protocolSection identificationModule nctId: NCT06285539, orgStudyIdInfo id: 2022-502968-20, briefTitle: Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases, acronym: DRIMID, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: UMC Utrecht, class: OTHER, collaborators name: Alfasigma S.p.A., collaborators name: ReumaNederland, collaborators name: Autoimmune Research and Collaboration Hub, descriptionModule 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., conditionsModule conditions: Behcet's Disease, conditions: Idiopathic Inflammatory Myopathies, conditions: IgG4-related Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo 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, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Filgotinib, outcomesModule primaryOutcomes measure: EQ-5D-5L, primaryOutcomes measure: Disease activity in Behcet's patients, primaryOutcomes measure: Disease activity in myositis patients, primaryOutcomes measure: Disease activity in IgG4-RD patients, secondaryOutcomes measure: Corticosteroid toxicity, secondaryOutcomes measure: Corticosteroid dosage, secondaryOutcomes measure: VAS score of pain, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Treatment-related adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Amsterdam UMC, city: Amsterdam, country: Netherlands, contacts name: Joost Raaphorst, Dr., role: CONTACT, email: j.raaphorst@amsterdamumc.nl, contacts name: Joost Raaphorst, Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Sander W Tas, Prof. dr., role: SUB_INVESTIGATOR, geoPoint lat: 52.37403, lon: 4.88969, locations facility: Hagaziekenhuis, city: Den Haag, country: Netherlands, contacts name: Robbert J Goekoop, MD, role: CONTACT, email: r.goekoop@hagaziekenhuis.nl, contacts name: Robbert J Goekoop, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.07667, lon: 4.29861, locations facility: Zuyderland Medical Center, city: Heerlen, country: Netherlands, contacts name: Cesar Magro Checa, Dr, role: CONTACT, email: c.magrocheca@zuyderland.nl, contacts name: Cesar Magro Checa, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.88365, lon: 5.98154, locations facility: Radboud university medical center, city: Nijmegen, country: Netherlands, contacts name: Rogier Thurlings, Dr, role: CONTACT, email: rogier.thurlings@radboudumc.nl, contacts name: Rogier Thurlings, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.8425, lon: 5.85278, locations facility: Erasmus MC, city: Rotterdam, country: Netherlands, contacts name: Jan van Laar, Dr., role: CONTACT, email: j.vanlaar@erasmusmc.nl, contacts name: Jan van Laar, Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.9225, lon: 4.47917, locations facility: University Medical Center, city: Utrecht, country: Netherlands, contacts name: Anne Karien Marijnissen, Dr., role: CONTACT, email: a.c.a.marijnissen@umcutrecht.nl, contacts name: Jaap M. van Laar, Prof. Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Bettina C. Geertsema-Hoeve, MD, role: SUB_INVESTIGATOR, geoPoint lat: 52.09083, lon: 5.12222, hasResults: False