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
IRCCS Humanitas Research Hospital	Rozzano	Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy
Centre Hospitalier Universitaire De Lille	Lille	France
Medizinische Hochschule Hannover	Hanover	Germany
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Universitaetsmedizin Goettingen	Goettingen	Germany

Other Sites

Site Name	City	Country
F D Roosevelt University General Hospital Of Banska Bystrica	Banska Bystrica	Slovakia
Ospedale San Raffaele S.r.l.	Milan	Italy
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital Beaujon	Clichy	France
Az Maria Middelares Gent	Gent	Belgium
MVZ Dachau	Dachau	Germany
Mvz Portal 10	Munster	Germany
Fjgfuyboef Irxes Ct Ggfftg Ogimawsq Mzhfejuw Pgvftegktuk	Milan	Italy
Ahqszmlagn Pntalqit Hhwdkzar Di Mwibzaepu	Marseille	France
Ccsqfpk Uhfazagjlmiksrjxgyzl Bqgfkj Keo	Berlin	Germany
Anhxjsl Owvsyntamki Utxphcxizovre Ftvgswgy Ib Do Nzrajp	Naples	Italy
Ctztxa Hjkqmvnmjdh Ugdfcjopjyzzu Aolazo Pxdczkid	Amiens	France
Awynudo Umqjg Syroiaaso Luxbqq Dx Bsjukes	Bologna	Italy
Caklmq hyvajtywhhv uwhcsjbxliein df Lqgsv	Liege	Belgium
Ifidipqt ffsz Kpooyrdfv Tzbznmgigzseydwpfra ucm Ikcypjnyhteb Uve gvsnr	Ulm	Germany
Sdofkcweumlx Kienmjla Lgfcdzkli gcrfh	Lueneburg	Germany
Uwuuxjugzprz Zhmwvlqzab Gbfo	Gent	Belgium
Uuqpmfxjgrjsvnakkkdfk Shpwapzwtrbqyyzedo Ayn	Kiel	Germany
Ahheqkw Smbvmjhfh Uxopxyvivkapz Fxqhfe Cmvsbqmh	Udine	Italy
Hdrgeakl Uidrksaqdtzda Pdslcu Da Hdabec Dv Msnifnwyheq	Majadahonda	Spain
Hzwznpef Utgngwggjebgl Dg Lg Posuljgz	Madrid	Spain
Fetugmisn Psrm Lo Ipgmnwtkezewv Blorhwrls Ddd Hxpekypv Uwjragenvvucl Ld Poz	Madrid	Spain
Vatrx	Sint-Niklaas	Belgium
Cfhyqivr Hqfwhvfaynjl Ufrbqexacrgul Dg Vuzd	Vigo	Spain
Enhtqii svmixn	Kosice	Slovakia
Griwnzmgdabkyl Srdcoynkxquctn	Berlin	Germany
Prnnbxl Mhckpq Smg z Oryk Eeb Pnqersrdz	Poniatowa	Poland
Akrjabv Ufq Tqokceq naly oemdh	Leghorn	Italy
Nrvadnvdq Cokpj Bghminsrgk acfg	Ceske Budejovice	Czechia
Mkcosa Mgsqvay sxk z otqv	Wroclaw	Poland
Uafefhkkgmoobdpfp Cnnpdj Bteipasdhu Dk Renv	Rome	Italy
Hhjdjtkolqrckenpyyeqqhsp Hp sdnbwp	Hradec Kralove	Czechia
Czfpot soxdzh	Bratislava	Slovakia
Gecdxv Uhmozuybzg Ftogiqcwr	Frankfurt	Germany
Grilmoswj Sup z ofdt	Torun	Poland
Kx Mbzlboyydq shtyv s roqt	Nitra	Slovakia
Csxswog Mtvjbnce Mhhpo Slk z ohka	Rzeszow	Poland
Ainv Fscbrgtejfdfvsja Shmkr	Milan	Italy
Csqk Swqwaeje Djcmp Scdsesdxxv	San Giovanni Rotondo	Italy
Uiisvvlhot Cbhyprath Dey Soxsj Cocum	Rome	Italy
Ipogjr asrv	Prague	Czechia
Umetaanqgcqvlrhbnubyk Abefiokf	Augsburg	Germany
Aypm Stbwamxfx Dw Fzoryk	Ferrol	Spain
Cjbfhpq Mvnrowgy Kjassp Rlgzjl Bgvvofjqegdxpw I Emp Kwdqwihrfv Smu jo	Bydgoszcz	Poland
Srypyoo Sgp z obcc	Szczecin	Poland
Sjanzh Sh Trtgynag Knwhqxje	Pforzheim	Germany
Cpfguyl Mauqyruy Otelwy	Wroclaw	Poland
Gortxe Lx smmggq	Presov	Slovakia
Srugqdrcxiecxllmavs Bga Uq (sbwieyvjimpcuyyrxpii	Halle (Saale)	Germany
Azubwle Simib Szgqyaktw Tcfvxjbspccg Rnmgtkyi	Rho	Italy
Weo Wzajic Imc Pyewc Pudolksb Khcouhe	Warsaw	Poland
Ehc Ivzoheqt Mnqeylsa Shkp	Poznan	Poland

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.

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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