Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases (DRIMID)

May 7, 2026 updated by: Jacob M van Laar, UMC Utrecht
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • Amsterdam UMC
        • Contact:
        • Principal Investigator:
          • Joost Raaphorst, Dr.
        • Sub-Investigator:
          • Sander W Tas, Prof. dr.
      • Heerlen, Netherlands
        • Recruiting
        • Zuyderland Medical Center
        • Contact:
        • Principal Investigator:
          • Cesar Magro Checa, Dr
      • Nijmegen, Netherlands
        • Recruiting
        • Radboud University Medical Center
        • Contact:
        • Principal Investigator:
          • Rogier Thurlings, Dr
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus MC
        • Contact:
        • Principal Investigator:
          • Jan van Laar, Dr.
      • The Hague, Netherlands
        • Recruiting
        • HagaZiekenhuis
        • Contact:
        • Principal Investigator:
          • Robbert J Goekoop, MD
      • Utrecht, Netherlands
        • Recruiting
        • University Medical Center
        • Contact:
        • Principal Investigator:
          • Jaap M. van Laar, Prof. Dr.
        • Sub-Investigator:
          • Bettina C. Geertsema-Hoeve, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
26 weeks of Filgotinib once daily, 200mg, orally,
Drug: Filgotinib
Filgotinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EQ-5D-5L
Time Frame: 26 weeks
Change from baseline in EuroQoL-5D-5L
26 weeks
Disease activity in Behcet's patients
Time Frame: 26 weeks
Change from baseline in Behcet's Disease Current Activity Form (BDCAF)
26 weeks
Disease activity in myositis patients
Time Frame: 26 weeks
Change from baseline in Total Improvement Score (TIS) of the International Myositis Assessment Clinical Studies (IMACS) group
26 weeks
Disease activity in IgG4-RD patients
Time Frame: 26 weeks
Change from baseline in IgG4-RD responder index
26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corticosteroid toxicity
Time Frame: 26 weeks
Change from baseline in Glucocorticoid Toxicity Index (GTI)
26 weeks
Corticosteroid dosage
Time Frame: 26 weeks
Change from baseline in glucocorticoid dose
26 weeks
VAS score of pain
Time Frame: 26 weeks
Change from baseline in pain scores on the Visual Analog Scale (0-100mm). A higher score is a worse outcome
26 weeks
Fatigue
Time Frame: 26 weeks
Change from baseline in fatigue scores on the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F). A higher score is a worse outcome
26 weeks
Treatment-related adverse events
Time Frame: 26 weeks
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Collaborators

Alfasigma S.p.A.
ReumaNederland
Autoimmune Research and Collaboration Hub

Investigators

  • Principal Investigator: Jaap M van Laar, Prof. dr., UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-502968-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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