Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
ID06285539

Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases

Led by UMC Utrecht · Updated on 2026-05-12

60

Participants Needed

6

Research Sites

52 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

Researchers are investigating new treatments for rare immune-mediated inflammatory diseases (IMIDs) such as Behet's disease, idiopathic inflammatory myopathy, and IgG4-related disease. Current treatments often involve high doses of steroids and other immunosuppressants that can cause long-term side effects, including infections. This study is exploring whether blocking a specific pathway called JAK-STAT, which is involved in inflammation, could offer a more targeted therapy. The role of type 1 interferon in these diseases suggests that inhibiting JAK1 may reduce disease activity. Participants in this study will receive Filgotinib, a drug taken orally once daily at a dose of 200 mg for 26 weeks. This treatment is being assessed to see how it affects disease activity in patients with the three conditions. The study does not include a placebo group and is open-label, meaning both researchers and participants know the treatment being given. During the 26-week period, participants will undergo regular assessments to monitor disease activity specific to each condition, quality of life using the EQ-5D-5L questionnaire, and symptoms such as pain and fatigue. Researchers will also track corticosteroid use and any side effects related to the treatment. Safety and treatment effects will be carefully evaluated throughout the study, which aims to better understand the potential of Filgotinib for these rare diseases.

CONDITIONS

Brief Title

Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of Behet's disease with active disease but without refractory life-, organ-, or sight-threatening symptoms
  • Diagnosis of idiopathic inflammatory myopathy with active disease according to specific diagnostic criteria
  • Diagnosis of IgG4-related disease with active disease based on 2019 ACR/EULAR guidelines
  • Refractory disease with lack of response to standard immunosuppressants or intolerance to standard treatment
  • No active, latent, or inadequately treated tuberculosis infection confirmed by tests and chest radiograph
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Age 65 years or older
  • Life expectancy less than 6 months
  • Juvenile dermatomyositis or myositis overlapping with other autoimmune diseases
  • End-stage idiopathic inflammatory myopathy with 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 infections or viral hepatitis B or C
  • History of shingles or recurrent herpes simplex infection
  • Recent or current malignancies except treated skin cancers
  • Increased cancer risk
  • Severe kidney or liver failure
  • Low neutrophil, leukocyte, or hemoglobin counts
  • Inability to comply with study procedures
  • Known substance abuse
  • Poor venous access or intolerance to blood sampling
  • Previous non-adherence to immunosuppressants
  • Hypersensitivity to study drug or excipients
  • Rare hereditary problems affecting sugar absorption or metabolism (galactose intolerance, lactase deficiency, glucose-galactose malabsorption)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 26 weeks

Participants receive Filgotinib once daily, 200mg orally, for up to 26 weeks.

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

Loading map...

Research Team

A

Anne Karien Marijnissen, Dr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Similar Trials

A Phase 1/2 Study of NKX019, a CD19 Chimeric Antigen Recepto...

Systemic Sclerosis

Actively Recruiting

17 locations

Cohort Study of Patients With IgG4-Related Disease

IgG4-related Disease

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Multicentre, 26-week, open-label phase 2 trial of the JAK inhibitor filgotinib in Behçet's disease, idiopathic inflammatory myopathies and IgG4-related disease: DRIMID study protocol.

Bettina C Geertsema-Hoeve, Jan A M van Laar, Joost Raaphorst...

https://pubmed.ncbi.nlm.nih.gov/39915014