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 medication called Guselkumab in individuals with Moderately to Severely Active Ulcerative Colitis. Ulcerative colitis is a chronic condition that causes inflammation and sores in the lining of the large intestine, leading to symptoms like abdominal pain and diarrhea. The medication being tested, Guselkumab, is a type of treatment known as a monoclonal antibody, which is administered through an injection or infusion. It is designed to target specific proteins in the body to help reduce inflammation.

The purpose of this study is to evaluate how effective and safe Guselkumab is for people with this condition. Participants in the study will receive either Guselkumab or a placebo, which is a substance with no active medication. The study will follow a structured plan where participants will receive the treatment over a period of time, and their health will be monitored to assess the medication’s impact on their ulcerative colitis symptoms.

Throughout the study, participants will undergo regular check-ups to track their progress and any changes in their condition. The goal is to determine if Guselkumab can provide relief from the symptoms of ulcerative colitis and improve the quality of life for those affected by this disease. The study is designed to ensure the safety and well-being of all participants while gathering important information about the potential benefits of this treatment.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age, diagnosis of ulcerative colitis for at least 3 months, and previous treatment history.

Initial assessments include a review of medical history and laboratory tests to ensure all parameters meet the study requirements.

2 treatment initiation

The treatment involves the administration of guselkumab, a medication provided as a solution for injection in a pre-filled syringe.

The medication is administered through subcutaneous use, which means it is injected under the skin.

3 treatment schedule

The dosage of guselkumab is 100 mg/mL. The frequency and duration of administration are determined by the study protocol.

Participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual medication.

4 monitoring and assessments

Regular monitoring is conducted to evaluate the efficacy and safety of the treatment. This includes clinical assessments and laboratory tests.

The primary goal is to achieve a clinical response by Induction Week 12.

5 completion of the study

The study is estimated to conclude by December 9, 2027.

Final assessments are conducted to determine the overall effectiveness and safety of the treatment.

Who Can Join the Study?

  • Must be a male or female who is 18 years of age or older.
  • Must have a documented diagnosis of Ulcerative Colitis (UC) for at least 3 months before the screening. Ulcerative Colitis is a condition that causes inflammation and sores in the colon.
  • Must have moderately to severely active UC, which is determined by a specific scoring system called the modified Mayo score. This score helps to measure the severity of the condition.
  • Must have a history of not responding well to or not being able to tolerate standard or advanced treatments as defined in the study protocol. This means previous treatments did not work well or caused side effects that were hard to handle.
  • Must have laboratory test results during screening that are within the limits set by the study protocol. This means certain blood tests and other tests must show results that are acceptable for the study.

Who Cannot Join the Study?

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who have had a recent infection that required treatment with antibiotics or other medications.
  • Patients who have received certain vaccines within a specific time frame before the study.
  • Patients who have a history of certain types of cancer.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have certain allergies or reactions to the study medication.
  • Patients who are unable to follow the study procedures or attend study visits.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Wojskowy Instytut Medyczny Państwowy Instytut Badawczy Warsaw Poland

Verified Sites

Other Sites

Site Name City Country Status
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
Karolinska University Hospital Solna Sweden
Semmelweis University Budapest Hungary
Centre Hospitalier Universitaire De Nice Nice France
Hopital Beaujon Clichy France
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
SYNEXUS Magyarorszag Kft. Budapest Hungary
Digestive Diseases Centre Gastro SIA Riga Latvia
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Algvuaw Ogofexdunwf da Phjxud Padua Italy
Cerdmz Hqvnukcnopv Ubkcnkfabrddl Di Ckih Nvhoqlduq Caen France
Fnfuxyftwu Ibmoo Cy Gyqccj Oqyhwdhr Mqjrdwpl Pgsqlelqwea Milan Italy
Udaunnj Uimixwymil Hjhwrttt Uppsala Sweden
Gkfcdlxmasrgeri Anegglfkj Antwerp Belgium
Cydf Dk Njzox Vandoeuvre Les Nancy France
Auofiho Ujwty Sdcolksue Lkankz Dm Bgqhezg Bologna Italy
Cajtul Hrzsqtzcof Ujsjyeybhhbxh Ds Swylr Albttyh Etenva Porto Portugal
Itnpuvnl fsju Kpbhaotkl Tbekpaaonecjqbybpav uaj Ihmvowgsgaee Uwh gxxoa Ulm Germany
Cbbpwr Hapsutqbcdj Leou Skm Pierre Benite France
Auorruwc Zluzjygmzy Dcjme Roeselare Belgium
Hepczsxh Udiqelykeilbvf Sapzvnygze &pxpuar Hauqwwy dl Hkjeaoujnnm STRASBOURG, Alsace France
Gpaasrlnt Kgazuii Rswuivhjtu Skriuqnokn Svd jh Bialystok Poland
Ehxvfbn sutnac Kosice Slovakia
Phuda Shggtmcn Cycbkyen Uvigkvejbl Hzcjpysc Riga Latvia
Aiit Chzgznxx siusph Prague Czechia
Dnkuloquhqh Afg Cmmzndgzwrkr Cdghyx Cckrpr Lcan Sofia Bulgaria
Pawzhwz Msrfkn Sfi z Osjq Evc Pufbhvwro Poniatowa Poland
Ittgctqh dw Ctcwqaroumij Hnciwrgubxj Upxxsqlrhuogv dv Sopjq Ejpdtys (mkgtdfy Saint Priest En Jarez France
Ntoatxfoz Ssrzjkliag aqyb Strakonice Czechia
Mohsydvv Sf z ohoo Bydgoszcz Poland
Srdmfig Sxjg Kluczbork Poland
Nqgfaapku Cowgf Bmbrordahs awyw Ceske Budejovice Czechia
Mvpkew Mhzizaw spr z ofnw Wroclaw Poland
Hzlokprz Ulmwagvsnhzhi Vbagye Df Vzpmu Sevilla Spain
Pdijlbgpx Iiyihgvb Mrttemef Mwbkwvtyhenc Srqet Wrncipqcysvr I Adcjhobgybobq Warsaw Poland
Cgcdfm sbqpbe Bratislava Slovakia
Gwaykiuda Soj z ovwo Torun Poland
Cbikkqg Mbquvjws Mkboa Ski z obey Rzeszow Poland
Cuzu Syivcuyh Dhfbx Suzislecfx San Giovanni Rotondo Italy
Ibbzty akiq Prague Czechia
Emnbuejn Hxvfnoq sbfxjd Havirov Czechia
Tntzm Ptaahcuiosd Svjvorsfplax Caainvp Mmrfynxf Sli z ojrk Szczecin Poland
Sttnaoc Celsk shcgsi Prague Czechia
Pyqdtf Pxksmi Rtqviibpbw Slf js Cracow Poland
Cahkflw Mlpadjst Pshruzd Mdzhufcng Cjvwkyef Ldoihannju Mthwjb Zogfwnzud sdnlo Cracow Poland
Vnemdodcqxerqzfwks Ngaylamll Ksqwxxmgnj Kzzm Debrecen Hungary
Agnkzysv Cmft Czhudz Unehmrqopx Mntlwgftjumz Hnmcdkzl Fnv Awkoai Tiwhjdfyr Ekmz Sofia Bulgaria
Edelzmhsug Syj z owgi Sopot Poland
Gwetbdhcjdxhltrot sssgyz Hradec Kralove Czechia
Hssuojiu Uwjwzxmczliwm Hpkeeheb Taylu y Pofumj Igoczkwb Cgcipu dmncizsmiixqlbxpf (ryrz Badalona Spain
Adrwegumy smviti Trebovice Czechia
Sfzdomotlsosadopfyl Bef Uk (ihsicoyhrirjheirubje Halle (Saale) Germany
Myqzyafw Sox z owky Oświęcim Poland
Wmv Wglfia Ipm Pxdnw Pkqyyskb Kzbftfj 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
30.09.2019
Bulgaria Bulgaria
Not recruiting
30.09.2019
Czechia Czechia
Not recruiting
30.09.2019
France France
Not recruiting
30.09.2019
Germany Germany
Not recruiting
30.09.2019
Hungary Hungary
Not recruiting
30.09.2019
Italy Italy
Not recruiting
30.09.2019
Latvia Latvia
Not recruiting
30.09.2019
Poland Poland
Not recruiting
30.09.2019
Portugal Portugal
Not recruiting
30.09.2019
Slovakia Slovakia
Not recruiting
30.09.2019
Spain Spain
Not recruiting
30.09.2019
Sweden Sweden
Not recruiting
30.09.2019

Trial locations

Investigated Drugs:

Guselkumab is a medication being studied for its effectiveness and safety in treating people with moderately to severely active ulcerative colitis. Ulcerative colitis is a condition that causes inflammation and sores in the digestive tract. This medication works by targeting specific proteins in the body that are involved in the inflammatory process, potentially reducing symptoms and improving the quality of life for patients with this condition.

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:
2023-504718-31-00
Protocol code:
CNTO1959UCO3001
Trial Phase:
Therapeutic use (Phase IV)

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