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Glow-in-the-Dark dyes reveal if IBD drugs hit their target

NCT ID NCT07258641

Knowledge-focused Sponsor: University Medical Center Groningen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether fluorescent dyes attached to two IBD drugs (adalimumab and risankizumab) can show where the drugs go in the gut. 30 adults with ulcerative colitis or Crohn's disease will receive a low dose of the labelled drugs, then undergo a special camera procedure 2-3 days later. The goal is to see if this imaging can predict who will respond to treatment, potentially avoiding ineffective therapies and their side effects.

What this could mean

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

Active substance
fluorescently labelled adalimumab and risankizumab
What this could lead to
If successful, this could lead to a way to predict which IBD drug will work for a patient before starting treatment, reducing trial-and-error.
What could go wrong
This is an early-phase imaging study with only 30 participants. It tests feasibility, not treatment effectiveness, and the dyes are experimental. The approach may not translate into routine clinical use.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 30 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

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 eligible for inclusion meet all of the following criteria: * Established IBD diagnosis (UC or CD). * Active disease: clinically active disease of the bowel is defined as at least mild activity using dedicated scoring indices or biochemically active disease as defined by a fecal calprotectin \> 60 µg/g * Patients must be eligible for adalimumab or risankizumab therapy. * Age of 18 years * Written informed consent * Clinical indication for an endoscopic procedure For female subjects who are of childbearing potential, are premenopausal with intact reproductive organs, or are less than 2 years postmenopausal: • A negative pregnancy test (urine or blood test) must be available. Exclusion Criteria: A female study patient who is pregnant or provides breastfeeding * A female study patient of premenopausal age who does not use any reliable form of contraception at the time of adalimumab-680LT and/or risankizumab 800CW administration * Medical or psychiatric conditions that compromise the patient's ability to give informed consent * Prior anti-IL23-specific therapy (IL23/IL12 combination therapy is not an exclusion criteria) * Prior anti-TNFα therapy in the last 6 weeks before inclusion * Previous treatment with adalimumab and detectable anti-adalimumab antibody levels

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel 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

  • University Medical Center Groningen

    Groningen, Provincie Groningen, 9713GZ, Netherlands

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