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A Phase 3b Study of Guselkumab Compared with Risankizumab in Adults with Moderately to Severely Active Crohn’s Disease

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What is this trial about?

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

The study focuses on Crohn’s Disease, a condition in which the digestive tract becomes inflamed and can cause pain, diarrhea, and weight loss. Two medicines are being examined: guselkumab, which is given as an injection under the skin, and risankizumab, which can be given either as an injection under the skin or as an infusion into a vein. Both drugs work by calming the immune system to reduce the inflammation that drives the disease.

The purpose of the study is to see which medication provides better control of the disease after one year. Participants will receive their assigned medication regularly for up to 52 weeks, with scheduled doctor visits to check how they feel and to perform simple tests that look for signs of healing. The main goal is to determine whether patients achieve “deep remission,” meaning they have no symptoms and their intestinal lining looks normal.

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

    Randomization

    After enrollment the patient is assigned by the study to receive either guselkumab (test medication) or risankizumab (comparator medication).

    The assignment is done using a computer‑generated random sequence to ensure unbiased distribution.

  2. Step 2

    Baseline assessments

    The patient undergoes initial medical evaluations, including physical examination, laboratory tests, and documentation of disease activity.

    These measurements create a reference point for later comparisons.

  3. Step 3

    First administration of study medication

    The patient receives the first dose of the assigned medication.

    guselkumab is given by subcutaneous injection (injection under the skin).

    risankizumab may be given either by intravenous infusion (slow injection into a vein) or by subcutaneous injection, depending on the study arm.

  4. Step 4

    Subsequent dosing

    The patient continues to receive the study medication at intervals specified in the study protocol.

    The exact dose amount, frequency, and total duration are defined by the protocol and are followed for the entire study period.

  5. Step 5

    Regular clinic visits

    The patient attends scheduled visits to the study site for safety monitoring, laboratory testing, and assessment of disease activity.

    Each visit includes collection of information needed to evaluate the effectiveness of the medication.

  6. Step 6

    Week 52 evaluation

    At week 52 the patient undergoes a comprehensive assessment to determine whether deep remission has been achieved.

    Deep remission is defined as the absence of clinical symptoms together with endoscopic healing, as measured by the study criteria.

  7. Step 7

    Study completion

    After the week 52 evaluation the patient completes the active treatment phase of the study.

    Final safety and efficacy data are recorded, and the patient may be offered standard care according to clinical guidelines.

Who can join the trial?

6 criteria

  • You must have Crohn’s disease (including a form that creates abnormal connections called fistulas) for at least 12 weeks, and it must involve the colon, the small intestine, or both, confirmed by an imaging test, tissue analysis, or a scope examination.
  • Your disease must be moderately to severely active, measured by a score called the Crohn’s Disease Activity Index (CDAI) that is 220 or higher but not more than 450.
  • A recent colonoscopy (scope exam) must show active disease in the small intestine and/or colon, with ulcer scores that meet a set level (an SES‑CD score of at least 4 for only small‑intestine disease or at least 6 for colon disease).
  • You must have tried at least one advanced medication for Crohn’s disease and had an inadequate response (the drug did not control symptoms), a loss of response (the drug stopped working), or an intolerance (a serious side effect). You may have tried only 1 or 2 of these medication classes: TNF‑α inhibitors (e.g., infliximab), integrin inhibitors (e.g., vedolizumab), IL‑12/23 inhibitors (e.g., ustekinumab), or JAK inhibitors (e.g., upadacitinib). If you have not responded to three or more classes, you cannot join.
  • The doctor must believe that your disease can be safely treated with the study’s dosing schedule (guselkumab injection every 4 weeks or risankizumab injection every 8 weeks).
  • Both men and women are eligible, and you must be within the age range allowed for the trial (the study includes adults and adolescents as defined by the investigators).

Who cannot join the trial?

5 criteria

  • You cannot join the study if you have serious complications of Crohn’s disease that may need surgery within the next year, such as painful narrowing of the intestine (stricturing or stenosis), a very short remaining intestine (short gut syndrome), an open draining bowel opening (active draining stoma), or large abnormal connections between organs (significant fistulizing disease), because these conditions can make it difficult to measure how well the medication works.
  • You cannot join if a stool test showed an intestinal infection (enteric pathogen) – for example, the bacteria Clostridioides difficile (formerly called Clostridium difficile) – within the last 16 weeks, unless a repeat test is negative and there are no signs that the infection is still present.
  • You cannot join if you currently have cancer (malignancy) or have had cancer in the past five years, except for a non‑melanoma skin cancer that was fully treated and has shown no return for at least 12 weeks, or cervical carcinoma in situ that was treated and has shown no return for at least 12 weeks. Any pre‑cancerous (premalignant) conditions need special review.
  • You cannot join if you have a known history of blood‑forming tissue cancers, such as lymphoma, leukemia, myeloproliferative disorder, multiple myeloma, or a condition called monoclonal gammopathy of undetermined significance (MGUS), or if you have any signs or symptoms that might suggest these diseases.
  • You cannot join if you meet any of the tuberculosis (TB) screening criteria, including: a history of active TB or symptoms that suggest active TB; untreated latent TB (inactive infection) unless you are already receiving treatment or start treatment before the first dose; recent close contact with someone who has active TB; a positive IGRA blood test for TB within five weeks before the first dose (unless you have documented treatment for latent TB or a confirmed false‑positive result); or a chest X‑ray or CT scan taken within 12 weeks that shows changes suggesting active or past TB.
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Investigated drugs

  • Skyrizi (risankizumab)

    is a medication that blocks a protein called interleukin‑23, which helps reduce inflammation in the gut. In this study it is used as the active‑controlled treatment to compare against the new drug. Participants receive it either as a drip into a vein (intravenous infusion) or as a quick injection under the skin (subcutaneous injection). The goal is to see how well it works and how safe it is for people with moderate to severe Crohn’s disease.

  • Guselkumab

    is the experimental treatment being tested in this trial. Like Skyrizi, it also blocks interleukin‑23, but it is a different medicine that is given by a single injection under the skin. The study looks at how effective Guselkumab is at improving Crohn’s disease symptoms and whether it is safe for patients over a year of treatment.

What is already known about the treatment

  • Risankizumab

    This medication is supplied as a solution for infusion that is given intravenously and also as a solution for injection that is administered subcutaneously using a pre‑filled syringe. It is an approved drug that is listed in medical literature for treating moderate to severe Crohn’s disease and plaque psoriasis. Risankizumab works by attaching to a part of the immune protein called interleukin‑23, stopping it from causing inflammation. It belongs to the pharmacological class of IL‑23‑targeting monoclonal antibodies.

  • Guselkumab

    Guselkumab is provided as a solution for injection in a pre‑filled syringe and is given by subcutaneous injection under the skin. It is an approved therapy for plaque psoriasis and psoriatic arthritis and is currently being studied for use in Crohn’s disease. The drug binds to the p19 subunit of interleukin‑23, thereby blocking the inflammatory signal that leads to disease symptoms. It is classified as an IL‑23 inhibitor monoclonal antibody.

Investigated diseases

Crohn disease - Crohn disease is a long‑lasting inflammation of the digestive tract that can affect any part from mouth to anus. In moderate to severe activity the inflammation is intense and causes frequent abdominal pain, persistent diarrhea, and weight loss. The disease often progresses in flares, where symptoms worsen, followed by periods of less intense activity. Repeated inflammation can thicken the bowel wall, leading to narrowing (strictures) or abnormal connections (fistulas). Over time, the pattern of flare‑ups may become more frequent, and the affected areas can become scarred. The condition is chronic, meaning it continues over many years.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521590-13-00Protocol codeCNTO1959CRD3009Estimated enrolment530 patientsSponsorJanssen Cilag International

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