Overview
Sponsor-declared trial summary
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.
Key facts
- Sponsor
- Amsterdam UMC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 3 Apr 2024 → 23 Oct 2025
- Decision date (initial)
- 2023-12-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Amsterdam UMC and Galapagos B.V.
External identifiers
- EU CT number
- 2023-507907-73-00
- WHO UTN
- U1111-1297-5981
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Diagnosis, Pharmacokinetic
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.
Secondary objectives 3
- 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
- To determine to what extent 68Ga-FAPi bowel uptake in UC patients corresponds to (phospohorylated and total) STAT protein (i.e. down-stream JAK targets) and gene expression
- 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
Conditions and MedDRA coding
Ulcerative colitis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Adults ≥18 years with confirmed diagnosis of ulcerative colitis - Active disease confirmed by endoscopy (endoscopic Mayo score ≥ 2) - Indication to start treatment with filgotinib AND one of the following: - Active disease confirmed by intestinal ultrasound (BWT > 3 mm in atleast one bowel segment and atleast one other pathological IUS parameter) or - Increased CRP (>5 mg/L) and/or fecal calprotectin levels (>250 mg/kg)
Exclusion criteria 1
- A potential subject who meets any of the following criteria will be excluded from participation in this study: - Pregnancy - Unable to provide informed consent - Colorectal carcinoma or high grade dysplasia
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Identified pathways obtained via pathway analysis (single-cell RNA sequencing). Changes in these identified pathways (in gene and protein expression at week 24 compared to week 0)
Secondary endpoints 3
- Binding of [68Ga]Ga-FAPi-46 will be measured using the standardized uptake value (SUV) and target to background ratios will aid in scoring and quantifying tracer uptake. Semi-quantitative uptake above local background will be corrected and uncorrected for tracer plasma concentration based on pharmacokinetic analysis. SUV quantified from the FAPi-PET/CT-scan participants will be compared to non-affected intestinal regions. FAPi PET uptake expressed as SUV. Percentage of SUV decrease at week 24.
- Changes in gene and protein expression levels expressed as percentages in mucosal biopsies at week 0 and at week 24 (increased/ decreased an to what degree this corresponds to the SUV.
- Changes in FAPi PET uptake and correlation to clinical (SCCAI score) and endoscopic (Mayo score) changes.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
GalliUC 370 MBq/mL precursor radiofarmacêutico, solução
PRD9374731 · Product
- Active substance
- Gallium (68GA) Chloride
- Pharmaceutical form
- RADIOPHARMACEUTICAL PRECURSOR, SOLUTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 370 MBq megabecquerel(s)
- Max total dose
- 750 MBq megabecquerel(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- V09X — OTHER DIAGNOSTIC RADIOPHARMACEUTICALS
- Marketing authorisation
- 5820220
- MA holder
- ICNAS PRODUÇÃO UNIPESSOAL LDA.
- MA country
- Portugal
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC
- Sponsor organisation
- Amsterdam UMC
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC
- Contact name
- D.A. Lartey
Public contact point
- Organisation
- Amsterdam UMC
- Contact name
- D.A. Lartey
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-04-03 | 2025-10-23 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-08 | Netherlands | Acceptable 2023-12-07
|
2023-12-08 |