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Behcet's DiseasePhase 2DRIMIDNCT06285539

Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases

A Phase 2 study testing Filgotinib in people with Behcet's Disease and Idiopathic Inflammatory Myopathies, run by UMC Utrecht at 6 sites in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Filgotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
6 sitesNetherlands
Study dates
12 Mar 2024to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 25Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Anne Karien Marijnissen, Dr contact

+887550459

a.c.a.marijnissen@umcutrecht.nl

6 sites in 1 country

Netherlands6 sites, 6 recruiting

  • Amsterdam UMC

    Amsterdam

    Joost Raaphorst, Dr., j.raaphorst@amsterdamumc.nl

    Joost Raaphorst, Dr.

    Recruiting

  • Zuyderland Medical Center

    Heerlen

    Cesar Magro Checa, Dr, c.magrocheca@zuyderland.nl

    Cesar Magro Checa, Dr

    Recruiting

  • Radboud university medical center

    Nijmegen

    Rogier Thurlings, Dr, rogier.thurlings@radboudumc.nl

    Rogier Thurlings, Dr

    Recruiting

  • Erasmus MC

    Rotterdam

    Jan van Laar, Dr., j.vanlaar@erasmusmc.nl

    Jan van Laar, Dr.

    Recruiting

  • Hagaziekenhuis

    The Hague

    Robbert J Goekoop, MD, r.goekoop@hagaziekenhuis.nl

    Robbert J Goekoop, MD

    Recruiting

  • University Medical Center

    Utrecht

    Anne Karien Marijnissen, Dr., a.c.a.marijnissen@umcutrecht.nl

    Jaap M. van Laar, Prof. Dr.

    Recruiting

Other trials in Netherlands

About this study

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.

Being tested
Filgotinib
Keywords
JAK-inhibition
Medical subject headings
Behcet Syndrome, Myositis, Immunoglobulin G4-Related Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FilgotinibDrug

    Filgotinib

Study groups in NCT06285539
Study groupRoleWhat they receive
InterventionExperimental26 weeks of Filgotinib once daily, 200mg, orally,
Receives: Drug: Filgotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EQ-5D-5L

    Change from baseline in EuroQoL-5D-5L

    Measured: 26 weeks

  2. Disease activity in Behcet's patients

    Change from baseline in Behcet's Disease Current Activity Form (BDCAF)

    Measured: 26 weeks

  3. Disease activity in myositis patients

    Change from baseline in Total Improvement Score (TIS) of the International Myositis Assessment Clinical Studies (IMACS) group

    Measured: 26 weeks

  4. Disease activity in IgG4-RD patients

    Change from baseline in IgG4-RD responder index

    Measured: 26 weeks

Secondary outcomes (5)

  1. Corticosteroid toxicity

    Change from baseline in Glucocorticoid Toxicity Index (GTI)

    Measured: 26 weeks

  2. Corticosteroid dosage

    Change from baseline in glucocorticoid dose

    Measured: 26 weeks

  3. VAS score of pain

    Change from baseline in pain scores on the Visual Analog Scale (0-100mm). A higher score is a worse outcome

    Measured: 26 weeks

  4. Fatigue

    Change from baseline in fatigue scores on the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F). A higher score is a worse outcome

    Measured: 26 weeks

  5. Treatment-related adverse events

    Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

    Measured: 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Feb 2024
  2. Study start12 Mar 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A 26-week multicenter, open-label, uncontrolled, non-randomized, non-blinded proof-of-concept, two-stage phase 2 study
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06285539
Sponsor's protocol ID
2022-502968-20
Acronym
DRIMID
Status last verified
May 2026
First submitted
12 Feb 2024
Last updated
12 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Geertsema-Hoeve BC, van Laar JAM, Raaphorst J, Tas SW, Welsing PMJ, Goekoop RJ, Checa CM, Thurlings RM, Rekers NH, Present E, van Laar JM. Multicentre, 26-week, open-label phase 2 trial of the JAK inhibitor filgotinib in Behcet's disease, idiopathic inflammatory myopathies and IgG4-related disease: DRIMID study protocol. BMJ Open. 2025 Feb 6;15(2):e089827. doi: 10.1136/bmjopen-2024-089827.

    PubMed 39915014

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Filgotinib in people with Behcet's Disease and Idiopathic Inflammatory Myopathies, run by UMC Utrecht at 6 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anne Karien Marijnissen, Dr (+887550459, a.c.a.marijnissen@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EQ-5D-5L (time frame: 26 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06285539, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

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