Overview
Sponsor-declared trial summary
Ulcerative Colitis, Crohn´s disease
The main aim is to determine the feasibility to run a proper RCT with a larger sample size with fecal microbiota transplant (FMT) + infliximab (IFX) or FMT + vedolizumab (VDZ) since this study is a pilot study. Objectives: To assess the efficacy of FMT + IFX as compared to IFX alone. To assess the efficacy of FMT + VD…
Key facts
- Sponsor
- Varsinais-Suomen hyvinvointialue
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2025-01-21
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-520373-12-00
- EudraCT number
- 2020-004914-36
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The main aim is to determine the feasibility to run a proper RCT with a larger sample size with fecal microbiota transplant (FMT) + infliximab (IFX) or FMT + vedolizumab (VDZ) since this study is a pilot study.
Objectives:
To assess the efficacy of FMT + IFX as compared to IFX alone.
To assess the efficacy of FMT + VDZ as compared to VDZ alone.
To assess the safety of FMT in patients receiving biologics for active
ulcerative colitis.
To assess fecal microbiota changes in patients receiving biologics as
compared to patients receiving biologics and FMT.
Secondary objectives 1
- -To assess the efficacy of FMT + IFX as compared to IFX alone. -To assess the efficacy of FMT + VDZ as compared to VDZ alone. -To assess the safety of FMT in patients receiving biologics for active ulcerative colitis. -To assess fecal microbiota changes in patients receiving biologics as compared to patients receiving biologics and FMT.
Conditions and MedDRA coding
Ulcerative Colitis, Crohn´s disease
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 18-75 years old
- Active ulcerative colitis or corticosteroid dependent disease and an indication for induction therapy with biological agents
- Bionaive, i.e. no previous exposure to TNF blockers, vedolizumab or other biologics
- Signed informed consent
Exclusion criteria 7
- Previous treatment with infliximab or vedolizumab or other biologics
- Fulminant severe colitis (Truelove and Witts citeria)
- Pregnancy
- Known contraindication to infliximab or vedolizumab
- Antibiotic therapy at the baseline
- On-going probiotic medication
- Impaired cognition and thus unable to provide signed informed consent
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Steroid free clinical remission at week 14 from first fecal microbiota transplant and week 12 from the first infliximab/vedolizumab infusion. Clinical remission here is defined as a total score of ≤2 on the Mayo scale and no subscore >1 on any of the four components.
Secondary endpoints 10
- Endoscopic healing defined as endoscopic Mayo subscore of 0
- Endoscopic improvement defined as Mayo endoscopic subscore of 0 or 1
- Improvement in quality of life (defined as an increase of ≥16 points in IBDQ score)
- Histologic remission
- Fecal calprotectin
- Weight
- Blood pressure
- Clinical response defined as a reduction in the partial Mayo score (stool frequency, rectal bleeding, and physician's global assessment) of ≥2 points and of ≥25% from baseline, with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point.
- Adherence to FMT
- Adverse events
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Entyvio 300 mg powder for concentrate for solution for infusion
PRD1598541 · Product
- Active substance
- Vedolizumab
- Substance synonyms
- MLN0002, PB016
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AG05 — -
- Marketing authorisation
- EU/1/14/923/001
- MA holder
- TAKEDA PHARMA A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entyvio 108 mg solution for injection in pre-filled pen
PRD8036296 · Product
- Active substance
- Vedolizumab
- Substance synonyms
- MLN0002, PB016
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 108 mg milligram(s)
- Max total dose
- 108 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AG05 — -
- Marketing authorisation
- EU/1/14/923/006
- MA holder
- TAKEDA PHARMA A/S
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 2
Zessly 100 mg powder for concentrate for solution for infusion
PRD6241737 · Product
- Active substance
- Infliximab
- Substance synonyms
- ABP 710, CT-P13, NI-071, PF-06438179, R-TPR-015
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 10 mg/kg milligram(s)/kilogram
- Max total dose
- 10 mg/kg milligram(s)/kilogram
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — -
- Marketing authorisation
- EU/1/18/1280/002
- MA holder
- SANDOZ GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Remsima 120 mg solution for injection in pre-filled pen
PRD7752781 · Product
- Active substance
- Infliximab
- Substance synonyms
- ABP 710, CT-P13, NI-071, PF-06438179, R-TPR-015
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 120 mg milligram(s)
- Max total dose
- 120 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — -
- Marketing authorisation
- EU/1/13/853/012
- MA holder
- CELLTRION HEALTHCARE HUNGARY KFT
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Varsinais-Suomen hyvinvointialue
- Sponsor organisation
- Varsinais-Suomen hyvinvointialue
- Address
- Kiinamyllynkatu 4-8
- City
- Turku
- Postcode
- 20520
- Country
- Finland
Scientific contact point
- Organisation
- Varsinais-Suomen hyvinvointialue
- Contact name
- TYKS gastroenterologian poliklinikka
Public contact point
- Organisation
- Varsinais-Suomen hyvinvointialue
- Contact name
- TYKS gastroenterologian poliklinikka
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 40 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
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) | Liite_6_The_Finnish_Colitis_Study071022 | 1 |
| Recruitment arrangements (for publication) | Liite_6_The_Finnish_Colitis_Study071022 | 1 |
| Subject information and informed consent form (for publication) | Liite_7_TIEDOTE TUTKIMUKSESTA_Finnish_Colitis_Study_071022 | 1 |
| Subject information and informed consent form (for publication) | Liite_8_Tutkittavan_suostumus_Finnish_Colitis_study041220 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | entyvio-epar-product-information_fi | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | remsima-epar-product-information_fi | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | zessly-epar-product-information_fi | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-09 | Finland | Acceptable 2025-01-21
|
2025-01-21 |