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

3 1 1

What is this study about?

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.

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

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

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

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

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 Study?

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
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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
University Of Debrecen	Debrecen	Hungary
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet	Budapest	Hungary
Gyongyosi Bugat Pal Korhaz	Gyongyos	Hungary

Trial status

Country	Status	Recruitment Start
Hungary	Not recruiting	01.01.2017

Trial locations

Investigated drugs:

Filgotinib

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.

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.

Trial ID:

2024-516199-14-00

Protocol code:

GS-US-418-3899

NCT ID:

NCT02914535

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?