Phase 2 Study of Filgotinib for Treating Rare Immune-Mediated Inflammatory Diseases Including Behcets Disease, Idiopathic Inflammatory Myopathies, and IgG4-Related Disease
Led by UMC Utrecht · Updated on 2026-05-12
60
Participants Needed
6
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating new treatments for rare immune-mediated inflammatory diseases IMIDs such as Behets disease, idiopathic inflammatory myopathy, and IgG4-related disease. Current treatments often involve high doses of steroids and other immunosuppressants that can cause long-term side effects, including infections. This study is exploring whether blocking a specific pathway called JAK-STAT, which is involved in inflammation, could offer a more targeted therapy. The role of type 1 interferon in these diseases suggests that inhibiting JAK1 may reduce disease activity.
Participants in this study will receive Filgotinib, a drug taken orally once daily at a dose of 200 mg for 26 weeks. This treatment is being assessed to see how it affects disease activity in patients with the three conditions. The study does not include a placebo group and is open-label, meaning both researchers and participants know the treatment being given.
During the 26-week period, participants will undergo regular assessments to monitor disease activity specific to each condition, quality of life using the EQ-5D-5L questionnaire, and symptoms such as pain and fatigue. Researchers will also track corticosteroid use and any side effects related to the treatment. Safety and treatment effects will be carefully evaluated throughout the study, which aims to better understand the potential of Filgotinib for these rare diseases.
CONDITIONS
Brief Title
Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases
Research Team
A
Anne Karien Marijnissen, Dr
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Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 26 weeks
Participants receive Filgotinib once daily, 200mg orally, for up to 26 weeks.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Multicentre, 26-week, open-label phase 2 trial of the JAK inhibitor filgotinib in Behçet's disease, idiopathic inflammatory myopathies and IgG4-related disease: DRIMID study protocol.
Bettina C Geertsema-Hoeve, Jan A M van Laar, Joost Raaphorst...