Active not recruitingPHASE3INTERVENTIONAL

Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis

This research study is checking the long-term safety of a medication called filgotinib for adults who have ulcerative colitis. Ulcerative colitis is a long-lasting condition that causes inflammation and ulcers in the lining of the large intestine. This study is specifically for people who have already taken part in a previous study involving filgotinib for their ulcerative colitis. The main purpose is to carefully monitor participants over an extended period to ensure that the medication continues to be safe when used for a longer time. Researchers will be looking out for any side effects or health issues that might develop with continued use of filgotinib. This helps doctors understand more about how the medicine works in the long run for patients.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Alfasigma S.p.A.

Enrolment target

1,173

Start

23 Feb 2017

Estimated completion

01 Sep 2026

Ulcerative Colitis

What is this study about?

This study is about a medicine called filgotinib, which is being investigated as a treatment for ulcerative colitis. Ulcerative colitis is a type of inflammatory bowel disease that affects the large intestine, causing symptoms like tummy pain and diarrhoea. This particular study is designed to look at the long-term safety of filgotinib. This means it's for people who have already been taking filgotinib in a previous research study for their ulcerative colitis.

The main reason for this study is that while new medicines are tested for a period, it's important to understand what happens when people take them for much longer. This study will carefully watch participants to see if there are any new or ongoing side effects, or any other health concerns that might become clear after using filgotinib for an extended time. This helps doctors and patients know more about the full picture of using this medicine.

By gathering this long-term safety information, researchers can get a better understanding of filgotinib. This information is crucial for health authorities to decide if the medicine is safe and effective enough for widespread use, and to provide doctors with clear guidelines on how to prescribe it. Ultimately, the goal is to provide the safest and most effective treatments for people living with ulcerative colitis.

Key takeaways

This study is about the long-term safety of filgotinib for ulcerative colitis.
It's for adults who were already in a filgotinib study.
Participants will be closely monitored for any lasting side effects.
You'll get regular health checks and access to the study medicine.
You can stop participating at any time if you change your mind.

Who may be eligible?

This study is looking for adults aged 18 and over who have ulcerative colitis. To join, you must have already taken part in a previous study where you received filgotinib for your ulcerative colitis. You also need to be able to understand the study information and give your permission to take part by signing a consent form.

There are some reasons why you might not be able to join. For example, if you are allergic to filgotinib or if you have other serious medical conditions that the study doctors think would make taking part unsafe for you. Women who could become pregnant will need to take a pregnancy test and agree to use specific birth control methods during the study.

Also, if you are not willing to avoid certain strong medications or live vaccines during the study period, you wouldn't be able to participate. The study team will review your full medical history to make sure taking part is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have ulcerative colitis?
Have you already participated in a previous filgotinib study for your ulcerative colitis?
Are you able to understand and sign consent forms?
If you are a woman who could become pregnant, are you willing to use specific birth control?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll continue to receive either filgotinib or a dummy drug (placebo), depending on what you were receiving at the end of the previous study. You will have regular visits to the clinic where study doctors and nurses will check your health, ask about your symptoms, and monitor for any side effects. These visits will likely include physical exams, blood tests, and possibly other tests to see how you're responding to the treatment and ensure your safety.

The total duration of your participation in this long-term study will vary for each person, as the main goal is to follow you over an extended period. The study team will explain the full schedule of visits and procedures. You'll be given detailed instructions about your medication and what to do between visits. You will have ongoing support from the study team throughout your time in the study.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as continuing to receive a study medication that may help manage your ulcerative colitis. You will also have very close medical monitoring by experts, which means any health changes will be noticed quickly. However, like all medications, filgotinib can have side effects, and some might be serious. There's also a chance the treatment might not work for you, or you might receive a placebo. The study team will explain all known side effects and risks in detail. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (323)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Digestive Health Specialists Of The Southeast
Verified postcode
Dothan, United States
Mayo Clinic Arizona
Verified postcode
Scottsdale, United States
VA Long Beach Healthcare System
Verified postcode
Long Beach, United States
Cedars Sinai Medical Center
Verified postcode
Los Angeles, United States
South Denver Gastroenterology, PC
Verified postcode
Lone Tree, United States
Connecticut GI PC-Research Division
Verified postcode
Farmington, United States
UF Clinical Research Center
Verified postcode
Gainesville, United States
Florida Research Institute
Verified postcode
Lakewood Rch, United States
University of Miami Crohn's and Colitis Center
Verified postcode
Miami, United States
Cordova Research Institute
Verified postcode
Miami, United States
Gastroenterology Group of Naples
Verified postcode
Naples, United States
Advanced Medical Research Center
Verified postcode
Port Orange, United States

Common questions

What is filgotinib?

Filgotinib is a medicine being studied for treating ulcerative colitis, a condition that causes inflammation in the large bowel.

Why is this study looking at long-term safety?

It's important to see how a medicine affects people over many months or years, not just a short time, to fully understand its safety.

Do I have to pay to join this study?

No, you don't have to pay to participate. All study-related medication and tests are provided for free.