Study on the Safety and Effectiveness of ABBV-668 for Adults with Moderate to Severe Ulcerative Colitis

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for ulcerative colitis, a condition that causes inflammation and sores in the digestive tract, specifically affecting the colon and rectum. The treatment being tested is a medication called ABBV-668, which is taken in capsule form. The purpose of the study is to evaluate how safe and effective ABBV-668 is for adults who have moderate to severe forms of this condition.

Participants in the study will take ABBV-668 orally for a period of up to 16 weeks. During this time, researchers will monitor the participants to see if there is any improvement in their symptoms and to ensure the treatment is safe. The main goal is to see if there is an improvement in the condition of the colon as observed through a procedure called an endoscopy, which allows doctors to look inside the digestive tract. This improvement is expected to be noticeable by the eighth week of treatment.

In addition to the primary goal, the study will also look at other aspects of the treatment’s effectiveness, such as whether participants experience a reduction in symptoms or achieve a state of remission, where symptoms are minimal or absent. The study is designed to provide valuable information about the potential benefits of ABBV-668 for people living with moderate to severe ulcerative colitis.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures of the trial. You will be asked to provide consent to participate.

You will undergo an initial assessment to confirm your eligibility, which includes verifying your diagnosis of ulcerative colitis and reviewing your medical history.

2 baseline visit

During the baseline visit, your current health status will be evaluated. This includes a physical examination and possibly some laboratory tests.

You will be asked about your symptoms and any previous treatments you have tried for ulcerative colitis.

3 medication administration

You will begin taking the study medication, ABBV-668, which is provided in capsule form for oral use.

The dosage and frequency of the medication will be explained to you by the study team. It is important to follow the instructions carefully.

4 weekly check-ins

You will have regular check-ins with the study team, typically on a weekly basis, to monitor your progress and any side effects.

These check-ins may involve answering questions about your symptoms and overall health.

5 week 8 assessment

At week 8, a detailed assessment will be conducted to evaluate the effectiveness of the treatment.

This assessment will include an endoscopic examination to check for improvement in your condition.

6 completion of study

Upon completion of the study, you will have a final visit to review your health status and discuss the outcomes of the trial.

You will be informed about any follow-up care or additional steps needed after the study ends.

Who Can Join the Study?

Adult male or female, at least 18 years old at the time of the Baseline visit.
Diagnosis of Ulcerative Colitis (UC) for at least 90 days before the Baseline visit. This means you have been diagnosed with UC and have medical records to prove it.
Currently experiencing active UC with a specific score called the Adapted Mayo score between 5 to 9 points, and an endoscopic subscore of 2 to 3. This will be confirmed by a central review.
Have shown an inadequate response, loss of response, or intolerance to at least one of the following treatments: oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologics or targeted immunomodulators. This means that these treatments did not work well for you or you could not tolerate them.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Gastromed Sp. z o.o.	Torun	Poland
Centre Medico Chirurgical Ambroise Pare Hartmann	Neuilly-Sur-Seine	France
H-T. Centrum Medyczne Sp. z o.o.	Tychy	Poland
Universitair Ziekenhuis Gent	Gent	Belgium
Vitaz	Sint-Niklaas	Belgium
Endoskopia Sp. z o.o.	Sopot	Poland
Hopital Saint Eloi	Montpellier	France
CHC	Liege	Belgium
Ivkwysek dt Cztyzygkuhle Hgxzoqjegxp Udducxtucrtft dr Sglgq Eqffzje (vvuylfi	Saint Priest En Jarez	France
Wgt Wgmjmr Iwn Povdy Pvirlgkr Khusmha	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.08.2023
France	Not recruiting	01.08.2023
Poland	Not recruiting	01.08.2023

Trial locations

Investigated drugs:

Abbv-668

ABBV-668 is a medication being studied for its potential to help people with moderate to severe ulcerative colitis, which is a condition that causes inflammation and sores in the colon and rectum. This medication is designed to reduce inflammation and improve symptoms in patients, making it easier for them to manage their condition. The trial aims to see how safe and effective ABBV-668 is for treating this condition, helping doctors understand if it can be a good option for patients who need relief from their symptoms.

Investigated diseases:

Colitis ulcerative

Ulcerative Colitis – Ulcerative Colitis is a chronic inflammatory condition affecting the colon, also known as the large intestine. It is characterized by continuous inflammation and ulceration of the innermost lining of the colon, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease typically begins in the rectum and may extend to involve the entire colon over time. The inflammation causes the colon to become swollen and develop open sores, or ulcers, which can produce pus and mucus. The progression of the disease can vary, with periods of active symptoms followed by times of remission. The exact cause of Ulcerative Colitis is not fully understood, but it is believed to involve an abnormal immune response in the gut.

Trial ID:

2022-501263-41-00

Protocol code:

M21-446

NCT ID:

NCT05570006

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of ABBV-668 for Adults with Moderate to Severe Ulcerative Colitis

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