Study on the Effectiveness and Safety of Guselkumab and Golimumab for Patients with Moderate to Severe Crohn’s Disease

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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 and diarrhea. The study is testing a combination of treatments to see if they can help people with moderate to severe Crohn’s disease. The treatments being studied include Guselkumab, Golimumab, and a new combination therapy known as JNJ-78934804. These treatments are given as injections under the skin using a pre-filled syringe.

The purpose of the study is to evaluate how effective the combination therapy is compared to using Guselkumab or Golimumab alone. Participants in the study will receive either the combination therapy, one of the individual treatments, or a placebo. The study will last for about 48 weeks, during which the participants’ health and response to the treatment will be monitored closely.

Throughout the study, participants will have regular check-ups to assess their condition and any changes in their symptoms. The goal is to see if the combination therapy can lead to clinical remission, which means a significant reduction in symptoms, and an endoscopic response, which is an improvement seen during an examination of the digestive tract. This study aims to provide new insights into the treatment of Crohn’s disease and potentially offer a more effective therapy option for those affected by this condition.

1 joining the study

Upon joining the study, the diagnosis of Crohn’s disease must be confirmed. This includes a review of medical history and assessment of disease activity using specific scores.

Eligibility is determined based on previous treatment responses and specific criteria related to the condition.

2 initial treatment phase

The initial phase involves receiving a combination of medications: guselkumab and golimumab. These are administered as injections under the skin.

The dosage and frequency of these medications are determined by the study protocol and are monitored by the study team.

3 maintenance treatment phase

After the initial treatment phase, the focus shifts to maintaining the treatment effects. This involves continued administration of the medications as per the study schedule.

The goal is to evaluate the long-term effectiveness and safety of the combination therapy.

4 evaluation at week 48

At week 48, the study assesses the effectiveness of the treatment. This includes checking for clinical remission and endoscopic response.

The results are compared with those from participants receiving only one of the medications to determine the benefits of the combination therapy.

Who Can Join the Study?

  • Must have been diagnosed with Crohn’s disease for at least 3 months before starting the study. Crohn’s disease is a condition that causes inflammation in the digestive tract.
  • Must have a confirmed diagnosis of moderate to severe Crohn’s disease. This is determined by specific scores that measure disease activity, stool frequency, abdominal pain, and results from an endoscopic exam.
  • Must have shown an inadequate response, lost response, or been intolerant to at least one advanced therapy for inflammatory bowel disease (IBD). This includes treatments like biologics or oral medications that work similarly to biologics.
  • If female and able to have children, must follow specific requirements for contraception and reproduction during the study.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitetssykehuset Nord-Norge HF Tromsø Norway
IRCCS Humanitas Research Hospital Rozzano Italy
Laiko General Hospital Of Athens Athens Greece
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Herlev Hospital Herlev Denmark
Universitaetsklinikum Erlangen AöR Erlangen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Medical University Of Vienna Vienna Austria
Amsterdam UMC Amsterdam The Netherlands
Akershus University Hospital Lorenskog Norway
Fakultni Nemocnice Brno Brno Czechia
Karolinska University Hospital Solna Sweden
Semmelweis University Budapest Hungary
CHRU De Nancy Vandoeuvre Les Nancy France
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Region Midtjylland Aarhus Denmark
Centre Hospitalier Universitaire Amiens Picardie Amiens France
University Hospital Maastricht Maastricht The Netherlands
Centre Hospitalier Universitaire De Rennes Rennes France
KBC Split Split Croatia
Oncopole Claudius Regaud Toulouse France
Technische Universitaet Dresden Dresden Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Oslo Universitetssykehus HF Oslo Norway
Medizinische Hochschule Hannover Hanover Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Vitaz Sint-Niklaas Belgium
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Hospital Universitario De Navarra Pamplona Spain
Institut de Cancérologie Hématologie Universitaire de Saint Etienne (iCHUSE) Saint Priest En Jarez France
Tartu University Hospital Tartu Estonia
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji Warsaw Poland
Rostock University Medical Center Rostock Germany
Vojenska Nemocnice Brno Brno-Zidenice Czechia
University Medical Center Ljubljana Ljubljana Slovenia
Helse Moere Og Romsdal HF Aalesund Norway
Martin-Luther-Universitaet Halle-Wittenberg Halle (Saale) Germany
Krajska zdravotni a.s. Teplice Czechia
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Wojewodzki Szpital Specjalistyczny W Olsztynie Olsztyn Poland
WIP Warsaw IBD Point Profesor Kierkus Warsaw Poland

Other Sites

Site Name City Country Status
CENTRUM MEDYCZNE REUMA PARK Warsaw Poland
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Sofia Bulgaria
Centrum Diagnostyczno Lecznicze Barska Sp. z o.o. Wloclawek Poland
CED-Studienzentrum Karlshorst Berlin Germany
Vivamed Sp. z o.o. Warsaw Poland
Bocfkl Smgicac Gjettum Norway
Bjwjqvrplm Slp z oepk seczt Warsaw Poland
Gcgnnpdlhnhywchkr Ovfpfjyzcnk Kassel Germany
Mys Pmvsax 1z Munster Germany
Mdgxnnew Sd z oxfl Bydgoszcz Poland
Lzetpuxypanpmw Kopgcombje Ah Pohja-Tallinna Linnaosa Estonia
Goftuakkp Sfl z ozct Torun Poland
Emsq Txplyti Ceivbxe Hcyiqsfz Tallin Estonia
Ibcgiw akrk Prague Czechia
Kmgjlukknug Wjpyqywull ehac Berlin Germany
Piarnt Puhjui Rdkpwegkdq Sxo je Cracow Poland
Nuofvsal Iwjypnyou Ob Gxxibkrdakeqhnva Sqvdyqb Dq Brryyb Rldqzxti Hphmwjvj Castellana Grotte Italy
Rseegu Spf z odzr Lublin Poland
Soqcwon Skf z oaxx Szczecin Poland
Evdcbikg Gcka Leipzig Germany
Epsnirntcz Sxw z ocng Sopot Poland
Rdrvdmne Sto z otfx Poznan Poland
Sboadnppdnwwdiywyru Bym Ut (spidmbxkpozfcmepulst Halle (Saale) Germany
Mpu Gyekzi Bsjamn Berlin Germany
Bvfoagpmgv Hqfpjtzy Copenhagen Denmark
Okzfzb Ueopfgmvcm Hvomnhvf Odense Denmark
Mcqfpv Mntnrpv Srv z oohl Wroclaw Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
21.02.2023
Belgium Belgium
Not recruiting
21.02.2023
Bulgaria Bulgaria
Not recruiting
21.02.2023
Croatia Croatia
Not recruiting
21.02.2023
Czechia Czechia
Not recruiting
21.02.2023
Denmark Denmark
Not recruiting
21.02.2023
Estonia Estonia
Not recruiting
21.02.2023
France France
Not recruiting
21.02.2023
Germany Germany
Not recruiting
21.02.2023
Greece Greece
Not recruiting
21.02.2023
Hungary Hungary
Not recruiting
21.02.2023
Italy Italy
Not recruiting
21.02.2023
Norway Norway
Not recruiting
21.02.2023
Poland Poland
Not recruiting
21.02.2023
Portugal Portugal
Not recruiting
21.02.2023
Slovenia Slovenia
Not recruiting
21.02.2023
Spain Spain
Not recruiting
21.02.2023
Sweden Sweden
Not recruiting
21.02.2023
The Netherlands The Netherlands
Not recruiting
21.02.2023

Trial locations

Investigated Drugs:

Guselkumab is a medication used in this trial to treat Crohn’s Disease. It works by targeting specific proteins in the immune system that are involved in inflammation. By blocking these proteins, guselkumab helps reduce inflammation in the gut, which can alleviate symptoms of Crohn’s Disease.

Golimumab is another medication used in the trial for Crohn’s Disease. It is an anti-inflammatory drug that targets a protein called tumor necrosis factor (TNF). By inhibiting TNF, golimumab helps decrease inflammation and can improve symptoms in patients with Crohn’s Disease.

JNJ-78934804 is an investigational therapy being studied in this trial. It is being tested to see how effective it is when used in combination with guselkumab and golimumab for treating Crohn’s Disease. The goal is to determine if this combination therapy can provide better results than using each medication alone.

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 periods of flare-ups and remission, where symptoms can vary in intensity. During active phases, individuals may experience abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications such as strictures or fistulas. The exact cause of Crohn’s Disease is unknown, but it involves an abnormal immune response. The disease can affect any part of the digestive tract, from the mouth to the anus, but most commonly impacts the end of the small intestine.

Trial ID:
2023-504741-32-00
Protocol code:
78934804CRD2001
NCT ID:
NCT05242471
Trial Phase:
Therapeutic exploratory (Phase II)

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