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New study aims to pinpoint fastest Crohn's symptom relief

NCT ID NCT06249555

Knowledge-focused Sponsor: Alimentiv Inc. 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study follows 300 adults with Crohn's disease who are starting standard treatments like vedolizumab or IL-23 blockers. Researchers will track how quickly patients feel improvements in pain, fatigue, and daily functioning using simple questionnaires. The goal is to better understand when these therapies start working, helping guide future treatment decisions.

What this could mean

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

Active substance
vedolizumab, ustekinumab, risankizumab, guselkumab, mirikizumab
What this could lead to
If successful, this study could help doctors predict which Crohn's treatment works fastest for each patient, improving personalized care.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may not apply to all patients.

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.

Participants

About 300 people

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

Started

Mar 2024

Expected to finish

Dec 2026

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.

Who is studied

This study will be conducted in US and Canadian participants with CD prescribed VDZ or IL-23 antagonists for the first time. Approximately 300 participants with CD who are initiating first-time treatment with VDZ or UIL-23 antagonists will be enrolled in this study.

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: 1. Participant is an adult 18 years of age or older with confirmed CD, as per standard clinical criteria which may include symptoms, endoscopy, histopathology, and imaging. 2. Participant has active CD and has been prescribed as standard of care (SOC) and is planned to start VDZ or IL-23 antagonist therapy (UST, RISA, or GUS or MIR \[if approved for the treatment of CD during the recruitment period for this study\]) for the first time in accordance with the product label, as determined by the treating physician. 3. Participant has a baseline PROMIS Pain Interference-SF score ≥ 15 (corresponding T-score ≥ 55) (PROMIS Pain Interference-SF 8a \[V1.1\]). a. Score is calculated by adding score (1 to 5) for each of the 8 subcomponents. 4. Participant has completed all SOC biologic work-up assessments (this may include assessment of tuberculosis, chronic infections, Clostridioides difficile infection and vaccination status per local practice). 5. Ability of participant to participate fully in all aspects of this observational study. Full comprehension of consent language and informed consent must be obtained from the participant and documented. Exclusion Criteria: 1. Participant has CD-related surgery planned or anticipated during the study. 2. Participant has prior exposure to an advanced therapy for the treatment of CD (biologic or small molecule) other than an anti-TNF (i.e., anti-integrin, anti-IL, Janus kinase inhibitors, or sphingosine-1-phosphate receptor 1). Prior failure or intolerance to 2 or more anti-TNF (i.e., infliximab, adalimumab, or certolizumab pegol) therapies in the past 3 years is also cause for exclusion. 3. Participant has an active infection at baseline requiring intravenous systemic antibiotics. Note: The treating physician must have completed all appropriate baseline screening tests as per the product label. 4. Participant has evidence of C. difficile toxin or is prescribed treatment for C. difficile infection, or other intestinal bacterial pathogen, ≤ 2 weeks prior to Screening. 5. Participant has chronic non-inflammatory bowel disease pain.

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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's disease

Contacts and locations

Locations

  • ABP Research Services Corp.

    Oakville, Ontario, L6L5L7, Canada

  • Alimentiv

    London, Ontario, N6Z5B6, Canada

  • Brigham and Women's Hospital

    Chestnut Hill, Massachusetts, 02467, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • GI Alliance - Bellevue - Washington Gastroenterology

    Bellevue, Washington, 98004, United States

  • GI Alliance - Sun City

    Sun City, Arizona, 85351, United States

  • GI Alliance Research Fort Worth

    Fort Worth, Texas, 76104, United States

  • GI Alliance Research Mansfield

    Mansfield, Texas, 76063, United States

  • GNRR Digestive Clinics and Research Center

    Brampton, Ontario, L6S0E2, Canada

  • London Health Sciences Centre

    London, Ontario, N6A5A5, Canada

  • McMaster University Medical Center

    Hamilton, Ontatrio, L8N 3Z5, Canada

  • Montreal General Hospital

    Montreal, Quebec, H3G1A4, Canada

  • Northwestern University

    Evanston, Illinois, 60611, United States

  • OR Clinic - East - GI

    Portland, Oregon, 97220, United States

  • Rajbir Rai Medicine Professional Corporation

    Oakville, Ontario, L6L4P7, Canada

  • Scarborough Center for Inflammatory Bowel Disease

    Scarborough Village, Ontario, M1B3V4, Canada

  • The Ottawa Hospital

    Ottawa, Ontario, K1H8L6, Canada

  • Toronto Immune & Digestive Health Institute Inc.

    Toronto, Ontario, M6A3B4, Canada

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112, United States

  • University of Alberta

    Edmonton, Alberta, T6G2X8, Canada

  • University of British Columbia

    Vancouver, British Columbia, V6Z2K5, Canada

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

  • West GTA Research Inc.

    Mississauga, Ontario, L5M7N4, Canada

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