Badanie porównujące skuteczność i bezpieczeństwo guselkumabu i risankizumabu u pacjentów z umiarkowanie do ciężko aktywną chorobą Crohna

Enrollment and baseline Assessment

After signing the informed consent, baseline measurements are taken, including medical history and current disease activity.

The study team confirms eligibility for participants with moderately to severely active Crohn’s disease.

Randomization to treatment Group

The participant is assigned by the study system to one of two groups: the guselkumab Group or the risankizumab Group.

The assignment is random and not influenced by the participant or the study staff.

First dose administration

The first dose of the assigned medication is given according to the study protocol.

If assigned to guselkumab, the drug is injected subcutaneously (under the skin) using a pre‑filled syringe.

If assigned to risankizumab, the drug may be given either as an intravenous infusion (through a vein) or as a subcutaneous injection, depending on the study arm.

Subsequent dosing schedule

Additional doses of the same medication are administered at regular intervals defined by the study protocol.

The exact amount of each dose is described in the protocol as 0 u unit(s); the clinical team follows the prescribed schedule for each participant.

The route of administration (intravenous or subcutaneous) remains the same as for the first dose.

Regular clinic visits and safety monitoring

The participant attends scheduled visits to the study site for clinical evaluation, laboratory tests, and Assessment of any side effects.

The study staff records any adverse events and adjusts care as needed, while continuing the assigned medication according to the schedule.

Week 52 evaluation (primary endpoint)

At week 52, the participant undergoes a comprehensive Assessment to determine whether deep remission has been achieved.

Deep remission means that signs and symptoms of Crohn’s disease are no longer detectable and intestinal inflammation is minimal.

Study completion and final follow‑up

After the week 52 assessment, the participant completes the study protocol, which may include a final safety visit.

The study team provides a summary of the participant’s results and ensures that appropriate medical care continues after the trial.