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

Verified siteInvestigational
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

4 criteria

  • 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.
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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

  • Amsterdam UMC

    Responsive

    The NetherlandsAmsterdam, The Netherlands

  • CHRU De Nancy

    Responsive

    FranceVandoeuvre Les Nancy, France

Trial locations

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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.

What is already known about the treatment

  • Guselkumab

    Guselkumab is administered via subcutaneous injection and is currently being studied for its effectiveness in treating moderately to severely active Crohn's Disease. It is a monoclonal antibody that targets interleukin-23 (IL-23), a protein involved in inflammatory processes. By inhibiting IL-23, guselkumab helps reduce inflammation and immune response. It is classified as an immunosuppressant and is already approved for other inflammatory conditions, such as psoriasis.

  • Golimumab

    Golimumab is delivered through subcutaneous injection and is under investigation for its potential benefits in managing moderately to severely active Crohn's Disease. It works by blocking tumor necrosis factor-alpha (TNF-alpha), a substance in the body that causes inflammation in autoimmune diseases. By inhibiting TNF-alpha, golimumab helps decrease inflammation and immune system activity. It belongs to the class of medications known as TNF inhibitors and is already used for conditions like rheumatoid arthritis and ulcerative colitis.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504741-32-00Protocol code78934804CRD2001Estimated enrolment1 096 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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