who are candidates for systemic therapy. Here, 52-week primary results are reported from two parallel phase 3, randomized, double-blind, placebo-controlled trials of once-daily povorcitinib (oral, highly selective JAK1 inhibitor) 30 mg in adults with moderate-to-severe NSV (STOP-V1 and STOP-V2). STOP-V1 and STOP-V2 enrolled 467 and 449 patients, respectively. In both studies, the primary endpoint of ≥75% improvement in the facial Vitiligo Area Scoring Index (F-VASI75) at week 52 was met, demonstrating statistically significant and clinically meaningful repigmentation with povorcitinib versus placebo (STOP-V1: 18.9% versus 6.8%; odds ratio, 3.1; 95% confidence interval 1.6-5.9; P = 0.0003; STOP-V2: 18.9% versus 3.1%; odds ratio, 7.5; 95% confidence interval 3.0-18.6; P < 0.0001). Povorcitinib was well tolerated; the percentage of patients with any treatment-emergent adverse event (TEAE) was similar between the povorcitinib and placebo groups in both studies (STOP-V1/STOP-V2, 68.7%/66.7% versus 63.7%/62.7%). The most common TEAEs with povorcitinib were nasopharyngitis (STOP-V1/STOP-V2, 11.2%/11.3% versus placebo, 9.8%/11.1%), acne (10.7%/10.8% versus 3.0%/2.2%) and upper respiratory tract infection (6.9%/14.0% versus 9.0%/10.7%). Serious TEAEs were generally single events, and Janus kinase inhibitor class-specific TEAEs were absent or rare. These results support once-daily povorcitinib as an effective and well-tolerated systemic treatment for adults with moderate-to-severe NSV. ClinicalTrials.gov identifiers: NCT06113445 , NCT06113471 .

Nature Medicine
Palo Alto Medical Foundation (US), University of British Columbia (CA), Inserm (FR), University of Toronto (CA), Université Paris-Est Créteil (FR), Université Côte d'Azur (FR), Ghent University Hospital (BE), Centre Hospitalier Universitaire de Nice (FR), Ghent University (BE), Lynde Centre for Dermatology (CA), Hospital Universitario Fundación Alcorcón (ES), University Medical Center Hamburg-Eppendorf (DE), Centre Méditerranéen de Médecine Moléculaire (FR), Probity Medical Research (CA), Vitiligo and Pigmentation Institute of Southern California (US), Hôpitaux Universitaires Henri-Mondor (FR), Centre de Recherche Dermatologique du Québec Métropolitain (CA), Walsall Healthcare NHS Trust (GB), Vancouver Coastal Health Research Institute (CA), Amsterdam University Medical Centers (NL), The Royal Wolverhampton NHS Trust (GB), Indiana University School of Medicine (US), Epidemiology in dermatology and evaluation of therapeutics (FR), McGill University (CA), Keele University (GB), The University of Texas Southwestern Medical Center (US), Incyte (United States) (US)
Incyte
Good health and well-being
Openalex Percentile: Top 19%
melanin and skin pigmentation
DOIOpen Access PDFOpenAlex
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