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New treatment option for Behcet's Disease
Official title Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases
ClinicalTrials.gov ID: NCT06285539
What this study is testing
What is Filgotinib?
Filgotinib is an investigational medicine, being studied as a potential treatment for behcet's disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Age 18 years of older
- One of the following rare IMIDs:
- Diagnosis of Behçet's disease without refractory life, organ or sight-threatening symptoms with active disease, defined as a BDCAF \>2 (new BDCAF) or...
- Diagnosis of idiopathic inflammatory myopathy, according to diagnostic criteria: Dermatomyositis: Dermatomyositis Classification Criteria according...
- Diagnosis of IgG4-related disease, according to 2019 ACR/EULAR guidelines, with active disease, defined as: IgG4-related disease responder index \>10...
You likely can't join if
- Age \<18 years
- Age ≥65 years
- Life expectancy less than 6 months
- Juvenile DM, myositis overlapping with other autoimmune diseases, immune mediated necrotizing myopathy (IMNM), inclusion-body myositis or...
- End-stage IIM wherein muscle weakness is most likely due to muscle damage, rather than myositis disease activity
- Increased risk of major cardiovascular problems
See the full eligibility criteria
- Age 18 years of older
- One of the following rare IMIDs:
- Diagnosis of Behçet's disease without refractory life, organ or sight-threatening symptoms with active disease, defined as a BDCAF \>2 (new BDCAF) or \>15 (old BDCAF) or with active disease, based on clinical grounds...
- Diagnosis of idiopathic inflammatory myopathy, according to diagnostic criteria: Dermatomyositis: Dermatomyositis Classification Criteria according to the European Neuromuscular Centre guidelines 201852 or...
- 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...
- Refractory disease, defined as symptomatic disease that persists despite a 12-week trial of glucocorticoid therapy as well as lack of response to at least one other immunosuppressive agent such as methotrexate (MTX)...
- No evidence of active or latent or inadequately treated infection with mycobacterium tuberculosis (TB) as defined by all of the following: both a negative QuantiFERON-TB Gold (QFT-G) In-Tube test and a Mantoux...
- Age \<18 years
- Age ≥65 years
- Life expectancy less than 6 months
- Juvenile DM, myositis overlapping with other autoimmune diseases, immune mediated necrotizing myopathy (IMNM), inclusion-body myositis or cancer-associated myositis
- End-stage IIM wherein muscle weakness is most likely due to muscle damage, rather than myositis disease activity
- Increased risk of major cardiovascular problems
- Current smoker or smoked for a long time in the past
- 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.
- Human Immunodeficiency Virus (HIV) infection
- Presence of an active infection or viral hepatitis type B or C
- History of shingles or recurrent herpes simplex infection
- Concomitant malignancies or previous malignancies within the last five years (with exception of adequately treated basal or squamous cell carcinoma of the skin)
- Increased risk of cancer
- 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 side effects of venipuncture or lack of adequate venous access for required blood sampling during the study period.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
- Heerlen, Netherlands
- Nijmegen, Netherlands
- Rotterdam, Netherlands
- The Hague, Netherlands
- Utrecht, Netherlands
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 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands; Heerlen, Netherlands; Nijmegen, Netherlands; Rotterdam, Netherlands; The Hague, Netherlands; Utrecht, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.