Condition: Vitiligo · Sponsor: Centre Hospitalier Universitaire de Nice
Vitiligo affects approximately 1 to 2% of the global population and significantly impacts people's quality of life. areas of high stress. Ritlecitinib, an orally administered inhibitor of JAK3 (Janus kinase)/ TEC (tyrosine kinase expressed in hepatocellular carcinoma) has shown effectiveness and safety for the treatment of vitiligo. In a phase 2b trial, three doses of ritlecitinib, 200/50 mg, 100/50 mg, and 50 mg, were all statistically significant versus placebo on the Facial Vitiligo Area Scoring Index (F-VASI) at week 24 in patients with active NSV. Considering that the immune process primarily contributes to depigmentation while ultraviolet (UV) radiation stimulates the differentiation and proliferation of melanocyte stem cells for re-pigmentation, the investigators propose that a combination therapy using ritlecitinib and narrowband UVB (nbUVB) could offer an optimal approach for treating vitiligo patients. The primary objective is thTo compare between the groups, the mean percentage change from baseline in F-VASI and T-VASI at week 52. Following central randomization, patients will be assigned to receive either ritlecitinib 100mg daily (QD) or a combined therapy using ritlecitinib 100mg QD + twice weekly narrowband UVB treatment for a duration of 52 weeks. At the end of this period, all participants will continue for the open-label phase, receiving ritlecitinib 100mg QD. Eligible participants will be stratified by Fitzpatrick Skin Type (FST, also known as phototype). …
This description comes directly from the study's public registry record.
Thierry Passeron, PhD · +33492036488 · passeron.t@chu-nice.fr
Always discuss trial participation with your own doctor first.
| CHu de Nice, Hôpital Archet | Nice, Alpes-Maritime, France | Recruiting |
| APHP | Paris, Creteil, France | Recruiting |
| CHU de Bordeaux | Bordeaux, France | Recruiting |
| CHU La Réunion | La Réunion, France | Recruiting |
| HCL | Lyon, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07152626