Active not recruitingPHASE3INTERVENTIONAL

ABTECT - Maintenance

This study is for people with ulcerative colitis that is moderately to severely active, and who haven't found enough relief from other common treatments like biologics or immunosuppressants. It's called ABTECT - Maintenance. The main goal is to find out if a new drug, ABX464, at doses of 25mg or 50mg taken once a day, can help keep symptoms in check over a long period. We also want to make sure it's safe. Participants in this study have already taken part in an earlier study where they started treatment. Now, this phase will check if the benefits of ABX464 can be maintained over many months or even years. Some people will receive ABX464, and others will receive a placebo (a dummy pill) to compare the results.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Abivax S.A.

Enrolment target

1,116

Start

16 Jan 2023

Estimated completion

01 May 2030

Ulcerative Colitis

What is this study about?

This research study is called ABTECT - Maintenance, and it's looking into a new medication for people living with ulcerative colitis. Ulcerative colitis is a long-term condition that causes inflammation and sores (ulcers) in your large intestine. This can lead to symptoms like tummy pain, diarrhoea, and needing to go to the toilet urgently. For many, existing treatments don't always work well enough, or their benefits don't last.

This study is for adults aged 16 and over who have moderately to severely active ulcerative colitis and haven't fully responded to, or can't tolerate, other common treatments. This includes standard medicines like steroids or immunosuppressants, as well as newer 'advanced' therapies like biologics. The new drug being tested is called ABX464. Researchers want to see if taking ABX464 regularly can help keep your ulcerative colitis symptoms under control for a long time, and if it's safe to use.

This particular study is a 'maintenance' phase. This means that people joining have already taken part in an earlier 'induction' study (ABX464-105 or ABX464-106) where they first started taking ABX464 or a placebo. The purpose now is to see if the positive effects of ABX464 can be maintained over a longer period, preventing symptoms from flaring up again.

Key takeaways

This study is for adults with moderate to severe ulcerative colitis.
It tests a new drug, ABX464, to see if it can keep symptoms stable long-term.
Participants must have completed a previous study with ABX464.
The study involves a 10-month treatment phase, possibly followed by a 4-year extension.
You might receive ABX464 or a placebo (dummy pill).

Who may be eligible?

To be considered for this part of the study, you must have already taken part in one of the earlier ABX464 studies (ABX464-105 or ABX464-106) and finished it. We also need to have received the results from an internal examination of your bowel that was done at the end of that first study. You must be able to understand what the study involves and be willing to sign a form saying you agree to take part.

There are also some important safety checks. Women who could become pregnant and men whose partners could become pregnant must agree to use effective birth control throughout the study. You also need to be willing to come to all the study visits and follow the instructions given by the study team. If required in your country, you should have health insurance.

You would not be able to join this study if you stopped your treatment early in the previous study. Also, if you have developed any other serious conditions since the last study, such as Crohn's disease, or anything that makes participating risky, you wouldn't be able to continue. This includes serious heart conditions or severe bowel problems like a perforated bowel.

Quick self-check

Have I already completed one of the first ABX464 studies (ABX464-105 or ABX464-106)?
Am I at least 16 years old?
Do I understand and agree to the study rules, including using birth control if needed?
Have I developed any new serious health problems since the last study?
Am I able and willing to attend all scheduled study visits?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, it actually has two main parts. The first part is a 44-week (about 10-month) treatment phase. During this time, you won't know if you're taking ABX464 or a placebo (a dummy pill), and neither will your study doctor. This is called a 'double-blind' study and helps us get the most accurate results. After these 44 weeks, if you're benefiting from the treatment, you could continue into a really long-term phase which lasts for up to 4 years.

Throughout these phases, you'll have regular visits to the clinic so the study team can check on your health and how you're responding to the treatment. This will involve physical examinations, blood tests, and discussing your symptoms. At the very end of the study, there will be one final follow-up visit about 4 weeks after your last dose of medication. The total time you could be involved in the study, if you continue through all phases, is almost 5 years.

Potential risks and benefits

Taking part in a study like this might offer some benefits, such as potentially receiving a new treatment that could help with your ulcerative colitis if other therapies haven't worked for you. You'll also receive careful monitoring of your health by a medical team. However, there are also potential risks; ABX464 is an investigational drug, which means we don't know all of its possible side effects yet, and you might experience side effects that we haven't seen before. If you receive the placebo, your ulcerative colitis might not improve or could even get worse. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (554)

University of Alabama -Birmingham
Birmingham, United States
Digestive Health Specialists of the Southeast
Dothan, United States
Lakeview Clinical Research
Guntersville, United States
Research Solutions of Arizona, PC
Litchfield Park, United States
Valleywise Health Medical Center
Phoenix, United States
GI Alliance
Sun City, United States
Del Sol Research Management, LLC
Tucson, United States
University of Arizona
Tucson, United States
University of Arkansas for Medical Sciences
Little Rock, United States
Applied Research Center of Arkansas
Little Rock, United States
National Institute of Clinical Research
Bakersfield, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, United States

+542 more sites — see the official record for the full list.

Common questions

What is ulcerative colitis?

It's a long-term condition that causes inflammation and sores in your large intestine, leading to tummy pain, diarrhoea, and urgent toilet visits.

What is ABX464?

It's a new medication being tested to see if it can help control ulcerative colitis symptoms and is safe to use for a long time.

Why is it called a 'maintenance' study?

It means you've already started treatment in an earlier part of the study, and now we're checking if the benefits can be kept up over many months or years.

What is a placebo?

A placebo is a dummy pill that looks like the real medicine but contains no active drug. It helps compare the new drug's effects accurately.

How long would I be in the study?

The first part is about 10 months, and if you continue, there's a longer phase that could last up to 4 years, plus a final check-up.