Unravelling Intestinal Fibrosis in Ulcerative Colitis (INTERACT)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status and phase: Enrolling; Phase 3; Phase 2

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

Treatments: Diagnostic Test: Fibroblast Activation Protein Inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT06604273

2023-507907-73-00 (EU Trial (CTIS) Number)

NL85277.018

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Group 2

Experimental group

Description:

This group undergoes FAPi-PET CT imaging

Treatment:

Diagnostic Test: Fibroblast Activation Protein Inhibitor

Group 1

No Intervention group

Description:

Does not undergo a FAPi scan