Ulcerative Colitis (UC)Phase 2/3INTERACTNCT06604273
Unravelling Intestinal Fibrosis in Ulcerative Colitis
A Phase 2/3 study testing Fibroblast Activation Protein Inhibitor in people with Ulcerative Colitis (UC) and Inflammatory Bowel Disease (IBD), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD), Fibroblast Activation Protein Inhibitor
- What is being tested?
- Fibroblast Activation Protein Inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Apr 2024to 3 Apr 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Pregnancy
- Unable to provide informed consent
- Colorectal carcinoma or high-grade dysplasia
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam, North Holland, 1081BT
About this study
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
- Being tested
- Fibroblast Activation Protein Inhibitor
- Keywords
- PET CT, FAPI, IBD, Ulcerative colitis, Filgotinib
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibroblast Activation Protein InhibitorDiagnostic test
Also called FAPi PET CT scan
PET CT imaging using the fibroblast activation protein inhibitor tracer
| Study group | Role | What they receive |
|---|---|---|
| Group 2 | Experimental | This group undergoes FAPi-PET CT imaging Receives: Diagnostic Test: Fibroblast Activation Protein Inhibitor |
| Group 1 | No intervention | Does not undergo a FAPi scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to end of study participation at 24 weeks
Secondary outcomes (3)
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.
Measured: 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
Measured: 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
Measured: From enrollment to end of study participation at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start3 Apr 2024
- Primary completion3 Oct 2025 (estimated)
- Study completion3 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Half of the study participants will undergo PET CT imaging. Therefore, the interventional study model only applies to half of the study partcipants.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Lartey, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Mark Lowenberg, MD PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604273
- Sponsor's protocol ID
- NL85277.018
- Other IDs
- 2023-507907-73-00, 2023
- Acronym
- INTERACT
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unravelling Intestinal Fibrosis in Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT06604273
- Acronym / sponsor ID
- INTERACT / NL85277.018
- Conditions
- Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD), Fibroblast Activation Protein Inhibitor
- Keywords
- PET CT, FAPI, IBD, Ulcerative colitis, Filgotinib
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 3 Oct 2025 (estimated)
- Study completion
- 3 Apr 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Half of the study participants will undergo PET CT imaging. Therefore, the interventional study model only applies to half of the study partcipants.
| Arm | Type | Receives |
|---|---|---|
| Group 2 | Experimental | Diagnostic Test: Fibroblast Activation Protein InhibitorThis group undergoes FAPi-PET CT imaging |
| Group 1 | No intervention | –Does not undergo a FAPi scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Active disease confirmed by intestinal ultrasound (BWT \> 3 mm in at least one bowel segment and at least one other pathological IUS parameter) or
Key exclusion criteria (3 listed)
- Pregnancy
- Unable to provide informed consent
- Colorectal carcinoma or high-grade dysplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibroblast Activation Protein InhibitorAlso: FAPi PET CT scanPET CT imaging using the fibroblast activation protein inhibitor tracer | Diagnostic test | Group 2 |
Primary outcome
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.
3 secondary outcomes
68Ga-FAPi-PET/CT imaging feasibility
Time frame: From enrollment to end of study participation at 24 weeks
Correspondance 68Ga-FAPi uptake and STAT expression
Time frame: From enrollment to end of study participation at 24 weeks
Correspondance 68Ga-FAPi uptake and clinical and endoscopic parameters
Time frame: From enrollment to end of study participation at 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Ulcerative Colitis (UC)
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
Not yet recruitingObservational study
Non-Invasive Biomarker Monitoring in UC on Biologics
Ulcerative Colitis
RecruitingPhase 2
LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
RecruitingPhase 1/2
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
RecruitingPhase 1/2
Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
Ulcerative Colitis (UC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Lowenberg, MD PhD principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fibroblast Activation Protein Inhibitor in people with Ulcerative Colitis (UC) and Inflammatory Bowel Disease (IBD), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalia A Lartey, MD (+31205668160, d.a.lartey@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Candidate fibrotic cellular pathways (time frame: From enrollment to end of study participation at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.