Unravelling Intestinal Fibrosis in Ulcerative Colitis

Phase 2

Recruiting

• Conditions: Ulcerative Colitis (UC); Inflammatory Bowel Disease (IBD); Fibroblast Activation Protein Inhibitor
• Interventions: Diagnostic Test: Fibroblast Activation Protein Inhibitor

• Registration Number: NCT06604273
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

The main objectives are: (i) to identify candidate fibrotic cellular pathways in UC patients treated with a JAK inhibitor filgotinib), and (ii) to detect and monitor in vivo fibrosis in UC patients using FAPi-PET/CT imaging

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-03
• Status Verified: 2024-09
• Study First Submitted: 2024-09-17
• Study First Submitted QC: 2024-09-17
• Last Update Submitted: 2024-09-17
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2025-10-03
• Study Completion: 2026-04-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Fibroblast Activation Protein Inhibitor	This group undergoes FAPi-PET CT imaging

Primary Outcome Measures

Name	Time	Method
Candidate fibrotic cellular pathways	From enrollment to end of study participation at 24 weeks	Identification of candidate fibrotic cellular pathways using single cell pathway analysis and mucosal biopsies from UC patients before and at week 24 weeks after treatment initiation with filgotinib.

Secondary Outcome Measures

Name	Time	Method
68Ga-FAPi-PET/CT imaging feasibility	From enrollment to end of study participation at 24 weeks	Feasilibility 68Ga-FAPi-PET/CT imaging as biomarker to monitor in vivo fibrosis in UC. By detection of in vivo intestinal fibrosis by means of measuring 68Ga-FAPi uptake, both visually as semi-quantitatively, in UC patients using FAPi-PET/CT imaging at baseline and 24 weeks after treatment initiation with filgotinib.
Correspondance 68Ga-FAPi uptake and STAT expression	From enrollment to end of study participation at 24 weeks	To determine to what extent 68Ga-FAPi bowel uptake in UC patients corresponds to (phospohorylated and total) STAT gene and protein (i.e. down-stream JAK targets) expression
Correspondance 68Ga-FAPi uptake and clinical and endoscopic parameters	From enrollment to end of study participation at 24 weeks	To determine to what extent 68Ga-FAPi bowel uptake in UC patients corresponds to clinical and endoscopic changes after 24 weeks of treatment with filgotinib

Trial Locations

Locations (1)

Amsterdam UMC; 🇳🇱 Amsterdam, Noord-Holland, Netherlands