Study on Guselkumab for Healing in Crohn’s Disease Patients

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What is this study about?

This clinical trial is focused on studying Crohn’s Disease, a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The treatment being tested in this study is called Guselkumab, which is a medication given as a solution for injection or infusion. It is designed to help reduce inflammation and promote healing in the intestines.

The purpose of the study is to evaluate how effective Guselkumab is in achieving healing of the intestinal walls in patients with Crohn’s Disease. Participants in the study will receive the medication over a period of time, and their progress will be monitored to see if there is improvement in their condition. The study will involve regular check-ups and assessments to track the healing process and any changes in symptoms.

Throughout the study, some participants may receive a placebo, which is a substance with no active medication, to compare the effects of Guselkumab. The study aims to provide valuable information on the potential benefits of this treatment for individuals with Crohn’s Disease, contributing to better management of the condition in the future.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes reviewing medical history and current health status related to Crohn’s Disease.

Eligibility is based on specific criteria, such as having active Crohn’s Disease for at least 3 months and a certain level of disease activity.

2 treatment initiation

The treatment involves the administration of guselkumab, a medication used to manage Crohn’s Disease.

Initially, guselkumab will be given as a solution for infusion, which means it will be administered directly into a vein.

3 ongoing treatment

After the initial infusion, guselkumab will be administered as a solution for injection using a pre-filled syringe. This is done subcutaneously, meaning it is injected under the skin.

The frequency and dosage of the injections will be determined by the study protocol and medical team.

4 regular monitoring

Throughout the study, regular monitoring will occur to assess the effectiveness of the treatment and any side effects.

This includes periodic evaluations using imaging techniques to measure the healing of the intestinal lining.

5 final assessment

At the end of the study period, a final assessment will be conducted to evaluate the overall impact of guselkumab on Crohn’s Disease.

The primary goal is to determine if there is significant healing of the intestinal lining after 48 weeks of treatment.

Who Can Join the Study?

Must have been diagnosed with Crohn’s Disease for at least 3 months. This means having inflammation in the digestive tract, confirmed by tests like X-rays, tissue samples, or a camera exam.
Must have clinically active Crohn’s Disease, which means having a certain level of symptoms. This includes a specific score on a test called the Crohn’s Disease Activity Index (CDAI), which should be between 220 and 450. Additionally, either having an average of 4 or more very soft or liquid stools per day or having an average abdominal pain score of 2 or more.
Must have active inflammation in at least one part of the digestive tract, shown by a test called MaRIA with a score of 11 or higher.
Must have tried standard treatments for Crohn’s Disease and either not responded well, stopped responding over time, or could not tolerate them. This includes having issues with up to one type of advanced treatment, such as certain medications like JAK inhibitors, infliximab, adalimumab, certolizumab pegol, vedolizumab, ustekinumab, or their approved similar versions.
Both males and females can participate.

Who Cannot Join the Study?

Patients with any other significant health conditions that could interfere with the study.
Patients who have had a recent infection that required treatment with antibiotics, antivirals, or antifungals.
Patients who have a history of cancer, except for certain types of skin cancer that have been treated.
Patients who have a history of heart problems, such as heart attack or heart failure.
Patients who have a history of liver disease or liver problems.
Patients who have a history of tuberculosis (TB) or have been in close contact with someone with TB.
Patients who have received certain vaccines within a specific time frame before the study.
Patients who are currently participating in another clinical trial.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have had a major surgery within a specific time frame before the study.
Patients who have a known allergy to the study medication or its ingredients.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
IRCCS Humanitas Research Hospital	Rozzano	Italy
Universitaetsmedizin Goettingen	Goettingen	Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Centre Hospitalier Universitaire De Lille	Lille	France
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Endomed s.r.o.	Kosice	Slovakia
F D Roosevelt University General Hospital Of Banska Bystrica	Banska Bystrica	Slovakia
ASST Fatebenefratelli Sacco	Milan	Italy
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Centre hospitalier universitaire de Liege	Liege	Belgium
Universita Cattolica Del Sacro Cuore	Rome	Italy
Iscare a.s.	Prague	Czechia
Staedtisches Klinikum Lueneburg gGmbH	Lueneburg	Germany
Universitair Ziekenhuis Gent	Gent	Belgium
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Az Maria Middelares Gent	Gent	Belgium
Vitaz	Sint-Niklaas	Belgium
Area Sanitaria De Ferrol	Ferrol	Spain
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.	Bydgoszcz	Poland
Sonomed Sp. z o.o.	Szczecin	Poland
Centrum Medyczne Oporow	Wroclaw	Poland
Siloah St Trudpert Klinikum	Pforzheim	Germany
MVZ Portal 10	Munster	Germany
Melita Medical sp. z o.o.	Wroclaw	Poland
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hepato-Gastroenterologie HK s.r.o.	Hradec Kralove	Czechia
Centre Hospitalier Universitaire De Nantes	Nantes	France
Cliniq s.r.o.	Bratislava	Slovakia
Gastromed Sp. z o.o.	Torun	Poland
KM Management spol. s r.o.	Nitra	Slovakia
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centrum Medyczne Medyk Sp. z o.o.	Rzeszow	Poland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Hopital Beaujon	Clichy	France
Gastro LM s.r.o.	Presov	Slovakia
Nemocnice Ceske Budejovice a.s.	Ceske Budejovice	Czechia
Horzpbdd Uxrngjwfrutmb Dw Lu Pwmyeknf	Madrid	Spain
Cbxfkjsc Hyodrwsvmivo Uwrcjiyktbouc Dj Vcin	Vigo	Spain
Gzlsgiddzrzzkk Stltfosytodzse	Berlin	Germany
Awnxopn Uck Tyzqbrf nwin occwk	Leghorn	Italy
Puwfzrr Mxronr Slq z Ooyl Edp Pxvxqxldi	Poniatowa	Poland
Pvltshdibrt Eryysekavldj	Wroclaw	Poland
Siurbywvaslqbp Mfo Dngzfk	Dachau	Germany
Avswmmjprj Pumrpekc Hjytavwv Dg Mfwendapk	Marseille	France
Gowunc Ukpuxvvckc Feqanabmr	Frankfurt	Germany
Awkbuli Uhdvu Scjcqjmjk Lyqffl Dk Bbjznoc	Bologna	Italy
Ugwttducwjrggzauakarf Amqfpobw	Augsburg	Germany
Fhcppgjoy Prnf Lw Iunhdrgbbfcsc Bwizokpok Dfx Higqepfg Urutkfutrjbnb Lb Plw	Madrid	Spain
Wiu Wztztu Igs Pfwkf Poxwblck Kcdrywd	Warsaw	Poland
Alzouna Sybbl Smwcbsitw Tkfzvvpkmcss Rlbkeyzu	Rho	Italy
Spflhcgzjaoiyrnaufl Bbv Uu (lojxrzxlacwxfhgwgbzg	Halle (Saale)	Germany

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	09.01.2025
Czechia	Not recruiting	09.01.2025
France	Not recruiting	09.01.2025
Germany	Not recruiting	09.01.2025
Italy	Not recruiting	09.01.2025
Poland	Not recruiting	09.01.2025
Slovakia	Not recruiting	09.01.2025
Spain	Not recruiting	09.01.2025

Trial locations

Investigated drugs:

Guselkumab

Guselkumab is a medication used in this clinical trial to help treat Crohn’s Disease. It works by targeting specific proteins in the body that are involved in inflammation. By doing this, it aims to reduce the inflammation in the intestines, which is a common problem for people with Crohn’s Disease. The goal of using Guselkumab in this study is to see if it can help heal the intestines and improve the overall condition of patients with this disease over time.

Investigated diseases:

Crohn's disease

Crohn’s Disease – Crohn’s Disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by inflammation that can penetrate deep into the layers of the bowel tissue, leading to symptoms such as abdominal pain, diarrhea, and weight loss. The disease often progresses with periods of remission and flare-ups, where symptoms can become more severe. Over time, the inflammation can cause complications like strictures, fistulas, and malabsorption of nutrients. The exact cause of Crohn’s Disease is unknown, but it involves an abnormal immune response to intestinal bacteria. The progression of the disease varies among individuals, with some experiencing mild symptoms and others facing more severe complications.

Trial ID:

2023-504040-34-01

Protocol code:

CNTO1959CRD3008

NCT ID:

NCT06408935

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Guselkumab for Healing in Crohn’s Disease Patients

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