Actively Recruiting
Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases
Led by UMC Utrecht · Updated on 2026-05-12
60
Participants Needed
6
Research Sites
194 weeks
Total Duration
On this page
Sponsors
U
UMC Utrecht
Lead Sponsor
A
Alfasigma S.p.A.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of Behcet's disease with active disease but without life, organ, or sight-threatening symptoms
- Diagnosis of idiopathic inflammatory myopathy according to specific diagnostic criteria and active disease
- Diagnosis of IgG4-related disease with active disease based on established guidelines
- Refractory disease unresponsive to standard immunosuppressive treatments or intolerance to them
- No evidence of active or inadequately treated tuberculosis infection confirmed by tests and chest radiograph
You will not qualify if you...
- Age younger than 18 years or 65 years and older
- Life expectancy less than 6 months
- Juvenile dermatomyositis, myositis with other autoimmune diseases, immune mediated necrotizing myopathy, inclusion-body myositis, or cancer-associated myositis
- End-stage idiopathic inflammatory myopathy due to muscle damage
- Increased risk of major cardiovascular problems
- Current or long-term past smoker
- Pregnancy or lactation
- Previous use of other JAK inhibitors
- Use of investigational drugs recently
- HIV infection
- Active infection or viral hepatitis B or C
- History of shingles or recurrent herpes simplex infection
- Recent or current malignancies except treated skin cancers
- Increased risk of cancer
- Severe kidney or liver failure
- Low neutrophil, leukocyte, or hemoglobin counts
- Inability to comply with study procedures
- Recent substance abuse
- Poor venous access or intolerance to blood sampling
- Previous non-adherence to immunosuppressants
- Allergy to the study drug or its components
- Rare hereditary problems affecting sugar metabolism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
2
Zuyderland Medical Center
Heerlen, Netherlands
Actively Recruiting
3
Radboud university medical center
Nijmegen, Netherlands
Actively Recruiting
4
Erasmus MC
Rotterdam, Netherlands
Actively Recruiting
5
Hagaziekenhuis
The Hague, Netherlands
Actively Recruiting
6
University Medical Center
Utrecht, Netherlands
Actively Recruiting
Research Team
A
Anne Karien Marijnissen, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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