Clinical trial • Phase IV • Gastroenterology

Vedolizumab for Ulcerative colitis | Crohn's disease

Phase IV trial of Vedolizumab for Ulcerative colitis | Crohn's disease.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Ulcerative colitis | Crohn's disease
Trial Stage
Phase IV
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
09-01-2025
First CTIS Authorization Date
21-01-2025

Trial design

Randomised, comparator arms: infliximab alone (products listed: zessly 100 mg powder for concentrate for solution for infusion, max dose 10 mg/kg as recorded; remsima 120 mg solution for injection in pre-filled pen, 120 mg listed) and vedolizumab alone (entyvio 300 mg powder for concentrate for infusion and entyvio 108 mg solution for injection in pre-filled pen). dosing/schedule reference: product entries list maximum/typical doses (zessly: up to 10 mg/kg; remsima: 120 mg pen; entyvio: 300 mg infusion or 108 mg pen) — specific trial administration schedule not specified in the available data.-controlled Phase IV trial across 3 sites in Finland.

Randomised
Yes
Comparator
Comparator arms: infliximab alone (products listed: Zessly 100 mg powder for concentrate for solution for infusion, max dose 10 mg/kg as recorded; Remsima 120 mg solution for injection in pre-filled pen, 120 mg listed) and vedolizumab alone (Entyvio 300 mg powder for concentrate for infusion and Entyvio 108 mg solution for injection in pre-filled pen). Dosing/schedule reference: product entries list maximum/typical doses (Zessly: up to 10 mg/kg; Remsima: 120 mg pen; Entyvio: 300 mg infusion or 108 mg pen) — specific trial administration schedule not specified in the available data.
Target Sample Size
40
Trial Duration For Participant
98

Eligibility

Recruits 40 Vulnerable populations not selected. Inclusion requires 'Signed informed consent'. Exclusion includes 'Impaired cognition and thus unable to provide signed informed consent' — participants unable to provide signed consent are excluded. No assent process or minor/guardian consent described in the available documentation..

Pregnancy Exclusion
Pregnancy
Vulnerable Population
Vulnerable populations not selected. Inclusion requires 'Signed informed consent'. Exclusion includes 'Impaired cognition and thus unable to provide signed informed consent' — participants unable to provide signed consent are excluded. No assent process or minor/guardian consent described in the available documentation.

Inclusion criteria

  • {"criterion_text":"-18-75 years old\n-Active ulcerative colitis or corticosteroid dependent disease and an indication for induction therapy with biological agents\n-Bionaive, i.e. no previous exposure to TNF blockers, vedolizumab or other biologics\n-Signed informed consent"}

Exclusion criteria

  • {"criterion_text":"-Previous treatment with infliximab or vedolizumab or other biologics\n-Fulminant severe colitis (Truelove and Witts citeria)\n-Pregnancy\n-Known contraindication to infliximab or vedolizumab\n-Antibiotic therapy at the baseline\n-On-going probiotic medication\n-Impaired cognition and thus unable to provide signed informed consent"}

Endpoints

Primary endpoints

  • {"endpoint_text":"-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.","definition_or_measurement_approach":"Steroid-free clinical remission assessed at week 14 after first FMT and week 12 after first biologic infusion; clinical remission defined as total Mayo score ≤2 and no subscore >1 on any component."}

Secondary endpoints

  • {"endpoint_text":"-Endoscopic healing defined as endoscopic Mayo subscore of 0","definition_or_measurement_approach":"Endoscopic Mayo subscore = 0"}
  • {"endpoint_text":"-Endoscopic improvement defined as Mayo endoscopic subscore of 0 or 1","definition_or_measurement_approach":"Endoscopic Mayo subscore = 0 or 1"}
  • {"endpoint_text":"-Improvement in quality of life (defined as an increase of ≥16 points in IBDQ score)","definition_or_measurement_approach":"Increase of ≥16 points in the Inflammatory Bowel Disease Questionnaire (IBDQ) score"}
  • {"endpoint_text":"-Histologic remission","definition_or_measurement_approach":"Histologic remission (definition not specified in available text)"}
  • {"endpoint_text":"-Fecal calprotectin","definition_or_measurement_approach":"Fecal calprotectin measurement (specific threshold or assay not specified)"}
  • {"endpoint_text":"-Weight","definition_or_measurement_approach":"Body weight measurement (method not specified)"}
  • {"endpoint_text":"-Blood pressure","definition_or_measurement_approach":"Blood pressure measurement (method not specified)"}
  • {"endpoint_text":"-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.","definition_or_measurement_approach":"Clinical response = reduction in partial Mayo score ≥2 points and ≥25% from baseline plus decrease in rectal bleeding subscore ≥1 point or absolute rectal bleeding subscore ≤1 point"}
  • {"endpoint_text":"-Adherence to FMT","definition_or_measurement_approach":"Adherence to fecal microbiota transplantation (specific adherence criteria not provided)"}
  • {"endpoint_text":"-Adverse events","definition_or_measurement_approach":"Recording of adverse events (standard safety reporting; details not specified)"}

Recruitment

Planned Sample Size
40
Recruitment Window Months
12
Consent Approach
Participation requires 'Signed informed consent' (inclusion criterion). Exclusion for 'Impaired cognition and thus unable to provide signed informed consent' is specified. Subject information and informed consent form documents are listed in the trial documents (titles available), but no age-specific consent/assent process or multi-language details are provided in the available data.

Geography

Total Number Of Sites
3
Total Number Of Participants
40

Finland

Earliest CTIS Part Ii Submission Date
19-12-2024
Latest Decision Or Authorization Date
21-01-2025
Processing Time Days
33
Number Of Sites
3
Number Of Participants
40

Sites

Site Name
HUS-Yhtymae
Department Name
Gastronenterologian klinikka
Principal Investigator Name
Perttu Arkkila
Principal Investigator Email
perttu.arkkila@hus.fi
Contact Person Name
Perttu Arkkila
Contact Person Email
perttu.arkkila@hus.fi
Site Name
Varsinais-Suomen hyvinvointialue
Department Name
Vatsakeskus
Principal Investigator Name
Kimmo Salminen
Principal Investigator Email
kimmo.salminen@varha.fi
Contact Person Name
Kimmo Salminen
Contact Person Email
kimmo.salminen@varha.fi
Site Name
Paeijaet-Haemeen hyvinvointialue
Department Name
Medisiininen alue
Principal Investigator Name
Perttu Lahtinen
Principal Investigator Email
perttu.lahtinen@paijatha.fi
Contact Person Name
Perttu Lahtinen
Contact Person Email
perttu.lahtinen@paijatha.fi

Sponsor

Primary sponsor

Full Name
Varsinais-Suomen hyvinvointialue
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Finland

Investigational products

Investigational Product Name
Entyvio 300 mg powder for concentrate for solution for infusion
Active Substance
Vedolizumab
Modality
Monoclonal antibody
Routes Of Administration
IV INFUSION
Route
IV infusion
Authorisation Status
Authorised (marketing authorisation: EU/1/14/923/001)
Starting Dose
300 mg (product entry maximum/nominal dose listed)
Maximum Dose
300 mg
Investigational Product Name
Entyvio 108 mg solution for injection in pre-filled pen
Active Substance
Vedolizumab
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
Subcutaneous injection
Authorisation Status
Authorised (marketing authorisation: EU/1/14/923/006)
Starting Dose
108 mg (product entry maximum/nominal dose listed)
Maximum Dose
108 mg
Investigational Product Name
Zessly 100 mg powder for concentrate for solution for infusion
Active Substance
Infliximab
Modality
Monoclonal antibody
Routes Of Administration
IV INFUSION
Route
IV infusion
Authorisation Status
Authorised (marketing authorisation: EU/1/18/1280/002)
Maximum Dose
10 mg/kg (as listed in product entry)
Investigational Product Name
Remsima 120 mg solution for injection in pre-filled pen
Active Substance
Infliximab
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
Subcutaneous injection
Authorisation Status
Authorised (marketing authorisation: EU/1/13/853/012)
Starting Dose
120 mg (product entry maximum/nominal dose listed)
Maximum Dose
120 mg
Combination Treatment
Yes

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