Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
278
Countries
1
Sites
7
Inflammatory Bowel Disease
Evaluating the effectiveness of subcutaneous vedolizumab dose de-escalation
Key facts
- Sponsor
- Stichting Amsterdam UMC
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 16 Jul 2025 → ongoing
- Decision date (initial)
- 2025-03-20
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- ZonMW · Zorgverzekeraars Nederland
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Evaluating the effectiveness of subcutaneous vedolizumab dose de-escalation
Secondary objectives 6
- Evaluating patient characteristics associated with successful interval extension
- Evaluating cost-effectiveness of interval extension
- Evaluating differences in adverse events
- Evaluating vedolizumab pharmacodynamics and pharmacokinetics
- Evaluation clinical and biochemical remission at all timepoints
- Evaluating quality of life
Conditions and MedDRA coding
Inflammatory Bowel Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10009900 | Colitis ulcerative | 100000004856 |
| 20.0 | PT | 10011401 | Crohn's disease | 100000004856 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Full trial Subjects are randomised into one of two arms for the full duration of the trial. No cross-over is used.
|
Randomised Controlled | None | Intervention: Subjects extend their injection interval to 3-weekly at baseline and to 4-weekly at week 24 (provided they sustained clinical and biochemical remission). Control: Subjects continue 2-weekly injections for the duration of the trial. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Adults diagnosed with Crohn's Disease or Ulcerative Colitis in steroïd-free clinical and biochemical remission treated with bi-weekly subcutaneous vedolizumab for six or more months
Exclusion criteria 1
- Use of corticosteroïds, active fistula or need for IBD-related surgery
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Difference in relapse rate
Secondary endpoints 7
- Factors associated with successful interval extension
- Proportion of patients having needed corticosteroïd treatment during follow-up
- Differences in emergency visits, hospitalizations and surgery
- Difference in quality of life
- Cost-effectiveness of interval extension
- Differences in adverse events
- Vedolizumab pharmacodynamics and pharmacokinetics
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Entyvio 108 mg solution for injection in pre-filled syringe
PRD8036142 · Product
- Active substance
- Vedolizumab
- Substance synonyms
- MLN0002, PB016
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 7.7 mg milligram(s)
- Max total dose
- 2816 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AG05 — -
- Marketing authorisation
- EU/1/14/923/002
- MA holder
- TAKEDA PHARMA A/S
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Stichting Amsterdam UMC
- Sponsor organisation
- Stichting Amsterdam UMC
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Stichting Amsterdam UMC
- Contact name
- IBD trial bureau
Public contact point
- Organisation
- Stichting Amsterdam UMC
- Contact name
- IBD trial bureau
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 278 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
UMC Groningen
Gastroenterology, Hanzeplein 1, 9700RB, Groningen
Universitair Medisch Centrum Utrecht
Gastroenterology, Heidelberglaan 100, 3584 CX, Utrecht
Maastricht University Medical Center
Gastroenterology, P Debyelaan 25, 6229HX, Maastricht
Amsterdam UMC
Gastroenterology, De Boelelaan 1117, 1081 HV, Amsterdam
Radboud universitair medisch centrum / RADBOUDUMC
Gastroenterology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Leids Universitair Medisch Centrum (LUMC)
Gastroenterology, Albinusdreef 2, 2333 ZA, Leiden
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Gastroenterology, Dr. Molewaterplein 60, 3015 GJ, Rotterdam
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 |
|---|---|---|---|---|---|
| Netherlands | 2025-07-16 | 2025-07-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol 2024 514740 82 00 | 3.0 |
| Protocol (for publication) | D1 Protocol Placeholder | 4.0 |
| Recruitment arrangements (for publication) | K1 Recruitment arrangements 2024 514740 82 00 | 1.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF 2024 514740 82 00 | 3.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF placeholder | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC Entyvio | 1 |
| Synopsis of the protocol (for publication) | D1 Protocol synopsis Dutch 2024 514740 82 00 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-18 | Netherlands | Acceptable with conditions 2025-03-17
|
2025-03-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-15 | Netherlands | Acceptable 2025-05-28
|
2025-05-28 |