NCT04822584

Evaluation of Effect and Tolerance of the Association of Baricitinib and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo

Evaluation of Effect and Tolerance of the Association of Baricitinib (4 mg) and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo: a Randomized, Double-blind, Prospective, Non-comparative Phase II Study.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this phase 2 study is to evaluate the effect and the safety of the combination of Baricitinib in combination with phototherapy in adult participants with non-segmental progressive vitiligo.

Detailed description

Treatment Strategy: Multicentric, parallel double blind randomized phase 2 prospective study comparing baricitinib (4mg/day) + narrowband UVB TL01 versus placebo + narrowband UVB TL01 Follow-up of the study: patients included in this study will start Baricitinib 3 months before starting narrowband UVB TL01. Phototherapy will be performed twice a week during 6 months. Follow-up visit will be done at week 12, 24, 36 and 48.

Conditions

• Vitiligo

Interventions

Type	Name	Description
DRUG	Baricitinib Oral Product	Baricitinib 4 mg/day orally for 36 weeks
DRUG	Placebo	Placebo once a day orally for 36 weeks

Timeline

• Start date: 2021-07-16
• Primary completion: 2023-04-26
• Completion: 2023-04-26
• First posted: 2021-03-30
• Last updated: 2023-06-13

Locations

4 sites across 1 country: France