2024-514326-23-00RecruitingPhase 4
An Open-Label Extension and long-term efficacy and safety monitoring study of patients with Crohn's disease previously included in the loss of RESponse to Ustekinumab treated by dose Escalation study (REScUE-OLE)
Belgian IBD Research and Development, Belgian IBD Research and Development15 sites in 1 country108 target enrollmentStarted: July 1, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 108
- Locations
- 15
- Primary Endpoint
- Proportion of patients in both treatment arms in steroid-free clinical remission (PRO-2 remission: average AP≤1 and average SF≤3 without any steroid use in the previous 28 days) at both week 56 and week 112 of the study (sustained steroid-free clinical remission).
Study Overview
Brief Summary
To assess the long-term clinical efficacy of a ustekinumab 90mg SC Q4w regimen in patients with CD previously enrolled in the REScUE study because of secondary loss of response to a ustekinumab 90mg SC Q8w regimen.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Previous inclusion in the REScUE study and having reached the end of this study at week
- •Adequate contraception in females of reproductive age (oral, transdermal, injectable contraception, intra-uterine device, sterilisation or barrier method). Adequate contraception in males (sterilization or barrier method) if his female partner is of reproductive age.
- •Have the capacity to understand and sign an informed consent form.
- •Be able to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria
- •Patients previously enrolled to the ustekinumab 90 mg SC Q4w-arm during REScUE who were on concomitant steroid use >20 mg prednisone equivalents (budesonide >6 mg; beclomethasone dipropionaat >5 mg) at any time point in the last 28 days before the end of REScUE at week
- •Patients previously enrolled to the ustekinumab 90 mg SC Q4w-arm during REScUE that did not reach the following criteria at the end of REScUE at week 48: Clinical remission (defined as average AP≤1 and average SF≤3) OR clinical response (defined as a drop of at least 50% in average AP and/or a drop of at least 50% in average SF as compared to REScUE baseline, and both average AP and SF no worse than REScUE baseline) AND Endoscopic remission (defined as a total SES-CD <5 or for isolated ileitis SES-CD <4) OR endoscopic response (defined as a drop of at least 50% in total SES-CD score as compared to REScUE baseline)
- •Patients who developed an anaphylactic or severe allergic reaction to study medication during REScUE.
- •Patients with any of the following laboratory tests at W0 of REScUE-OLE : Hemoglobin level <8.5 g/dL, Platelets level <100.000 /mm3, Serum creatinine level ≥1.7 mg/dL, AST and ALT level >3 times the upper limit of normal range, Direct (conjugated) bilirubin level ≥3.0 mg/dL
- •Patients with an ongoing treatment with another concomitant biological (vedolizumab, anti-TNF), a JAK-inhibitor or any investigational product for the treatment of CD at the end of REScUE at week
- •Patients who experience or have an ongoing infection event confirmed by positive stool or blood testing (including gastrointestinal pathogens, tuberculosis, HIV, hepatitis B, hepatitis C) should not initiate REScUE-OLE until (i) this event has completely resolved as shown by the termination of treatment with anti-infective medication, or (ii) this event is considered to be in stable remission under anti-infective medication in case of HIV, hepatitis B and hepatitis C.
- •Patients with an impassable stenosis even after attempt of endoscopic balloon dilatation.
- •Patients with an intra-abdominal abscess, or patients with an intra-anal abscess without adequate drainage by e.g. a seton placement.
Outcomes
Primary Outcomes
Proportion of patients in both treatment arms in steroid-free clinical remission (PRO-2 remission: average AP≤1 and average SF≤3 without any steroid use in the previous 28 days) at both week 56 and week 112 of the study (sustained steroid-free clinical remission).
Proportion of patients in both treatment arms in steroid-free clinical remission (PRO-2 remission: average AP≤1 and average SF≤3 without any steroid use in the previous 28 days) at both week 56 and week 112 of the study (sustained steroid-free clinical remission).
Secondary Outcomes
- Incidence and severity of adverse events in both treatment arms.
- Time to CD worsening (as defined in section 3.2.1 of the protocol) in both treatment arms.
- Proportion of patients in both treatment arms in steroid-free clinical remission (PRO-2 remission: average AP≤1 and average SF≤3 without any steroid use in the previous 28 days) at week 56 of the study.
- Proportion of patients in both treatment arms in steroid-free clinical remission (PRO-2 remission: average AP≤1 and average SF≤3 without any steroid use in the previous 28 days) at week 112 of the study.
- Proportion of patients previously enrolled to the ustekinumab 90 mg SC Q8w-arm during REScUE who needed dose optimization to ustekinumab 90 mg SC Q4w at the start or during REScUE-OLE (≤week 100), and that reached steroid-free clinical remission (PRO-2 remission: average AP≤1 and average SF≤3 without any steroid use in the previous 28 days) at week 112.
- Proportion of patients in both treatment arms in clinical remission (PRO-2 remission: average AP≤1 and average SF≤3) at both week 56 and week 112 of the study (sustained clinical remission).
- Proportion of patients in both treatment arms in clinical remission (PRO-2 remission: average AP≤1 and average SF≤3) at week 56 of the study.
- Proportion of patients in both treatment arms in clinical remission (PRO-2 remission: average AP≤1 and average SF≤3) at week 112 of the study.
- Proportion of patients previously enrolled to the ustekinumab 90 mg SC Q8w-arm during REScUE who needed dose optimization to ustekinumab 90 mg SC Q4w at the start or during REScUE-OLE (≤week 100), and that reached clinical remission (PRO-2 remission: average AP≤1 and average SF≤3) at week 112.
- Proportion of patients in both treatment arms with biomarker remission (CRP <5 mg/L and FC≤250 µg/g) at week 56 of the study.
- Proportion of patients in both treatment arms with biomarker remission (CRP <5 mg/L and FC≤250 µg/g) at week 112 of the study.
- Proportion of patients previously enrolled to the ustekinumab 90 mg SC Q8w-arm during REScUE who needed dose optimization to ustekinumab 90 mg SC Q4w at the start or during REScUE-OLE (≤week 100), and that reached biomarker remission (CRP<5 mg/L and FC≤250 µg/g) at week 112.
- Proportion of patients in both treatment arms in endoscopic remission (total SES-CD <5 or for isolated ileitis <4) at week 56 of the study.
- Proportion of patients in both treatment arms in endoscopic remission (total SES-CD <5 or for isolated ileitis <4) at week 112 of the study.
- Proportion of patients previously enrolled to the ustekinumab 90 mg SC Q8w-arm during REScUE who needed dose optimization to ustekinumab 90 mg SC Q4w at the start or during REScUE-OLE (≤ week 100), and that reached endoscopic remission (total SES-CD <5 or for isolated ileitis <4) at week 112.
- Proportion of patients in both treatment arms in complete endoscopic remission (total SES-CD <3) at week 56 of the study.
- Proportion of patients in both treatment arms in complete endoscopic remission (total SES-CD <3) at week 112 of the study.
- Proportion of patients previously enrolled to the ustekinumab 90 mg SC Q8w-arm during REScUE who needed dose optimization to ustekinumab 90 mg SC Q4w at the start or during REScUE-OLE (≤ week 100), and that reached complete endoscopic remission (total SES-CD<3) at week 112.
Investigators
Lieven Pouillon
Scientific
Belgian IBD Research and Development
Study Sites (15)
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