ClinicalTrials.gov record NCT06285539

Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Age18 years old to 65 years old
SexAll
LocationNetherlands
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 2, single-group study gives oral filgotinib 200 mg once daily for 26 weeks to people with Behcet's disease, idiopathic inflammatory myopathy, or IgG4-related disease. The study measures quality of life and disease activity before and after treatment. It also tracks steroid use, pain, fatigue, and treatment-related adverse events.

What it is studying. The study tests filgotinib's effects on disease activity and quality of life in these rare immune-mediated inflammatory diseases, and collects data on steroid use, symptoms (pain and fatigue), and treatment-related adverse events.

What the researchers hope to learn. Scientific goals: measure how filgotinib affects quality of life and disease activity in each condition, assess changes in steroid use and toxicity, evaluate symptoms such as pain and fatigue, and collect safety data on treatment-related adverse events.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Filgotinib

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion 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 (e.g. the need to start new or additional medication
  • Diagnosis of idiopathic inflammatory myopathy, according to diagnostic criteria:
  • Dermatomyositis: Dermatomyositis Classification Criteria according to the European Neuromuscular Centre guidelines 201852 or anti-synthetase syndrome: Anti- synthetase syndrome Classification Criteria according to the European Neuromuscular Centre guidelines 200353, both with active disease, defined as 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 a 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
  • 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
  • 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), 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: both a negative QuantiFERON-TB Gold (QFT-G) In-Tube test and a Mantoux tuberculin skin test performed at or within 3 months prior to screening and no signs suggestive of active TB infection as determined (and documented) by a qualified radiologist or pulmonologist as per local standard of care on a chest radiograph and no history of either untreated or inadequately treated latent or active TB infection.

Exclusion criteria

  • 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 tolerability 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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will take filgotinib 200 mg by mouth once daily for 26 weeks. They will have health and disease‑activity assessments using questionnaires and clinical scores named in the record (EQ‑5D‑5L; BDCAF for Behçet's; IMACS Total Improvement Score for myositis; IgG4‑RD responder index) and outcome measures such as the Glucocorticoid Toxicity Index, pain VAS, and FACIT‑F fatigue score. Screening and safety testing named in the record include blood tests (venipuncture), tuberculosis screening with both a QuantiFERON‑TB Gold blood test and a Mantoux tuberculin skin test (performed at or within 3 months prior to screening), and review of a chest X‑ray; participants will be monitored for adverse events. The main measurements and safety assessments are recorded over a 26‑week treatment period.

How the study is structured. Phase 2, interventional, single-group and non-masked. All participants receive filgotinib 200 mg by mouth once daily for 26 weeks. Main assessments compare baseline measures with measures at 26 weeks, using general quality-of-life tools (EQ-5D-5L) and disease-specific activity scores (BDCAF for Behcet's, IMACS Total Improvement Score for myositis, and the IgG4-RD responder index). The study also records glucocorticoid toxicity and dose, pain and fatigue scores, and treatment-related adverse events.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in Netherlands. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on IgG4-related disease

This trial is also listed on this site under Behçet's disease and familial Mediterranean fever.

Clinical trials32 trials listed for IgG4-related diseaseEvery trial the registry lists for IgG4-related disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in IgG4-related disease researchLatest monthly update: September 2026. Includes: Relapse prevention trial. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Mar 12, 2024
Primary completion
December 2026 (estimated)
Study completion
December 2027 (estimated)
Target enrollment
60 participants (estimated)
Last updated on registry
May 12, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
UMC Utrecht
Principal investigator
Jacob M van Laar, Prof. dr.
UMC Utrecht
Collaborators
  • Alfasigma S.p.A.
  • ReumaNederland
  • Autoimmune Research and Collaboration Hub

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (6)

Terms used on this page · explanations by MedicalUpdates.ai

glucocorticoids
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
upper limit of normal
The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
immunosuppressive
A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
prior to screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
standard of care
Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
Life expectancy
Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
investigational drug
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
five half-lives
The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
estimated glomerular filtration rate
A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
Absolute neutrophil count
The number of neutrophils, a type of white blood cell that fights infection, in a blood sample. Studies often require it to be above a set level.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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