Drug Rediscovery for rare Immune Mediated Inflammatory Diseases (DRIMID)
EU CTIS ID: 2022-502968-20-01
What this study is testing
To examine the safety and efficacy of filgotinib, an approved JAK-inhibitor in patients with refractory BD, IIM and IgG4-RD.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 18 years of older
- Refractory disease, defined as symptomatic disease that persists despite a 12-week trial of corticoid therapy as well as lack of response to at least prednisone and one other immunosuppressive agent such as methotrexate (MTX), mycophenolate mofetil (MMF), azathioprine (AZA) or rituximab or intolerance to standard-of-care treatment, as defined by the treating physician.
- No evidence of active or latent or inadequately treated infection with mycobacterium tuberculosis (TB) as defined by all of the following: (1) A negative QuantiFERON-TB Gold (QFT-G) In-Tube test performed at or within 3 months prior to screening. Subjects with a history of Bacille Calmette Guerin (BCG) vaccination will be tested with the QFT-G test and (2) No signs suggestive of active TB infection as determined (and documented) by a qualified radiologist or pulmonologist as per local standard of care and (3) no history of either untreated or inadequately treated latent or active TB infection. If a subject has previously received an adequate course of therapy for either latent (9 months of isoniazid in a locale where rates of primary multi-drug resistant TB infection are <5% or an acceptable alternative regimen) or active (acceptable multi-drug regimen) TB infection, neither a purified protein derivative (PPD) test nor a QuantiFERON- TB Gold In TubeR™ (QFT Gold test) need be obtained, but a chest radiograph must be obtained if not done so within the prior three months.
- One of the following: (1) Diagnosis of Behçet’s disease without refractory life, organ or sight-threatening symtoms with active disease, defined as a BDCAF >2 (new BDCAF) or >15 (old BDCAF) or with active disease, based on clinical grounds (e.g. the need to start new or additional medication) or (2) Diagnosis of idiopathic inflammatory myopathy, according to diagnostic criteria: Dermatomyositis Classification Criteria according to the European Neuromuscular Centre guidelines 2018 or Anti-synthetase syndrome Classification Criteria according to the European Neuromuscular Centre guidelines 2003 with active disease, defined as: dermatomyositis with a CDASI score of ≥5 or abnormal levels of at least 1 of the following enzymes: creatine kinase (≥ 4× upper limit of normal [ULN]), aldolase (≥4× ULN), lactate dehydrogenase (LDH ≥4× ULN), aspartate transaminase (AST ≥4× ULN), alanine aminotransferase (ALT ≥4× ULN) or MRI within the last 3 months indicative of active inflammation (e.g. edema signal pattern in affected proximal muscles) or active disease based on clinical grounds, e.g. the need to start new or additional medication or (3) Diagnosis of IgG4-related disease, according to 2019 ACR/EULAR guidelines with active disease, defined as: IgG4-related disease responder index >10 or active disease based on clinical grounds, e.g. the need to start new or additional medication
You likely can't join if
- Age <18 years
- History of VTE
- Concomitant malignancies or previous malignancies within the last five years (with exception of adequately treated basal or squamous cell carcinoma of the skin)
- Kidney injury with estimated glomerular filtration rate <15mL/min/1.73m2
- Liver failure Child Pugh C
- Absolute neutrophil count <1*109
See the full eligibility criteria
- Age 18 years of older
- Refractory disease, defined as symptomatic disease that persists despite a 12-week trial of corticoid therapy as well as lack of response to at least prednisone and one other immunosuppressive agent such as methotrexate (MTX), mycophenolate mofetil (MMF), azathioprine (AZA) or rituximab or intolerance to standard-of-care treatment, as defined by the treating physician.
- No evidence of active or latent or inadequately treated infection with mycobacterium tuberculosis (TB) as defined by all of the following: (1) A negative QuantiFERON-TB Gold (QFT-G) In-Tube test performed at or within 3 months prior to screening. Subjects with a history of Bacille Calmette Guerin (BCG) vaccination will be tested with the QFT-G test and (2) No signs suggestive of active TB infection as determined (and documented) by a qualified radiologist or pulmonologist as per local standard of care and (3) no history of either untreated or inadequately treated latent or active TB infection. If a subject has previously received an adequate course of therapy for either latent (9 months of isoniazid in a locale where rates of primary multi-drug resistant TB infection are <5% or an acceptable alternative regimen) or active (acceptable multi-drug regimen) TB infection, neither a purified protein derivative (PPD) test nor a QuantiFERON- TB Gold In TubeR™ (QFT Gold test) need be obtained, but a chest radiograph must be obtained if not done so within the prior three months.
- One of the following: (1) Diagnosis of Behçet’s disease without refractory life, organ or sight-threatening symtoms with active disease, defined as a BDCAF >2 (new BDCAF) or >15 (old BDCAF) or with active disease, based on clinical grounds (e.g. the need to start new or additional medication) or (2) Diagnosis of idiopathic inflammatory myopathy, according to diagnostic criteria: Dermatomyositis Classification Criteria according to the European Neuromuscular Centre guidelines 2018 or Anti-synthetase syndrome Classification Criteria according to the European Neuromuscular Centre guidelines 2003 with active disease, defined as: dermatomyositis with a CDASI score of ≥5 or abnormal levels of at least 1 of the following enzymes: creatine kinase (≥ 4× upper limit of normal [ULN]), aldolase (≥4× ULN), lactate dehydrogenase (LDH ≥4× ULN), aspartate transaminase (AST ≥4× ULN), alanine aminotransferase (ALT ≥4× ULN) or MRI within the last 3 months indicative of active inflammation (e.g. edema signal pattern in affected proximal muscles) or active disease based on clinical grounds, e.g. the need to start new or additional medication or (3) Diagnosis of IgG4-related disease, according to 2019 ACR/EULAR guidelines with active disease, defined as: IgG4-related disease responder index >10 or active disease based on clinical grounds, e.g. the need to start new or additional medication
- Age <18 years
- History of VTE
- Concomitant malignancies or previous malignancies within the last five years (with exception of adequately treated basal or squamous cell carcinoma of the skin)
- Kidney injury with estimated glomerular filtration rate <15mL/min/1.73m2
- Liver failure Child Pugh C
- Absolute neutrophil count <1*109
- Absolute leukocyte count <0.5*109
- Hemoglobin <5mmol/L
- Inability to comply with study and/or follow-up procedures
- Known recent substance abuse (drugs or alcohol).
- Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling during the study period.
- Life expectancy less than 6 months
- Previous non-adherence to immunosuppressants
- Hypersensitivity to the active substance or to any of the excipients
- Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
- Juvenile DM, myositis overlapping with other autoimmune diseases, immune mediated necrotizing myopathy (IMNM) or cancer-associated myositis
- End-stage IIM wherein muscle weakness is most likely due to muscle damage, rather than myositis disease activity
- Pregnancy or lactation
- Previous use of other JAK-inhibitors
- Use of any investigational drug within one month prior to screening or within five half-lives of the investigational agent, whichever is longer.
- History of HIV
- Presence of an active infection or hepatitis
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.