Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
352
Countries
2
Sites
28
Patients with Crohn's disease undergoing surgery and having at least one risk factor for postoperative recurrence of the disease.
To compare the postoperative endoscopic recurrence rate in patients with Crohn’s disease undergoing an ileocolonic resection with ileocolonic anastomosis randomized to systematic biological therapy or endoscopy-driven biological therapy
Key facts
- Sponsor
- UZ Leuven
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 8 Sep 2022 → ongoing
- Decision date (initial)
- 2022-07-20
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- KCE TRIALS, Belgian Health Care Knowledge Centre
External identifiers
- EU CT number
- 2022-500311-39-00
- ClinicalTrials.gov
- NCT05169593
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacokinetic, Efficacy, Prophylaxis, Pharmacoeconomic, Pharmacodynamic, Therapy
To compare the postoperative endoscopic recurrence rate in patients with Crohn’s disease undergoing an ileocolonic resection with ileocolonic anastomosis randomized to systematic biological therapy or endoscopy-driven biological therapy
Secondary objectives 2
- To compare the postoperative clinical, biological and surgical recurrence rate in patients with Crohn’s disease undergoing an ileocolonic resection with ileocolonic anastomosis randomized to systematic biological therapy or endoscopy-driven biological therapy
- To compare the direct costs, quality of life, work productivity, and safety in patients with Crohn’s disease undergoing an ileocolonic resection with ileocolonic anastomosis randomized to systematic biological therapy or endoscopy-driven biological therapy
Conditions and MedDRA coding
Patients with Crohn's disease undergoing surgery and having at least one risk factor for postoperative recurrence of the disease.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10011401 | Crohn's disease | 100000004856 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | systematic biological therapy versus endoscopy-driven biological therapy The first and the last patient for SOPRANO CD will be recruited, respectively, in June 2022 and December 2026. Patients will be followed for 86 weeks in the main study and an additional 156±8 weeks in the long-term follow-up study. The last patient will have achieved the final main study visit in June 2028 and the final visit in the long-term follow-up in June 2031.
Eligible patients will be allocated to one of the two treatment arms (1:1) according to a computer generated randomisation list in REDCap.
Stratified randomisation will be performed to achieve approximate balance for:
• Type of selected postoperative prophylactic therapy: adalimumab, infliximab, ustekinumab, vedolizumab or IL-23 inhibitors (guselkumab, mirikizumab, or risankizumab).
• Number of risk factors for postoperative recurrence: 1, 2 or >2 (out of 5 predefined factors: active smoking, penetrating disease, previous ileocolonic resection ≤10 years of index surgery, ≥2 previous ileocolonic resections, biological therapy ≤6 months of index ileocolonic resection).
|
Randomised Controlled | None | Active Comparator: Systematic postoperative prophylaxis with a biological: Biological therapy (adalimumab, guselkumab, infliximab, mirikizumab, rizankizumab, ustekinumab and vedolizumab) will be initiated within 14 to 40 days after ileocolonic resection or restoration of the faecal stream (day 0). In patients with endoscopic recurrence (updated Rutgeerts score ≥i2b) at week 30, dose optimization of the selected biological therapy is required. In case dose optimization is not allowed based on local reimbursement criteria and not available through a free goods program, a switch of biological therapy should be performed. Beyond week 34, dose optimization of this biological therapy will be allowed following daily clinical practice including proactive therapeutic drug monitoring. However, the timing, type and reason for dose optimization should be recorded. Furthermore, if the patient requires a switch of (biological) therapy between week 34 and week 86 (not based on the study algorythm for endoscopic recurrence at week 30), this will be regarded as a failure for the primary endpoint. Nevertheless, the patient should continue both the main study (including an endoscopy at week 86) and the long-term follow-up. Adalimumab: 160 mg subcutaneous (SC) at day 0, 80 mg SC at week 2, 40 mg SC at week 4 and every two weeks thereafter. In case of endoscopic recurrence at week 30, adalimumab should be optimized to 40 mg SC every week and this from week 34 onwards. Infiximab: Induction with 5 mg/kg intravenous (IV) at day 0, and 5 mg/kg IV at week 2; maintenance with 5 mg/kg IV at week 6 and every eight weeks thereafter or with 120 mg SC from week 6, week 10 or week 14 onwards and every two weeks thereafter. In case of endoscopic recurrence at week 30, infliximab should be optimized to 5 mg/kg IV every four weeks from week 34 onwards or 120 mg SC every week from week 32 onwards. Ustekinumab: 260 mg (body weight ≤55kg), 390 mg (55-85kg) or 520 mg (>85kg) IV at day 0, 90 mg SC at week 8 and every eight weeks thereafter. In case of endoscopic recurrence at week 30, an optimization with a new IV administration of 260 mg (body weight ≤55kg), 390 mg (55-85kg) or 520 mg (>85kg) ustekinumab IV should be foreseen at week 32 and followed by 90 mg SC every four or every eight weeks. Vedolizumab: induction with 300 mg IV at day 0, and 300 mg IV at week 2; maintenance with 300 mg IV at week 6 and every eight weeks thereafter or with 108 mg SC from week 6, week 10 or week 14 onwards and every two weeks thereafter. In case of endoscopic recurrence at week 30, vedolizumab should be optimized to 300 mg IV every four weeks from week 34 onwards or 108 mg SC every week from week 34 onwards. Risankizumab: Induction with 600 mg IV at day 0, week 4 and week 8; maintenance with 360 mg SC at week 12 and every eight weeks thereafter. In case of endoscopic recurrence at week 30, risankizumab should be optimized following daily clinical practice. Mirikizumab: Induction with 900 mg IV at day 0, week 4 and week 8; maintenance with 300 mg SC at week 12 and every four weeks thereafter. In case of endoscopic recurrence at week 30, mirikizumab should be optimized following daily clinical practice. guselkumab: Induction Option 1 with 200 mg IV at day 0, week 4 and week 8 or Induction Option II with 400 mg SC at day 0, week 4 and week 8. Followed by Maintenance Option I with 100 mg SC at week 16 and every eight weeks thereafter or Maintenance Option II with 200 mg SC at week 12 and every four weeks thereafter. In case of endoscopic recurrence: Induction Option 1 with 200 mg IV at day 0, week 4 and week 8 or Induction Option II with 400 mg SC at day 0, week 4 and week 8. Followed by Maintenance Option I with 100 mg SC at week 16 and every eight weeks thereafter or Maintenance Option II with 200 mg SC at week 12 and every four weeks thereafter. Endoscopy-driven postoperative biological therapy: No CD related therapy will be administered between Baseline (14 to 40 days after ileocolonic resection or restoration of the faecal stream) and the endoscopic evaluation at week 30 Patients with endoscopic recurrence (updated Rutgeerts score ≥i2b) at week 30 will initiate biological therapy (adalimumab, guselkumab, infliximab, mirikizumab, risankizumab, ustekinumab or vedolizumab) following a classical induction and maintenance schedule, and this within four weeks of the endoscopy. The type of biological therapy has to be decided already in the perioperative phase to allow a proper stratification. In patients initiating biological therapy at week 30, dose optimization of this therapy will be allowed from week 34 onwards following daily clinical practice including proactive therapeutic drug monitoring. However, the timing, type and reason for dose optimization should be recorded. Furthermore, if the patient requires a switch of (biological) therapy between week 34 and week 86, this will be regarded as a failure for the primary endpoint. Nevertheless, the patient should continue both the main study (including an endoscopy at week 86) and the long-term follow-up. In patients not on biological therapy yet, but developing clinical recurrence (Harvey-Bradshaw Index, HBI >4) with objective signs of disease recurrence (faecal calprotectin >250 µg/g, C-reactive protein >5 mg/L or endoscopic recurrence ≥i2b or clear radiological disease activity at the neoterminal ileum) beyond week 34, biological therapy can be initiated, but this will be regarded as a failure for the primary endpoint. The patient should continue both the main study (including an endoscopy at week 86) and the long-term follow-up. Adalimumab: In case of endoscopic recurrence at week 30, induction with 160 mg SC at week 32, 80 mg SC at week 34, 40 mg SC at week 36 and every two weeks thereafter. Infliximab: In case of endoscopic recurrence at week 30, induction with 5 mg/kg IV at week 32, and 5 mg/kg IV at week 34; maintenance with 5 mg/kg IV from week 38 onwards and every eight weeks thereafter or with 120 mg SC at week 38, week 42 or week 46 and every two weeks thereafter. Ustekinumab: In case of endoscopic recurrence at week 30, induction with 260 mg (body weight ≤55kg) or 390 mg (55-85kg) or 520 mg (>85kg) IV at week 32, 90 mg SC at week 40, and every eight weeks thereafter. Vedolizumab: In case of endoscopic recurrence at week 30, induction with 300 mg IV at week 32, and 300 mg IV at week 34; maintenance with 300 mg IV at week 38 and every eight weeks thereafter or with 108 mg SC from week 38, week 42 or week 46 onwards and every two weeks thereafter. Risankizumab: In case of endoscopic recurrence at week 30, induction with 600 mg IV at week 32, week 36 and week 40; maintenance with 360 mg SC at week 44 and every eight weeks thereafter. Mirikizumab: In case of endoscopic recurrence at week 30, induction with 900 mg IV at day 0, week 4 and week 8; maintenance with 300 mg SC at week 12 and every four weeks thereafter. Guselkumab: In case of endoscopic recurrence at week 30, Induction Option 1 with 200 mg IV at day 0, week 4 and week 8 or Induction Option II with 400 mg SC at day 0, week 4 and week 8. Followed by Maintenance Option I with 100 mg SC at week 16 and every eight weeks thereafter or Maintenance Option II with 200 mg SC at week 12 and every four weeks thereafter. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- Patients with a diagnosis of Crohn’s disease based on radiology, endoscopy and/or histology.
- Males and females ≥18 years old.
- Patients undergoing an ileocolonic resection with ileocolonic anastomosis (with or without temporary ileostomy) within 3 and 40 days prior to the Screening visit. Patients who underwent an ileocolonic resection with ileocolonic anastomosis with a temporary ileostomy are also eligible if the ileocolonic resection was performed within eight months prior to the Screening visit, and the restoration of the faecal stream was performed within 3 and 40 days prior to the Screening visit.
- Patients having an increased risk for postoperative recurrence for any of the following reasons: a) Penetrating disease as reason for ileocolonic resection; b) Previous ileocolonic resection within ten years of index surgery; c) Two or more previous ileocolonic resections aside from the index ileocolonic resection; d) Active smoking (i.e. smoked at least 7 sigarets during the past month); e) Advanced therapy (including biological therapy and small molecules) within 3 months of index ileocolonic resection.
- Curative ileocolonic resection. All inflamed colon segments should have been removed. Strictureplasties in the small bowel not involving the anastomotic region are allowed.
- Patients previously failing (for Belgium: at least three months of) steroids and/or three months of immunosuppressive therapy, or showing intolerance or a real contraindication for any of these therapies. Local reimbursement criteria should be followed at all times.
- Patients able and willing to start and continue biological therapy, and this at the timepoint indicated through study randomization.
Exclusion criteria 16
- Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol.
- Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial.
- Participation in an interventional Trial with an Investigational Medicinal Product (IMP) or device.
- Patients initiating biological therapy for CD as part of another clinical trial or a medical need program.
- Patients not understanding Dutch, French, German, Italian or English.
- Patients with ulcerative colitis or inflammatory bowel disease type unclassified.
- Patients with an ileorectal anastomosis, or an ileal pouch-anal anastomosis.
- Patients with active perianal disease.
- Females who are pregnant or nursing at the moment of Screening.
- Patients with a colorectal stenosis.
- Patients with an ostomy.
- Patients with sepsis or other postoperative complications necessitating the use of antibiotics for more than 15 days after ileocolonic resection or restoration of the faecal stream.
- Patients with (an imminent risk) of a short bowel syndrome.
- Patients who had qualifying ileocolonic resection for dysplasia or cancer without ongoing inflammation.
- Participant has a history of primary non-response, secondary loss of response, intolerance or contraindication to all seven biological therapies of interest, namely adalimumab, guselkumab, infliximab, mirikizumab, risankizumab, ustekinumab and vedolizumab.
- Any other factors that might jeopardise the participant’s safety or integrity of the trial (e.g. non-compliant patients).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Endoscopic recurrence (updated Rutgeerts score ≥i2b) at week 86 or need for unscheduled treatment adaptation prior to week 86.
Secondary endpoints 45
- Endoscopic recurrence (updated Rutgeerts score ≥i2b) at week 86.
- Harvey-Bradshow index (HBI) based clinical recurrence prior to week 86.
- Direct costs from Baseline to week 86.
- Need for a new ileocolonic resection prior to week 86.
- Severe adverse reactions to biological therapy prior to week 86.
- Serious adverse events prior to week 86.
- Quality of life (EQ-5D 5L) at week 30, week 62 and week 86 in comparison to Baseline.
- Crohn’s disease activity index (CDAI) based clinical recurrence at week 86.
- CDAI based clinical recurrence prior to week 86.
- Time to CDAI based clinical recurrence.
- HBI based clinical recurrence at week 86.
- Time to HBI based clinical recurrence.
- PRO-2 based clinical recurrence at week 86.
- PRO-2 based clinical recurrence prior to week 86.
- Time to PRO-2 clinical recurrence.
- Endoscopic disease activity (≥i3, ≥i2a, or ≥i1) at week 86.
- Endoscopic recurrence at week 30 (updated Rutgeerts score ≥i2b).
- Endoscopic disease activity (≥i3, ≥i2a, or ≥i1) at week 30
- Persistent endoscopic recurrence at week 86 after development of endoscopic recurrence at week 30.
- Need for a new ileocolonic resection, a balloon dilation or a strictureplasty at the site of the ileocolonic anastomosis prior to week 86.
- Work productivity and activity impairment (WPAI:CD) at week 30, week 62 and week 86 in comparison to Baseline.
- Change in medical therapy for Crohn’s disease prior to week 86.
- Change in C-reactive protein (CRP) at week 14, week 30, week 46, week 62, and week 86 in comparison to Baseline.
- Change in faecal calprotectin at week 14, week 30, week 46, week 62, and week 86 in comparison to Baseline.
- Number of unscheduled visits related to CD (clinical visit, endoscopic or radiological evaluation).
- Suspected unexpected serious adverse reactions prior to week 86.
- Predictors of clinical, biological, endoscopic, and surgical outcome prior to week 86.
- Evolution of CDAI, HBI and PRO-2 at week 138, 190 and 242 in comparison to Baseline and Week 86.
- Evolution of EQ-5D 5L at week 138, 190 and 242 in comparison to Baseline and Week 86.
- Evolution of WPAI:CD at week 138, 190 and 242 in comparison to Baseline and Week 86.
- Evolution of CRP at week 138, 190 and 242 in comparison to Baseline and Week 86.
- Evolution of faecal calprotectin at week 138, 190 and 242 in comparison to Baseline and Week 86.
- Change in medical therapy for Crohn’s disease prior to week 138, 190 and 242.
- Need for a new ileocolonic resection prior to week 138, 190 and 242.
- Need for a new ileocolonic resection, a balloon dilation or a strictureplasty at the site of the ileocolonic anastomosis prior to week 138, 190 and 242.
- Serious adverse reactions to biological therapy prior to week 138, 190 and 242
- Serious adverse events prior to week 138, 190 and 242.
- Suspected unexpected serious adverse reactions prior to week 138, 190 and 242
- Predictors of clinical, biological, endoscopic, and surgical outcome prior to week 138, 190 and 242.
- Building a risk score at Baseline that is predictive for endoscopic, biological, clinical and surgical recurrence.
- Evaluating whether macroscopic or microscopic involvement (including presence of granulomas) of the proximal resection margin at index surgery is predictive of endoscopic, biological, clinical and surgical recurrence.
- Evaluating the association between the use of GLP-1 agonists (e.g. semaglutide and tirzepatide) at Baseline and endoscopic, biological, clinical and surgical recurrence at week 30 and 86.
- Evaluating the association between vaping or the use of e-cigarettes at Baseline and endoscopic, biological, clinical and surgical recurrence at week 30 and 86.
- Evaluating the association between the use of GLP-1 agonists (e.g. semaglutide and tirzepatide) at Baseline and endoscopic, biological, clinical and surgical recurrence at week 138, 190 and 242
- Evaluating the association between vaping or the use of e-cigarettes at Baseline and endoscopic, biological, clinical and surgical recurrence at week 138, 190 and 242
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 17
Tremfya 200 mg concentrate for solution for infusion
PRD12400475 · Product
- Active substance
- Guselkumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 13000 mg milligram(s)
- Max treatment duration
- 242 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC16 — -
- Marketing authorisation
- EU/1/17/1234/005
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Tremfya 200 mg solution for injection in pre-filled syringe
PRD12400479 · Product
- Active substance
- Guselkumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 13000 mg milligram(s)
- Max treatment duration
- 242 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC16 — -
- Marketing authorisation
- EU/1/17/1234/006
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Tremfya 100 mg solution for injection in pre-filled syringe.
PRD5602542 · Product
- Active substance
- Guselkumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 13000 mg milligram(s)
- Max treatment duration
- 242 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC16 — -
- Marketing authorisation
- EU/1/17/1234/001
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Omvoh 300 mg concentrate for solution for infusion
PRD10448233 · Product
- Active substance
- Mirikizumab
- Substance synonyms
- LY-3074828
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 900 mg milligram(s)
- Max total dose
- 21000 mg milligram(s)
- Max treatment duration
- 242 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC — -
- Marketing authorisation
- EU/1/23/1736/001
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Omvoh 100 mg + 200 mg solution for injection in pre-filled syringe
PRD12100334 · Product
- Active substance
- Mirikizumab
- Substance synonyms
- LY-3074828
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 900 mg milligram(s)
- Max total dose
- 21000 mg milligram(s)
- Max treatment duration
- 242 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC — -
- Marketing authorisation
- EU/1/23/1736/007
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20016 · Substance
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 5000 mg milligram(s)
- Max treatment duration
- 242 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20016 · Substance
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 160 mg milligram(s)
- Max total dose
- 5000 mg milligram(s)
- Max treatment duration
- 242 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20016 · Substance
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 160 mg milligram(s)
- Max total dose
- 5000 mg milligram(s)
- Max treatment duration
- 242 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB27761 · Substance
- Active substance
- Ustekinumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 520 mg milligram(s)
- Max total dose
- 520 mg milligram(s)
- Max treatment duration
- 242 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB27761 · Substance
- Active substance
- Ustekinumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 90 mg milligram(s)
- Max total dose
- 2700 mg milligram(s)
- Max treatment duration
- 242 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02681MIG · Substance
- Active substance
- Infliximab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 120 mg milligram(s)
- Max total dose
- 14520 mg milligram(s)
- Max treatment duration
- 242 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02681MIG · Substance
- Active substance
- Infliximab
- Pharmaceutical form
- POWDER FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 5 mg/Kg milligram(s)/kilogram
- Max total dose
- 160 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 242 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB182635 · Substance
- Active substance
- Risankizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 360 mg milligram(s)
- Max total dose
- 9450 mg milligram(s)
- Max treatment duration
- 242 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB182635 · Substance
- Active substance
- Risankizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 360 mg milligram(s)
- Max total dose
- 9450 mg milligram(s)
- Max treatment duration
- 242 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB30452 · Substance
- Active substance
- Vedolizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 108 mg milligram(s)
- Max total dose
- 13068 mg milligram(s)
- Max treatment duration
- 242 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB30452 · Substance
- Active substance
- Vedolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 9450 mg milligram(s)
- Max treatment duration
- 242 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB30452 · Substance
- Active substance
- Vedolizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 108 mg milligram(s)
- Max total dose
- 13068 mg milligram(s)
- Max treatment duration
- 242 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
UZ Leuven
- Sponsor organisation
- UZ Leuven
- Address
- Herestraat 49
- City
- Leuven
- Postcode
- 3000
- Country
- Belgium
Scientific contact point
- Organisation
- UZ Leuven
- Contact name
- Marc Ferrante
Public contact point
- Organisation
- UZ Leuven
- Contact name
- Marc Ferrante
Locations
2 EU/EEA countries · 28 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 292 | 24 |
| Italy | Ongoing, recruiting | 60 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
CHU De Liège
Gastroenterology, Avenue De L'hopital 1, 4000, Liege
Cliniques Universitaires Saint-Luc
Gastroenterology, Batiment 54, Hippokrateslaan 10, Brussels
Az Maria Middelares Gent
Gastroenterology, Buitenring-Sint-Denijs 30, 9000, Gent
Algemeen Ziekenhuis Oostende
gastroenterology, Gouwelozestraat 100, 8400, Ostend
Algemeen Ziekenhuis Klina
Gastroenterology, Augustijnslei 100, 2930, Brasschaat
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Gastroenterology, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
Az Delta
Gastroenterology, Deltalaan 1, 8800, Roeselare
Ziekenhuis Oost Limburg
Gastroenterology, Synaps Park 1, 3600, Genk
UZ Leuven
Gastroenterology and Hepatology, Herestraat 49, 3000, Leuven
Verenigde Ziekenhuizen Van Waas En Durme
Gastroenterology, Moerlandstraat 1, 9100, Sint-Niklaas
Sint-Lucas General Hospital
Gastroenterology, Sint-Lucaslaan 29, 8310, Brugge
Antwerp University Hospital
Gastroenterology, Drie Eikenstraat 655, 2650, Edegem
Centre Hospitalier De Wallonie Picarde
Gastroenterology, Rue Des Sports 51, 7500, Tournai
Az Sint-Lucas & Volkskliniek
Gastroenterology, Groenebriel 1, 9000, Gent
Erasme University Hospital
Gastroenterology, Route De Lennik 808, 1070, Brussels
Universitair Ziekenhuis Gent
Gastroenterology, Corneel Heymanslaan 10, 9000, Gent
Algemeen Ziekenhuis Groeninge
Gastroenterology, President Kennedylaan 4, 8500, Kortrijk
UZ Brussel
Gastroenterology, Laarbeeklaan 101, 1090, Jette
Imelda vzw
Gastroenterology, Imeldalaan 9, 2820, Bonheiden
Az St-Jan Brugge-Oostende A.V.
Gastroenterology, Ruddershove 10, 8000, Brugge
GZA Sint-Vincentius
Gastroenterology, Sint-Vincentiusstraat 20, 2018, Antwerp
Azorg
Gastroenterology, Moorselbaan 164, 9300, Aalst
Jessa Ziekenhuis
Gastroenterology, Stadsomvaart 11, 3500, Hasselt
CHC
Gastroenterology, Rue De Hesbaye 75, 4000, Liege
Humanitas Research Hospital
Gastroenterology, Via Alessandro Manzoni 56, 20089, Rozzano
IRCCS San Raffaele
Gastroenterology, Via Olgettina 58, 20132, Milan
Careggi University Hospital
Gastroenterology, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
IRCCS De Bellis Castellana Grotte
Gastroenterology, Via Turi 27, 70013, Castellana Grotte
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2022-09-08 | 2023-10-21 | |||
| Italy | 2024-05-13 | 2024-06-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 142 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol SOPRANO CD_2022-500311-39_Public | 4 |
| Protocol (for publication) | D2_SOP videorecordings_2022-500311-39_Public | 2 |
| Protocol (for publication) | S62015_Protocol SOPRANO CD | 1 |
| Protocol (for publication) | S62015_Protocol SOPRANO CD_TC | 1 |
| Recruitment arrangements (for publication) | Article SOPRANO CD_IT | 1 |
| Recruitment arrangements (for publication) | ccare newsletter 2022 SOPRANO CD | 1 |
| Recruitment arrangements (for publication) | FB post_FR | 1 |
| Recruitment arrangements (for publication) | FB post_NL | 1 |
| Recruitment arrangements (for publication) | FOLDER_DTS | 1 |
| Recruitment arrangements (for publication) | FOLDER_DTS | 1 |
| Recruitment arrangements (for publication) | FOLDER_DTS_TC | 1 |
| Recruitment arrangements (for publication) | FOLDER_ENG | 1 |
| Recruitment arrangements (for publication) | FOLDER_ENG_Clean | 1 |
| Recruitment arrangements (for publication) | FOLDER_ENG_TC | 1 |
| Recruitment arrangements (for publication) | FOLDER_FR | 1 |
| Recruitment arrangements (for publication) | FOLDER_FR | 1 |
| Recruitment arrangements (for publication) | FOLDER_FR_TC | 1 |
| Recruitment arrangements (for publication) | FOLDER_IT | 1 |
| Recruitment arrangements (for publication) | FOLDER_IT_TC | 1 |
| Recruitment arrangements (for publication) | FOLDER_ITA | 1 |
| Recruitment arrangements (for publication) | FOLDER_NL | 1 |
| Recruitment arrangements (for publication) | FOLDER_NL | 1 |
| Recruitment arrangements (for publication) | FOLDER_NL_TC | 1 |
| Recruitment arrangements (for publication) | Script video pour les patients en francais | 1 |
| Recruitment arrangements (for publication) | social media_FR | 1 |
| Recruitment arrangements (for publication) | social media_FR_TC | 1 |
| Recruitment arrangements (for publication) | social media_NL | 1 |
| Recruitment arrangements (for publication) | social media_NL_TC | 1 |
| Recruitment arrangements (for publication) | Videoscript voor patienten in Nederlands | 1 |
| Recruitment arrangements (for publication) | Way of recruiting | 1 |
| Recruitment arrangements (for publication) | Way of recruiting - Recruiting material | 1 |
| Recruitment arrangements (for publication) | Way of recruiting - Recruiting material | 1 |
| Recruitment arrangements (for publication) | Way of recruiting_IT | 1 |
| Recruitment arrangements (for publication) | Way of recruiting_IT_TC | 1 |
| Recruitment arrangements (for publication) | Way of recruiting_TC | 1 |
| Subject information and informed consent form (for publication) | CDAI_English | 1 |
| Subject information and informed consent form (for publication) | CDAI_Italian | 1 |
| Subject information and informed consent form (for publication) | D10_Questionnaire_EQ-5D_BE_nl_Public | 2 |
| Subject information and informed consent form (for publication) | EQ 5D 5L_EN | 1 |
| Subject information and informed consent form (for publication) | EQ 5D 5L_FR | 1 |
| Subject information and informed consent form (for publication) | EQ-5D-5L_IT | 1 |
| Subject information and informed consent form (for publication) | EQ-5D-5L_IT | 1 |
| Subject information and informed consent form (for publication) | EQ5D-5L_DTS | 1 |
| Subject information and informed consent form (for publication) | EQ5D-5L_DTS | 1 |
| Subject information and informed consent form (for publication) | EQ5D-5L_DTS_TC | 1 |
| Subject information and informed consent form (for publication) | ICF_DTS | 1 |
| Subject information and informed consent form (for publication) | ICF_DTS_TC | 1 |
| Subject information and informed consent form (for publication) | ICF_ENG | 1 |
| Subject information and informed consent form (for publication) | ICF_ENG_TC | 1 |
| Subject information and informed consent form (for publication) | ICF_FR | 1 |
| Subject information and informed consent form (for publication) | ICF_FR_TC | 1 |
| Subject information and informed consent form (for publication) | ICF_ITA | 1 |
| Subject information and informed consent form (for publication) | ICF_ITA_TC | 1 |
| Subject information and informed consent form (for publication) | ICF_Italian sites | 1 |
| Subject information and informed consent form (for publication) | ICF_Italian sites_CLEAN | 1 |
| Subject information and informed consent form (for publication) | ICF_Italian sites_TC | 1 |
| Subject information and informed consent form (for publication) | ICF_Italian sites_TRACK | 1 |
| Subject information and informed consent form (for publication) | ICF_Italian sites_V1_18May2022 | 1 |
| Subject information and informed consent form (for publication) | ICF_Italian sites_V2_01AUGUST2022_Final | 1 |
| Subject information and informed consent form (for publication) | ICF_Italian sites_V2_01AUGUST2022_TC_Final | 1 |
| Subject information and informed consent form (for publication) | ICF_NED | 1 |
| Subject information and informed consent form (for publication) | ICF_NED_TC | 1 |
| Subject information and informed consent form (for publication) | Informativa privacy_CLEAN | 1 |
| Subject information and informed consent form (for publication) | Informativa privacy_Clean | 1 |
| Subject information and informed consent form (for publication) | Informativa privacy_TC | 1 |
| Subject information and informed consent form (for publication) | Informativa privacy_TRACK | 1 |
| Subject information and informed consent form (for publication) | Journal patients CDAI_FR | 1 |
| Subject information and informed consent form (for publication) | K1_Recruitment material_Monizze folder_en_public | 1.2 |
| Subject information and informed consent form (for publication) | K1_Recruitment material_Monizze folder_fr_public | 1.2 |
| Subject information and informed consent form (for publication) | K1_Recruitment material_Monizze folder_nl_public | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF_BE_de_Public | 4.1 |
| Subject information and informed consent form (for publication) | L10_Terugbetaling Persoonlijk Aandeel_BE_nl_Public | 2 |
| Subject information and informed consent form (for publication) | L11_Information leaflet 2FA_BE_en_Public | 1 |
| Subject information and informed consent form (for publication) | L12_Information leaflet 2FA_BE_fr_Public | 1 |
| Subject information and informed consent form (for publication) | L13_Information leaflet 2FA_BE_nl_Public | 1 |
| Subject information and informed consent form (for publication) | L14_Injection worksheet_de | 2 |
| Subject information and informed consent form (for publication) | L14_Injection worksheet_en | 2 |
| Subject information and informed consent form (for publication) | L14_Injection worksheet_fr | 2 |
| Subject information and informed consent form (for publication) | L14_Injection worksheet_it | 2 |
| Subject information and informed consent form (for publication) | L14_Injection worksheet_ne | 2 |
| Subject information and informed consent form (for publication) | L2_ICF_BE_en_Public | 4.1 |
| Subject information and informed consent form (for publication) | L3_ICF_BE_fr_Public | 4.1 |
| Subject information and informed consent form (for publication) | L4_ICF_BE_it_Public | 4.1 |
| Subject information and informed consent form (for publication) | L5_ICF_IT_it_public | 6.1 |
| Subject information and informed consent form (for publication) | L6_ICF_BE_nl_Public | 4.1 |
| Subject information and informed consent form (for publication) | L7_Informativa privacy_IT_it_public | 5 |
| Subject information and informed consent form (for publication) | L8_Reimbursement Personal Share_BE_en_Public | 2 |
| Subject information and informed consent form (for publication) | L9_Remboursement Part Personnelle_BE_fr_Public | 2 |
| Subject information and informed consent form (for publication) | Patients diary CDAI_DTS | 1 |
| Subject information and informed consent form (for publication) | Patients diary CDAI_ENG | 1 |
| Subject information and informed consent form (for publication) | Patients diary CDAI_ITA | 1 |
| Subject information and informed consent form (for publication) | Patients diary CDAI_ITA | 1 |
| Subject information and informed consent form (for publication) | Patients diary CDAI_NL | 1 |
| Subject information and informed consent form (for publication) | Receipt_DTS | 1 |
| Subject information and informed consent form (for publication) | Receipt_EN | 1 |
| Subject information and informed consent form (for publication) | Receipt_FR | 1 |
| Subject information and informed consent form (for publication) | Receipt_NL | 1 |
| Subject information and informed consent form (for publication) | SOPRANO CD Monizze brochure_ENG | 1 |
| Subject information and informed consent form (for publication) | SOPRANO CD Monizze brochure_FR | 1 |
| Subject information and informed consent form (for publication) | SOPRANO CD Monizze brochure_NL | 1 |
| Subject information and informed consent form (for publication) | SOPRANO CD_SC Injection worksheet_V1_29May2022_Dutch | 1 |
| Subject information and informed consent form (for publication) | SOPRANO CD_SC Injection worksheet_V1_29May2022_English | 1 |
| Subject information and informed consent form (for publication) | SOPRANO CD_SC Injection worksheet_V1_29May2022_French | 1 |
| Subject information and informed consent form (for publication) | SOPRANO CD_SC Injection worksheet_V1_29May2022_German | 1 |
| Subject information and informed consent form (for publication) | SOPRANO CD_SC Injection worksheet_V1_29May2022_ITA | 1 |
| Subject information and informed consent form (for publication) | SOPRANO CD_SC Injection worksheet_V1_29May2022_ITA | 1 |
| Subject information and informed consent form (for publication) | WPAI-CD_DTS | 1 |
| Subject information and informed consent form (for publication) | WPAI-CD_ENG | 1 |
| Subject information and informed consent form (for publication) | WPAI-CD_FR | 1 |
| Subject information and informed consent form (for publication) | WPAI-CD_IT | 1 |
| Subject information and informed consent form (for publication) | WPAI-CD_IT | 1 |
| Subject information and informed consent form (for publication) | WPAI-CD_NL | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Amgevita | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Entyvio | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Flixabi | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Hukyndra | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Hulio | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Humira | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Hyrimoz | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Idacio | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Imraldi | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Inflectra | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_omvoh | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_otulfi | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_pyzchiva | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Remicade | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Remsima | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Skyrizi | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Stelara | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_steqeyma | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_tremfya | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_uzpruvo | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_wezenla | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_yesintek | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Yuflyma | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Zessly | 1 |
| Synopsis of the protocol (for publication) | D4_Study short Synopsis_BE_en_public | 3 |
| Synopsis of the protocol (for publication) | D5_Study Short Synopsis_IT_it_public | 3 |
| Synopsis of the protocol (for publication) | D6_Study Synopsis_BE_en_public | 3 |
| Synopsis of the protocol (for publication) | D7_Study Synopsis_BE_fr_public | 3 |
| Synopsis of the protocol (for publication) | D8_Study Synopsis_BE_it_public | 3 |
| Synopsis of the protocol (for publication) | D9_Study Synopsis_BE_nl_public | 3 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-03-04 | Belgium | Acceptable 2022-06-16
|
2022-06-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2022-08-04 | Acceptable | 2022-09-15 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-05-15 | Belgium | Acceptable 2023-06-15
|
2023-06-27 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-09-18 | Belgium | Acceptable 2023-06-15
|
2023-09-18 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-10-20 | Belgium | Acceptable 2023-06-15
|
2023-10-20 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-05-29 | Belgium | Acceptable 2024-06-26
|
2024-06-26 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-07-09 | Acceptable 2024-06-26
|
2024-07-09 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-04-08 | Belgium | Acceptable 2024-06-26
|
2025-04-08 |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-01-13 | Belgium | Acceptable 2026-02-26
|
2026-03-06 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-03-26 | Belgium | Acceptable 2026-02-26
|
2026-03-26 |