Unravelling Intestinal Fibrosis in Ulcerative Colitis

NCT06604273 | Recruiting Phase 2

• 2 other identifiers: NL85277.0182023-507907-73-00
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

PET CT; FAPI; IBD; Ulcerative colitis; Filgotinib

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 68Ga-FAPi-PET/CT imaging feasibility

  From enrollment to end of study participation at 24 weeks

• Correspondance 68Ga-FAPi uptake and STAT expression

  From enrollment to end of study participation at 24 weeks

• Correspondance 68Ga-FAPi uptake and clinical and endoscopic parameters

  From enrollment to end of study participation at 24 weeks

Study Arms (2)

Group 2

EXPERIMENTAL

This group undergoes FAPi-PET CT imaging

Diagnostic Test: Fibroblast Activation Protein Inhibitor

Group 1

NO INTERVENTION

Does not undergo a FAPi scan

Interventions

Fibroblast Activation Protein Inhibitor DIAGNOSTIC_TEST

PET CT imaging using the fibroblast activation protein inhibitor tracer

Also known as: FAPi PET CT scan

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Pregnancy
• Unable to provide informed consent
• Colorectal carcinoma or high-grade dysplasia

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1081BT, Netherlands

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Mark Lowenberg, MD PhD

  Amsterdam University Medical Centers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dalia A Lartey, MD

CONTACT

+31205668160; d.a.lartey@amsterdamumc.nl

Kelly van Wijnbergen, Msc

CONTACT

+31205668160; k.vanwijnbergen@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Drs

Model Details: Half of the study participants will undergo PET CT imaging. Therefore, the interventional study model only applies to half of the study partcipants.

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: April 3, 2024
• Primary Completion: October 3, 2025
• Study Completion: April 3, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

NL (1)