nctId: NCT06285539 id: 2022-502968-20 briefTitle: Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases acronym: DRIMID overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-12 date: 2026-12 date: 2024-02-29 date: 2024-02-29 name: UMC Utrecht class: OTHER name: Alfasigma S.p.A. name: ReumaNederland name: Autoimmune Research and Collaboration Hub briefSummary: 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. conditions: Behcet's Disease conditions: Idiopathic Inflammatory Myopathies conditions: IgG4-related Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A 26-week multicenter, open-label, uncontrolled, non-randomized, non-blinded proof-of-concept, two-stage phase 2 study primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Filgotinib measure: EQ-5D-5L measure: Disease activity in Behcet's patients measure: Disease activity in myositis patients measure: Disease activity in IgG4-RD patients measure: Corticosteroid toxicity measure: Corticosteroid dosage measure: VAS score of pain measure: Fatigue measure: Treatment-related adverse events sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC city: Amsterdam country: Netherlands name: Joost Raaphorst, Dr. role: CONTACT email: j.raaphorst@amsterdamumc.nl name: Joost Raaphorst, Dr. role: PRINCIPAL_INVESTIGATOR name: Sander W Tas, Prof. dr. role: SUB_INVESTIGATOR lat: 52.37403 lon: 4.88969 facility: Hagaziekenhuis city: Den Haag country: Netherlands name: Robbert J Goekoop, MD role: CONTACT email: r.goekoop@hagaziekenhuis.nl name: Robbert J Goekoop, MD role: PRINCIPAL_INVESTIGATOR lat: 52.07667 lon: 4.29861 facility: Zuyderland Medical Center city: Heerlen country: Netherlands name: Cesar Magro Checa, Dr role: CONTACT email: c.magrocheca@zuyderland.nl name: Cesar Magro Checa, Dr role: PRINCIPAL_INVESTIGATOR lat: 50.88365 lon: 5.98154 facility: Radboud university medical center city: Nijmegen country: Netherlands name: Rogier Thurlings, Dr role: CONTACT email: rogier.thurlings@radboudumc.nl name: Rogier Thurlings, Dr role: PRINCIPAL_INVESTIGATOR lat: 51.8425 lon: 5.85278 facility: Erasmus MC city: Rotterdam country: Netherlands name: Jan van Laar, Dr. role: CONTACT email: j.vanlaar@erasmusmc.nl name: Jan van Laar, Dr. role: PRINCIPAL_INVESTIGATOR lat: 51.9225 lon: 4.47917 facility: University Medical Center city: Utrecht country: Netherlands name: Anne Karien Marijnissen, Dr. role: CONTACT email: a.c.a.marijnissen@umcutrecht.nl name: Jaap M. van Laar, Prof. Dr. role: PRINCIPAL_INVESTIGATOR name: Bettina C. Geertsema-Hoeve, MD role: SUB_INVESTIGATOR lat: 52.09083 lon: 5.12222 hasResults: False