Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A single arm, open-label study to evaluate the efficacy and safety of ABBV-668 in subjects with moderate to severe ulcerative colitis.

This research study is investigating a new medication, ABBV-668, for individuals living with moderate to severe ulcerative colitis. Ulcerative colitis is a long-term condition that causes inflammation in the large intestine. The main goal of this study is to find out if ABBV-668 can help heal the inside of the bowel, which doctors check using a special procedure called an endoscopy, measuring improvement after 8 weeks of treatment. They will also be looking closely at whether the medicine helps reduce symptoms and if it is safe for people to use. This is a "Phase II" study, meaning it's an important early step to see how well the treatment works and if it has any side effects, before it can be offered more widely.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Abbvie Deutschland GmbH & Co. KG

Enrolment target

Start

19 Jul 2023

Ulcerative Colitis

What is this study about?

This study is about a new medicine called ABBV-668, which is being tested for people who have moderate to severe ulcerative colitis. Ulcerative colitis is a type of inflammatory bowel disease (IBD) where the lining of your large intestine (bowel) becomes inflamed and develops tiny open sores, called ulcers. This can cause symptoms like tummy pain, diarrhoea, and blood in your poo.

The main aim of this research is to see if ABBV-668 can help the inside of your bowel to heal. Doctors will check this specifically after 8 weeks of treatment using a procedure called an endoscopy, which involves looking inside your bowel with a small camera. They are hoping to see significant improvement or complete healing of the bowel lining. They also want to understand if the medicine helps reduce your other symptoms, like tummy pain or how often you need to go to the toilet.

This is a "Phase II" study, which means it's an important step in developing new treatments. In this phase, researchers are careful to check how effective the new medicine is and if it has any side effects. It helps them decide if it's promising enough to be studied in a larger group of people later on. The results from this study will help doctors learn more about ABBV-668 and its potential to help people with ulcerative colitis.

Key takeaways

This study is testing a new medicine called ABBV-668 for moderate to severe ulcerative colitis.
The main goal is to see if it helps heal the bowel lining after 8 weeks.
It's a 'Phase II' study, which means it’s an early test of effectiveness and safety.
Participants will receive the real medicine, and doctors will closely monitor their health.
Both men and women aged 18 and over with the condition can be considered.

Who may be eligible?

To join this study, you need to be at least 18 years old. Both men and women are welcome to take part.

Because this study is specifically for people with moderate to severe ulcerative colitis, you would need to have received that diagnosis from your doctor. The researchers will also have specific health criteria to make sure the study is safe and appropriate for everyone involved.

If you are interested, the study team would go through a full list of these criteria with you to see if the study is a good fit for your individual health situation.

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 a diagnosis of moderate to severe ulcerative colitis?
Are you able to attend regular clinic appointments?
Are you willing to have an endoscopy procedure as part of the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the new medicine called ABBV-668. This study is "open-label," which means both you and the study doctors will know you are receiving ABBV-668. Over the course of the study, you will have regular visits to the clinic so the doctors can monitor your health, check for any changes in your ulcerative colitis symptoms, and see if the medicine is working. These visits will likely include physical examinations, blood tests, and discussions about how you are feeling. The main check to see if the medicine is working will be an endoscopy at Week 8 to look at the lining of your bowel. There will also be follow-up appointments after this to ensure your well-being.

Potential risks and benefits

Taking part in this study might offer you access to a new treatment, ABBV-668, before it becomes widely available. It could potentially improve the health of your bowel and your symptoms. However, like all medicines, ABBV-668 may have side effects, and some people may not respond to the treatment. The research team will explain all known potential risks to you. Remember, you can decide to leave the study at any time, for any reason, without it affecting your medical care.

Locations (3)

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

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Unverified
Belgium
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Unverified
France
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Unverified
Poland

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition that causes inflammation and sores in the lining of your large intestine (colon and rectum).

What is ABBV-668?

ABBV-668 is the name of the new medicine being tested in this study to see if it can help people with ulcerative colitis.

What does 'moderate to severe' mean?

It means your ulcerative colitis symptoms are quite troublesome and have a noticeable impact on your daily life, usually requiring ongoing treatment.

What is an endoscopy?

An endoscopy is a procedure where a doctor uses a thin, flexible tube with a camera to look inside your bowel. It helps them see how healthy the lining is.

How long will the study last?

The main part of the study where they check if the medicine helps heal your bowel is at Week 8, but there will be further appointments to follow your progress.