CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 60 target
Drug / intervention
Filgotinibdrug
Likely dose
Not stated in record
Key inclusion· 7
  • Age 18 years or older
  • Behçet's disease without refractory life/organ/sight-threatening symptoms with active disease (BDCAF >2 new or >15 old, or clinical grounds)
  • Dermatomyositis per European Neuromuscular Centre 2018 guidelines with active disease (CDASI ≥5, elevated muscle enzymes, MRI evidence, or clinical grounds)
  • Anti-synthetase syndrome per European Neuromuscular Centre 2003 guidelines with active disease (CDASI ≥5, elevated muscle enzymes, MRI evidence, or clinical grounds)
Key exclusion· 26
  • Age <18 years
  • Age ≥65 years
  • Life expectancy less than 6 months
  • Juvenile dermatomyositis, myositis overlapping with other autoimmune diseases, IMNM, inclusion-body myositis, or cancer-associated myositis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06285539
NCT06285539Phase 2RecruitingOn Track

Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases

UMC Utrecht·interventional·Posted Feb 29, 2024·Updated May 12, 2026

In Brief

A Phase 2 clinical trial evaluating Filgotinib for Behcet's Disease and 2 related conditions. Currently recruiting, targeting 60 participants across 6 sites.

Detailed Summary

Research into novel therapies for rare, immune-mediated inflammatory diseases (IMIDs) is limited due to small patient populations. Patients with Behçet's disease (BD), idiopathic inflammatory myopathy (IIM, also known as myositis) and IgG4-related disease (IgG4-RD) are treated with high-dosed glucocorticoids, methotrexate, azathioprine and mycophenolate mofetil, mostly for long periods of time with attendant risks of long-term toxicity, including infections. Therefore, there is an urgent need for new, more specific anti-inflammatory therapies such as targeted synthetic and biological disease-modifying antirheumatic drugs. Due to the role of type 1 interferon in both BD, IIM and IgG4-RD, JAK-STAT inhibition may be a promising treatment strategy in these conditions, because JAK1 is critical for the signal transduction of pro-inflammatory cytokine receptors. Previous research showed that JAK1 inhibition reduces activation of type 1 interferon-regulated proteins and key chemokines that control tissue inflammation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands

Timeline

Phase 2Recruiting
2025202620272028
First PostedFeb 29, 2024
Enrollment StartMar 12, 2024
Primary CompletionDec 1, 2026
Study CompletionDec 1, 2027
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 2.3 years agoPrimary completion in 5 months

Interventions

Filgotinibdrug

Filgotinib