Study on the Effectiveness and Safety of Guselkumab for Patients with Moderate to Severe Ulcerative Colitis

4 1

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

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Azienda Ospedaliera di Padova Padua Italy
Endomed s.r.o. Kosice Slovakia
SYNEXUS Magyarorszag Kft. Budapest Hungary
Pauls Stradins Clinical University Hospital Riga Latvia
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
Diagnostics And Consultation Center Convex Ltd. Sofia Bulgaria
Nemocnice Strakonice a.s. Strakonice Czechia
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Karolinska University Hospital Solna Sweden
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw Poland
Hospital Universitario Virgen De Valme Sevilla Spain
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Cliniq s.r.o. Bratislava Slovakia
Gastromed Sp. z o.o. Torun Poland
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Iscare a.s. Prague Czechia
Hopital Beaujon Clichy France
Algemeen Ziekenhuis Delta Roeselare Belgium
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Synexus Czech s.r.o. Prague Czechia
Promed P.Lach R.Glowacki Sp. j. Cracow Poland
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Vasutegeszseguegyi Nonprofit Koezhasznu Kft. Debrecen Hungary
Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD Sofia Bulgaria
Endoskopia Sp. z o.o. Sopot Poland
Gastroenterologie s.r.o. Hradec Kralove Czechia
Digestive Diseases Centre Gastro SIA Riga Latvia
Melita Medical sp. z o.o. Wroclaw Poland
Semmelweis University Budapest Hungary
Gasthuiszusters Antwerpen Antwerp Belgium
Centre Hospitalier Universitaire De Nice Nice France
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Nemocnice Ceske Budejovice a.s. Ceske Budejovice Czechia
Gdmuoxrsy Kgwzwxe Rkittxpyef Srxxlzclek Svo jo Bialystok Poland
Anyv Clxvnjvf sqgjth Prague Czechia
Pdgwqcxwt Iujwrszd Mymblsdc Mvdtkikuiqau Sgoty Wxqekcdtxzwb I Awnphojqcivvh Warsaw Poland
Elppjoru Hdnwbpj sfjfeu Havirov Czechia
Mfcgbfbz Ss z ocux Bydgoszcz Poland
Agyvefo Ultdp Suhwbozrp Lmrojt Dd Bwcbxea Bologna Italy
Pbxtfcl Mlrrsq Smb z Omtp Eii Pwrkvjqoo Poniatowa Poland
Umasyqu Unjyivgxga Hdjmxfty Uppsala Sweden
Cgwj Df Ntqlx Vandoeuvre Les Nancy France
Hlzwxcfb Ukttcanhnsvaj Hxsajsin Tfkro y Pttelz Ighgrrtp Csxgll dtbvqpxslzxucxtwq (ckts Badalona Spain
Sfsqitg Spva Kluczbork Poland
Ixgrgoit du Cwcwquevmwbw Hmcpjpwsslm Uhsilkjkxhzjg dd Srave Enodqng (xuimjvd Saint Priest En Jarez France
Wgp Wozbwr Ivk Prcjb Ppcuuyfg Kkvduie Warsaw Poland
Aegwylgoc sffolq Trebovice Czechia
Hvjvqwjm Uksdifjoxewupj Sheoarxizz &quigvn Haoflzz db Hhxisyscbmq STRASBOURG, Alsace France
Sajjbctorspkqlmbwdc Byz Uf (vmmzmxogwthufkosxwhm Halle (Saale) Germany
Msywdqfm Seq z ojgf Oświęcim 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)

Other Trials to Consider

  • A study to evaluate the safety and effectiveness of MB-001 in adults with moderate to severe ulcerative colitis

    Recruiting

    1 1
    Investigated drugs:
    Poland
  • A study of mirikizumab levels in breast milk of breastfeeding women with ulcerative colitis or Crohn’s disease

    Recruiting

    3 1 1 1
    Investigated drugs:
    Denmark Germany Italy Poland Spain