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

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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 the effects of a medication called Guselkumab in individuals with moderately to severely active Crohn's disease. Crohn's disease is a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The study aims to evaluate how effective and safe Guselkumab is for treating this condition. Guselkumab is administered as a solution for injection, and participants may also receive a placebo or another medication called Ustekinumab for comparison.

The trial is designed to be conducted in two phases. In the first phase, the focus is on assessing the clinical efficacy, which means how well the medication works in reducing the symptoms of Crohn's disease. The second phase will look at both clinical and endoscopic efficacy, which involves using a camera to examine the inside of the digestive tract to see how the medication affects the inflammation. Participants will receive the treatment over a period of time, and their progress will be monitored to gather information on the medication's safety and effectiveness.

Throughout the study, participants will receive injections of Guselkumab or Ustekinumab, or a placebo, and their health will be closely monitored by healthcare professionals. The study will help determine if Guselkumab can be a beneficial treatment option for people with Crohn's disease, providing valuable insights into managing this challenging condition. The trial is expected to continue until 2027, allowing researchers to collect comprehensive data on the long-term effects of the treatment.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm the diagnosis of Crohn's disease. This includes reviewing medical history and conducting necessary tests such as radiography, histology, or endoscopy.

  2. Step 2

    Screening tests

    Screening tests are performed to ensure eligibility. These include laboratory tests to check health parameters and a pregnancy test for female participants of childbearing potential.

  3. Step 3

    Randomization

    Participants are randomly assigned to receive either guselkumab, ustekinumab, or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

  4. Step 4

    Treatment phase 2

    During Phase 2, participants receive guselkumab via subcutaneous injection. The dosage is 100 mg/mL, administered according to the study schedule. The primary goal is to evaluate changes in the Crohn's Disease Activity Index (CDAI) score at Week 12.

  5. Step 5

    Treatment phase 3

    In Phase 3, the treatment continues with guselkumab to assess both clinical and endoscopic efficacy. The primary endpoints include clinical response and remission at Week 12 and Week 48, as well as endoscopic response at these intervals.

  6. Step 6

    Safety monitoring

    Throughout the trial, safety is monitored closely. Regular check-ups and tests are conducted to ensure the well-being of participants and to track any side effects or adverse reactions.

  7. Step 7

    End of study

    The study concludes with a final assessment to evaluate the overall efficacy and safety of guselkumab in treating moderately to severely active Crohn's disease. Results are compared to baseline measurements and placebo effects.

Who can join the trial?

5 criteria

  • Have **Crohn's disease** or **fistulizing 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.
  • Have **moderate to severe Crohn's disease**. This is determined by specific scores that measure symptoms like stool frequency and abdominal pain, as well as a score from a camera exam of the intestines.
  • Have lab test results that meet the study's specific requirements.
  • If female and able to have children, must have a negative pregnancy test at the start of the study.
  • Have shown that standard treatments or special medications for Crohn's disease do not work well or cause bad reactions.

Who cannot join the trial?

10 criteria

  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who have a history of severe allergic reactions to medications.
  • Patients who are pregnant or breastfeeding.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of cancer, except for certain types of skin cancer.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have received certain medications that could affect the study results.
  • Patients who have a history of certain mental health conditions that could interfere with the study.
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Investigated drugs

Guselkumab is a medication being studied for its effectiveness and safety in treating people with moderately to severely active Crohn's disease. This trial aims to see how well it works in reducing the symptoms of Crohn's disease and to ensure it is safe for patients to use.

What is already known about the treatment

Guselkumab – Guselkumab is administered as an injection under the skin. It is currently being studied in clinical trials for its effectiveness and safety in treating moderately to severely active Crohn's disease. The medication works by targeting a specific protein in the immune system, known as interleukin-23, which plays a role in inflammation. Guselkumab is classified as a monoclonal antibody, a type of medication designed to interact with specific targets in the body to reduce inflammation and improve symptoms.

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 active symptoms and remission. 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 is believed to involve a combination of genetic, environmental, and immune system factors. The disease can vary greatly in severity and symptoms from person to person.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-504736-18-00Protocol codeCNTO1959CRD3001Estimated enrolment1 401 patientsSponsorJanssen - Cilag International

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