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Study on the Effectiveness and Safety of Guselkumab 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 treatment for ulcerative colitis, a condition that causes inflammation and sores in the colon and rectum. The treatment being tested is called guselkumab, which is a type of medication known as a monoclonal antibody. This medication is given as an injection under the skin using a pre-filled syringe. The study also includes a comparison with a placebo, which is a substance with no active medication.

The purpose of the study is to evaluate how effective and safe guselkumab is for people with moderately to severely active ulcerative colitis. Participants in the study will receive either the medication or a placebo. The study will last for a period of time, during which participants will receive regular injections and attend follow-up visits to monitor their health and the effects of the treatment.

Throughout the study, researchers will assess whether participants achieve clinical remission, which means a significant reduction or disappearance of symptoms. The study aims to provide valuable information about the potential benefits of guselkumab for individuals living with ulcerative colitis.

1 joining the study

Upon joining the study, the participant will be assessed to confirm a documented diagnosis of ulcerative colitis for at least 3 months prior to the baseline.

The participant must have moderately to severely active ulcerative colitis as assessed by the modified mayo score.

The participant must have demonstrated an inadequate response to or intolerance of conventional therapies or advanced therapies.

2 treatment initiation

The participant will begin treatment with guselkumab, administered as a subcutaneous injection.

The medication is provided in a pre-filled syringe with a concentration of 100 mg/mL.

The treatment aims to evaluate the efficacy of guselkumab in achieving clinical remission by week 12.

3 treatment administration

The participant will receive the guselkumab injection according to the study protocol.

The frequency and dosage will be determined by the study guidelines and monitored by the study team.

4 monitoring and assessment

Throughout the study, the participant’s health and response to the treatment will be regularly monitored.

Assessments will focus on the participant’s progress towards clinical remission and any side effects experienced.

5 completion of the study

The study is estimated to conclude by December 4, 2025.

Upon completion, the participant’s overall response to the treatment will be evaluated to determine the efficacy and safety of guselkumab for ulcerative colitis.

Who Can Join the Study?

  • You must have a documented diagnosis of ulcerative colitis (UC) for at least 3 months before starting the study. Ulcerative colitis is a condition that causes inflammation and sores in the colon.
  • Your UC must be moderately to severely active, which is determined by a specific scoring system called the modified Mayo score. This score helps doctors understand how active your UC is.
  • You must have shown an inadequate response to or intolerance of conventional treatments or advanced therapies. Conventional treatments include medications like 6-MP, AZA, or corticosteroids. Advanced therapies include medications like TNFα antagonists, vedolizumab, ozanimod, or approved JAK inhibitors. This means that these treatments did not work well for you or you could not tolerate them.
  • Both male and female participants are eligible to join the study.
  • The study includes participants from a vulnerable population, which means it considers people who might need extra care or protection.

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
Oncopole Claudius Regaud Toulouse France
Medizinische Hochschule Hannover Hanover Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Semmelweis University Budapest Hungary
Nouvelles Cliniques Nimoises Nimes France
Cmpd Dc Nvjaw Vandoeuvre Les Nancy France
Gmxctwdix Kmmrohb Rvtkhgjsii Scvribnzne Spk jy Bialystok Poland
Etsprcu sfrovr Kosice Slovakia
Afin Csawtliw stjzfe Prague Czechia
Mtpejmk cfszwk Atuwotbsf hdprhh mwczdetf rlhmzkditv Ewwk Sofia Bulgaria
Dnejerzuurc Ahb Cosorqftfzuq Cldiab Cevief Lrke Sofia Bulgaria
Bgheefgvnb Scf z orgz swamw Warsaw Poland
Ptnsxxj Mbuuwe Sep z Ovww Eti Pwkskslql Poniatowa Poland
Ccyydiy Mlderxwt Lfdsber Jbhzkc Łzwt Chojnice Poland
Nfgnnqeem Cwmke Bgubyjylka acmp Ceske Budejovice Czechia
Mfpjpk Mdpdwdo suj z okge Wroclaw Poland
Srhsvbfbfsyfuf Mdo Dgmknc Dachau Germany
Cqxoex sdiwrz Bratislava Slovakia
Gbsndkilc Src z otnj Torun Poland
Ctuqft Mmkwqd Cpvrriaqxue Aiitaasc Pcvj Hqknhkke Neuilly-Sur-Seine France
Cnybrcp Mvkwlwld Mfmcg Sqb z odrm Rzeszow Poland
Cwc Sgkhg Paukuu Brussels Belgium
Twmuv Pxbpestdtjo Stdlfwttafki Culwoim Mdzaoxkk Sua z omyg Szczecin Poland
Pfiyqq Pjbjwa Rblmhtrcqn Sci jp Cracow Poland
Cqpltnv Mmcgtlff Phhdyei Mtflbkssv Cowpjadg Lljafvpgir Mkxibk Zzxhpnnlw stnvk Cracow Poland
Hsbpnlpr Mjdbsy Bhdsl Dm Ll Vrmc Jjpsyf Villajoyosa Spain
Vtoinksfxkarcairnp Nhsmvbxrf Kmcphioimw Kpvi Debrecen Hungary
Vqywcnls &jqij Vsuxggh Syp z oopr Wroclaw Poland
Goergfqfkaljznfhs sqhvil Hradec Kralove Czechia
Wgo Wtwkej Iqk Pkhlc Poocwoab Kusmlvy Warsaw Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
13.10.2023
Bulgaria Bulgaria
Not recruiting
13.10.2023
Czechia Czechia
Not recruiting
13.10.2023
France France
Not recruiting
13.10.2023
Germany Germany
Not recruiting
13.10.2023
Hungary Hungary
Not recruiting
13.10.2023
Poland Poland
Not recruiting
13.10.2023
Slovakia Slovakia
Not recruiting
13.10.2023
Spain Spain
Not recruiting
13.10.2023

Trial locations

Investigated Drugs:

Guselkumab is a medication used in this clinical trial to treat people with moderately to severely active ulcerative colitis. It is given as an injection under the skin. The goal of using guselkumab in this study is to see how well it works in helping patients achieve clinical remission, which means reducing or eliminating the symptoms of ulcerative colitis.

Investigated Diseases:

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the large intestine. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The disease typically progresses with periods of exacerbation and remission. Over time, the inflammation can lead to complications such as strictures or increased risk of colon cancer. The exact cause is unknown, but it is believed to involve an abnormal immune response in the gut.

Trial ID:
2023-504719-34-00
Protocol code:
CNTO1959UCO3004
Trial Phase:
Therapeutic confirmatory (Phase III)

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