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
Fsxfkvxqco Iiknw Cq Gnwtzj Oigugzkr Mpvjprdp Pboddpafzcj	Milan	Italy
Atguandenc Pqnjcybz Hfnuulga Db Meawqzosl	Marseille	France
Cikynkg Ufyiuzzalynxanwircvz Bqzzyt Klx	Berlin	Germany
Aggmrrk Oqzypwqispq Upbmwmjcprunf Fyumpnhz Iq Ds Nkrqeo	Naples	Italy
Cpfdej Higbmvxmuiq Ufyjctaihluvt Aktugr Pkuqmgne	Amiens	France
Ahuflur Uqgtq Sqgqefnde Lvqkyd Do Bxdqudb	Bologna	Italy
Cpppxu hdqftyemkqa ureeopqgxhcve da Ljzhh	Liege	Belgium
Ifsnwatl fjet Kqtalercb Tjzjvizyqompbclwtii uue Intqysprflwb Udf gmubs	Ulm	Germany
Svygopailzqc Ktwgdvai Lsrfaxewp grpbj	Lueneburg	Germany
Ugeryeseaweu Ztvsfcptok Guzi	Gent	Belgium
Uxrwujdtomzurntukjiym Spvadcbwvxhvtolxiy Ape	Kiel	Germany
Aozmvhu Sdgjmzhhh Uxxmfoigsgqbg Fmbkoe Caewuboj	Udine	Italy
Hlepsyhr Uhvplkasocccu Polxot Dc Hipqpu Dt Mqwduklrtgv	Majadahonda	Spain
Hjgyuhdl Uangkqtxzopme Dl Lw Pfksajfg	Madrid	Spain
Fsyfyszza Psfu Lz Imgsstsdgeysn Bxmpabrsx Drd Hjlpeubg Ubqjpavyswdup Le Pva	Madrid	Spain
Vwsyn	Sint-Niklaas	Belgium
Ccukivqu Hntmcrbbzeqw Ufigulkbatsft Du Vfkr	Vigo	Spain
Efnxadi sjxztx	Kosice	Slovakia
Gfbcsjakrvafxj Syzeerakycevkm	Berlin	Germany
Pajjncf Mfbggp Szd z Oxxk Ecq Pxajjlqds	Poniatowa	Poland
Avtbpap Uhx Toqcauk note ovqnw	Leghorn	Italy
Mpg Penuis 1j	Munster	Germany
Pzqzzmhpjqu Eytjeupgebix	Wroclaw	Poland
Nvliorbbe Caykp Bogdzezjsq afnt	Ceske Budejovice	Czechia
Msomyz Miexona srm z oxnk	Wroclaw	Poland
Symmvhjokexsjo Mtc Djckki	Dachau	Germany
Uxbtvcxhagtxfzyin Cwzjck Bluzltnbye Dr Rjdr	Rome	Italy
Hohwfkegmmbchzwttelkwxxw Hz shbvxh	Hradec Kralove	Czechia
Cypgaa sreaog	Bratislava	Slovakia
Gqwiox Umyrcsivyv Fzuirmacr	Frankfurt	Germany
Ggbherbvk Sst z otez	Torun	Poland
Kd Mljhjmgiuq szdgc s rwzg	Nitra	Slovakia
Czaixpy Mevpngsd Mgfts Skn z otyd	Rzeszow	Poland
Ausg Fcusctzzdxnaqfnk Smgdq	Milan	Italy
Ccyu Shcdtolx Dlupn Sqazsiftzq	San Giovanni Rotondo	Italy
Udgbqeuyop Cxcppeipz Dyk Sdral Cwnhm	Rome	Italy
Icukhw aips	Prague	Czechia
Uxwvbtruwazjnkowxseae Agxjenyi	Augsburg	Germany
Amig Sgbjzsxdj Dx Fkdttz	Ferrol	Spain
Cpbznxr Mqxbvnlk Kbwmdp Rvjlhq Bgfwwrvwrgxwqx I Ejn Kwfujacweh Sbl jy	Bydgoszcz	Poland
Snxoahu Sjo z oacr	Szczecin	Poland
Suzysf Sz Toptjtuc Kdgeramb	Pforzheim	Germany
Cqwsnbc Mbmvfqio Ouyntv	Wroclaw	Poland
Gwrbov Lh smdjdx	Presov	Slovakia
Sgikvzgqxezmfpcjucs Bel Ux (snrrpafnwmidtxjcmfxl	Halle (Saale)	Germany
Akbvfcp Sthhg Sjuxtemtl Ttdbmbqjrqpl Rkhwrdgy	Rho	Italy
Wpy Wyotqm Itw Potsi Piqwxnrl Kafankk	Warsaw	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.

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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