Human research · Human RCT, phase 2 (methods and limitations appraisal)
Seneschal J et al., JAMA Dermatology, 2025 (published online 22 Jan 2025)
Methods and limits of the baricitinib+NB-UVB vitiligo trial: a small (n=49) noncomparative phase 2 RCT funded by Eli Lilly, prospectively registered (NCT04822584) with a single primary endpoint (total VASI at week 36) whose success criterion was beating a 42.9% historical NB-UVB threshold rather than the concurrent placebo arm. Several registered secondary outcomes (all week-48 measures and the blood/skin inflammatory biomarkers) are not reported in this paper, and the article carries several internal counting inconsistencies.
Source: Seneschal J, Guyon M, Merhi R, et al. Combination of Baricitinib and Phototherapy in Adults With Active Vitiligo: A Randomized Clinical Trial. JAMA Dermatology. 2025;161(4):375-382. Trial registration ClinicalTrials.gov NCT04822584.
Verified research card EL-LM-T04-01-b-R1