Study on the Effects of Tamuzimod in Patients with Moderate to Severe Ulcerative Colitis

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 treatment being tested is called tamuzimod, also known by its code name VTX002. This medication is taken as a film-coated tablet and is designed to help reduce the symptoms of the disease by acting as a selective immunosuppressive agent, which means it helps to calm down the immune system’s response that causes inflammation.

The purpose of the study is to evaluate how effective and safe VTX002 is for people with moderately to severely active Ulcerative Colitis. Participants in the study will be randomly assigned to receive either the VTX002 tablets or a placebo, which looks like the real medication but does not contain the active ingredient. The study will last for about 13 weeks, during which time participants will take the tablets orally. Throughout the study, the health and progress of the participants will be closely monitored to assess the treatment’s impact on their condition.

The study aims to see if VTX002 can help achieve clinical remission, which means reducing the symptoms to a minimal level, and to observe any improvements in the condition of the colon as seen through endoscopic examinations. The trial will also look at other aspects such as symptom relief and tissue healing in the colon. This research is important for finding new ways to manage and treat Ulcerative Colitis effectively.

1 joining the study

Upon joining the study, participants are required to provide informed consent, confirming their understanding and agreement to comply with the study requirements and restrictions.

2 initial assessment

Participants undergo an initial assessment to confirm the diagnosis of moderately to severely active ulcerative colitis. This includes endoscopic and histologic evaluations to verify the condition.

3 medication administration

Participants receive either tamuzimod or a placebo in the form of film-coated tablets. The medication is administered orally.

The treatment period lasts for 13 weeks, during which the efficacy of tamuzimod is assessed in achieving clinical remission.

4 ongoing monitoring

Throughout the 13-week treatment period, participants are monitored for clinical remission using a modified Mayo score. This involves regular assessments to track symptoms and any changes in condition.

5 end of treatment evaluation

At the end of the 13-week period, participants undergo a final evaluation to determine the proportion of those who have achieved clinical remission, endoscopic improvement, symptomatic remission, and histologic remission.

Who Can Join the Study?

Men or women aged 18 to 80 years can participate. In Germany and Italy, the age range is 18 to 75 years.
Participants can take certain medications, like oral 5-ASA compounds, oral corticosteroids, and probiotics, if they have been on a stable dose or stopped taking them for at least 2 weeks before the screening endoscopy. In Germany and Italy, this period is 4 weeks for oral 5-ASA compounds.
Women must either be unable to have children or agree to use a highly effective birth control method during the study and for 30 days after the last dose. In Germany and Italy, this period is 35 days. Men must agree to use condoms during the study and for 30 days after the last dose. In Germany and Italy, this period is 90 days.
Participants must be able to give informed consent, which means they understand the study and agree to follow its rules.
Participants must have been diagnosed with ulcerative colitis (UC) for at least 3 months before the screening. This diagnosis must be confirmed by a procedure called endoscopy and by examining tissue samples.
Participants must have active UC confirmed by endoscopy, with at least 10 cm of the rectum involved. Those with only proctitis (inflammation of the rectum) at the start can join if they meet other criteria, but they will be limited to 10% of the total participants.
Participants must have moderately to severely active UC, which is determined by a specific scoring system that includes an endoscopic subscore of at least 2 and a rectal bleeding subscore of at least 1.
Participants with long-term pancolitis (inflammation of the entire colon) or left-sided colitis must have had a colonoscopy within the last 12 months to check for abnormal growths. If not, they will have a colonoscopy during screening.
Participants must have shown an inadequate response, loss of response, or intolerance to at least one type of therapy, such as conventional therapy (like oral 5-ASA compounds or corticosteroids), biologic therapy, or JAK inhibitor therapy.
Participants must have adequate liver function, which means certain liver-related blood tests must be within normal limits. Those with Gilbert’s syndrome, a mild liver condition, can participate if other liver tests are normal.
Participants must have adequate kidney function, which is measured by a test called the estimated glomerular filtration rate (eGFR). This rate must be at least 60 mL/min/1.73 m².

Who Cannot Join the Study?

Patients who do not have moderately to severely active ulcerative colitis cannot participate. This means the condition must be at a certain level of activity.
Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
Patients who are not part of the specified clinical trial groups cannot participate. These groups are usually defined by the study.
Patients who are not male or female cannot participate, as the study includes both genders.
Patients who are considered part of a vulnerable population cannot participate. This term refers to groups who may need special protection, like children or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Kiepury Clinic Malgorzata Jarnot Specjalistyczna Praktyka Ginekologiczno-Położnicza	Sosnowiec	Poland

Other Sites

Site Name	City	Country
Endomed s.r.o.	Kosice	Slovakia
Amicare Sp. z o.o. S.K.	Lodz	Poland
Clinical Best Solutions Sp. z o.o. S.K.	Lublin	Poland
Eb Group Sp. z o.o.	Warsaw	Poland
Centrum Medyczne Oporow	Wroclaw	Poland
Centrum Medyczne Med-Gastr Sp. z o.o.	Lodz	Poland
University Multiprofessional Hospital For Active Treatment Kanev AD	Ruse	Bulgaria
Respublikine Panevezio ligonine VšĮ	Panevezys	Lithuania
Accout Center s.r.o.	Sahy	Slovakia
Gastro LM s.r.o.	Presov	Slovakia
Termedia Sp. z o.o.	Poznan	Poland
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz	Szekesfehervar	Hungary
Nemocnice Slany	Slany	Czechia
Ospedale San Raffaele S.r.l.	Milan	Italy
Vilniaus universiteto ligonine Santaros klinikos VšĮ	Vilnius	Lithuania
Semmelweis University	Budapest	Hungary
Hepato-Gastroenterologie HK s.r.o.	Hradec Kralove	Czechia
Vojenska Nemocnice Brno	Brno-Zidenice	Czechia
Centrum Medyczne Medyk Sp. z o.o.	Rzeszow	Poland
Krajska zdravotni a.s.	Teplice	Czechia
Bekes Varmegyei Koezponti Korhaz	Gyula	Hungary
Mmb fbzh snceehouqkoqbrfir Vjrvftwwvc Ptjvwyddi Dhu Fjbvfgqxgs Glse	Duisburg	Germany
Tflgebpwegpb Nbilhyrxhoffum Gccy	Nordhausen	Germany
Pcqzyaivrom Eeiwolpdvssf	Wroclaw	Poland
Wra Wuwwhg Iot Pxwaw Pajmttqr Kasojmx	Warsaw	Poland
Mgungkau Sbr z oeyj	Oświęcim	Poland

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	07.02.2022
Czechia	Not recruiting	07.02.2022
Germany	Not recruiting	07.02.2022
Hungary	Not recruiting	07.02.2022
Italy	Not recruiting	07.02.2022
Lithuania	Not recruiting	07.02.2022
Poland	Not recruiting	07.02.2022
Slovakia	Not recruiting	07.02.2022

Trial locations

Investigated drugs:

Tamuzimod Acetate

VTX002 is a medication being studied for its effectiveness in treating people with moderately to severely active ulcerative colitis. The trial aims to see if taking this medication for 13 weeks can help achieve clinical remission, which means reducing or eliminating the symptoms of the disease.

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by continuous inflammation of the innermost lining of the large intestine, leading to ulcers and sores. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The disease typically progresses with periods of flare-ups and remissions. Over time, the inflammation can cause the colon to lose its ability to function properly. The severity of symptoms can vary, with some individuals experiencing mild discomfort and others facing more severe complications.

Trial ID:

2023-509233-39-00

Protocol code:

VTX002-201

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Tamuzimod in Patients with Moderate to Severe Ulcerative Colitis

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