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Recruiting

NCT Number: NCT06604273

Unravelling Intestinal Fibrosis in Ulcerative Colitis

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

Recruiting

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Key information

Conditions

Ulcerative Colitis (UC) Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Fibroblast Activation Protein Inhibitor Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Disease (IBD) Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Amsterdam UMC

Amsterdam, North Holland, 1081BT, Netherlands

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fibroblast Activation Protein Inhibitor

Diagnostic Test

PET CT imaging using the fibroblast activation protein inhibitor tracer

Other names: FAPi PET CT scan

Primary outcomes

  1. Candidate fibrotic cellular pathways

    Time frame: 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 outcomes

  1. 68Ga-FAPi-PET/CT imaging feasibility

    Time frame: 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.

  2. Correspondance 68Ga-FAPi uptake and STAT expression

    Time frame: 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

  3. Correspondance 68Ga-FAPi uptake and clinical and endoscopic parameters

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Dalia A Lartey, MD

CONTACT

[email protected]

+31205668160

Kelly van Wijnbergen, Msc

CONTACT

[email protected]

+31205668160

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: INTERACT

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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