Clinical trial • Phase II • Gastroenterology

LUTIKIZUMAB for Ulcerative colitis

Phase II trial of LUTIKIZUMAB for Ulcerative colitis.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Ulcerative colitis
Trial Stage
Phase II
Drug Modality
Monoclonal antibody|Monoclonal antibody

Key dates

Initial CTIS Submission Date
02-04-2024
First CTIS Authorization Date
23-07-2024

Trial design

Randomised, humira (adalimumab) 40 mg solution for injection in pre-filled syringe; humira (adalimumab) 80 mg solution for injection in pre-filled syringe. dose and schedule not specified in the record.-controlled Phase II trial in Netherlands, Belgium, Bulgaria and others.

Randomised
Yes
Comparator
Humira (adalimumab) 40 mg solution for injection in pre-filled syringe; Humira (adalimumab) 80 mg solution for injection in pre-filled syringe. Dose and schedule not specified in the record.
Target Sample Size
111

Eligibility

Recruits 111 No vulnerable populations selected. Trial population is adult participants (no paediatric subjects). Informed consent is obtained from adult participants via country-specific informed consent forms (ICFs); no assent process described..

Vulnerable Population
No vulnerable populations selected. Trial population is adult participants (no paediatric subjects). Informed consent is obtained from adult participants via country-specific informed consent forms (ICFs); no assent process described.

Inclusion criteria

  • {"criterion_text":"- Participant has had a diagnosis of UC for at least 90 days prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the investigator, must be available.\n- Active UC with a Modified Mayo Score (mMS) of 5 to 9 points and Mayo Endoscopic Subscore (ESS) of 2 to 3 (confirmed by central review).\n- Demonstrated inadequate response to, loss of response to, or intolerance to at least one of the following: oral aminosalicylates, corticosteroids, immunomodulators, and/or advanced therapies."}

Exclusion criteria

  • {"criterion_text":"- Current diagnosis of CD or inflammatory bowel disease-unclassified.\n- Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n- Prior inadequate response, intolerance or loss of response to adalimumab (including biosimilars). Note: Subject may be enrolled if he/she discontinued adalimumab for reasons other than those listed above (e.g., loss of insurance) or if he/she has been exposed to other advanced therapies, including anti-TNFs other than adalimumab."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percentage of Participants who Achieve Endoscopic Improvement at week 12","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Percentage of Participants who Achieve Clinical Remission Per Modified Mayo Score (mMS) at week 12","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Percentage of Participants who Achieve Clinical Response Per mMS at week 12","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Percentage of Participants who Achieve Endoscopic Remission at week 12","definition_or_measurement_approach":""}

Recruitment

Digital Remote Recruitment
True, recruitment materials include a video script (Darmplus.at) and electronic/online recruitment flyers/brochures; Medable Inc. is listed among third parties (suggesting digital platform support).
Planned Sample Size
111
Recruitment Window Months
44
Consent Approach
Informed consent obtained via country-specific ICFs for adult participants. Multiple country ICF documents and language versions are provided (e.g., English, Dutch, French, German, Bulgarian, Italian, Greek, etc.). Optional substudy consent forms and LTE (long-term extension) consent/I CF addenda are provided for some countries; pregnancy-specific ICFs exist for some countries (e.g., AT). No assent process described (adults only).

Methods

  • Country-specific recruitment materials (posters, flyers, brochures, doctor-to-patient letters) targeted to adult patients with ulcerative colitis and distributed via participating hospital/clinic sites (examples provided in documentation for BE, AT, IT, IE, FR, SI, LV, NO, DE, ES, LT, PL, HU, HR, EE, GR).
  • Use of video/ad scripts for online or broadcast recruitment in at least Austria (document: 'Advertisement and Recruitment Materials_Video Script Darmplus.at').
  • Site-based recruitment through participating gastroenterology departments and hospitals (site contact details provided for each country).

Geography

Total Number Of Sites
71
Total Number Of Participants
96

Netherlands

Earliest CTIS Part Ii Submission Date
04-07-2024
Latest Decision Or Authorization Date
23-07-2024
Processing Time Days
19
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Elisabeth-Tweesteden Ziekenhuis
Contact Person Name
Maurice Lutgens
Contact Person Email
researchmdl@etz.nl
Site Name
Radboud universitair medisch centrum / RADBOUDUMC
Contact Person Name
Marjolijn Duijvestein

Belgium

Earliest CTIS Part Ii Submission Date
03-07-2024
Latest Decision Or Authorization Date
23-07-2024
Processing Time Days
20
Number Of Sites
6
Number Of Participants
6

Sites

Site Name
Vitaz
Department Name
Gastro Enterology
Contact Person Name
Tom Holvoet
Contact Person Email
tom.holvoet@aznikolaas.be
Site Name
UZ Leuven
Department Name
Gastro Enterology
Contact Person Name
Severine Vermeire
Contact Person Email
severine.vermeire@uzleuven.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Gastro Enterology
Contact Person Name
Sophie Vieujean
Contact Person Email
s.vieujean@chuliege.be
Site Name
Hopital Erasme
Department Name
Gastro Enterology
Contact Person Name
Denis Franchimont
Site Name
Az Maria Middelares Gent
Department Name
Gastro Enterology
Contact Person Name
Nele Deprez
Contact Person Email
nele.deprez@azmmsj.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Gastro Enterology
Contact Person Name
Jeroen Geldof
Contact Person Email
jeroen.geldof@uzgent.be

Bulgaria

Earliest CTIS Part Ii Submission Date
03-07-2024
Latest Decision Or Authorization Date
13-09-2024
Processing Time Days
72
Number Of Sites
7
Number Of Participants
7

Sites

Site Name
University Hospital St Marina Varna
Department Name
Clinic of Gastroenterology
Contact Person Name
Antonia Atanassova
Contact Person Email
aniatanassova@abv.bg
Site Name
Second Multiprofile Hospital For Active Treatment Sofia EAD
Department Name
Department of Gastroenterology in clinic of internal medicine
Contact Person Name
Nikolay Tsonev
Contact Person Email
dr.n.tsonev@abv.bg
Site Name
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Department Name
Clinic of Gastroenterology
Contact Person Name
Plamen Penchev
Contact Person Email
penchev.dr@gmail.com
Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
Clinic of Gastroenterology
Contact Person Name
Rosen Nikolov
Contact Person Email
roskinik@gmail.com
Site Name
Medicinski Centar Doverie AD
Contact Person Name
Jordan Churchev
Contact Person Email
churchev@abv.bg
Site Name
Acibadem City Clinic Diagnostic And Consultation Center Ltd.
Department Name
Clinic of Gastroenterology
Contact Person Name
Asen Petrov
Contact Person Email
dr_assenp@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Department Name
Department of Gastroenterology
Contact Person Name
Desislav Stanchev
Contact Person Email
dessislavs@gmail.com

Austria

Earliest CTIS Part Ii Submission Date
09-07-2024
Latest Decision Or Authorization Date
29-07-2024
Processing Time Days
20
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Internal Medicine III, Division of Gastroenterology and Hepatology
Contact Person Name
Walter Reinisch
Site Name
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Department Name
LKH Salzburg, Department of Internal Medicine I
Contact Person Name
Sonja Heeren
Contact Person Email
s.heeren@salk.at
Site Name
Noe LGA Gesundheit Region Mitte GmbH
Department Name
University Hospital St. Poelten, Department of Internal Medicine II
Contact Person Name
Andreas Maieron

Italy

Earliest CTIS Part Ii Submission Date
11-07-2024
Latest Decision Or Authorization Date
24-07-2024
Processing Time Days
13
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
IRCCS Ospedale Sacro Cuore Don Calabria
Department Name
Gastroenterologia ed endoscopia Digestiva
Contact Person Name
Angela Variola
Contact Person Email
angela.variola@sacrocuore.it
Site Name
San Camillo Forlanini Hospital
Department Name
UOC Gastroenterologia ed Endoscopia Digestiva Diagnostica ed Operativa
Contact Person Name
Rocco Cosintino
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC CEMAD
Contact Person Name
Antonio Gasbarrini
Contact Person Email
antonio.gasbarrini@unicatt.it
Site Name
Azienda Ospedaliero-Universitaria Di Cagliari
Department Name
UOC Gastroenterologia
Contact Person Name
Massimo Claudio Fantini
Contact Person Email
massimoc.fantini@unica.it

Ireland

Earliest CTIS Part Ii Submission Date
03-07-2024
Latest Decision Or Authorization Date
26-07-2024
Processing Time Days
23
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
St Vincent's University Hospital
Department Name
Gastroenterology
Contact Person Name
Glen Anthony Doherty
Contact Person Email
g.doherty@st-vincents.ie
Site Name
Beaumont Hospital
Department Name
Gastroenterology
Contact Person Name
Aoibhlinn O'Toole

France

Earliest CTIS Part Ii Submission Date
05-07-2024
Latest Decision Or Authorization Date
25-07-2024
Processing Time Days
20
Number Of Sites
5
Number Of Participants
5

Sites

Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Gastroenterology
Contact Person Name
Arnaud BOURREILLE
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Gastroenterology
Contact Person Name
Xavier ROBLIN
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Gastroenterology and Nutrition
Contact Person Name
Adrien NICOLAU
Contact Person Email
nicolau.a@chu-nice.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Gastroenterology
Contact Person Name
Mathieu UZZAN
Contact Person Email
mathieu.uzzan@aphp.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Gastroenterology and Nutrition
Contact Person Name
Cyrielle GILLETTA DE SAINT JOSEPH
Contact Person Email
gilletta.c@chu-toulouse.fr

Slovenia

Earliest CTIS Part Ii Submission Date
05-07-2024
Latest Decision Or Authorization Date
23-07-2024
Processing Time Days
18
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
University Medical Center Ljubljana
Department Name
Clinical Department of Gastroenterology
Contact Person Name
David Drobne
Contact Person Email
david.drobne@kclj.si
Site Name
Splosna Bolnisnica Celje
Department Name
Department for intestinal diseases
Contact Person Name
Renata Sibli
Contact Person Email
renata.sibli@sb-celje.si
Site Name
Splosna Bolnisnica Murska Sobota
Department Name
Department of internal medicine
Contact Person Name
Miran Geric
Contact Person Email
miran.geric@gmail.com

Latvia

Earliest CTIS Part Ii Submission Date
21-06-2024
Latest Decision Or Authorization Date
07-08-2024
Processing Time Days
47
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Pauls Stradins Clinical University Hospital
Department Name
Center of Gastroenterology Hepatology and Nutrition
Contact Person Name
Aldis Pukitis
Contact Person Email
pukitis@latnet.lv
Site Name
Liepajas Regionala Slimnica SIA
Department Name
Outpatient department
Contact Person Name
Linda Erne
Contact Person Email
liepaajaa@inbox.lv
Site Name
SIA Polana-D
Department Name
Private practice
Contact Person Name
Anzela Kiselevska
Contact Person Email
leo2014@inbox.lv

Norway

Earliest CTIS Part Ii Submission Date
03-07-2024
Latest Decision Or Authorization Date
23-07-2024
Processing Time Days
20
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Akershus University Hospital
Department Name
Department of Gastroenterology
Contact Person Name
Stephan Andreas Brackmann
Site Name
Universitetssykehuset Nord-Norge HF
Department Name
Department of Gastroenterology
Contact Person Name
Rasmus Goll
Contact Person Email
rasmus.goll@unn.no

Germany

Earliest CTIS Part Ii Submission Date
04-07-2024
Latest Decision Or Authorization Date
26-07-2024
Processing Time Days
22
Number Of Sites
6
Number Of Participants
6

Sites

Site Name
Universitaetsklinikum Ulm AöR
Contact Person Name
Jochen Klaus
Site Name
Eugastro GmbH
Contact Person Name
Ingolf Schiefke
Contact Person Email
studien@eugastro.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Contact Person Name
Stefan Schreiber
Contact Person Email
study@ikmb.uni-kiel.de
Site Name
University Medical Center Hamburg-Eppendorf
Contact Person Name
Samuel Huber
Contact Person Email
t.fruendt@uke.de
Site Name
St. Marien Und St. Annastiftskrankenhaus
Contact Person Name
Tanja Kuehbacher
Contact Person Email
Innere@st-marienkrankenhaus.de
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Contact Person Name
Matthias Treiber
Contact Person Email
direktion.med2@mri.tum.de

Spain

Earliest CTIS Part Ii Submission Date
02-07-2024
Latest Decision Or Authorization Date
24-07-2024
Processing Time Days
22
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Digestive
Contact Person Name
Manuel Barreiro de Acosta
Site Name
Hospital Universitario La Paz
Department Name
Digestive
Contact Person Name
Maria Dolores Martin Arranz
Contact Person Email
martinarranz.lapaz@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Digestive
Contact Person Name
Federico Arguelles Arias
Contact Person Email
farguelles@telefonica.net

Lithuania

Earliest CTIS Part Ii Submission Date
24-06-2024
Latest Decision Or Authorization Date
07-08-2024
Processing Time Days
44
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Panevezys Republican Hospital VšĮ
Department Name
Gastroenterology Department
Contact Person Name
Darius Kriukas
Contact Person Email
drkriukas@gmail.com
Site Name
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Department Name
Gastroenterology Department
Contact Person Name
Laimas Jonaitis
Contact Person Email
laimasjonaitis@lsmuni.lt
Site Name
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Department Name
Santaros Clinics
Contact Person Name
Ieva Stundienė
Contact Person Email
ieva.stundiene@santa.lt

Poland

Earliest CTIS Part Ii Submission Date
12-07-2024
Latest Decision Or Authorization Date
29-07-2024
Processing Time Days
17
Number Of Sites
7
Number Of Participants
16

Sites

Site Name
H-T.Centrum Medyczne Sp. z o.o. sp.k.
Contact Person Name
Tomasz Romanczyk
Contact Person Email
romanczyk@htcentrum.pl
Site Name
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Contact Person Name
Beata Gawdis-Wojnarska
Contact Person Email
gawdis@twojaprzychodnia.com
Site Name
Melita Medical Sp. z o.o.
Contact Person Name
Jaroslaw Leszczyszyn
Contact Person Email
j.leszczyszyn@melitamedical.pl
Site Name
Medrise Sp. z o.o.
Contact Person Name
Wit Danilkiewicz
Contact Person Email
wit.danilkiewicz@medrise.pl
Site Name
Centrum Medyczne Lukamed Sp. z o.o.
Contact Person Name
Piotr Drobinski
Contact Person Email
piotrdrobinski@lukamed.com
Site Name
Centrum Opieki Zdrowotnej Orkan-Med Stec - Michalska Sp. j.
Contact Person Name
Krystyna Stec-Michalska
Contact Person Email
stemii@wp.pl
Site Name
Centrum Medyczne Lukamed Sp. z o.o. (duplicate listing in dataset)

Hungary

Earliest CTIS Part Ii Submission Date
04-07-2024
Latest Decision Or Authorization Date
24-07-2024
Processing Time Days
20
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Clinexpert Kft.
Contact Person Name
Gabor Tamas Toth

Croatia

Earliest CTIS Part Ii Submission Date
10-07-2024
Latest Decision Or Authorization Date
26-07-2024
Processing Time Days
16
Number Of Sites
6
Number Of Participants
11

Sites

Site Name
Poliklinika Borzan d.o.o.
Department Name
Gastroenterology
Contact Person Name
Vladimir Borzan
Contact Person Email
info@poliklinika-borzan.hr
Site Name
Specijalna Bolnica Medico
Department Name
Department for gastroenterology
Contact Person Name
Boris Brozovic
Contact Person Email
medico@medico.hr
Site Name
KBC Split
Department Name
Department for gastroenterology
Contact Person Name
Ivan Zaja
Contact Person Email
gastro_zavod@kbsplit.hr
Site Name
Poliklinika Solmed d.o.o.
Department Name
Department for gastroenterology
Contact Person Name
Dominik Kralj
Contact Person Email
info@solmed-clinic.com
Site Name
KBC Zagreb
Department Name
Gastroenterology and Hepatology
Contact Person Name
Zeljko Krznaric
Contact Person Email
kbc-zagreb@kbc-zagreb.hr
Site Name
Poliklinika Borzan d.o.o. (additional listing)
Department Name
Gastroenterology
Contact Person Email
info@poliklinika-borzan.hr

Estonia

Earliest CTIS Part Ii Submission Date
03-07-2024
Latest Decision Or Authorization Date
25-07-2024
Processing Time Days
22
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Laane-Tallinna Keskhaigla AS
Department Name
Endoscopy department
Contact Person Name
Kulliki Suurmaa
Contact Person Email
kulliki.suurmaa@keskhaigla.ee
Site Name
Sihtasutus Parnu Haigla
Department Name
Endoscopy department
Contact Person Name
Leana Sits
Contact Person Email
leana.sits@ph.ee
Site Name
Aktsiaselts Medicum Tervishoiuteenused
Department Name
Medicum
Contact Person Name
Julia Borissova
Contact Person Email
julia.borissova@medicum.ee
Site Name
Tartu University Hospital
Department Name
Gastroenterology department
Contact Person Name
Karin Kull
Contact Person Email
Karin.kull@kliinikum.ee

Greece

Earliest CTIS Part Ii Submission Date
20-06-2024
Latest Decision Or Authorization Date
24-07-2024
Processing Time Days
34
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Evaggelismos Hospital
Department Name
Gastroenterology Department
Contact Person Name
Nikolaos Viazis
Contact Person Email
nikos.viazis@gmail.com
Site Name
University General Hospital Of Heraklion
Department Name
Gastroenterology Department
Contact Person Name
Ioannis Koutroubakis
Contact Person Email
ikoutroub2@gmail.com
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
3rd University Internal Medicine Department
Contact Person Name
Georgios Bamias
Contact Person Email
gbamias@gmail.com
Site Name
Ippokratio General Hospital Of Thessaloniki
Department Name
B’ Propaeudeutic Medicine Department
Contact Person Name
Olga Giouleme
Contact Person Email
olgagi@med.auth.gr

Sponsor

Primary sponsor

Full Name
AbbVie Deutschland GmbH & Co. KG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
IQVIA Limited
Responsibilities
code: 2
Name
Q Squared Solutions Holdings LLC
Responsibilities
code: 4
Name
Endpoint Clinical Inc.
Responsibilities
code: 3

Third parties

  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Equipment","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code: 2","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"code: 7","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Q Squared Solutions Holdings LLC","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"code: 3","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"Central Reader","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"code: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"Data Monitoring Committee","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
Lutikizumab (solution for infusion)
Active Substance
LUTIKIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Authorisation Status
prodAuthStatus: 1
Investigational Product Name
Lutikizumab (solution for injection)
Active Substance
LUTIKIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
prodAuthStatus: 1
Investigational Product Name
Humira 80 mg solution for injection in pre-filled syringe
Active Substance
ADALIMUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
prodAuthStatus: 2
Starting Dose
80 mg (product name indicates strength)
Maximum Dose
maxDailyDoseAmount: 160 mg
Investigational Product Name
Humira 40 mg solution for injection in pre-filled syringe
Active Substance
ADALIMUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
prodAuthStatus: 2
Starting Dose
40 mg (product name indicates strength)
Maximum Dose
maxDailyDoseAmount: 160 mg

Related trials

Other published trials that may interest you.