Phase III Trial of Baricitinib Added to Usual Care for Adults With Relapsing or New Dermatomyositis

What this Trial Is About

Dermatomyositis DM is a rare and disabling condition that can severely affect quality of life and may lead to life-threatening complications. Current treatments rely on high doses of corticosteroids, which can cause serious side effects and are linked to disease relapses when tapered. This trial evaluates the addition of baricitinib, a Janus kinase 1 and 2 JAK12 inhibitor, to usual care to improve DM symptoms while reducing the need for corticosteroids. The study is a multicenter, phase III, double-blind, randomized placebo-controlled trial conducted across hospitals in France. Participants are randomly assigned to one of two groups one group receives baricitinib along with a prednisone taper and an immunosuppressive drug either methotrexate or azathioprine, and the other group receives a placebo plus the same prednisone taper and immunosuppressive drug. Treatment lasts for 24 weeks, during which corticosteroids are gradually reduced according to a predefined protocol. This add-on approach aims to compare the effect of baricitinib versus placebo in achieving moderate improvement in DM without the use of prednisone. Throughout the study, participants will attend five visits screening, baseline, two follow-ups at weeks 5 and 12, and an end-of-study visit at week 24. Researchers will collect data electronically, monitoring disease improvement, corticosteroid use, skin activity, relapse rates, and adverse events. The primary outcome is the rate of moderate improvement without prednisone at 24 weeks. This trial aims to enroll 62 patients aged 18 to 64 years with active DM, and all assessments and treatments are supervised by medical professionals.

Baricitinib in Patients With Relapsing or naïve Dermatomyositis