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Crohn DiseasePhase 3REScUENCT04245215

Loss of RESponse to Ustekinumab Treated by Dose Escalation

A Phase 3 study testing Ustekinumab in people with Crohn Disease, run by Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to investigate the effect of re-induction with ustekinumab ≈6mg/kg IV followed by two different maintenance dosing regimens 90 mg subcutaneous every 8 weeks (Q8W) vs 90 mg subcutaneous every 4 weeks(Q4W) on clinical, biological and pharmacological outcomes in patients with Crohn's disease who… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn Disease
What is being tested?
Ustekinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
108 participants
Where
1 siteBelgium
Study dates
11 Mar 2020to 25 Sep 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥18 years
  • Diagnosis of Crohn's disease by endoscopic and/or radiologic examination.
  • Patient currently treated with ustekinumab, independent of previous biological exposure.
  • Patients treated with maintenance dose of ustekinumab subcutaneous 90 mg every 8 weeks
  • Documented primary response at any time point during induction (up to week 20) defined as a clinical response (physician discretion) AND confirmed by either any of the following:
  • 1. A documented decrease in biomarkers based on a value during induction period compared to a value prior to ustekinumab induction (max. 3 months prior to start of ustekinumab induction)
Show all 14Show fewer
  • A decrease in CRP OR b. A decrease in FCP 2. A documented endoscopic improvement (evaluation during the induction period compared to an evaluation prior to ustekinumab induction (max. 6 months prior to start of ustekinumab induction) 6. Documented loss of response after induction (at any timepoint after week 16) assessed by the physician as moderate to severe active Crohn's disease. The increase in symptoms reported by the patient is defined as Patient Reported Outcome-2 (Abdominal Pain > 1 AND Stool Frequency > 3) AND confirmed by either any of the following* :
  • Documentation of endoscopic lesions in at least one segment of the ileum or colon as assessed by ileocolonoscopy AND a documented increase in biomarkers based on an increased value compared to the lowest value obtained during induction or after week 16 ustekinumab induction
  • An increase in CRP and > 5 mg/L OR
  • An increase in FCP and > 250µg/mg
  • A documented relapse on endoscopy : Presence of mucosal ulcers in at least one segment of the ileum or colon and a SES-CD ≥ 6 (for patients with isolated ileitis ≥ 4), as assessed by ileocolonoscopy.
  • 7. Adequate contraception in female of reproductive age (oral contraception, intra uterine device, sterilisation or barrier method) 8. Have the capacity to understand and sign an informed consent form. 9. Be able to adhere to the study visit schedule and other protocol requirements.
  • 10. All Crohn's Disease treatments stable for at least 2 weeks prior to baseline.
  • the criterium used to proof loss of response does not have to be identical to the one used to proof primary response : e.g. one can use an increase in biomarkers to proof primary response and a relapse on endoscopy to proof loss of response

Who cannot join

  • Ongoing treatment with
  • other concomitant biological (vedolizumab, anti-TNF)
  • Steroids >20 mg prednisolone or equivalent at baseline (budesonide >6 mg, > 5mg beclomethasone dipropionate at baseline)
  • Q4w ustekinumab (ustekinumab treatment every four weeks)
  • Women that are pregnant, nursing, or planning pregnancy
  • Have screening laboratory test results within the following parameters:
Show all 18Show fewer
  • Haemoglobin < 8.5 g/dL
  • Platelets < 100,000 /mm3
  • Serum creatinine ≥ 1.7 mg/dL
  • aspartate aminotransferase and alanine aminotransferase > 3 times the upper limit of normal range
  • Direct (conjugated) bilirubin ≥ 3.0 mg/dL.
  • Have current signs or symptoms of infection confirmed by positive stool or blood testing (including gastrointestinal pathogens, tuberculosis, human immunodeficiency virus, hepatitis B, hepatitis C).
  • Patients with a positive stool sample for gastrointestinal pathogen including Clostridium difficile.
  • Evidence of current or previous clinically significant disease, medical condition other than Crohn's Disease, finding of the medical examination, or laboratory value at the screening visit outside the reference range that is of clinical relevance, that in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data.
  • Patients with an ileostomy
  • Patients that received an intravenous re-induction with ustekinumab within the 6 months prior to baseline.
  • Patients with an impassable stenosis even after attempt of endoscopic balloon dilation.
  • Patients with an abscess

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Ingrid Arijs

    Zaventem, 1930

Other trials in Belgium

About this study

The aim of the study is to investigate the effect of re-induction with ustekinumab ≈6mg/kg IV followed by two different maintenance dosing regimens 90 mg subcutaneous every 8 weeks (Q8W) vs 90 mg subcutaneous every 4 weeks(Q4W) on clinical, biological and pharmacological outcomes in patients with Crohn's disease who show a secondary loss of response over time

Read the detailed description

The study is a prospective double blind interventional study in patients with Crohn Disease treated with ustekinumab that show an objective secondary loss of response to ustekinumab after induction treatment (>Week 16). Patients can be screened during a four week period. The screening includes a clinical, biochemical and endoscopic assessment. Patients will be randomized 8 weeks after the last subcutaneous injection with ustekinumab. All patient will receive an intravenous re-induction with ustekinumab ≈6mg/kg at baseline (8 weeks after last subcutaneous administration). After the intravenous re-induction, the patients receive either ustekinumab 90 mg subcutaneous Q4W or Q8W (altered with q8w placebo to mimic Q4W injections) till week 48. Clinical and biochemical evaluation will be planned every 8 weeks until week 36 with a final evaluation at week48. Primary endpoint will be assessed at week 48. Final assessment at week 48 will include clinical, biochemical and endoscopic evaluation.

Conditions
Crohn Disease
Being tested
Ustekinumab
Keywords
dose escalation, ustekinumab
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UstekinumabDrug

    Also called dose escalation only in arm 2

    re-induction and dose escalation form every 8 weeks to every 4 weeks only in arm 2

Study groups in NCT04245215
Study groupRoleWhat they receive
1. Subcutaneous ustekinumab every 8 weeksPlacebo comparatorre-induction (≈6mg/kg) intravenous ustekinumab followed by 90 mg Subcutaneous ustekinumab every 8 weeks (Q8W) for 48 weeks - receiving Q8W placebo to mimic Q4W injections
Receives: Drug: Ustekinumab
2. Subcutaneous ustekinumab every 4 weeksActive comparatorre-induction (≈6mg/kg) intravenous ustekinumab followed by 90 mg Subcutaneous ustekinumab every 4 weeks (Q4W) for 48 weeks
Receives: Drug: Ustekinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Patients With Steroid Free Clinical Remission and Fecal Calprotectin<250µg/g at Week 48

    Proportion of patients with steroid free clinical remission (patient reported outcome-2 remission: abdominal pain ≤ 1 AND stool frequency ≤ 3) and fecal calprotectin<250µg/g at week 48. [stool frequency (ST): average number of liquid stools for 1 week abdominal pain (AP): average scoring for abdominal pain for 1 week (0=none; 1=mild, 2=moderate; 3= severe)]

    Measured: week 48

Secondary outcomes (7)

  1. Proportion of Patients With Complete Endoscopic Remission at Week 48

    Proportion of patients with complete endoscopic remission (simple endoscopic score for Crohn's disease (SES-CD )<3) at week 48

    Measured: week 48

  2. Proportion of Patients With Endoscopic Remission at Week 48

    Proportion of patients with endoscopic remission (simple endoscopic score for Crohn's disease (SES-CD) <5) at week 48

    Measured: week 48

  3. Proportion of Patients With Endoscopic Response at Week 48

    Proportion of patients with endoscopic response (≥50% decrease in simple endoscopic score for Crohn's disease (SES-CD)) at week 48

    Measured: week 48

  4. Proportion of Patients With Clinical Remission at Week 8

    Proportion of patients with clinical remission (patient reported outcome-2 remission: abdominal pain ≤ 1 AND stool frequency ≤ 3) at week 8

    Measured: week 8

  5. Proportion of Patients With Clinical Remission at Week 48

    Proportion of patients with clinical remission (patient reported outcome-2 remission: abdominal pain ≤ 1 AND stool frequency ≤ 3) at week 48

    Measured: week 48

  6. Proportion of Patients With Biomarker Remission at Week 48

    Proportion of patients with biomarker remission (C-reactive protein <5 mg/L and fecal calprotectin <250 µg/g) at week 48

    Measured: week 48

  7. Proportion of Patients With Serious Adverse Events at Week 48

    Proportion of patients with serious adverse events at week 48

    Measured: Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2020
  2. Study start11 Mar 2020
  3. Primary completion25 Sep 2024
  4. Study completion25 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04245215
Sponsor's protocol ID
BIRD2018001
Acronym
REScUE
Status last verified
Jun 2026
First submitted
23 Jan 2020
Last updated
1 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bossuyt P, Rahier JF, Baert F, Louis E, Macken E, Lobaton T, Busschaert J, Peeters H, Dewint P, Franchimont D, Willandt B, Claessens C, Vansteenkiste L, Dewit O, Ferrante M; Belgian IBD Research and Development (BIRD) group; Vermeire S. The Effect of Dose Intensification After Secondary Loss of Response to Ustekinumab in Crohn's Disease: Results of the REScUE Study. Gastroenterology. 2026 Jul;171(1):99-109. doi: 10.1053/j.gastro.2026.01.042. Epub 2026 Feb 24.

    PubMed 41747777

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ustekinumab in people with Crohn Disease, run by Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients With Steroid Free Clinical Remission and Fecal Calprotectin<250µg/g at Week 48 (time frame: week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04245215, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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