Clinical trial • Phase III • Gastroenterology

MIRIKIZUMAB for Crohn's disease

Phase III trial of MIRIKIZUMAB for Crohn's disease. open-label, none/not specified-controlled. 442 participants.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Crohn's disease
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
13-05-2024
First CTIS Authorization Date
19-06-2024

Trial design

open-label, none/not specified-controlled Phase III trial in Italy, Germany, Latvia and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
442
Trial Duration For Participant
364

Eligibility

Recruits 442 adults.

Pregnancy Exclusion
Participation must not be pregnant, lactating, or planning to become pregnant while enrolled in the study or 16 weeks after receiving the last dose of study drug.

Inclusion criteria

  • {"criterion_text":"- Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130)\n- If female, participant must meet the contraception requirements."}

Exclusion criteria

  • {"criterion_text":"- Participants must not have developed a new condition, including cancer in the previous study (I6T-MC-AMAG or I6T-MC-AMAM) that would pose an unacceptable risk in the trial.\n- Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either previous study.\n- Participants must not have a known hypersensitivity to any component of mirikizumab or have experienced acute systemic hypersensitivity event with previous study drug administration in the originating study that precludes mirikizumab therapy.\n- Participation must not be pregnant, lactating, or planning to become pregnant while enrolled in the study or 16 weeks after receiving the last dose of study drug."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percentage of Participants Achieving Endoscopic Response (Endoscopic response based on Simple Endoscopic Score for Crohn’s Disease (SES-CD) total score) [Time Frame: Week 52]","definition_or_measurement_approach":"Endoscopic response defined based on Simple Endoscopic Score for Crohn’s Disease (SES-CD) total score; time frame Week 52."}
  • {"endpoint_text":"- Percentage of Participants Achieving Clinical Remission (Clinical remission based on CDAI) [Time Frame: Week 52]","definition_or_measurement_approach":"Clinical remission defined based on Crohn's Disease Activity Index (CDAI); time frame Week 52."}

Recruitment

Planned Sample Size
442
Recruitment Window Months
75
Consent Approach
Informed consent is obtained using subject information sheets and informed consent forms (ICFs) provided in the submission. ICFs and related materials include main ICFs, continued access addenda, pregnancy/partner ICFs and site-specific versions. Translations and country-specific ICF versions are provided (examples in the dossier: French, German, Polish, Hungarian, Dutch, Slovak, Croatian, Latvian, Russian, Ukrainian, English, Italian, Romanian, Czech, Lithuanian). Consent is obtained at site level from participants; continued access and pregnancy-specific addenda are included. (No specific assent or minor consent procedures are described in the available record.)

Methods

  • Recruitment from participants of originating studies: 'Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130)' (explicit target: prior-study participants).
  • Site-based recruitment via the listed hospital/clinic research sites across Member States (trialSites listed per country).
  • Third-party-supported recruitment, screening and retention activities: organisations listed with duties including patient screening, recruitment, and/or retention (e.g. Praxis Communications LLC, Greenphire LLC) performing recruitment support and translations of materials.
  • Use of participant reimbursement/retention programs (documents and third-party services such as Greenphire ClinCard / Patient Reimbursement Program are included in submitted materials).

Geography

Total Number Of Sites
83
Total Number Of Participants
338

Italy

Earliest CTIS Part Ii Submission Date
31-05-2024
Latest Decision Or Authorization Date
02-07-2024
Processing Time Days
32
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Gastroenterologia ed Endoscopia
Principal Investigator Name
Flavio Caprioli
Principal Investigator Email
flavio.caprioli@unimi.it
Contact Person Name
Flavio Caprioli
Contact Person Email
flavio.caprioli@unimi.it
Site Name
Azienda Socio Sanitaria Territoriale Rhodense
Department Name
Gastroenterologia ed Endoscopia Digestiva
Principal Investigator Name
Simone Saibeni
Principal Investigator Email
saibo@tiscali.it
Contact Person Name
Simone Saibeni
Contact Person Email
saibo@tiscali.it
Site Name
IRCCS Policlinico San Donato
Department Name
Gastroenterologia
Principal Investigator Name
Vito Annese
Principal Investigator Email
vito.annese@grupposandonato.it
Contact Person Name
Vito Annese
Contact Person Email
vito.annese@grupposandonato.it

Germany

Earliest CTIS Part Ii Submission Date
31-05-2024
Latest Decision Or Authorization Date
25-06-2024
Processing Time Days
25
Number Of Sites
10
Number Of Participants
31

Sites

Site Name
Synexus Clinical Research GmbH
Department Name
Synexus Clinical Research GmbH Loc. 13
Principal Investigator Name
Christel Contzen
Principal Investigator Email
christel.contzen@synexus.com
Contact Person Name
Christel Contzen
Contact Person Email
christel.contzen@synexus.com
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Allgemeine Innere Medizin I Loc. 1
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
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
Department Name
RED-Institut GmbH
Principal Investigator Name
Thomas Schaum
Principal Investigator Email
schaum@red-institut.de
Contact Person Name
Thomas Schaum
Contact Person Email
schaum@red-institut.de
Site Name
Siloah St Trudpert Klinikum
Department Name
Zentrum für Innere Medizin Loc. 1
Principal Investigator Name
Oliver Bachmann
Principal Investigator Email
o.bachmann@siloah.de
Contact Person Name
Oliver Bachmann
Contact Person Email
o.bachmann@siloah.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Universitaetsklinikum Wuerzburg Loc. 1
Principal Investigator Name
Katrin Schöttker
Principal Investigator Email
schoettker_k@ukw.de
Contact Person Name
Katrin Schöttker
Contact Person Email
schoettker_k@ukw.de
Site Name
Synexus Clinical Research GmbH
Department Name
Synexus Leipzig Clinical Research Centre Loc. 3
Principal Investigator Name
Angelika Bold
Principal Investigator Email
angelika.bold@globalaes.com
Contact Person Name
Angelika Bold
Contact Person Email
angelika.bold@globalaes.com
Site Name
Tumorzentrum Nordthueringen GmbH
Department Name
Tumorzentrum Nordthüringen
Principal Investigator Name
Michael Ibe
Principal Investigator Email
michael.ibe@tumorzentrum-nordthueringen.de
Contact Person Name
Michael Ibe
Site Name
Medizinische Hochschule Hannover
Department Name
Medizinische Hochschule Hannover Loc. 25
Principal Investigator Name
Ursula Seidler
Principal Investigator Email
seidler.ursula@mh-hannover.de
Contact Person Name
Ursula Seidler
Contact Person Email
seidler.ursula@mh-hannover.de
Site Name
Studiengesellschaft BSF UG (haftungsbeschraenkt)
Department Name
Studiengesellschaft BSF Unternehmergesellschaft Loc. 7
Principal Investigator Name
Lars Fechner
Principal Investigator Email
dr.fechner@gastro-halle.de
Contact Person Name
Lars Fechner
Contact Person Email
dr.fechner@gastro-halle.de
Site Name
Studiengesellschaft Jakobeit UG
Department Name
Gemeinschaftspraxis Jakobeit Loc. 5
Principal Investigator Name
Christian Jakobeit
Principal Investigator Email
cj@gp-jakobeit.de
Contact Person Name
Christian Jakobeit
Contact Person Email
cj@gp-jakobeit.de

Latvia

Earliest CTIS Part Ii Submission Date
31-05-2024
Latest Decision Or Authorization Date
17-09-2024
Processing Time Days
109
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Pauls Stradins Clinical University Hospital
Department Name
Gastroenterology
Principal Investigator Name
Alda Bumbure
Principal Investigator Email
aldabumbure@inbox.lv
Contact Person Name
Alda Bumbure
Contact Person Email
aldabumbure@inbox.lv

Belgium

Earliest CTIS Part Ii Submission Date
31-05-2024
Latest Decision Or Authorization Date
19-06-2024
Processing Time Days
19
Number Of Sites
4
Number Of Participants
11

Sites

Site Name
UZ Leuven
Department Name
Gastroenterology
Principal Investigator Name
Marc Ferrante
Principal Investigator Email
marc.ferrante@uzleuven.be
Contact Person Name
Marc Ferrante
Contact Person Email
marc.ferrante@uzleuven.be
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
Site Name
Universitair Ziekenhuis Gent
Department Name
Gastroenterology
Principal Investigator Name
Triana Lobaton
Principal Investigator Email
triana.lobatonortega@uzgent.be
Contact Person Name
Triana Lobaton
Contact Person Email
triana.lobatonortega@uzgent.be
Site Name
Hopital Erasme
Department Name
Gastroenterology
Principal Investigator Name
Denis Franchimont
Principal Investigator Email
denis.franchimont@erasme.ulb.ac.be
Contact Person Name
Denis Franchimont

Netherlands

Earliest CTIS Part Ii Submission Date
31-05-2024
Latest Decision Or Authorization Date
19-06-2024
Processing Time Days
19
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Amsterdam UMC Stichting
Department Name
Inflammatory Bowel Disease
Principal Investigator Name
Geert D'Haens
Principal Investigator Email
g.dhaens@amsterdamumc.nl
Contact Person Name
Geert D'Haens
Contact Person Email
g.dhaens@amsterdamumc.nl
Site Name
St. Elisabeth Hospital Tilburg
Department Name
Department of 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

Poland

Earliest CTIS Part Ii Submission Date
31-05-2024
Latest Decision Or Authorization Date
17-07-2024
Processing Time Days
47
Number Of Sites
23
Number Of Participants
142

Sites

Site Name
Nzoz For Med Sp. z o.o.
Principal Investigator Name
Beata Mroziak
Principal Investigator Email
beata_mroziak@op.pl
Contact Person Name
Beata Mroziak
Contact Person Email
beata_mroziak@op.pl
Site Name
Dc-Med Sp. z o.o. S.K.
Principal Investigator Name
Jakub Orleański
Principal Investigator Email
j.orleanski@dc-med.pl
Contact Person Name
Jakub Orleański
Contact Person Email
j.orleanski@dc-med.pl
Site Name
Synexus Polska Sp. z o.o.
Principal Investigator Name
Izabela Sein-Anand
Principal Investigator Email
izabela.sein@globalaes.com
Contact Person Name
Izabela Sein-Anand
Contact Person Email
izabela.sein@globalaes.com
Site Name
Topolowa Medicenter Mrozek i Wspolnicy Sp.J.
Principal Investigator Name
Wylęgała Zbigniew
Principal Investigator Email
z.wylegala@gmail.com
Contact Person Name
Wylęgała Zbigniew
Contact Person Email
z.wylegala@gmail.com
Site Name
Melita Medical Sp. z o.o.
Principal Investigator Name
Jarosław Leszczyszyn
Principal Investigator Email
j.leszczyszyn@melitamedical.pl
Contact Person Name
Jarosław Leszczyszyn
Contact Person Email
j.leszczyszyn@melitamedical.pl
Site Name
Kiepury Clinic
Principal Investigator Name
Łukasz Firkowski
Principal Investigator Email
lukaszf@poczta.onet.pl
Contact Person Name
Łukasz Firkowski
Contact Person Email
lukaszf@poczta.onet.pl
Site Name
Gastromed ZOZ
Principal Investigator Name
Wit Danilikiewicz
Principal Investigator Email
wdanilk@gmail.com
Contact Person Name
Wit Danilikiewicz
Contact Person Email
wdanilk@gmail.com
Site Name
Synexus Polska Sp. z o.o.
Principal Investigator Name
Magdalena Olszanecka-Glinianowicz
Contact Person Name
Magdalena Olszanecka-Glinianowicz
Site Name
ETG Zamość
Principal Investigator Name
Katarzyna Wójcik
Principal Investigator Email
k.wojcik@etg-network.com
Contact Person Name
Katarzyna Wójcik
Contact Person Email
k.wojcik@etg-network.com
Site Name
Endoskopia Sp. z o.o.
Principal Investigator Name
Marek Horyński
Principal Investigator Email
badanie.kliniczne@wp.pl
Contact Person Name
Marek Horyński
Contact Person Email
badanie.kliniczne@wp.pl
Site Name
Reumatop Grzegorz Rozumek Karin Pistorius Sp. j.
Principal Investigator Name
Grzegorz Rozumek
Principal Investigator Email
grozumek@wp.pl
Contact Person Name
Grzegorz Rozumek
Contact Person Email
grozumek@wp.pl
Site Name
Centrum Zdrowia MDM
Principal Investigator Name
Marek Woynarowski
Principal Investigator Email
marek.woynarowski@czmdm.pl
Contact Person Name
Marek Woynarowski
Contact Person Email
marek.woynarowski@czmdm.pl
Site Name
WIP Warsaw IBD Point Profesor Kierkus
Principal Investigator Name
Jarosław Kierkuś
Principal Investigator Email
j.kierkus@med-net.pl
Contact Person Name
Jarosław Kierkuś
Contact Person Email
j.kierkus@med-net.pl
Site Name
Centrum Medyczne Medyk Sp. z o.o.
Principal Investigator Name
Rafał Filip
Principal Investigator Email
r.filip.medyk@gmail.com
Contact Person Name
Rafał Filip
Contact Person Email
r.filip.medyk@gmail.com
Site Name
Synexus Polska Sp. z o.o.
Principal Investigator Name
Marek Cesarz
Principal Investigator Email
marek.cesarz@globalaes.com
Contact Person Name
Marek Cesarz
Contact Person Email
marek.cesarz@globalaes.com
Site Name
Synexus Polska Sp. z o.o.
Principal Investigator Name
Magdalena Andrzejewska
Principal Investigator Email
magdalena.andrzejewska@globalaes.com
Contact Person Name
Magdalena Andrzejewska
Site Name
Nova Reuma Domyslawska I Rusilowicz Lekarza Reumatologa I Fizjoterapeuty sp.p.
Principal Investigator Name
Marzenna Konopko
Principal Investigator Email
marzeniedoc@yahoo.com
Contact Person Name
Marzenna Konopko
Contact Person Email
marzeniedoc@yahoo.com
Site Name
Synexus Polska Sp. z o.o.
Principal Investigator Name
Jaroslaw Ziemba
Principal Investigator Email
jaroslaw.ziemba@globalaes.com
Contact Person Name
Jaroslaw Ziemba
Contact Person Email
jaroslaw.ziemba@globalaes.com
Site Name
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Principal Investigator Name
Beata Gawdis-Wojnarska
Principal Investigator Email
gawdis@twojaprzychodnia.com
Contact Person Name
Beata Gawdis-Wojnarska
Contact Person Email
gawdis@twojaprzychodnia.com
Site Name
Korczowski Bartosz, Gabinet Lekarski
Principal Investigator Name
Bartosz Korczowski
Principal Investigator Email
korczowski@op.pl
Site Name
Synexus Polska Sp. z o.o.
Principal Investigator Name
Agnieszka Ciesiołkiewicz-Wójcik
Principal Investigator Email
agnieszka.wojcik@globalaes.com
Contact Person Name
Agnieszka Ciesiołkiewicz-Wójcik
Contact Person Email
agnieszka.wojcik@globalaes.com

France

Earliest CTIS Part Ii Submission Date
31-05-2024
Latest Decision Or Authorization Date
24-06-2024
Processing Time Days
24
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Hépato-gastroentérologie et assistance nutritive
Principal Investigator Name
Gaëlle SICKERSEN
Principal Investigator Email
gaelle.sickersen@chu-poitiers.fr
Contact Person Name
Gaëlle SICKERSEN
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
HEGA
Principal Investigator Name
Romain ALTWEGG
Principal Investigator Email
r-altwegg@chu-montpellier.fr
Contact Person Name
Romain ALTWEGG
Contact Person Email
r-altwegg@chu-montpellier.fr
Site Name
CHRU De Nancy
Department Name
Gastroenterology - clinical Investgation Unit
Principal Investigator Name
Marine Ferry
Principal Investigator Email
m.ferry@chru-nancy.fr
Contact Person Name
Marine Ferry
Contact Person Email
m.ferry@chru-nancy.fr

Hungary

Earliest CTIS Part Ii Submission Date
31-05-2024
Latest Decision Or Authorization Date
20-06-2024
Processing Time Days
20
Number Of Sites
11
Number Of Participants
31

Sites

Site Name
Pannonia Maganorvosi Centrum Kft.
Principal Investigator Name
Robert Schnabel
Principal Investigator Email
schnabelrobert@hotmail.com
Contact Person Name
Robert Schnabel
Contact Person Email
schnabelrobert@hotmail.com
Site Name
Bekes Varmegyei Koezponti Korhaz
Department Name
Rethy Pal tagkorhaz, II. Belgyogyaszat - IV. Gasztroenterologia
Principal Investigator Name
Marta Varga
Principal Investigator Email
drvargamarta@gmail.com
Contact Person Name
Marta Varga
Contact Person Email
drvargamarta@gmail.com
Site Name
Gyongyosi Bugat Pal Korhaz
Principal Investigator Name
Gabor Makai
Principal Investigator Email
domagab@gmail.com
Contact Person Name
Gabor Makai
Contact Person Email
domagab@gmail.com
Site Name
SYNEXUS Magyarorszag Kft.
Principal Investigator Name
Ferenc Izbeki
Principal Investigator Email
ferenc.izbeki@synexus.com
Contact Person Name
Ferenc Izbeki
Contact Person Email
ferenc.izbeki@synexus.com
Site Name
Javorszky Oedoen Korhaz
Department Name
Gasztronenterológiai Osztály
Principal Investigator Name
Tibor Szaloki
Principal Investigator Email
szalokitdr@vnet.hu
Contact Person Name
Tibor Szaloki
Contact Person Email
szalokitdr@vnet.hu
Site Name
Clinfan Kft.
Department Name
Gasztroenterológiai Rendelő
Principal Investigator Name
Agnes Salamon
Principal Investigator Email
salamonagidr@gmail.com
Contact Person Name
Agnes Salamon
Contact Person Email
salamonagidr@gmail.com
Site Name
DRC Kft.
Principal Investigator Name
Katalin Bezzegh
Principal Investigator Email
katalin.bezzegh@drc.hu
Contact Person Name
Katalin Bezzegh
Contact Person Email
katalin.bezzegh@drc.hu
Site Name
SYNEXUS Magyarorszag Kft.
Principal Investigator Name
Laszlo Szalai
Principal Investigator Email
laszlo.szalai@synexus.com
Contact Person Name
Laszlo Szalai
Contact Person Email
laszlo.szalai@synexus.com
Site Name
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Principal Investigator Name
Andras Kafony
Principal Investigator Email
kafony@gmail.com
Contact Person Name
Andras Kafony
Contact Person Email
kafony@gmail.com
Site Name
DRC Kft. (other location)
Principal Investigator Name
Katalin Bezzegh
Principal Investigator Email
katalin.bezzegh@drc.hu
Contact Person Name
Katalin Bezzegh
Contact Person Email
katalin.bezzegh@drc.hu
Site Name
Other listed Hungarian site
Principal Investigator Name
Andras Kafony
Principal Investigator Email
kafony@gmail.com
Contact Person Name
Andras Kafony
Contact Person Email
kafony@gmail.com

Austria

Earliest CTIS Part Ii Submission Date
31-05-2024
Latest Decision Or Authorization Date
24-06-2024
Processing Time Days
24
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Medizinische Universitaet Innsbruck
Department Name
Universitätsklinik für Innere Medizin I Innsbruck
Principal Investigator Name
Robert Koch
Principal Investigator Email
robert.koch@i-med.ac.at
Contact Person Name
Robert Koch
Contact Person Email
robert.koch@i-med.ac.at
Site Name
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Department Name
Universitätsklinik für Innere Medizin I
Principal Investigator Name
Sonja Heeren
Principal Investigator Email
s.heeren@salk.at
Contact Person Name
Sonja Heeren
Contact Person Email
s.heeren@salk.at
Site Name
Medical University Of Vienna
Department Name
Abteilung für Gastroenterologie und Hepatologie
Principal Investigator Name
Walter Reinisch
Principal Investigator Email
walter.reinisch@meduniwien.ac.at
Contact Person Name
Walter Reinisch

Croatia

Earliest CTIS Part Ii Submission Date
31-05-2024
Latest Decision Or Authorization Date
19-06-2024
Processing Time Days
19
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
University Hospital Centre Zagreb
Department Name
Department of Gastroenterology and Hepatology
Principal Investigator Name
Željko Krznarić
Principal Investigator Email
zeljko.krznaric1@zg.t-com.hr
Contact Person Name
Željko Krznarić
Contact Person Email
zeljko.krznaric1@zg.t-com.hr

Romania

Earliest CTIS Part Ii Submission Date
31-05-2024
Latest Decision Or Authorization Date
20-06-2024
Processing Time Days
20
Number Of Sites
4
Number Of Participants
17

Sites

Site Name
Memorial Healthcare International S.R.L.
Department Name
Gastroenterology
Principal Investigator Name
Ion Eugeniu Craciun
Principal Investigator Email
eugencraciun@yahoo.com
Contact Person Name
Ion Eugeniu Craciun
Contact Person Email
eugencraciun@yahoo.com
Site Name
Centrul De Gastroenterologie Dr. Goldis S.R.L.
Department Name
Gastroenterology
Principal Investigator Name
Adrian Eugen Goldis
Principal Investigator Email
goldisadi@yahoo.com
Contact Person Name
Adrian Eugen Goldis
Contact Person Email
goldisadi@yahoo.com
Site Name
Delta Health Care S.R.L.
Department Name
Gastroenterology
Principal Investigator Name
Camelia Chioncel
Principal Investigator Email
cameliachioncel@yahoo.com
Contact Person Name
Camelia Chioncel
Contact Person Email
cameliachioncel@yahoo.com
Site Name
Monza-Ares S.R.L.
Department Name
Gastroenterology
Principal Investigator Name
Theodor Alexandru Voiosu
Principal Investigator Email
theodor.voiosu@yahoo.com
Contact Person Name
Theodor Alexandru Voiosu
Contact Person Email
theodor.voiosu@yahoo.com

Lithuania

Earliest CTIS Part Ii Submission Date
31-05-2024
Latest Decision Or Authorization Date
19-07-2024
Processing Time Days
49
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Department Name
Gastroenterology
Principal Investigator Name
Gediminas Kiudelis
Principal Investigator Email
gediminaskiudelis@gmail.com
Contact Person Name
Gediminas Kiudelis
Contact Person Email
gediminaskiudelis@gmail.com

Slovakia

Earliest CTIS Part Ii Submission Date
31-05-2024
Latest Decision Or Authorization Date
24-06-2024
Processing Time Days
24
Number Of Sites
5
Number Of Participants
14

Sites

Site Name
Endomed s.r.o.
Department Name
Gastroenterologická ambulancia
Principal Investigator Name
Miroslav Fedurco
Principal Investigator Email
fedurco@endomed.sk
Contact Person Name
Miroslav Fedurco
Contact Person Email
fedurco@endomed.sk
Site Name
Gastro LM s.r.o.
Department Name
Gastroenterologická ambulancia
Principal Investigator Name
Ľubomír Mihalkanin
Principal Investigator Email
mihalkanin@gmail.com
Contact Person Name
Ľubomír Mihalkanin
Contact Person Email
mihalkanin@gmail.com
Site Name
Gastromedic s.r.o.
Department Name
Gastroenterologická ambulancia
Principal Investigator Name
Iveta Kališová
Principal Investigator Email
iveta.kalisova@gmail.com
Contact Person Name
Iveta Kališová
Contact Person Email
iveta.kalisova@gmail.com
Site Name
F D Roosevelt University General Hospital Of Banska Bystrica
Department Name
Gastroenterologická ambulancia
Principal Investigator Name
Jozef Baláž
Principal Investigator Email
balaz@scouting.sk
Contact Person Name
Jozef Baláž
Contact Person Email
balaz@scouting.sk
Site Name
Cliniq s.r.o.
Department Name
Gastroenterologicke Centrum
Principal Investigator Name
Tibor Hlavatý
Principal Investigator Email
tibor.hlavaty2@gmail.com
Contact Person Name
Tibor Hlavatý
Contact Person Email
tibor.hlavaty2@gmail.com

Czechia

Earliest CTIS Part Ii Submission Date
31-05-2024
Latest Decision Or Authorization Date
20-06-2024
Processing Time Days
20
Number Of Sites
13
Number Of Participants
58

Sites

Site Name
Oblastni Nemocnice Nachod a.s.
Department Name
Endoskopické centrum
Principal Investigator Name
Zdeněk Papík
Principal Investigator Email
papik.zdenek@nemocnicenachod.cz
Contact Person Name
Zdeněk Papík
Site Name
Fakultni Thomayerova nemocnice
Department Name
Interní klinika 3. LF UK a TN
Principal Investigator Name
Pavel Kohout
Principal Investigator Email
pavel.kohout@ftn.cz
Contact Person Name
Pavel Kohout
Contact Person Email
pavel.kohout@ftn.cz
Site Name
Krajska zdravotni a.s.
Department Name
Interní odd.- Gastroenterologie
Principal Investigator Name
Michal Tichý
Principal Investigator Email
Michal.Tichy@KZCR.EU
Contact Person Name
Michal Tichý
Contact Person Email
Michal.Tichy@KZCR.EU
Site Name
Iscare a.s.
Department Name
Klinické a výzkumné centrum pro střevní záněty
Principal Investigator Name
Milan Lukáš
Principal Investigator Email
milan.lukas@email.cz
Contact Person Name
Milan Lukáš
Contact Person Email
milan.lukas@email.cz
Site Name
MUDr. GREGAR s.r.o.
Principal Investigator Name
Jan Gregar
Principal Investigator Email
jan.gregar@fnol.cz
Contact Person Name
Jan Gregar
Contact Person Email
jan.gregar@fnol.cz
Site Name
Synexus Czech s.r.o.
Principal Investigator Name
Lucie Veberová
Principal Investigator Email
lucie.veberova@synexus.com
Contact Person Name
Lucie Veberová
Contact Person Email
lucie.veberova@synexus.com
Site Name
Vojenska Nemocnice Brno
Department Name
Interní oddělení
Principal Investigator Name
David Štěpek
Principal Investigator Email
DStepek@vnbrno.cz
Contact Person Name
David Štěpek
Contact Person Email
DStepek@vnbrno.cz
Site Name
Hepato-Gastroenterologie HK s.r.o.
Department Name
Gastroenterologie
Principal Investigator Name
Miroslava Volfová
Principal Investigator Email
miroslava.volfova@hepato-gastro.com
Contact Person Name
Miroslava Volfová
Site Name
Axon Clinical s.r.o.
Principal Investigator Name
Jan Matouš
Principal Investigator Email
jmatous@gmail.com
Contact Person Name
Jan Matouš
Contact Person Email
jmatous@gmail.com
Site Name
Institute For Clinical And Experimental Medicine
Department Name
Klinika hepatogastroenterologie
Principal Investigator Name
Pavel Drastich
Principal Investigator Email
pavel.drastich@ikem.cz
Contact Person Name
Pavel Drastich
Contact Person Email
pavel.drastich@ikem.cz
Site Name
EndoArt s.r.o.
Principal Investigator Name
Radka Košková
Principal Investigator Email
studie.endo@seznam.cz
Contact Person Name
Radka Košková
Contact Person Email
studie.endo@seznam.cz
Site Name
Krajska Nemocnice T Bati a.s.
Department Name
Interní odd.
Principal Investigator Name
Vladimír Kojecký
Principal Investigator Email
kojecky@bnzlin.cz
Contact Person Name
Vladimír Kojecký
Contact Person Email
kojecky@bnzlin.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
Interní klinika 2. LF UK a FN Motol
Principal Investigator Name
Radan Keil
Principal Investigator Email
radan.keil@lfmotol.cuni.cz
Contact Person Name
Radan Keil
Contact Person Email
radan.keil@lfmotol.cuni.cz

Sponsor

Primary sponsor

Full Name
Eli Lilly & Co.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Development Solutions LLC
Responsibilities
sponsorDuties codes: [4]
Name
Icon Clinical Research Limited
Responsibilities
sponsorDuties codes: [6]
Name
Syneos Health Inc.
Responsibilities
sponsorDuties codes: [11]
Name
Iqvia Rds Inc.
Responsibilities
sponsorDuties codes: [1,12,5]
Name
WCG Clinical Inc.
Responsibilities
sponsorDuties codes: [10]

Third parties

  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Lab and Diagnostic sample storage (code 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"sponsorDuties codes: [10]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Praxis Communications LLC","duties_or_roles":"Study Development/Conduct - Patient Screening, Recruitment, and/or Retention (including translations of materials) (code 15; value provided)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"sponsorDuties codes: [1,12,5]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"sponsorDuties codes: [6]","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [6]","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: [11]","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Cleveland Clinic Foundation","duties_or_roles":"sponsorDuties codes: [13]","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Study Development/Conduct - Patient Screening, Recruitment, and/or Retention (including translations of materials) (code 15; value provided)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL (additional entry)","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Manermed Sp. z o.o.","duties_or_roles":"sponsorDuties codes: [ ]","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
Mirikizumab
Active Substance
MIRIKIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | SOLUTION FOR INJECTION OR INFUSION
Authorisation Status
Authorised

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