Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Long-Term Study of Ustekinumab for Patients with Crohn's Disease Who Previously Lost Response to Treatment

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Crohn's disease, a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The treatment being tested in this study is called ustekinumab, which is given as a 90 mg solution for injection in a pre-filled syringe. Ustekinumab is a type of medication known as a biologic, which means it is made from living organisms or their cells and is used to target specific parts of the immune system.

The purpose of this study is to monitor the long-term effectiveness and safety of ustekinumab in patients with Crohn's disease who have previously participated in a related study. In this trial, patients will receive ustekinumab injections every four weeks. The study will observe how well patients respond to this treatment over time, particularly those who had a reduced response to a previous dosing schedule of every eight weeks.

Participants in the study will be monitored for a period of time to assess their response to the treatment, including whether they achieve remission, which means their symptoms are reduced or disappear. The study will also track any side effects or adverse events that may occur. The goal is to determine if the adjusted dosing schedule of ustekinumab can help maintain symptom control and improve the quality of life for patients with Crohn's disease.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after completing the previous REScUE study. Eligibility requires reaching the end of the REScUE study at week 48.

    Participants must be able to understand and sign an informed consent form and adhere to the study visit schedule and other protocol requirements.

  2. Step 2

    Medication administration

    The medication used is STELARA 90 mg, which is a solution for injection in a pre-filled syringe.

    The medication is administered through a subcutaneous injection.

    The dosage is 90 mg every four weeks (Q4w).

  3. Step 3

    Monitoring and assessments

    The study aims to assess the long-term clinical efficacy of the ustekinumab 90 mg SC Q4w regimen in patients with Crohn's disease.

    Participants will be monitored for the proportion of patients in steroid-free clinical remission at both week 56 and week 112.

    Secondary assessments include the incidence and severity of adverse events, time to Crohn's disease worsening, and various remission statuses at specified weeks.

  4. Step 4

    Study duration

    The estimated end date of the study is December 31, 2026.

    The study began recruiting participants on September 10, 2021.

Who can join the trial?

4 criteria

  • Must have been part of the REScUE study and completed it at week 48.
  • Females of childbearing age must use **adequate contraception**. This means using methods like birth control pills, patches, injections, an intra-uterine device (IUD), sterilization, or barrier methods like condoms. Males must use sterilization or barrier methods if their female partner can have children.
  • Must be able to understand and sign a form that explains the study and gives their permission to participate.
  • Must be able to follow the schedule for study visits and meet other study requirements.

Who cannot join the trial?

4 criteria

  • Patients who have not previously participated in the REScUE study.
  • Patients who have not experienced a secondary loss of response to the ustekinumab 90mg SC Q8w regimen. This means the treatment stopped working as well as it did before.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Ustekinumab: This medication is used to treat Crohn's disease, a condition that causes inflammation in the digestive tract. In this trial, patients who previously did not respond well to a lower frequency of this medication are being given a higher frequency to see if it improves their symptoms over the long term.

What is already known about the treatment

Ustekinumab – This medication is administered as a subcutaneous injection and is currently being studied for its long-term efficacy and safety in treating Crohn's disease. Ustekinumab is well-documented in medical literature as a treatment option for inflammatory conditions like Crohn's disease. It works by targeting specific proteins in the immune system, helping to reduce inflammation. Ustekinumab is classified as a monoclonal antibody, which is a type of biological therapy used to modulate the immune response.

Investigated diseases

Crohn's disease – Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of flare-ups and remission, where symptoms can vary in intensity. During flare-ups, individuals may experience abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications such as strictures or fistulas. The disease can progress unpredictably, with some people experiencing frequent symptoms and others having long periods without issues. The exact cause of Crohn's disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514326-23-00Protocol codeBIRD2020001Estimated enrolment108 patientsSponsorBelgian IBD Research and Development

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.