6/30/23, 2:21 AM TRuE-V2 Pathway Feedback Search Clinical Topics Home Studies TRuE V2 TRuE V2 Disease Vitiligo Trial question What is the role of ruxolitinib cream in patients with vitiligo? Study design Multi-center Double blinded RCT Population Characteristics of study participants 50.0% female N = 343 50.0% male 343 patients (172 female, 171 male) Inclusion criteria: patients 12 years of age who had non-segmental vitiligo with depigmentation covering 10% of total body-surface area Key exclusion criteria: complete leukotrichia within any facial lesions; any biologic or experimental therapy within 12 weeks; phototherapy within 8 weeks; immunomodulating treatments within 4 weeks, or topical treatments within 1 week Interventions N=228 ruxolitinib (application of ruxolitinib 1.5% cream BID for 24 weeks with treatment extension through week 52) N=115 placebo (vehicle cream applied BID for 24 weeks with treatment extension and use of 1.5% ruxolitinib cream through week 52) https://web.pathway.md/studies/rec7HrzUPeShWdr1V 1/2 6/30/23, 2:21 AM TRuE-V2 Pathway Primary outcome Percentage of patients achieving depigmentation of 75% in facial vitiligo area scoring index at week 24 30.9 % 30.9 23.2 % 15.4 % Significant increase 11.4 7.7 % NNT = 5 0.0 % Ruxolitinib Placebo Significant increase in the percentage of patients achieving depigmentation of 75% in the facial vitiligo area scoring index at week 24 (30.9% vs. 11.4%; RR 2.7, 95% CI 1.5 to 4.9) Secondary outcomes Significant increase in the percentage of patients achieving depigmentation of 50% in the facial vitiligo area scoring index at week 24 (51.4% vs. 20.9%; RR 2.5, 95% CI 1.6 to 3.7) Significant increase in the percentage of patients achieving depigmentation of 90% in the facial vitiligo area scoring index at week 24 (16.3% vs. 1.3%; RR 13.1, 95% CI 1.9 to 90.2) Significant increase in the percentage of patients achieving depigmentation of 50% in the total body vitiligo area scoring index at week 24 (23.9% vs. 6.8%; RR 3.5, 95% CI 1.7 to 7.5) Safety outcomes No significant difference in any adverse event. Conclusion In patients 12 years of age who had non-segmental vitiligo with depigmentation covering 10% of total body-surface area, ruxolitinib was superior to placebo with respect to the percentage of patients achieving depigmentation of 75% in the facial vitiligo area scoring index at week 24. Reference David Rosmarin, Thierry Passeron, Amit G Pandya et al. Two Phase 3, Randomized, Controlled Trials of Ruxolitinib Cream for Vitiligo. N Engl J Med. 2022 Oct 20;387(16):1445-1455. Open reference URL https://web.pathway.md/studies/rec7HrzUPeShWdr1V 2/2