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Study on Ulcerative Colitis: Effects of Filgotinib and Gallium (68Ga) Chloride in Patients with Intestinal Fibrosis

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying ulcerative colitis, a chronic condition that causes inflammation and sores in the digestive tract, specifically in the colon and rectum. The study will explore the effects of a treatment using a medication called filgotinib, which is a type of drug known as a JAK inhibitor. JAK inhibitors work by blocking certain enzymes in the body that contribute to inflammation. Additionally, the study will use a special imaging technique called FAPi-PET/CT to detect and monitor fibrosis, which is the thickening and scarring of tissue, in patients with ulcerative colitis.

The purpose of the study is to identify potential pathways in the body that lead to fibrosis in patients treated with filgotinib and to monitor these changes using FAPi-PET/CT imaging. Participants in the study will receive the treatment and undergo imaging scans to observe any changes in their condition. The study will last for several months, with participants being monitored at different stages to assess the effects of the treatment and the progression of fibrosis.

Throughout the study, researchers will analyze changes in gene and protein expression in the participants' tissues to better understand how the treatment affects the body. This information will help in identifying specific pathways that may be involved in the development of fibrosis in ulcerative colitis. The findings from this study could provide valuable insights into new ways to manage and treat this condition in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of ulcerative colitis and active disease through endoscopy, with an endoscopic Mayo score of 2 or higher.
Additional criteria include active disease confirmed by intestinal ultrasound or increased levels of CRP and/or fecal calprotectin.
Step 2
Treatment initiation
Eligible participants begin treatment with a JAK inhibitor called filgotinib. The dosage and frequency of administration are determined by the study protocol and the treating physician.
Step 3
Imaging and monitoring
Participants undergo FAPi-PET/CT imaging to detect and monitor fibrosis in the intestines. This imaging uses a tracer called [68Ga]Ga-FAPi-46, administered through intravenous injection.
The uptake of the tracer is measured and analyzed to assess fibrosis levels.
Step 4
Follow-up assessments
Throughout the study, follow-up assessments are conducted to monitor changes in gene and protein expression levels in mucosal biopsies. These assessments occur at the start of the study and at week 24.
The study also evaluates changes in clinical and endoscopic scores, correlating them with imaging results.
Step 5
Study completion
The study is expected to conclude by December 31, 2024. Final assessments will be conducted to compare data collected at the beginning and end of the study period.

Who can join the trial?

7 criteria

Must be an adult aged 18 years or older.
Must have a confirmed diagnosis of ulcerative colitis, which is a condition affecting the colon.
Must have active disease confirmed by an endoscopy, a procedure where a camera is used to look inside the colon, with a score of 2 or higher on the endoscopic Mayo score.
Must need to start treatment with a medication called filgotinib.
Must have one of the following conditions:
Active disease confirmed by an intestinal ultrasound, which is an imaging test to look at the intestines, showing a bowel wall thickness greater than 3 mm in at least one bowel segment and at least one other abnormal ultrasound finding.
Increased levels of CRP (C-reactive protein) greater than 5 mg/L, which is a blood test that shows inflammation, and/or increased levels of fecal calprotectin greater than 250 mg/kg, which is a stool test that indicates inflammation in the intestines.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with ulcerative colitis cannot participate. Ulcerative colitis is a condition that causes inflammation and sores in the colon and rectum.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups, but the exact ages are not specified here.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may have difficulty giving informed consent or are at higher risk of harm.
Patients who do not meet the specific health criteria required for the study cannot participate. These criteria are not detailed here.

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Responsive
Amsterdam UMC
Amsterdam, The Netherlands

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Investigated drugs

Filgotinib
is a medication used in this clinical trial to treat patients with ulcerative colitis. It works by inhibiting certain enzymes known as Janus kinases (JAK), which play a role in the inflammation process. By blocking these enzymes, filgotinib helps reduce inflammation and may improve symptoms in patients with ulcerative colitis. The study aims to identify how this medication affects fibrotic pathways in the intestines of patients.
FAPi-PET/CT Imaging
is a type of imaging technique used in this trial to detect and monitor fibrosis in patients with ulcerative colitis. This method involves using a special tracer that binds to fibroblast activation protein (FAP), which is often present in fibrotic tissues. The PET/CT scan then provides detailed images that help researchers see the extent and progression of fibrosis in the intestines, allowing for better understanding and monitoring of the condition.

Gallium (68Ga) Chloride

What is already known about the treatment

Filgotinib – Filgotinib is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating ulcerative colitis, a chronic inflammatory bowel disease. The medication works by inhibiting Janus kinase (JAK), a type of enzyme that plays a role in the inflammatory process, thereby reducing inflammation in the colon. Filgotinib is classified as a JAK inhibitor and is being explored for its potential to manage symptoms and improve the quality of life for patients with ulcerative colitis.

Investigated diseases

Ulcerative colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by continuous inflammation of the innermost lining of the large intestine, leading to the formation of ulcers. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The disease typically progresses with periods of exacerbation and remission. Over time, the inflammation can cause complications such as strictures or increased risk of colon cancer. The exact cause is unknown, but it is believed to involve an abnormal immune response in genetically predisposed individuals.