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Can adjusting guselkumab doses tame tough Crohn's cases?

NCT ID NCT07616687

Disease control Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 01, 2026 · Updated 3 times

Summary

This study tests whether increasing the dose of guselkumab can help people with Crohn's disease who don't get better with standard doses. About 210 adults with active Crohn's will receive guselkumab, and after 12 weeks, those who haven't responded will get a higher dose more often. The goal is to see if this approach leads to steroid-free remission and less inflammation at one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
guselkumab (a monoclonal antibody targeting IL-23)
What this could lead to
If successful, this could show that adjusting guselkumab doses helps more Crohn's patients achieve remission without steroids.
What could go wrong
This is a phase 4 study with 210 participants, so results may not apply to all patients. Dose escalation may not improve outcomes and could increase side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 210 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * \- Patients with a diagnosis of CD according to ECCO guidelines, * 18 years of age or older at the time of informed consent, * Absence of contraindication to guselkumab, * Active disease according to PRO2 (abdominal pain \> 1 or stool frequency \> 3), and faecal calprotectin \> 250 ug/g, * Objective active disease documented within ≤ 2 months by endoscopy or by MRI when not contraindicated, orby IUS), * Not currently participating in any interventional research. * Patient naïve or exposed to one or more advanced therapy, in accordance with the approved indication for guselkumab in Crohn's disease. * Females of childbearing potential must have a negative serum pregnancy test at the baseline Visit. Exclusion Criteria: * \- Patient under legal protection, * Previous exposure to an anti-IL23 * Combination of advanced therapy with GUS, * Patient with ostomy, * Pregnant or breastfeeding woman, * Patient with perianal CD predominant disease. * Active clinically significant infection or HIV, Hep B, Hep C, or active tuberculosis

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease (CD) Intensification

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chu Amiens Picardie

    RECRUITING

    Amiens, 80054, France

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