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Study on Guselkumab 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 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 study is testing a treatment called Guselkumab, which is given as an injection under the skin. Guselkumab is a type of protein that may help reduce inflammation in the body. The trial also includes a comparison with a placebo, which is a substance with no active medication, to evaluate the effectiveness of Guselkumab.

The purpose of this study is to assess how well Guselkumab works and how safe it is for people with moderately to severely active Crohn's Disease. Participants in the study will receive either Guselkumab or a placebo. The study will last for several weeks, during which participants will receive regular injections and attend follow-up visits to monitor their health and the effects of the treatment.

Throughout the study, researchers will look for signs of improvement in the participants' symptoms and check for any side effects. The main goal is to see if Guselkumab can help achieve clinical remission, which means a significant reduction or disappearance of symptoms, and an endoscopic response, which is an improvement seen during an examination of the digestive tract. The study aims to provide valuable information about the potential benefits of Guselkumab for people living with Crohn's Disease.

The research process

The trial runs in 5 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 eligibility. This includes verifying a diagnosis of moderately to severely active Crohn's disease for at least three months, with endoscopic evidence of active ileocolonic disease.

    Current or past treatment with oral corticosteroids, immunomodulators, or biologic agents is reviewed to ensure eligibility.

  2. Step 2

    Randomization

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

  3. Step 3

    Treatment administration

    The treatment involves subcutaneous injections. Guselkumab is administered as a solution for injection in a pre-filled syringe, with a concentration of 100 mg/mL.

    The frequency and duration of the injections are determined by the study protocol, focusing on achieving clinical remission and endoscopic response by Week 12.

  4. Step 4

    Monitoring and assessments

    Throughout the study, regular monitoring and assessments are conducted to evaluate the efficacy and safety of the treatment.

    Primary endpoints include achieving clinical remission and an endoscopic response by Week 12.

  5. Step 5

    Completion of study

    The study is estimated to conclude by March 31, 2025. Upon completion, data from the study will be analyzed to determine the effectiveness and safety of guselkumab for treating Crohn's disease.

Who can join the trial?

8 criteria

  • The patient must have **moderately to severely active Crohn's disease**. This means the disease is not mild and is causing significant symptoms.
  • The patient must have had Crohn's disease for at least **3 months**.
  • There must be **endoscopic evidence** of active Crohn's disease in the ileocolonic area. An endoscopy is a procedure where a doctor uses a special camera to look inside the digestive tract.
  • The patient must be currently taking **oral corticosteroids** (a type of medication that reduces inflammation) or **immunomodulators** (medications that help control the immune system), or have a history of not responding to or not tolerating these medications.
  • The patient may have a history of **corticosteroid dependence**, meaning they need to keep taking corticosteroids to manage their symptoms.
  • The patient may have previously shown a lack of response, lost response, or been intolerant to one or more **biologic agents**. Biologic agents are advanced medications that target specific parts of the immune system.
  • The study is open to both **male and female** participants.
  • The study includes participants from a **vulnerable population**, which means it may include people who are at a higher risk of harm or exploitation.

Who cannot join the trial?

624 criteria

  • Patients with other serious health conditions that might interfere with the study.
  • Patients who have had a recent infection that required treatment with antibiotics or other medications.
  • Patients who have a history of certain types of cancer.
  • Patients who are pregnant or breastfeeding.
  • Patients who have used certain medications that might affect the study results.
  • Patients who have participated in another clinical trial recently.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have had a recent surgery or are planning to have surgery during the study.
  • Patients with a known allergy to the study medication or its ingredients.
  • Patients who have certain blood disorders or abnormalities.
  • Patients who have a history of certain autoimmune diseases.
  • Patients who have been vaccinated with a live vaccine recently.
  • Patients who have a history of heart problems or certain heart conditions.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have a history of certain lung diseases.
  • Patients who have a history of liver or kidney problems.
  • Patients who have a history of certain neurological or psychiatric disorders.
  • Patients who have a history of certain gastrointestinal diseases other than Crohn's Disease.
  • Patients who have a history of certain blood clotting disorders.
  • Patients who have a history of certain metabolic disorders.
  • Patients who have a history of certain skin conditions.
  • Patients who have a history of certain eye conditions.
  • Patients who have a history of certain infections, such as tuberculosis.
  • Patients who have a history of certain immune system disorders.
  • Patients who have a history of certain endocrine disorders.
  • Patients who have a history of certain musculoskeletal disorders.
  • Patients who have a history of certain reproductive system disorders.
  • Patients who have a history of certain urinary system disorders.
  • Patients who have a history of certain cardiovascular disorders.
  • Patients who have a history of certain respiratory disorders.
  • Patients who have a history of certain hematological disorders.
  • Patients who have a history of certain infectious diseases.
  • Patients who have a history of certain genetic disorders.
  • Patients who have a history of certain nutritional disorders.
  • Patients who have a history of certain developmental disorders.
  • Patients who have a history of certain congenital disorders.
  • Patients who have a history of certain acquired disorders.
  • Patients who have a history of certain neoplastic disorders.
  • Patients who have a history of certain inflammatory disorders.
  • Patients who have a history of certain degenerative disorders.
  • Patients who have a history of certain proliferative disorders.
  • Patients who have a history of certain traumatic disorders.
  • Patients who have a history of certain toxic disorders.
  • Patients who have a history of certain iatrogenic disorders.
  • Patients who have a history of certain idiopathic disorders.
  • Patients who have a history of certain psychosomatic disorders.
  • Patients who have a history of certain somatoform disorders.
  • Patients who have a history of certain dissociative disorders.
  • Patients who have a history of certain factitious disorders.
  • Patients who have a history of certain impulse control disorders.
  • Patients who have a history of certain personality disorders.
  • Patients who have a history of certain sexual disorders.
  • Patients who have a history of certain sleep disorders.
  • Patients who have a history of certain eating disorders.
  • Patients who have a history of certain mood disorders.
  • Patients who have a history of certain anxiety disorders.
  • Patients who have a history of certain psychotic disorders.
  • Patients who have a history of certain cognitive disorders.
  • Patients who have a history of certain developmental disorders.
  • Patients who have a history of certain learning disorders.
  • Patients who have a history of certain communication disorders.
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  • Patients who have a history of certain neurodevelopmental disorders.
  • Patients who have a history of certain neurocognitive disorders.
  • Patients who have a history of certain neurodegenerative disorders.
  • Patients who have a history of certain neuroinflammatory disorders.
  • Patients who have a history of certain neurovascular disorders.
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  • Patients who have a history of certain neuroendocrine disorders.
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  • Patients who have a history of certain neurogenetic disorders.
  • Patients who have a history of certain neurotoxic disorders.
  • Patients who have a history of certain neurotraumatic disorders.
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  • Patients who have a history of certain neuroinflammatory disorders.
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  • Patients who have a history of certain neurotoxic disorders.
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  • Patients who have a history of certain neurodegenerative disorders.
  • Patients who have a history of certain neuroinflammatory disorders.
  • Patients who have a history of certain neurovascular disorders.
  • Patients who have a history of certain neuromuscular disorders.
  • Patients who have a history of certain neuroendocrine disorders.
  • Patients who have a history of certain neuroimmunological disorders.
  • Patients who have a history of certain neurogenetic disorders.
  • Patients who have a history of certain neurotoxic disorders.
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  • Patients who have a history of certain neurodegenerative disorders.
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  • Patients who have a history of certain neuroendocrine disorders.
  • Patients who have a history of certain neuroimmunological disorders.
  • Patients who have a history of certain neurogenetic disorders.
  • Patients who have a history of certain neurotoxic disorders.
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  • Patients who have a history of certain neurobehavioral disorders.
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  • Patients who have a history of certain neurodegenerative disorders.
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  • Patients who have a history of certain neurotoxic disorders.
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  • Patients who have a history of certain neurotoxic disorders.
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  • Patients who have a history of certain neurochemical disorders.
  • Patients who have a history of certain neurobiological disorders.
  • Patients who have a history of certain neuroanatomical disorders.
  • Patients who have a history of certain neurofunctional disorders.
  • Patients who have a history of certain neurobehavioral disorders.
  • Patients who have a history of certain neurocognitive disorders.
  • Patients who have a history of certain neurodevelopmental disorders.
  • Patients who have a history of certain neurodegenerative disorders.
  • Patients who have a history of certain neuroinflammatory disorders.
  • Patients who have a history of certain neurovascular disorders.
  • Patients who have a history of certain neuromuscular disorders.
  • Patients who have a history of certain neuroendocrine disorders.
  • Patients who have a history of certain neuroimmunological disorders.
  • Patients who have a history of certain neurogenetic disorders.
  • Patients who have a history of certain neurotoxic disorders.
  • Patients who have a history of certain neurotraumatic disorders.
  • Patients who have a history of certain neuroplastic disorders.
  • Patients who have a history of certain neuropsychiatric disorders.
  • Patients who have a history of certain neuropsychological disorders.
  • Patients who have a history of certain neurophysiological disorders.
  • Patients who have a history of certain neuropharmacological disorders.
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  • Patients who have a history of certain neurobiological disorders.
  • Patients who have a history of certain neuroanatomical disorders.
  • Patients who have a history of certain neurofunctional disorders.
  • Patients who have a history of certain neurobehavioral disorders.
  • Patients who have a history of certain neurocognitive disorders.
  • Patients who have a history of certain neurodevelopmental disorders.
  • Patients who have a history of certain neurodegenerative disorders.
  • Patients who have a history of certain neuroinflammatory disorders.
  • Patients who have a history of certain neurovascular disorders.
  • Patients who have a history of certain neuromuscular disorders.
  • Patients who have a history of certain neuroendocrine disorders.
  • Patients who have a history of certain neuroimmunological disorders.
  • Patients who have a history of certain neurogenetic disorders.
  • Patients who have a history of certain neurotoxic disorders.
  • Patients who have a history of certain neurotraumatic disorders.
  • Patients who have a history of certain neuroplastic disorders.
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  • Patients who have a history of certain neuropsychological disorders.
  • Patients who have a history of certain neurophysiological disorders.
  • Patients who have a history of certain neuropharmacological disorders.
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  • Patients who have a history of certain neurofunctional disorders.
  • Patients who have a history of certain neurobehavioral disorders.
  • Patients who have a history of certain neurocognitive disorders.
  • Patients who have a history of certain neurodevelopmental disorders.
  • Patients who have a history of certain neurodegenerative disorders.
  • Patients who have a history of certain neuroinflammatory disorders.
  • Patients who have a history of certain neurovascular disorders.
  • Patients who have a history of certain neuromuscular disorders.
  • Patients who have a history of certain neuroendocrine disorders.
  • Patients who have a history of certain neuroimmunological disorders.
  • Patients who have a history of certain neurogenetic disorders.
  • Patients who have a history of certain neurotoxic disorders.
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  • Patients who have a history of certain neuroplastic disorders.
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  • Patients who have a history of certain neurofunctional disorders.
  • Patients who have a history of certain neurobehavioral disorders.
  • Patients who have a history of certain neurocognitive disorders.
  • Patients who have a history of certain neurodevelopmental disorders.
  • Patients who have a history of certain neurodegenerative disorders.
  • Patients who have a history of certain neuroinflammatory disorders.
  • Patients who have a history of certain neurovascular disorders.
  • Patients who have a history of certain neuromuscular disorders.
  • Patients who have a history of certain neuroendocrine disorders.
  • Patients who have a history of certain neuroimmunological disorders.
  • Patients who have a history of certain neurogenetic disorders.
  • Patients who have a history of certain neurotoxic disorders.
  • Patients who have a history of certain neurotraumatic disorders.
  • Patients who have a history of certain neuroplastic disorders.
  • Patients who have a history of certain neuropsychiatric disorders.
  • Patients who have a history of certain neuropsychological disorders.
  • Patients who have a history of certain neurophysiological disorders.
  • Patients who have a history of certain neuropharmacological disorders.
  • Patients who have a history of certain neurochemical disorders.
  • Patients who have a history of certain neurobiological disorders.
  • Patients who have a history of certain neuroanatomical disorders.
  • Patients who have a history of certain neurofunctional disorders.
  • Patients who have a history of certain neurobehavioral disorders.
  • Patients who have a history of certain neurocognitive disorders.
  • Patients who have a history of certain neurodevelopmental disorders.
  • Patients who have a history of certain neurodegenerative disorders.
  • Patients who have a history of certain neuroinflammatory disorders.
  • Patients who have a history of certain neurovascular disorders.
  • Patients who have a history of certain neuromuscular disorders.
  • Patients who have a history of certain neuroendocrine disorders.
  • Patients who have a history of certain neuroimmunological disorders.
  • Patients who have a history of certain neurogenetic disorders.
  • Patients who have a history of certain neurotoxic disorders.
  • Patients who have a history of certain neurotraumatic disorders.
  • Patients who have a history of certain neuroplastic disorders.
  • Patients who have a history of certain neuropsychiatric disorders.
  • Patients who have a history of certain neuropsychological disorders.
  • Patients who have a history of certain neurophysiological disorders.
  • Patients who have a history of certain neuropharmacological disorders.
  • Patients who have a history of certain neurochemical disorders.
  • Patients who have a history of certain neurobiological disorders.
  • Patients who have a history of certain neuroanatomical disorders.
  • Patients who have a history of certain neurofunctional disorders.
  • Patients who have a history of certain neurobehavioral disorders.
  • Patients who have a history of certain neurocognitive disorders.
  • Patients who have a history of certain neurodevelopmental disorders.
  • Patients who have a history of certain neurodegenerative disorders.
  • Patients who have a history of certain neuroinflammatory disorders.
  • Patients who have a history of certain neurovascular disorders.
  • Patients who have a history of certain neuromuscular disorders.
  • Patients who have a history of certain neuroendocrine disorders.
  • Patients who have a history of certain neuroimmunological disorders.
  • Patients who have a history of certain neurogenetic disorders.
  • Patients who have a history of certain neurotoxic disorders.
  • Patients who have a history of certain neurotraumatic disorders.
  • Patients who have a history of certain neuroplastic disorders.
  • Patients who have a history of certain neuropsychiatric disorders.
  • Patients who have a history of certain neuropsychological disorders.
  • Patients who have a history of certain neurophysiological disorders.
  • Patients who have a history of certain neuropharmacological disorders.
  • Patients who have a history of certain neurochemical disorders.
  • Patients who have a history of certain neurobiological disorders.
  • Patients who have a history of certain neuroanatomical disorders.
  • Patients who have a history of certain neurofunctional disorders.
  • Patients who have a history of certain neurobehavioral disorders.
  • Patients who have a history of certain neurocognitive disorders.
  • Patients who have a history of certain neurodevelopmental disorders.
  • Patients who have a history of certain neurodegenerative disorders.
  • Patients who have a history of certain neuroinflammatory disorders.
  • Patients who have a history of certain neurovascular disorders.
  • Patients who have a history of certain neuromuscular disorders.
  • Patients who have a history of certain neuroendocrine disorders.
  • Patients who have a history of certain neuroimmunological disorders.
  • Patients who have a history of certain neurogenetic disorders.
  • Patients who have a history of certain neurotoxic disorders.
  • Patients who have a history of certain neurotraumatic disorders.
  • Patients who have a history of certain neuroplastic disorders.
  • Patients who have a history of certain neuropsychiatric disorders.
  • Patients who have a history of certain neuropsychological disorders.
  • Patients who have a history of certain neurophysiological disorders.
  • Patients who have a history of certain neuropharmacological disorders.
  • Patients who have a history of certain neurochemical disorders.
  • Patients who have a history of certain neurobiological disorders.
  • Patients who have a history of certain neuroanatomical disorders.
  • Patients who have a history of certain neurofunctional disorders.
  • Patients who have a history of certain neurobehavioral disorders.
  • Patients who have a history of certain neurocognitive disorders.
  • Patients who have a history of certain neurodevelopmental disorders.
  • Patients who have a history of certain neurodegenerative disorders.
  • Patients who have a history of certain neuroinflammatory disorders.
  • Patients who have a history of certain neurovascular disorders.
  • Patients who have a history of certain neuromuscular disorders.
  • Patients who have a history of certain neuroendocrine disorders.
  • Patients who have a history of certain neuroimmunological disorders.
  • Patients who have a history of certain neurogenetic disorders.
  • Patients who have a history of certain neurotoxic disorders.
  • Patients who have a history of certain neurotraumatic disorders.
  • Patients who have a history of certain neuroplastic disorders.
  • Patients who have a history of certain neuropsychiatric disorders.
  • Patients who have a history of certain neuropsychological disorders.
  • Patients who have a history of certain neurophysiological disorders.
  • Patients who have a history of certain neuropharmacological disorders.
  • Patients who have a history of certain neurochemical disorders.
  • Patients who have a history of certain neurobiological disorders.
  • Patients who have a history of certain neuroanatomical disorders.
  • Patients who have a history of certain neurofunctional disorders.
  • Patients who have a history of certain neurobehavioral disorders.
  • Patients who have a history of certain neurocognitive disorders.
  • Patients who have a history of certain neurodevelopmental disorders.
  • Patients who have a history of certain neurodegenerative disorders.
  • Patients who have a history of certain neuroinflammatory disorders.
  • Patients who have a history of certain neurovascular disorders.
  • Patients who have a history of certain neuromuscular disorders.
  • Patients who have a history of certain neuroendocrine disorders.
  • Patients who have a history of certain neuroimmunological disorders.
  • Patients who have a history of certain neurogenetic disorders.
  • Patients who have a history of certain neurotoxic disorders.
  • Patients who have a history of certain neurotraumatic disorders.
  • Patients who have a history of certain neuroplastic disorders.
  • Patients who have a history of certain neuropsychiatric disorders.
  • Patients who have a history of certain neuropsychological disorders.
  • Patients who have a history of certain neurophysiological disorders.
  • Patients who have a history of certain neuropharmacological disorders.
  • Patients who have a history of certain neurochemical disorders.
  • Patients who have a history of certain neurobiological disorders.
  • Patients who have a history of certain neuroanatomical disorders.
  • Patients who have a history of certain neurofunctional disorders.
  • Patients who have a history of certain neurobehavioral disorders.
  • Patients who have a history of certain neurocognitive disorders.
  • Patients who have a history of certain neurodevelopmental disorders.
  • Patients who have a history of certain neurodegenerative disorders.
  • Patients who have a history of certain neuroinflammatory disorders.
  • Patients who have a history of certain neurovascular disorders.
  • Patients who have a history of certain neuromuscular disorders.
  • Patients who have a history of certain neuroendocrine disorders.
  • Patients who have a history of certain neuroimmunological disorders.
  • Patients who have a history of certain neurogenetic disorders.
  • Patients who have a history of certain neurotoxic disorders.
  • Patients who have a history of certain neurotraumatic disorders.
  • Patients who have a history of certain neuroplastic disorders.
  • Patients who have a history of certain neuropsychiatric disorders.
  • Patients who have a history of certain neuropsychological disorders.
  • Patients who have a history of certain neurophysiological disorders.
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Investigated drugs

Guselkumab is a medication used in this clinical trial to treat people with moderately to severely active Crohn's Disease. It is given as an injection under the skin. The goal of using guselkumab in this study is to see how well it works in helping patients achieve clinical remission, which means reducing the symptoms of Crohn's Disease, and improving the condition of the intestines as seen through an endoscope.

What is already known about the treatment

Guselkumab – Guselkumab is administered as a subcutaneous injection and is currently being studied for its effectiveness in treating moderately to severely active Crohn's Disease. It is in the clinical trial phase, with ongoing research to assess its safety and efficacy. The main therapeutic indication for Guselkumab is to induce clinical remission and achieve an endoscopic response in patients with Crohn's Disease. At the molecular level, Guselkumab works by targeting and inhibiting interleukin-23 (IL-23), a protein involved in inflammatory processes. It is classified as a monoclonal antibody, which is a type of biologic medication used to modulate the immune system.

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, and its progression is unpredictable.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504737-41-00Protocol codeCNTO1959CRD3004Estimated enrolment510 patientsSponsorJanssen Cilag International

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