Unravelling Intestinal Fibrosis in Ulcerative Colitis (INTERACT)

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

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Disease (IBD); Ulcerative Colitis (UC); Fibroblast Activation Protein Inhibitor
• Intervention / Treatment: Diagnostic test: Fibroblast Activation Protein Inhibitor

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Dalia A Lartey, MD; Phone Number: +31205668160; Email: d.a.lartey@amsterdamumc.nl
• Study Contact Backup: Name: Kelly van Wijnbergen, Msc; Phone Number: +31205668160; Email: k.vanwijnbergen@amsterdamumc.nl

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1081BT
      • Recruiting
      • Amsterdam UMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 2; This group undergoes FAPi-PET CT imaging	Diagnostic test: Fibroblast Activation Protein Inhibitor; PET CT imaging using the fibroblast activation protein inhibitor tracer; Other Names: FAPi PET CT scan
No Intervention: Group 1; Does not undergo a FAPi scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Candidate fibrotic cellular pathways	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.	From enrollment to end of study participation at 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
68Ga-FAPi-PET/CT imaging feasibility	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.	From enrollment to end of study participation at 24 weeks
Correspondance 68Ga-FAPi uptake and STAT expression	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	From enrollment to end of study participation at 24 weeks
Correspondance 68Ga-FAPi uptake and clinical and endoscopic parameters	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	From enrollment to end of study participation at 24 weeks

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Mark Lowenberg, MD PhD, Amsterdam University Medical Centers

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2024
• Primary Completion (Estimated): October 3, 2025
• Study Completion (Estimated): April 3, 2026

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: IBD; Ulcerative colitis; PET CT; FAPI; Filgotinib
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Ulcer; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: NL85277.018; 2023-507907-73-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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