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Could less be more? study tests cutting biologic doses for Crohn's and colitis

NCT ID NCT07303686

Disease control Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether people with Crohn's disease or ulcerative colitis who are in deep remission can safely reduce their dose of the biologic drug ustekinumab. Participants will either switch from injections every 4 weeks to every 8 weeks, or from every 8 weeks to every 12 weeks. Researchers will monitor blood levels, inflammation markers, and gut health to see if remission holds. The goal is to find out if lower doses can still keep the disease under control.

What this could mean

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

Active substance
ustekinumab
What this could lead to
If successful, this could show that some patients with Crohn's disease or ulcerative colitis can safely take less medication while staying well, reducing treatment burden and side effects.
What could go wrong
This is a small pilot study, so results may not apply to everyone. Reducing the dose could cause the disease to flare up again, and the study does not yet prove long-term safety.

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 115 people

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

Started

Oct 2025

Expected to finish

Oct 2027

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: * Clinical remission * Biochemical remission * Endoscopy remission * Not on corticosteroid * A woman must be ; * not of childbearing potential * of childbearing potential and practicing a medically accepted method of contraception. * Able t provide informed consent Exclusion Criteria: * On more than one biologics drug * Use of oral or topical steroids within 6months of study entry * pregnancy * Any issue that could lead to non-compliance, as alcohol, drug use * Unable to provide consent or t comply with follw-up visit

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Conditions

The condition(s) this trial relates to.

Crohn disease ulcerative colitis

As listed by the trial registrant

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

Crohn disease (CD) Ulcerative colitis (UC)

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

  • MUHC - Montreal General Hospital

    RECRUITING

    Montreal, Quebec, H3G1A4, Canada

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