Clinical trial • Phase II/III • Gastroenterology

GUSELKUMAB for Ulcerative colitis | Moderately to severely active ulcerative colitis

Phase II/III trial of GUSELKUMAB for Ulcerative colitis | Moderately to severely active ulcerative colitis.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Ulcerative colitis | Moderately to severely active ulcerative colitis
Trial Stage
Phase II/III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
29-05-2024
First CTIS Authorization Date
10-07-2024

Trial design

Randomised, guselkumab - solution for injection in pre-filled syringe - 100 mg/ml (active); guselkumab 1 ml pfs placebo (placebo)-controlled Phase II/III trial in Bulgaria, Italy, Latvia and others.

Randomised
Yes
Comparator
Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL (active); Guselkumab 1 mL PFS Placebo (placebo)
Target Sample Size
1011
Trial Duration For Participant
84

Eligibility

Recruits 1011 Vulnerable population selected (isVulnerablePopulationSelected = true). Study documentation includes subject information and informed consent forms (SIS and ICF) and specific ICFs for pregnant partners and 12-month infant follow-up / post-birth child follow-up, indicating provisions for vulnerable subjects and parental/partner consent where applicable. Country-specific ICFs are provided..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Study documentation includes subject information and informed consent forms (SIS and ICF) and specific ICFs for pregnant partners and 12-month infant follow-up / post-birth child follow-up, indicating provisions for vulnerable subjects and parental/partner consent where applicable. Country-specific ICFs are provided.

Inclusion criteria

  • {"criterion_text":"- 1. Male or female, 18 years of age or older\n- 2. Documented diagnosis of UC at least 3 months before screening\n- 3. Moderately to severely active UC as defined by baseline modified Mayo score\n- 4. History of inadequate response to or failure to tolerate conventional or advanced therapy as defined in the protocol\n- 5. Screening laboratory test results within the study protocol defined parameters"}

Exclusion criteria

  • {"criterion_text":"- 1. Severe extensive colitis as defined in the study protocol\n- 2. UC limited to the rectum only\n- 3. Presence of a stoma\n- 4. Presence or history of a fistula\n- 5. Presence of symptomatic colonic or small bowel obstruction\n- 6. History of extensive colonic resection\n- 7. History of colonic mucosal dysplasia\n- 8. Indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Clinical Response at Induction Week 12","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
1011
Recruitment Window Months
98
Consent Approach
Informed consent obtained from participating adults (participants must be 18 years or older). Study-specific Subject Information Sheets (SIS) and Informed Consent Forms (ICF) are provided; country-specific ICFs are available including forms for pregnant partners and for 12-month infant/post-birth child follow-up, indicating parental/partner consent provisions where relevant. ICFs and study documents are provided in multiple country languages (examples in the file list include English, Bulgarian, Italian, Latvian, Russian, Polish, Portuguese, Spanish, French, German, Swedish, Czech, Hungarian, Slovak).

Geography

Total Number Of Sites
66
Total Number Of Participants
456

Bulgaria

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
12-07-2024
Processing Time Days
23
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Acibadem City Clinic University Hospital EOOD
Department Name
Gastroenterology Clinic
Contact Person Name
Asen Petrov
Contact Person Email
mladost@acibademcityclinic.bg
Site Name
Second Multiprofile Hospital For Active Treatment Sofia EAD
Department Name
Department of Gastroenterology, Internal Diseases Clinic
Contact Person Name
Nikolay Tsonev
Contact Person Email
secondmbal@abv.bg
Site Name
Diagnostics And Consultation Center Convex Ltd.
Contact Person Name
Ludmila Tankova
Contact Person Email
crc@convex.bg

Italy

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
15-07-2024
Processing Time Days
26
Number Of Sites
5
Number Of Participants
42

Sites

Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
UOC Gastroenterologia ed Endoscopia
Contact Person Name
Flavio Caprioli
Contact Person Email
flavio.caprioli@unimi.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Medicina Interna e Gastroenterologia Complesso Integrato Columbus
Contact Person Name
Antonio Gasbarrini
Contact Person Email
antonio.gasbarrini@unicatt.it
Site Name
Casa Sollievo Della Sofferenza
Department Name
Unità Operativa Complessa di Endoscopia Digestiva
Contact Person Name
Fabrizio Bossa
Contact Person Email
f.bossa@operapadrepio.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Malattie Infiammatorie Croniche Intestinali
Contact Person Name
Fernando Rizzello
Contact Person Email
fernando.rizzello@unibo.it
Site Name
Azienda Ospedaliera di Padova
Department Name
Dipartimento Scienze Chirurgiche e Gastroenterologiche UOC Gastroenterologia
Contact Person Name
Edoardo Savarino
Contact Person Email
edoardo.savarino@unipd.it

Latvia

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
10-07-2024
Processing Time Days
21
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Digestive Diseases Centre Gastro SIA
Department Name
Gastroenterology
Contact Person Name
Ivars Tolmanis
Contact Person Email
it@gastrocentrs.lv
Site Name
Pauls Stradins Clinical University Hospital
Department Name
Gastroenterology department
Contact Person Name
Aldis Pukitis
Contact Person Email
pukitis@latnet.lv
Site Name
Pauls Stradins Clinical University Hospital
Department Name
Gastroenterology
Contact Person Name
Alda Bumbure
Contact Person Email
aldabumbure@inbox.lv

Poland

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
29-07-2024
Processing Time Days
40
Number Of Sites
15
Number Of Participants
188

Sites

Site Name
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Contact Person Name
Monika Augustyn
Contact Person Email
amonika@interia.pl
Site Name
Promed P.Lach R.Glowacki Sp. j.
Contact Person Name
Danuta Owczarek
Contact Person Email
dowczarek@cmpromed.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
Manermed Sp. z o.o.
Department Name
Centrum Medyczne Medis
Contact Person Name
Maria Klopocka
Contact Person Email
mariaklopocka@wp.pl
Site Name
Gastromed Sp. z o.o.
Contact Person Name
Adam Kopon
Contact Person Email
adamkopon@interia.pl
Site Name
Gastromed Kralisz Romatowski Stachurska Sp. j.
Contact Person Name
Jacek Romatowski
Contact Person Email
jromatowski@wp.pl
Site Name
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department Name
Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia NCHZL
Contact Person Name
Grazyna Rydzewska-Wyszkowska
Site Name
Centrum Medyczne Medyk Sp. z o.o.
Contact Person Name
Rafal Filip
Contact Person Email
r.s.filip@wp.pl
Site Name
Scanmed S.A.
Department Name
Gastromed ZOZ
Contact Person Name
Wit Danilkiewicz
Contact Person Email
wdanilk@gmail.com
Site Name
Medical Network Sp. z o.o.
Department Name
WIP Warsaw IBD Point Profesor Kierkus
Contact Person Name
Jaroslaw Kierkus
Contact Person Email
j.kierkus@med-net.pl
Site Name
Endoskopia Sp. z o.o.
Contact Person Name
Dariusz Kleczkowski
Contact Person Email
szach999@wp.pl
Site Name
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Department Name
Klinika Gastroenterologii i Chorob Wewnetrznych
Contact Person Name
Maciej Gonciarz
Contact Person Email
gonciarzmaciej125@gmail.com
Site Name
Medicome Sp. z o.o.
Contact Person Name
Iwona Kobielusz-Gembala
Contact Person Email
iwonagembala@wp.pl
Site Name
Melita Medical Sp. z o.o.
Contact Person Name
Jaroslaw Leszczyszyn
Contact Person Email
j.leszczyszyn@melitamedical.pl
Site Name
Pro Life Medica Sp. z o.o.
Department Name
ETG Zamosc
Contact Person Name
Katarzyna Wojcik
Contact Person Email
k.wojcik@etg-network.com

Portugal

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
10-07-2024
Processing Time Days
21
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Gastroenterology
Contact Person Name
Paula Lago

Slovakia

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
10-07-2024
Processing Time Days
21
Number Of Sites
3
Number Of Participants
14

Sites

Site Name
Endomed s.r.o.
Department Name
Gastroenterology
Contact Person Name
Miroslav Fedurco
Contact Person Email
fedurco@endomed.sk
Site Name
F D Roosevelt University General Hospital Of Banska Bystrica
Department Name
Gastroenterology
Contact Person Name
Jozef Balaz
Contact Person Email
balaz@scouting.sk
Site Name
Cliniq s.r.o.
Department Name
Gastroenterology
Contact Person Name
Tibor Hlavaty
Contact Person Email
tibor.hlavaty2@gmail.com

Belgium

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
11-07-2024
Processing Time Days
22
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Algemeen Ziekenhuis Delta
Department Name
CTC MDL
Contact Person Name
Filip Baert
Contact Person Email
Filip.baert@azdelta.be
Site Name
Het Ziekenhuisnetwerk Antwerpen
Department Name
Gastroenterology
Contact Person Name
Joris Dutré
Contact Person Email
joris.dutre@zna.be

Spain

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
11-07-2024
Processing Time Days
22
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Hospital Universitari De Girona Doctor Josep Trueta
Department Name
Gastroenterology Service
Contact Person Name
Leyanira del Valle Torrealba Medina
Contact Person Email
leyatorrealba26@gmail.com
Site Name
Hospital Universitario Virgen De Valme
Department Name
Gastroenterology Service
Contact Person Name
Angeles Perez Pastor
Contact Person Email
angelesppastor@gmail.com
Site Name
Hospital Germans Trias I Pujol
Department Name
Gastroenterology Service
Contact Person Name
Eugeni Domenech Morral
Contact Person Email
eugenidomenech@gmail.com

Czechia

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
11-07-2024
Processing Time Days
22
Number Of Sites
8
Number Of Participants
36

Sites

Site Name
Synexus Czech s.r.o.
Department Name
Klinika Praha
Contact Person Name
Vaclav Smid
Contact Person Email
klinikapraha@synexus.com
Site Name
Endohope Havirov s.r.o.
Department Name
Gastroenterologie
Contact Person Name
Evzen Machytka
Contact Person Email
havirov@endohope.cz
Site Name
Nemocnice Strakonice a.s.
Department Name
Interni oddeleni
Contact Person Name
Ivo Horny
Contact Person Email
interna@nemst.cz
Site Name
Nemocnice Ceske Budejovice a.s.
Department Name
Gastroenterologicke oddeleni
Contact Person Name
Martin Bortlik
Contact Person Email
gastro@nemcb.cz
Site Name
Iscare a.s.
Department Name
Klinicke a vyzkumne centrum pro strevni zanety (IBD)
Contact Person Name
Milan Lukas
Contact Person Email
recepce@iscare.cz
Site Name
Gastroenterologie s.r.o.
Contact Person Name
Milan Siroky
Contact Person Email
gastro@gastroenterologie-hk.cz
Site Name
Axon Clinical s.r.o.
Contact Person Name
Jan Matous
Contact Person Email
info@axon-clinical.com
Site Name
Artroscan s.r.o.
Department Name
Gastroenterologicka ambulance
Contact Person Name
Vit Smajstrla
Contact Person Email
bormed-gastro@seznam.cz

France

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
11-07-2024
Processing Time Days
22
Number Of Sites
11
Number Of Participants
65

Sites

Site Name
CHRU De Nancy
Department Name
Hepato-gastroenterology
Contact Person Name
Benedicte CARON
Contact Person Email
b.caron@chru-nancy.fr
Site Name
Hopital Beaujon
Department Name
Gastroenterology
Contact Person Name
Clement BRESTEAU
Contact Person Email
clement.bresteau@aphp.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Gastroenterology
Contact Person Name
Cyrielle GILLETTA
Contact Person Email
giletta.c@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Service des Maladies de l'Appareil Digestif
Contact Person Name
Pierre DESREUMAUX
Contact Person Email
pdesreumaux@hotmail.com
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Hepato-gastroenterology and Nutrition
Contact Person Name
François Habersetzer
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Hepato-gastroenterology and Nutrition
Contact Person Name
Xavier HEBUTERNE
Contact Person Email
hebuterne.x@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Hepato-gastroenterology and Nutrition
Contact Person Name
Marie-Astrid PIQUET
Contact Person Email
piquet-ma@chu-caen.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hepato-gastroenterology and Nutrition
Contact Person Name
David LAHARIE
Contact Person Email
david.laharie@chu-bordeaux.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Hepato-gastroenterology and Digestive Oncology
Contact Person Name
Xavier ROBLIN
Site Name
Hospices Civils De Lyon
Department Name
Gastroenterology
Contact Person Name
Stéphane NANCEY
Contact Person Email
stephane.nancey@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Toulouse (additional listing)
Department Name
Gastroenterology (duplicate entry in file list)

Germany

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
10-07-2024
Processing Time Days
21
Number Of Sites
4
Number Of Participants
28

Sites

Site Name
Praxisgemeinschaft Jerichow
Department Name
(not applicable)
Contact Person Name
Joerg Schulze
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik fuer Innere Medizin I
Contact Person Name
Jochen Klaus
Contact Person Email
jochen.klaus@uniklinik-ulm.de
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Gastroenterologie, Hepatologie und Endokrinologie
Contact Person Name
Ursula Seidler
Contact Person Email
seidler.ursula@mh-hannover.de
Site Name
Studiengesellschaft BSF UG (haftungsbeschraenkt)
Department Name
(not applicable)
Contact Person Name
Lars Fechner
Contact Person Email
dr.fechner@gastro-halle.de

Sweden

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
10-07-2024
Processing Time Days
21
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Uppsala University Hospital
Department Name
Medicinsk vetenskap, Gastroenterologi & Hepatologi
Contact Person Name
Per Hellstrom
Contact Person Email
Per.Hellstrom@medsci.uu.se
Site Name
Karolinska University Hospital
Department Name
Gastroenterologi, Dermatovenerologi & Reumatologi
Contact Person Name
Charlotte Hedin
Contact Person Email
charlotte.hedin@ki.se

Hungary

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
15-07-2024
Processing Time Days
26
Number Of Sites
6
Number Of Participants
42

Sites

Site Name
Central Hospital Of Northern Pest Military Hospital
Contact Person Name
Tibor Gyokeres
Contact Person Email
gyokereshonvedstudy@gmail.com
Site Name
Vasutegeszseguegyi Nonprofit Koezhasznu Kft.
Contact Person Name
Gyula G.Kiss
Contact Person Email
gkissgyula@gmail.com
Site Name
Semmelweis University
Department Name
I. sz. Sebészeti Klinika
Contact Person Name
Pal Miheller
Contact Person Email
pmiheller@gmail.com
Site Name
SYNEXUS Magyarorszag Kft.
Contact Person Name
Ferenc Izbeki
Contact Person Email
ferenc.izbeki@globalaes.com
Site Name
Semmelweis University (additional site)
Department Name
Belgyogyaszati es Hematologiai Klinika
Contact Person Name
Zsolt Tulassay
Site Name
Gyoengyosi Bugat Pal Koerhaz
Contact Person Name
Gabor Makai
Contact Person Email
domagab@gmail.com

Sponsor

Primary sponsor

Full Name
Janssen - Cilag International
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Contract research organisations

Name
Iqvia Rds Inc.
Responsibilities
Central CRO facilities
Name
Syneos Health Inc.
Responsibilities
Medical and safety services (manage SAE reporting, address protocol-related questions)
Name
Bioclinica Inc.
Responsibilities
Central Technical facilities (image processing facilities)
Name
Eresearchtechnology Inc.
Responsibilities
code 7
Name
Signant Health Global LLC
Responsibilities
eSource/ePRO/eCOA services (code 3)

Third parties

  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"code 7","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Sample management services and forwarding shipments to other Labs/JnJ facilities; code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Tata Consultancy Services Limited","duties_or_roles":"code 6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"code 1; Central CRO facilities","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Kcas LLC","duties_or_roles":"PK analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
  • {"country":"Singapore","full_name":"Labcorp Development (Asia) Pte Ltd","duties_or_roles":"Sample management services and forwarding shipments to other Labs/JnJ facilities; code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Imperial Clinical Research Services International Limited","duties_or_roles":"Translations and printing","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Sample management services and forwarding shipments to other Labs/JnJ facilities; code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central Technical facilities (image processing facilities)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"medical and safety services (manage SAE reporting, address protocol-related questions); code 13; code 8","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Synexus Clinical Research Limited","duties_or_roles":"code 2","organisation_type":"Health care"}
  • {"country":"Belgium","full_name":"Katholieke Universiteit te Leuven","duties_or_roles":"code 4","organisation_type":"Educational Institution"}

Investigational products

Investigational Product Name
Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL
Active Substance
GUSELKUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Authorisation Status
EU product (euMpNumber PRD2827309, prodAuthStatus: 1)
Investigational Product Name
Guselkumab 1 mL PFS Placebo
Modality
Other

Related trials

Other published trials that may interest you.