Study on the Safety and Effectiveness of OD-07656 and Vedolizumab for Patients 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. The study will test a medication called OD-07656, which is taken as a capsule, and a subsequent treatment with Vedolizumab, also known as Entyvio, which is given through an intravenous infusion. The purpose of the study is to evaluate the safety and effectiveness of these treatments in people with moderately to severely active Ulcerative Colitis.

Participants in the study will first receive the OD-07656 capsule, which is a chemical compound, for a period of up to 12 weeks. After this initial phase, they will receive Vedolizumab, a protein-based medication, for up to 38 weeks. The study will monitor how well these treatments work in reducing the symptoms of Ulcerative Colitis and will also check for any side effects or changes in health indicators like blood tests and heart function.

The trial aims to provide valuable information on whether these treatments can help manage the symptoms of Ulcerative Colitis and improve the quality of life for those affected by this condition. Participants will be closely monitored throughout the study to ensure their safety and to gather data on the effectiveness of the treatments.

1 initial visit and consent

Upon joining the study, you will have an initial visit where you will be asked to provide informed consent. This means you will be given detailed information about the study, including its purpose, procedures, and any potential risks or benefits. You will need to agree to participate by signing a consent form.

2 screening procedures

You will undergo screening procedures to confirm your eligibility for the study. This includes a colonoscopy or flexible sigmoidoscopy to assess the extent of your ulcerative colitis. If you have extensive colitis or pancolitis for more than 8 years, or left-sided colitis for more than 12 years, a colonoscopy will be required if your last one was over a year ago.

A pregnancy test will be conducted if applicable, and your medical history will be reviewed to ensure you meet the study criteria.

3 study medication phase 1

In the first phase of the study, you will receive the study medication OD-07656 in the form of oral capsules. The dosage and frequency will be determined by the study team based on your specific needs and condition.

4 monitoring and assessments

Throughout the study, you will have regular visits for monitoring and assessments. This includes checking your vital signs, conducting laboratory tests, and evaluating your response to the medication. You will be asked about any side effects or changes in your condition.

5 study medication phase 2

If you continue to the second phase of the study, you will receive vedolizumab therapy. This medication is administered through an intravenous infusion. The frequency and duration of this treatment will be explained to you by the study team.

6 final assessments and follow-up

At the end of the study, you will have final assessments to evaluate the overall effects of the treatment. This includes a review of your condition and any changes observed during the study.

You may be asked to return for follow-up visits to monitor your health after the study concludes.

Who Can Join the Study?

Adults between 18 and 75 years old can participate.
You must have been diagnosed with Ulcerative Colitis (UC) that affects at least 15 cm from the anal verge. This diagnosis should have been made at least 90 days before the screening visit, confirmed by a doctor through a procedure like a colonoscopy or flexible sigmoidoscopy, and supported by tissue examination (histology).
Your UC should be classified as moderately to severely active. This means a specific score between 5 to 9 points on a medical scale, with certain criteria met in stool frequency and endoscopic findings.
You need to have a colonoscopy or flexible sigmoidoscopy during the screening period. If you have had extensive colitis for more than 8 years or left-sided colitis for more than 12 years, a colonoscopy is required if your last one was over a year ago. Otherwise, a flexible sigmoidoscopy is acceptable.
You must have shown, in the opinion of the study doctor, an inadequate response, loss of response, or intolerance to at least one of the following treatments: oral aminosalicylates, corticosteroids, immunosuppressants, biologics, Janus kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) modulators.
If you are a person of childbearing potential, you must have a negative pregnancy test at the screening visit and again on the first day of receiving the study treatment. If you cannot have children, this must be documented in your medical records.
You must be able to provide signed informed consent, which means you agree to follow the study requirements and restrictions, including using electronic data capture methods.

Who Cannot Join the Study?

Patients with any other significant health conditions that could interfere with the study.
Patients who have had a recent surgery or are planning to have surgery during the study period.
Patients who are currently participating in another clinical trial.
Patients who have a history of severe allergic reactions to medications.
Patients who are pregnant or breastfeeding.
Patients with a history of drug or alcohol abuse.
Patients who have an active infection that requires treatment.
Patients who have been diagnosed with cancer in the past five years, except for certain skin cancers.
Patients who have a history of heart disease or uncontrolled high blood pressure.
Patients who have a history of liver or kidney disease.

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

Other Sites

Site Name	City	Country
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos	Kaunas	Lithuania
Nowe Zdrowie-Ck Kieltucki I Wspolnicy Sp. j.	Staszow	Poland
Vita Longa Sp. z o.o.	Katowice	Poland
Endoskopia Sp. z o.o.	Sopot	Poland
Poliklinika Borzan d.o.o.	Osijek	Croatia
Semmelweis University	Budapest	Hungary
Hepato-Gastroenterologie HK s.r.o.	Hradec Kralove	Czechia
Poliklinika Solmed d.o.o.	Zagreb	Croatia
KBC Split	Split	Croatia
Centrum Medyczne Medyk Sp. z o.o.	Rzeszow	Poland
University Of Szeged	Szeged	Hungary
Comnuqf Mwtahxkn Ljlzptl Jqfodr Łyrm	Chojnice	Poland
Plpjsemokhb Elczsvprlwho	Wroclaw	Poland
Mwjnwiah St z ogca	Bydgoszcz	Poland
Mkqzpzr Uwuztozyxk Ov Gwti	Graz	Austria
Whw Wakmrd Ivi Pvvwj Putvznfx Kfnqwmi	Warsaw	Poland
Cwnfggmb Hrjhgtph Ddjqtnr	Zagreb	Croatia

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.05.2025
Belgium	Not recruiting	01.05.2025
Croatia	Not recruiting	01.05.2025
Czechia	Not recruiting	01.05.2025
Hungary	Not yet recruiting	01.05.2025
Lithuania	Not recruiting	01.05.2025
Poland	Not recruiting	01.05.2025

Trial locations

Investigated drugs:

Vedolizumab

OD-07656 is a new medication being tested to see if it can help people with ulcerative colitis, which is a condition that causes inflammation and sores in the colon. This medication is being studied to understand if it is safe for people to use and if it can effectively reduce the symptoms of ulcerative colitis. The trial aims to find out how well people tolerate this medication and how it impacts their condition.

Vedolizumab is a medication that is already used to treat ulcerative colitis. It works by blocking certain cells in the body that cause inflammation in the gut. In this trial, researchers are looking at how well vedolizumab works after patients have been treated with OD-07656. The goal is to see if using vedolizumab after OD-07656 can help improve the symptoms of ulcerative colitis even more.

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 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 can extend to involve the entire colon over time. The inflammation causes the colon to empty frequently, resulting in loose and urgent bowel movements. As the disease progresses, it can lead to complications such as severe bleeding, dehydration, and malnutrition. The severity and extent of the inflammation can vary, leading to periods of remission and flare-ups.

Trial ID:

2024-520201-39-00

Protocol code:

OD-07656-201

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of OD-07656 and Vedolizumab for Patients with Moderate to Severe Ulcerative Colitis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?