Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A randomized, double-blind, placebo-controlled, multicenter phase III study to evaluate the efficacy and safety of ABX464 once daily for induction treatment in subjects with moderately to severely active ulcerative colitis

This research study is looking into a new medication called ABX464 for adults who have ulcerative colitis that is moderate to severe. Ulcerative colitis is a long-term condition that causes inflammation and ulcers in the lining of the large intestine. The study aims to find out if ABX464 can help reduce symptoms, like frequent urgent trips to the toilet, and improve the health of the gut lining inside the body after eight weeks. It also checks if the medicine is safe and if there are any side effects. Participants will receive either the new medicine or a placebo (a dummy pill) to compare the effects properly. This is a common and important way to test new treatments.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Abivax

Enrolment target

322

Start

22 May 2023

Moderately to severely active ulcerative colitis

What is this study about?

This study is a Phase III clinical trial, which means it's one of the final steps in testing a new medicine before it might become widely available. The medicine being tested is called ABX464, and it's for people who have ulcerative colitis that is causing significant problems (moderate to severe). Ulcerative colitis is a condition where the large bowel (colon) and rectum become inflamed and develop ulcers, leading to symptoms like tummy pain, bloody stools, and frequent trips to the toilet.

The main goals of this study are to see how well ABX464 works. Specifically, after 8 weeks of treatment, the researchers want to know if a larger number of people taking ABX464 experience an improvement in the lining of their gut (which doctors can see during a procedure called an endoscopy) and a significant reduction in their symptoms compared to those taking a placebo. They also want to understand if the medicine is safe and what side effects, if any, people might experience.

By comparing ABX464 to a placebo, the researchers can be confident that any improvements noticed are genuinely due to the medicine itself and not just chance. If the study shows that ABX464 is both effective and safe, it could potentially become a new treatment option for people living with ulcerative colitis.

Key takeaways

This study is testing a new medicine (ABX464) for moderate to severe ulcerative colitis.
It aims to see if ABX464 improves gut healing and reduces symptoms over 8 weeks.
Participants will receive either ABX464 or a placebo.
The study also carefully checks for any side effects and safety concerns.
This is a major step (Phase III) in testing new treatments for ulcerative colitis.

Who may be eligible?

To join this study, called A randomized, double-blind, placebo-controlled, multicenter phase III study to evaluate the efficacy and safety of ABX464 once daily for induction treatment in subjects with moderately to severely active ulcerative colitis, you need to be an adult, meaning you must be 18 years old or older. There is no upper age limit for participating.

Both men and women are welcome to take part in this research. The most important thing is that you have been diagnosed with ulcerative colitis that is currently considered moderate to severe, meaning your symptoms are significantly affecting you. The study team will check your medical records and perform some tests to confirm this.

There will also be other specific medical criteria that the study doctors will explain. For example, they will need to make sure that other health conditions or medicines you are taking wouldn't interfere with the study medicine or your safety in the trial.

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 moderate to severe ulcerative colitis?
Are you able to attend regular clinic visits?
Are you willing to potentially receive either the new medicine or a dummy pill?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the new medicine, ABX464, or a placebo (a dummy pill that looks like the medicine but contains no active drug). You won't know which one you are taking, and neither will your study doctor, which helps to keep the results fair and unbiased. You will take the study medicine once a day.

Your participation will involve regular visits to the study clinic over several weeks. During these visits, the study team will carry out various checks. This will include physical examinations, blood tests, and potentially other tests like endoscopies (where a small camera is used to look inside your bowel) to see how your gut lining is responding. You'll also be asked about your symptoms and any side effects you might be experiencing.

After the initial 8-week treatment period, there will be follow-up appointments to continue monitoring your health and the effects of the treatment. The total duration of your involvement in the study, including all treatments and follow-ups, will be clearly explained to you by the study team before you make any decisions.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. A potential benefit of joining could be receiving a new investigational treatment, ABX464, which might improve your ulcerative colitis symptoms and gut health. However, there's also a chance you could receive the placebo, which has no active medicine. Potential risks include experiencing side effects from ABX464, which will be carefully monitored by the study team through various tests and check-ups. All known potential risks will be thoroughly explained to you, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (14)

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

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Unverified
France
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Unverified
Spain
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Unverified
Italy
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Unverified
Germany
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Unverified
Belgium
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Unverified
Poland
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Unverified
Bulgaria
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Unverified
Croatia
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Unverified
Czechia
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Unverified
Hungary
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Unverified
Ireland
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Unverified
Lithuania

Common questions

What is 'moderate to severe' ulcerative colitis?

This means your ulcerative colitis symptoms, like frequent urgent bowel movements, bloody stools, or tummy pain, are significantly affecting your daily life and haven't fully responded to standard treatments.

What is a placebo?

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

Will I know if I'm getting the real medicine or the placebo?

No, during the main part of this study, neither you nor your study doctor will know whether you are receiving ABX464 or the placebo. This is called 'double-blind' and ensures the study results are unbiased.

How long will I be in the study?

The main treatment period is 8 weeks, but there will be follow-up appointments after that. The study team will tell you the exact total length of your participation.

What does 'endoscopic improvement' mean?

This means that when doctors look inside your bowel with a tiny camera (during an endoscopy), they see that the inflammation and damage to the lining of your gut have improved or healed.