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.
1randomization
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.
2baseline 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.
3first 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.
4subsequent 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.
5regular 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.
6week 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.
7study 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 Study?
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 Study?
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.
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.
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.
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