Clinical trial • Phase IV • Gastroenterology

VEDOLIZUMAB for Moderately to severely active Crohn's disease

Phase IV trial of VEDOLIZUMAB for Moderately to severely active Crohn's disease.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Moderately to severely active Crohn's disease
Trial Stage
Phase IV
Drug Modality
Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
15-03-2024
First CTIS Authorization Date
03-07-2024

Trial design

Randomised, open-label, group 1: treatment escalated until achievement of corticosteroid-free tmh + clinical remission + biomarker remission; group 2: treatment escalated until achievement of corticosteroid-free clinical remission + biomarker remission-controlled, adaptive Phase IV trial in Netherlands, Denmark, Germany and others.

Randomised
Yes
Open Label
Yes
Comparator
Group 1: Treatment escalated until achievement of corticosteroid-free TMH + clinical remission + biomarker remission; Group 2: Treatment escalated until achievement of corticosteroid-free clinical remission + biomarker remission
Adaptive
True, treatment escalation per a treat-to-target algorithm (participants' treatment is escalated until prespecified targets are met); no formal interim analyses or stopping rules are specified in the provided Part I/II text.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
304
Trial Duration For Participant
700

Stratification factors

  • Prior exposure to an approved biologic/small molecule for CD (yes or no)
  • Disease location (ileal-predominant or colonic)
  • Disease duration (≤ 2 years or >2 years, based on date of diagnosis)

Eligibility

Recruits 304 No vulnerable populations selected. Participants are adults (18–80 years). Written informed consent must be obtained and documented (country-specific ICFs available)..

Pregnancy Exclusion
Pregnant, lactating, or intending to become pregnant/impregnate a partner before, during, or within 18 weeks after the last dose; or intending to donate ova or sperm during such time period;
Vulnerable Population
No vulnerable populations selected. Participants are adults (18–80 years). Written informed consent must be obtained and documented (country-specific ICFs available).

Inclusion criteria

  • {"criterion_text":"-Adults aged 18 to 80 years, inclusive, at the time of consent;"}
  • {"criterion_text":"-Moderately to severely active CD at baseline defined by a CDAI score of 220 to 450 inclusive and SES-CD, excluding the presence of narrowing component, ≥6 (or ≥4 for participants with isolated ileal disease);"}
  • {"criterion_text":"-BWT on IUS of >4.0 mm in the terminal ileum or any colonic segment (excluding the rectum) as assessed by the mean of 2 longitudinal and 2 cross-sectional measurements of the same segment;"}
  • {"criterion_text":"-Biologic-naïve or have previous exposure (within the last 5 years of the screening date) to no more than 1 advanced therapeutic compound (approved biologic or small molecule drug) for the treatment of their CD. Note: only approximately 15% to 30% of the enrolled population will have had prior exposure to an advanced therapeutic;"}
  • {"criterion_text":"-Participants may continue stable dose (initiated at least 4 weeks prior to Screening) of 5-ASA for CD;"}
  • {"criterion_text":"-Persons of childbearing potential must have a negative serum pregnancy test prior to randomization and must use a highly effective method of contraception throughout the study. Females unable to bear children must have documentation of such in the source records;"}
  • {"criterion_text":"-Able to participate fully in all aspects of this clinical trial;"}
  • {"criterion_text":"-Written informed consent must be obtained and documented"}

Exclusion criteria

  • {"criterion_text":"-Current or previous treatment with vedolizumab, etrolizumab, or natalizumab;"}
  • {"criterion_text":"-Abscess >2 cm, detected by IUS or endoscopy; participants with draining fistulas are not excluded;"}
  • {"criterion_text":"-Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the participant’s ability to participate fully in the study or would compromise participant safety;"}
  • {"criterion_text":"-Positive stool test for Clostridioides difficile infection (as demonstrated by positive toxin);"}
  • {"criterion_text":"-Known HIV or hepatitis B or C infection. If a negative test result is available in the 12 months prior to randomization, retesting is not required;"}
  • {"criterion_text":"-Known active or latent tuberculosis (TB); if a negative test result is available in the 12 months prior to randomization, confirmatory testing (per standard of care) is not required before randomization;"}
  • {"criterion_text":"-Other systemic or opportunistic infection (including cytomegalovirus), any other clinically significant extraintestinal infection, or recurring infection within 6 months of randomization;"}
  • {"criterion_text":"-Has active cerebral/meningeal disease, signs, symptoms, or any history of progressive multifocal leukoencephalopathy (PML) prior to randomization;"}
  • {"criterion_text":"-Hypersensitivity, allergy, or intolerance to any excipient of vedolizumab or any other contraindication to vedolizumab;"}
  • {"criterion_text":"-Active severe infection such as sepsis, cytomegalovirus, listeriosis, or opportunistic infection."}
  • {"criterion_text":"-Unwillingness to withhold protocol-prohibited medications during the trial;"}
  • {"criterion_text":"-Previously exposed to 2 or more compounds or classes of an advanced therapeutic compound (approved biologic or small molecule drug) for the treatment of their CD;"}
  • {"criterion_text":"-Concurrent or previous participation in another clinical trial and received any investigational therapy within 30 days prior to randomization;"}
  • {"criterion_text":"-History of alcohol or drug abuse that in the opinion of the investigator may interfere with the participant’s ability to comply with the study procedures;"}
  • {"criterion_text":"-Prior enrolment in the current study and had received study treatment;"}
  • {"criterion_text":"-Pregnant, lactating, or intending to become pregnant/impregnate a partner before, during, or within 18 weeks after the last dose; or intending to donate ova or sperm during such time period;"}
  • {"criterion_text":"-Vaccination with a live or live-attenuated vaccine within 4 weeks prior to randomization, or planned vaccination with a live or live-attenuated vaccine during participation in the study;"}
  • {"criterion_text":"-Any person performing mandatory military service, deprived of liberty, in a residential care setting, or any person who, due to a judicial decision, cannot take part in clinical studies;"}
  • {"criterion_text":"-The person is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling)."}
  • {"criterion_text":"-Change to oral corticosteroid therapy dosing within 2 weeks prior to randomization or a corticosteroid dose of >40 mg of prednisone or equivalent at randomization;"}
  • {"criterion_text":"-Only have inflammation proximal to the terminal ileum that cannot be reached by ileocolonoscopy;"}
  • {"criterion_text":"-Have a CD complication, such as symptomatic strictures in the small bowel with >3 cm prestenotic dilatation on any imaging modality, requiring procedural intervention;"}
  • {"criterion_text":"-Previous extensive colonic resection or missing >2 segments out of 5 (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum), ileorectal anastomosis, or a proctocolectomy"}
  • {"criterion_text":"-Ostomy or ileoanal pouch;"}
  • {"criterion_text":"-Short bowel syndrome;"}
  • {"criterion_text":"-Fibrotic-only stricture in the ileum or colon without evidence of active inflammation (in the investigator’s judgment), including any impassable stenosis"}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Corticosteroid-free endoscopic remission at Week 48","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"-Corticosteroid-free TMH + endoscopic remission + clinical remission at Week 48; Corticosteroid-free IUS response + endoscopic remission + clinical remission at Week 48; Corticosteroid-free endoscopic remission + clinical remission at Week 48; Corticosteroid-free endoscopic response + clinical response at Week 48","definition_or_measurement_approach":"Composite outcomes assessed at Week 48 (TMH, IUS response, endoscopic remission/response, clinical remission/response at Week 48)."}
  • {"endpoint_text":"-Corticosteroid-free clinical remission at Weeks 14, 22, and 48; Corticosteroid-free clinical response at Weeks 14, 22, and 48; CDAI total score and corresponding change from baseline during follow-up (Weeks 6, 14, 22, 30, 38, and 48)","definition_or_measurement_approach":"Clinical remission/response measured at Weeks 14, 22, 48; CDAI total score and change from baseline measured at Weeks 6, 14, 22, 30, 38, 48."}
  • {"endpoint_text":"-Corticosteroid-free endoscopic response at Week 48; SES-CD total score and corresponding change from baseline to Week 48","definition_or_measurement_approach":"Endoscopic response and SES-CD total score change from baseline assessed at Week 48."}
  • {"endpoint_text":"-TMH at Week 48; IUS response at Week 48; BWT and corresponding change from baseline at Week 48; CDS and corresponding change from baseline at Week 48; International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) (per segment as well as total) and corresponding change from baseline at Week 48","definition_or_measurement_approach":"IUS and ultrasound-derived metrics (BWT, CDS, IBUS-SAS) assessed per segment and total, with change from baseline at Week 48."}
  • {"endpoint_text":"-TMH at Weeks 14, 22, 30, 38, and 48; IUS response at Weeks 14, 22, 30, 38, and 48; BWT and corresponding change from baseline at Weeks 14, 22, 30, 38, and 48; CDS and corresponding change from baseline at Weeks 14, 22, 30, 38, and 48; IBUS-SAS and corresponding change from baseline at Weeks 14, 22, 30, 38, and 48","definition_or_measurement_approach":"Serial assessment of TMH, IUS response, BWT, CDS, and IBUS-SAS at Weeks 14, 22, 30, 38, 48 with change from baseline."}
  • {"endpoint_text":"-Histologic remission at Week 48; Histologic response at Week 48","definition_or_measurement_approach":"Histologic remission/response assessed at Week 48 (histology endpoints as specified in protocol)."}
  • {"endpoint_text":"-Biomarker remission at Week 48; Biomarker response at Week 48; CRP response during follow-up (Weeks 6, 14, 22, 30, 38, and 48); FCal response during follow-up (Weeks 6, 14, 22, 30, 38, and 48); CRP and FCal and their corresponding changes from baseline during follow-up (Weeks 6, 14, 22, 30, 38, and 48)","definition_or_measurement_approach":"Biomarker (CRP, FCal) remission/response and changes from baseline measured at Weeks 6, 14, 22, 30, 38, 48."}
  • {"endpoint_text":"-2-item Patient-Reported Outcome (PRO 2) score, Symptoms and Impacts Questionnaire for CD (SIQ-CD) score, and Urgency Numerical Rating Score (NRS) and their corresponding changes from baseline during follow-up (Weeks 6, 14, 22, 30, 38, and 48); Inflammatory Bowel Disease Questionnaire (IBDQ) score and corresponding changes from baseline during follow-up (Weeks 30 and 48)","definition_or_measurement_approach":"Patient-reported outcomes (PRO-2, SIQ-CD, Urgency NRS, IBDQ) and changes from baseline measured at specified follow-up weeks (PROs at Weeks 6,14,22,30,38,48; IBDQ at Weeks 30 and 48)."}
  • {"endpoint_text":"-Time to CD-related complication from randomization through Week 96.; Time to each component of CD-related complication; Switched to an alternate biologic (yes/no) by Week 48 and Week 96; Endpoints related to CDAI, CRP, FCal, and patient-reported measures (as specified above) at Weeks 64, 80, and 96.","definition_or_measurement_approach":"Time-to-event endpoints through Week 96; switch to alternate biologic measured at Weeks 48 and 96; extended assessments of CDAI, CRP, FCal and PROs at Weeks 64, 80, 96."}
  • {"endpoint_text":"-Exposure-adjusted incidence rates of serious adverse events (SAEs), all adverse events (AEs), and AEs of special interest (AESIs)","definition_or_measurement_approach":"Safety endpoints reported as exposure-adjusted incidence rates for SAEs, all AEs, and AESIs."}

Recruitment

Planned Sample Size
304
Recruitment Window Months
44
Consent Approach
Written informed consent must be obtained and documented. Country-specific subject information and informed consent forms (ICFs) are available (multiple languages/countries listed). A Denmark-specific POA document is present in the public documents list (L1_SIS and ICF_DK POA). Consent is provided by the adult participant (study enrolls adults 18–80).

Methods

  • Clinician letters and recruitment materials targeted to treating clinicians/GPs (K2 Clinician letter documents available; country-specific versions listed for BE, NL, DE, PL, FR, IT, PT, DK).
  • Recruitment arrangements documents (K1) published per country (documents listed for multiple member states).

Geography

Total Number Of Sites
42
Total Number Of Participants
191

Netherlands

Earliest CTIS Part Ii Submission Date
26-06-2024
Latest Decision Or Authorization Date
27-05-2025
Processing Time Days
335
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Elisabeth-Tweesteden Ziekenhuis
Department Name
Gastroenterology and Hepatology
Principal Investigator Name
Robert Laheij
Principal Investigator Email
r.laheij@etz.nl
Contact Person Name
Robert Laheij
Contact Person Email
r.laheij@etz.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Gastroenterology and Hepatology
Principal Investigator Name
A.C. De Vries
Principal Investigator Email
a.c.devries@erasmusmc.nl
Contact Person Name
A.C. De Vries
Contact Person Email
a.c.devries@erasmusmc.nl
Site Name
Radboud universitair medisch centrum / RADBOUDUMC
Department Name
Gastroenterology and Hepatology
Principal Investigator Name
Marjolijn Duijvestein
Principal Investigator Email
Marjolijn.Duijvestein@radboudumc.nl
Contact Person Name
Marjolijn Duijvestein
Site Name
Amsterdam UMC
Department Name
VUmc
Principal Investigator Name
Krisztina Gecse
Principal Investigator Email
k.b.gecse@amsterdamumc.nl
Contact Person Name
Krisztina Gecse
Contact Person Email
k.b.gecse@amsterdamumc.nl

Denmark

Earliest CTIS Part Ii Submission Date
13-12-2024
Latest Decision Or Authorization Date
28-05-2025
Processing Time Days
166
Number Of Sites
7
Number Of Participants
22

Sites

Site Name
Region Midtjylland
Department Name
Department of Medicine
Principal Investigator Name
Mia Bendix
Principal Investigator Email
miabendi@rm.dk
Contact Person Name
Mia Bendix
Contact Person Email
miabendi@rm.dk
Site Name
Region Sjaelland
Department Name
Section of Gastroenterology, Department Internal Medicine
Principal Investigator Name
Nynne Andersen
Principal Investigator Email
nyna@regionsjaelland.dk
Contact Person Name
Nynne Andersen
Contact Person Email
nyna@regionsjaelland.dk
Site Name
Copenhagen University Hospital
Department Name
Digestive Disease Center
Principal Investigator Name
Kristian Mikkelsen
Principal Investigator Email
Kristian.hallundbaek.mikkelsen@regionh.dk
Contact Person Name
Kristian Mikkelsen
Site Name
Nordsjaellands Hospital
Department Name
Department of Surgery, Gastromedicine section
Principal Investigator Name
Salvatore Leotta
Principal Investigator Email
salvatore.leotta.02@regionh.dk
Contact Person Name
Salvatore Leotta
Contact Person Email
salvatore.leotta.02@regionh.dk
Site Name
Region Hovedstaden
Department Name
Gastroenterology and Hepatology
Principal Investigator Name
Jacob Bjerrum
Principal Investigator Email
Jacob.wium.bjerrum@regionh.dk
Contact Person Name
Jacob Bjerrum
Contact Person Email
Jacob.wium.bjerrum@regionh.dk
Site Name
Region Midtjylland
Department Name
Hepatology and Gastroenterology
Principal Investigator Name
Anders Dige
Principal Investigator Email
andedige@rm.dk
Contact Person Name
Anders Dige
Contact Person Email
andedige@rm.dk
Site Name
Hvidovre Hospital
Department Name
Gastrounit, Medical Division
Principal Investigator Name
Klaus Theede
Principal Investigator Email
Klaus.Theede@regionh.dk
Contact Person Name
Klaus Theede
Contact Person Email
Klaus.Theede@regionh.dk

Germany

Earliest CTIS Part Ii Submission Date
14-06-2024
Latest Decision Or Authorization Date
02-06-2025
Processing Time Days
353
Number Of Sites
4
Number Of Participants
23

Sites

Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Clinic for Internal Medicine
Principal Investigator Name
Stefan Schreiber
Principal Investigator Email
stefan.schreiber@uksh.de
Contact Person Name
Stefan Schreiber
Contact Person Email
stefan.schreiber@uksh.de
Site Name
Staedtisches Klinikum Lueneburg gGmbH
Department Name
Geriatric Medicine and Outpatient Gastroenterology Center
Principal Investigator Name
Christian Maaser
Principal Investigator Email
Christian.Maaser@klinikum-lueneburg.de
Contact Person Name
Christian Maaser
Site Name
Universitätsklinikum Augsburg - Gastroenterology
Department Name
Gastroenterology
Principal Investigator Name
Elisabeth Schnoy
Principal Investigator Email
Elisabeth.schnoy@uk-augsburg.de
Contact Person Name
Elisabeth Schnoy
Site Name
Universitaetsklinikum Frankfurt AöR
Department Name
Medizinische Klinik 1
Principal Investigator Name
Irina Blumenstein
Principal Investigator Email
blumenstein@em.uni-frankfurt.de
Contact Person Name
Irina Blumenstein

Poland

Earliest CTIS Part Ii Submission Date
20-06-2024
Latest Decision Or Authorization Date
01-06-2025
Processing Time Days
346
Number Of Sites
11
Number Of Participants
76

Sites

Site Name
Melita Medical Sp. z o.o.
Principal Investigator Name
Jaroslaw Leszczyszyn
Principal Investigator Email
b.lapuszynski@melitamedical.pl
Contact Person Name
Jaroslaw Leszczyszyn
Contact Person Email
b.lapuszynski@melitamedical.pl
Site Name
EMC Instytut Medyczny S.A.
Department Name
Przychodnia Specjalistyczna
Principal Investigator Name
Patryk Smoliński
Principal Investigator Email
psmolinski@poczta.onet.pl
Contact Person Name
Patryk Smoliński
Contact Person Email
psmolinski@poczta.onet.pl
Site Name
Bodyclinic Sp. z o.o. sp.k.
Department Name
Klinika Gastroenterologii i Chorób Wewnętrznych
Principal Investigator Name
Piotr Gietka
Principal Investigator Email
dyrekcja@wim.mil.pl
Contact Person Name
Piotr Gietka
Contact Person Email
dyrekcja@wim.mil.pl
Site Name
Centrum Medyczne Medyk Sp. z o.o.
Department Name
Gastroenterologia
Principal Investigator Name
Rafał Filip
Principal Investigator Email
badaniakliniczne.rejtana@medyk.rzeszow.pl
Contact Person Name
Rafał Filip
Site Name
Vita Longa Sp. z o.o.
Department Name
Badań Klinicznych
Principal Investigator Name
Przemysław Ramos
Principal Investigator Email
Przemyslaw.ramos@researchsolutions.pl
Contact Person Name
Przemysław Ramos
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Lecznej
Department Name
Gastroenterologiczny
Principal Investigator Name
Łukasz Wolański
Principal Investigator Email
lancius@poczta.onet.pl
Contact Person Name
Łukasz Wolański
Contact Person Email
lancius@poczta.onet.pl
Site Name
Sonomed Sp. z o.o.
Department Name
Pracownia Endoskopii
Principal Investigator Name
Anna Wiechowska-Kozłowska
Principal Investigator Email
joanna.wasylow@sonomedszczecin.pl
Contact Person Name
Anna Wiechowska-Kozłowska
Site Name
Gastromed Sp. z o.o.
Principal Investigator Name
Adam Kopoń
Principal Investigator Email
gastromedtrials@gmail.com
Contact Person Name
Adam Kopoń
Contact Person Email
gastromedtrials@gmail.com
Site Name
Medical Network Sp. z o.o.
Department Name
WIP Warsaw IBD Point Profesor Kierkuś
Principal Investigator Name
Jarosław Kierkuś
Principal Investigator Email
j.kierkus@wip.waw.pl
Contact Person Name
Jarosław Kierkuś
Contact Person Email
j.kierkus@wip.waw.pl
Site Name
Solumed Sp. z o.o. sp.k.
Department Name
Centrum Medyczne
Principal Investigator Name
Magdalena Andzrzejewska
Principal Investigator Email
magdalena.andrzejewska@solumed.pl
Contact Person Name
Magdalena Andzrzejewska
Site Name
Twoja Przychodnia - Opolskie Centrum Medyczne
Principal Investigator Name
Marzena Kwinto
Principal Investigator Email
mkwinto@opolemed.com
Contact Person Name
Marzena Kwinto
Contact Person Email
mkwinto@opolemed.com

France

Earliest CTIS Part Ii Submission Date
28-05-2024
Latest Decision Or Authorization Date
27-05-2025
Processing Time Days
364
Number Of Sites
2
Number Of Participants
16

Sites

Site Name
Hospices Civils De Lyon
Department Name
Lyon Sud Hospital - Gastroenterology
Principal Investigator Name
Stéphane Nancey
Principal Investigator Email
stephane.nancey@chu-lyon.fr
Contact Person Name
Stéphane Nancey
Contact Person Email
stephane.nancey@chu-lyon.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Hepatology-Gastro-Enterology
Principal Investigator Name
Mélanie Serrero
Principal Investigator Email
melanie.serrero@ap-hm.fr
Contact Person Name
Mélanie Serrero
Contact Person Email
melanie.serrero@ap-hm.fr

Belgium

Earliest CTIS Part Ii Submission Date
11-06-2024
Latest Decision Or Authorization Date
26-05-2025
Processing Time Days
349
Number Of Sites
6
Number Of Participants
9

Sites

Site Name
Vitaz
Department Name
Gastroenterology
Principal Investigator Name
Tom Holvoet
Principal Investigator Email
Tom.holvoet@vitaz.be
Contact Person Name
Tom Holvoet
Contact Person Email
Tom.holvoet@vitaz.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Gastroenterology
Principal Investigator Name
Filip Baert
Principal Investigator Email
filip.baert@azdelta.be
Contact Person Name
Filip Baert
Contact Person Email
filip.baert@azdelta.be
Site Name
UZ GENT
Department Name
Gastroenterology
Principal Investigator Name
Triana Lobaton
Principal Investigator Email
triana.lobatonortega@uzgent.be
Contact Person Name
Triana Lobaton
Site Name
UZ Leuven
Department Name
Gastroenterology
Principal Investigator Name
Bram Verstockt
Principal Investigator Email
bram.verstockt@uzleuven.be
Contact Person Name
Bram Verstockt
Contact Person Email
bram.verstockt@uzleuven.be
Site Name
Hopital Erasme
Department Name
Gastroenterology
Principal Investigator Name
Denis Franchimont
Principal Investigator Email
denis.franchimont@hubruxelles.be
Contact Person Name
Denis Franchimont
Site Name
Imelda
Department Name
Gastroenterology
Principal Investigator Name
Peter Bossuyt
Principal Investigator Email
peter.bossuyt@imelda.be
Contact Person Name
Peter Bossuyt
Contact Person Email
peter.bossuyt@imelda.be

Portugal

Earliest CTIS Part Ii Submission Date
16-01-2026
Latest Decision Or Authorization Date
05-02-2026
Processing Time Days
20
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Gastroenterology
Principal Investigator Name
Samuel RM Fernandes
Principal Investigator Email
samuelrmfernandes@gmail.com
Contact Person Name
Samuel RM Fernandes
Contact Person Email
samuelrmfernandes@gmail.com
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Gastroenterology
Principal Investigator Name
Francisco AS Portela
Principal Investigator Email
fasportela@gmail.com
Contact Person Name
Francisco AS Portela
Contact Person Email
fasportela@gmail.com
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Gastroenterology
Principal Investigator Name
Daniela Ferreira
Principal Investigator Email
danielagonferreira@gmail.com
Contact Person Name
Daniela Ferreira
Contact Person Email
danielagonferreira@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
20-06-2024
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
606
Number Of Sites
5
Number Of Participants
16

Sites

Site Name
ASST Fatebenefratelli Sacco
Department Name
Gastroenterologia e Endoscopia Digestiva
Principal Investigator Name
Giovanni Maconi
Principal Investigator Email
maconi.giovanni@asst-fbf-sacco.it
Contact Person Name
Giovanni Maconi
Site Name
Casa Sollievo Della Sofferenza
Department Name
U.O.C di Gastroenterologia ed Endoscopia Digestiva
Principal Investigator Name
Fabrizio Bossa
Principal Investigator Email
f.bossa@operapadrepio.it
Contact Person Name
Fabrizio Bossa
Contact Person Email
f.bossa@operapadrepio.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Medicina Interna e Gastroenterologia
Principal Investigator Name
Antonio Gasbarrini
Principal Investigator Email
antonio.gasbarrini@unicatt.it
Contact Person Name
Antonio Gasbarrini
Contact Person Email
antonio.gasbarrini@unicatt.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
IBD Centre / Gastroenterology and Endoscopic Unit
Principal Investigator Name
Mariangela Allocca
Principal Investigator Email
Allocca.Mariangela@hsr.it
Contact Person Name
Mariangela Allocca
Contact Person Email
Allocca.Mariangela@hsr.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Malattie Infiammatorie Croniche Intestinali (Chronic Inflammatory Bowel Diseases Unit)
Principal Investigator Name
Alessandro Armuzzi
Principal Investigator Email
alessandro.armuzzi@hunimed.eu
Contact Person Name
Alessandro Armuzzi
Contact Person Email
alessandro.armuzzi@hunimed.eu

Sponsor

Primary sponsor

Full Name
Alimentiv Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Canada

Third parties

  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"payment vendor","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"GxP Brain GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Acelabio (US) Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Entyvio 300 mg powder for concentrate for solution for infusion
Active Substance
VEDOLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Authorised (EU/1/14/923/001)
Maximum Dose
300 mg
Investigational Product Name
ADALIMUMAB
Active Substance
ADALIMUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Maximum Dose
160 mg
Investigational Product Name
INFLIXIMAB
Active Substance
INFLIXIMAB
Modality
Monoclonal antibody
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Maximum Dose
5 mg/kg
Investigational Product Name
BUDESONIDE
Active Substance
BUDESONIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
9 mg
Investigational Product Name
PREDNISONE
Active Substance
PREDNISONE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
40 mg
Investigational Product Name
UPADACITINIB
Active Substance
UPADACITINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
45 mg
Investigational Product Name
USTEKINUMAB
Active Substance
USTEKINUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS (IV) OR SUBCUTANEOUS (SC)
Route
INTRAVENOUS (IV) OR SUBCUTANEOUS (SC)
Maximum Dose
520 mg
Investigational Product Name
RISANKIZUMAB
Active Substance
RISANKIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS (IV) OR SUBCUTANEOUS (SC)
Route
INTRAVENOUS (IV) OR SUBCUTANEOUS (SC)
Maximum Dose
600 mg
Combination Treatment
Yes

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