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

Sponsor
University Hospital, Bordeaux
Study ID
NCT04822584
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib Oral Product — DRUG
    Baricitinib 4 mg/day orally for 36 weeks
  • Placebo — DRUG
    Placebo once a day orally for 36 weeks

Study Details

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.

Key Dates

Start date
Jul 16, 2021
Status verified
Jun 2023
Primary completion
Apr 26, 2023
Completion
Apr 26, 2023

Study Design

Enrollment
49 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phototherapy associated with active treatment
    Baricitinib 4 mg/day orally for 36 weeks + UVB TL01: 2 times a week during 24 weeks. (Phototherapy will be started 12 weeks after the beginning of baricitinib)
  • Placebo Comparator: Phototherapy associated with placebo
    Placebo once a day orally for 36 weeks + UVB TL01: 2 times a week during 24 weeks. (Phototherapy will be started 12 weeks after the beginning of placebo of baricitinib).

Primary Outcome Measure

Score with Vitiligo Area Scoring Index (VASI) [ Time Frame: week 36 ]

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