Understanding Intestinal Fibrosis in Ulcerative Colitis
Unravelling Intestinal Fibrosis in Ulcerative Colitis
PHASE2; PHASE3 · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT06604273
This study is testing how well the JAK inhibitor filgotinib works for people with Ulcerative Colitis by looking at changes in their intestinal scarring using special imaging.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other) |
| Drugs / interventions | filgotinib |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT06604273 on ClinicalTrials.gov |
What this trial studies
This study aims to identify fibrotic cellular pathways in patients with Ulcerative Colitis (UC) who are being treated with the JAK inhibitor filgotinib. It will also utilize FAPi-PET/CT imaging to detect and monitor fibrosis in these patients. The study is interventional and includes both Phase 2 and Phase 3 components to assess the effectiveness of the treatment. Participants will undergo imaging and assessments to evaluate their condition and response to therapy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of active Ulcerative Colitis.
Not a fit: Patients who are pregnant, unable to provide informed consent, or have colorectal carcinoma or high-grade dysplasia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients suffering from Ulcerative Colitis and related fibrosis.
How similar studies have performed: Other studies have explored similar approaches in inflammatory bowel disease, but this specific focus on fibrosis and the use of FAPi-PET/CT imaging is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults with confirmed diagnosis of UC - Group 1 criterion: ≥18 years of age regardless of gender * Group 2 criterion: ≥30 years of age for males and ≥40 years of age for females * Active disease confirmed by endoscopy (endoscopic Mayo score ≥ 2) * Indication to start treatment with filgotinib AND one of the following criteria: * Active disease confirmed by intestinal ultrasound (BWT \> 3 mm in at least one bowel segment and at least one other pathological IUS parameter) or * Increased CRP (\>5 mg/L) and/or fecal calprotectin levels (\>250 mg/kg) Exclusion Criteria: * Pregnancy * Unable to provide informed consent * Colorectal carcinoma or high-grade dysplasia
Where this trial is running
Amsterdam, North Holland
- Amsterdam UMC — Amsterdam, North Holland, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Mark Lowenberg, MD PhD — Amsterdam UMC, location VUmc
- Study coordinator: Dalia A Lartey, MD
- Email: d.a.lartey@amsterdamumc.nl
- Phone: +31205668160
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ulcerative Colitis, Inflammatory Bowel Disease, Fibroblast Activation Protein Inhibitor, PET CT, FAPI, IBD, Ulcerative colitis, Filgotinib