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Long-term safety study of filgotinib tablets in adults with ulcerative colitis who completed previous filgotinib treatment

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 study focuses on patients with Ulcerative Colitis, a chronic inflammatory condition affecting the large intestine. The research evaluates the long-term safety of filgotinib, which is available as film-coated tablets under the brand name Jyseleca. This medication is taken by mouth and comes in two strengths: 100 mg and 200 mg.

The purpose of this research is to observe how safe filgotinib is when used over an extended period by patients who have previously participated in other studies of this medication for Ulcerative Colitis. The study will monitor various aspects of patient health while they are taking the medication.

During the study, participants will continue receiving filgotinib treatment while researchers track their health through regular check-ups and laboratory tests. The study will also measure how well the medication controls the symptoms of Ulcerative Colitis using a scoring system that evaluates disease activity. The total duration of treatment may extend up to several years to gather comprehensive long-term safety information.

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 screening and enrollment
You will be enrolled after completing a previous study with filgotinib for ulcerative colitis treatment
You must sign an informed consent form before starting any study procedures
If you are a woman who can become pregnant, you will need to take a pregnancy test
Step 2
Medication administration
You will receive Jyseleca (filgotinib) tablets to take by mouth
The tablets come in two strengths: 100 mg and 200 mg film-coated tablets
Your doctor will determine the appropriate dose for you
Step 3
Regular monitoring
Your safety will be monitored through regular check-ups
Laboratory tests will be performed to check your health status
Your vital signs will be measured during visits
Your ulcerative colitis symptoms will be evaluated using the Mayo Clinic Score
Step 4
Ongoing requirements
If you are a woman who can become pregnant, you will need monthly pregnancy tests
You must use appropriate birth control methods as specified in the study protocol
You should not receive live or weakened vaccines during the study and for 12 weeks after the last dose
Step 5
Study duration
This is a long-term study that will continue until December 2026
The purpose is to evaluate the long-term safety of filgotinib in treating ulcerative colitis

Who can join the trial?

7 criteria

Must be able to understand and sign an informed consent form (ICF) before starting any study procedures
Must have previously participated in specific Ulcerative Colitis research studies involving filgotinib treatment
Must have either completed all required procedures or met criteria for stopping treatment in a previous filgotinib study for Ulcerative Colitis
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Women who can become pregnant must:
- Have a negative pregnancy test on the first day of the study
- Agree to monthly pregnancy testing while taking filgotinib
- Use approved birth control methods if sexually active with men
- Must agree not to receive live or attenuated vaccines (vaccines containing weakened forms of viruses or bacteria) during the study and for 12 weeks after the last dose of study medication

Who cannot join the trial?

14 criteria

History of allergic reactions or hypersensitivity to filgotinib or similar medications
Active or chronic infections, including but not limited to tuberculosis (TB) or hepatitis B or C
Significant liver problems, indicated by abnormal liver function tests
Severe kidney disease or impaired kidney function
Current or recent history of cancer within the past 5 years (except for successfully treated non-melanoma skin cancer)
Pregnant or breastfeeding women, or those planning pregnancy during the study period
Use of other investigational drugs within 30 days or 5 half-lives before starting this study
Major surgery within 4 weeks before starting the study
Severe heart conditions or uncontrolled high blood pressure
History of blood clotting disorders or recent blood clots
Current use of medications that could interact with filgotinib
Mental health conditions that could interfere with study compliance
Active substance abuse or alcohol dependency
Unable to follow study procedures or attend scheduled visits

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Budapest, Hungary
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Gyongyosi Bugat Pal Korhaz
Gyongyos, Hungary
Verified
University Of Debrecen
Debrecen, Hungary

Trial locations

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Investigated drugs

Filgotinib is a medication used to treat ulcerative colitis, which is a chronic inflammatory condition affecting the large intestine. It works by reducing inflammation in the digestive system by targeting specific proteins involved in the inflammatory process. This medication helps manage symptoms of ulcerative colitis and may help prevent flare-ups of the condition.

Filgotinib

What is already known about the treatment

Filgotinib – An oral medication that belongs to the class of Janus kinase (JAK) inhibitors, specifically targeting JAK1, used in the treatment of Ulcerative Colitis (UC). The drug works by blocking specific enzymes involved in inflammation, helping to reduce the symptoms and inflammation associated with UC, a chronic inflammatory bowel disease. Filgotinib is administered as a tablet taken by mouth, and its development represents a newer approach to treating inflammatory conditions through selective immune system modulation. Clinical trials have been conducted to evaluate its long-term safety and effectiveness in patients with UC who have previously received filgotinib treatment.

Investigated diseases

Ulcerative Colitis - A chronic inflammatory bowel disease that affects the large intestine (colon) and rectum. The condition causes inflammation and sores (ulcers) in the digestive tract's innermost lining. The inflammation typically begins in the rectum and extends continuously up into the colon, causing the colon's lining to become red and swollen. People with ulcerative colitis experience recurring periods of active disease followed by periods of remission. The condition can develop gradually or suddenly, and it affects each person differently in terms of severity and extent of colon involvement.