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COMPLETEDPHASE3

Loss of RESponse to Ustekinumab Treated by Dose Escalation

NCT04245215•Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW

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 show a secondary loss of response over time

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 week36 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. ≥18 years
•2. Diagnosis of Crohn's disease by endoscopic and/or radiologic examination.
•3. Patient currently treated with ustekinumab, independent of previous biological exposure.
•4. Patients treated with maintenance dose of ustekinumab subcutaneous 90 mg every 8 weeks
•5. Documented primary response at any time point after induction (week 16) and during maintenance defined as a clinical response (physician discretion) AND confirmed by either any of the following:
•a. if biomarker elevated at start of ustekinumab (C-reactive protein\>5 mg/l or fecal calprotectin \>250µg/g): i. decrease of C-reactive protein by 50 % or more compared to baseline( prior to ustekinumab induction) ii. C-reactive protein \<5 mg/l iii. decrease of fecal calprotectin by 50 % or more compared to baseline( prior to ustekinumab induction) iv. fecal calprotectin\<250µg/g b. Documented mucosal healing (simple endoscopic score for Crohn's disease (SES-CD)\<3)
•6. Documented loss of response after induction (\> week 16) assessed by the physician as Moderate to severe active Crohn's disease, defined as Patient Reported Outcome-2 (Abdominal Pain \> 1 AND Stool Frequency \> 3) AND C-reactive protein and/or fecal calprotectin increased by 25 % or more compared to the lowest value under ustekinumab treatment (C-reactive protein\>5 mg/L and/or fecal calprotectin\>250µg/g).
•7. Presence of mucosal ulcers in at least one segment of the ileum or colon and a simple endoscopic score for Crohn's disease (SES-CD) ≥6 (for patients with isolated ileitis ≥4), as assessed by ileocolonoscopy
•8. Adequate contraception in female of reproductive age
•9. Have the capacity to understand and sign an informed consent form.
+1 more criteria

Exclusion Criteria

•1. Ongoing treatment with
•1. other concomitant biological (vedolizumab, anti-TNF)
•2. Steroids \>20 mg prednisolone or equivalent at baseline (budesonide \>6 mg)
•3. Patient already receiving ustekinumab every 4 weeks
•2. Women that are pregnant, nursing, or planning pregnancy
•3. Have screening laboratory test results within the following parameters:
•1. Haemoglobin \< 8.5 g/dL
•2. Platelets \< 100,000 /mm3
•3. Serum creatinine ≥ 1.7 mg/dL
•4. aspartate aminotransferase and alanine aminotransferase \> 3 times the upper limit of normal range
+8 more criteria

Locations (1)

Ingrid Arijs

Zaventem, Belgium

Key Dates

Start Date

March 11, 2020

Primary Completion Date

September 25, 2024

Completion Date

September 25, 2024

Last Updated

October 1, 2024

Enrollment

108

ACTUAL participants

Conditions

Crohn Disease

Interventions

Ustekinumab

DRUG

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

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Inflammatory Bowel Disease (IBD)Crohn Disease (CD)+2 more

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RECRUITING

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Loss of RESponse to Ustekinumab Treated by Dose Escalation

Inclusion Criteria

Exclusion Criteria

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

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