Clinical trial • Phase II • Gastroenterology

BALINATUNFIB for Crohn's disease | Ulcerative colitis

Phase II trial of BALINATUNFIB for Crohn's disease | Ulcerative colitis.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Crohn's disease | Ulcerative colitis
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
31-10-2025
First CTIS Authorization Date
06-03-2026

Trial design

Placebo: 'Not the same excipients as test' (oral); dosing/schedule not specified in provided record.-controlled Phase II trial in Austria, Belgium, Bulgaria and others.

Comparator
Placebo: 'Not the same excipients as test' (oral); dosing/schedule not specified in provided record.
Target Sample Size
240
Trial Duration For Participant
728

Eligibility

Recruits 240 Vulnerable population selected (isVulnerablePopulationSelected = true). The public CTIS record provides no detailed description of consent/assent handling beyond the availability of subject information and informed consent form documents for multiple countries and languages..

Pregnancy Exclusion
Women participants should not be pregnant or breastfeeding.
Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). The public CTIS record provides no detailed description of consent/assent handling beyond the availability of subject information and informed consent form documents for multiple countries and languages.

Inclusion criteria

  • {"criterion_text":"- Participants with Crohn's Disease (CD) or ulcerative colitis (UC) who completed treatment at Week 52 of the SPECIFI-CD (DRI18212) or SPECIFI-UC (DRI17822) studies, respectively: ·\t Participants with CD 1.\twho complete double-blinded treatment at Week 52 of SPECIFI-CD (DRI18212) study; 2.\twho complete open label treatment and achieve the appropriate outcomes at Week 52 of SPECIFI-CD (DRI18212) study. OR ·\tParticipants with UC 1.\twho complete double-blinded treatment at Week 52 of SPECIFI-UC (DRI17822) study; 2.\twho complete open label treatment and achieve the appropriate outcomes at Week 52 of the SPECIFI-UC (DRI17822) study.\n- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women participants should not be pregnant or breastfeeding."}

Exclusion criteria

  • {"criterion_text":"- Participants with CD who develop a new medical condition precluding participation as described in Exclusion criteria of SPECIFI-CD (DRI18212) clinical trial protocol.\n- Participants with UC who develop a new medical condition precluding participation as described in Exclusion criteria of SPECIFI-UC (DRI17822) clinical trial protocol.\n- Participants who developed a new medical condition or a change in status of an established medical condition which (per Investigator’s medical judgment) would adversely affect the participation in this study or would require permanent IMP discontinuation.\n- Participants who permanently discontinued IMP during the parent study or temporarily discontinued IMP for more than 14 consecutive calendar days by the time of Day 1 of LTS19689.\n- Participants who, during their participation in the parent study, developed an adverse event (AE) or a serious adverse event (SAE) deemed related to balinatunfib, which in the opinion of the Investigator could indicate that continued treatment with balinatunfib may present an unreasonable risk for the participant.\n- Participants who in the parent study had documented nonadherence to IMP or to standard therapies for CD or UC, or who used a prohibited medication concomitant with IMP or during a temporary IMP discontinuation period."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Number of participants with Crohn's Disease with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)","definition_or_measurement_approach":"Measured as the number of participants with Crohn's Disease who experience TEAEs, SAEs and AESIs during the study period."}
  • {"endpoint_text":"- Number of participants with ulcerative colitis with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)","definition_or_measurement_approach":"Measured as the number of participants with ulcerative colitis who experience TEAEs, SAEs and AESIs during the study period."}

Secondary endpoints

  • {"endpoint_text":"- Proportion of participants with Crohn's Disease in endoscopic remission based on simple endoscopic score for Crohn’s disease (SES-CD)","definition_or_measurement_approach":"Measured as the proportion of participants meeting endoscopic remission criteria per SES-CD."}
  • {"endpoint_text":"- Proportion of participants with Crohn's Disease in endoscopic remission based on simple endoscopic score for Crohn’s disease (SES-CD)","definition_or_measurement_approach":"Measured as the proportion of participants meeting endoscopic remission criteria per SES-CD."}
  • {"endpoint_text":"- Proportion of participants with Crohn's Disease in clinical remission based on Crohn’s disease activity index (CDAI)","definition_or_measurement_approach":"Measured as the proportion of participants achieving clinical remission defined by CDAI."}
  • {"endpoint_text":"- Proportion of participants with Crohn's Disease in clinical remission based on Crohn’s disease activity index (CDAI)","definition_or_measurement_approach":"Measured as the proportion of participants achieving clinical remission defined by CDAI."}
  • {"endpoint_text":"- Proportion of participants with ulcerative colitis in clinical remission based on modified Mayo Score (mMS)","definition_or_measurement_approach":"Measured as the proportion of participants achieving clinical remission per modified Mayo Score (mMS)."}
  • {"endpoint_text":"- Proportion of participants with ulcerative colitis in clinical remission based on modified Mayo Score (mMS)","definition_or_measurement_approach":"Measured as the proportion of participants achieving clinical remission per modified Mayo Score (mMS)."}

Recruitment

Planned Sample Size
240
Recruitment Window Months
48
Consent Approach
Informed consent is obtained from participants. Subject information and informed consent form (SIS/ICF) documents are provided in multiple country-specific languages (documents available in EN, FR, NL, DE, BG, HR, CS, ES, IT, HU, PL, RO, EL as per document titles). Partner/partner-pregnancy information forms are also provided. No paediatric assent provisions are described (study population is adults).

Geography

Total Number Of Sites
69
Total Number Of Participants
131

Austria

Earliest CTIS Part Ii Submission Date
13-02-2026
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
24
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department Name
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

Belgium

Earliest CTIS Part Ii Submission Date
20-11-2025
Latest Decision Or Authorization Date
06-03-2026
Processing Time Days
106
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
maag-, darm- en leverziekten
Principal Investigator Name
Jeroen Geldof
Principal Investigator Email
jeroen.geldof@uzgent.be
Contact Person Name
Jeroen Geldof
Contact Person Email
jeroen.geldof@uzgent.be
Site Name
UZ Leuven
Department Name
maag-, darm- en leverziekten
Principal Investigator Name
Marc Ferrante
Principal Investigator Email
marc.ferrante@uzleuven.be
Contact Person Name
Marc Ferrante
Contact Person Email
marc.ferrante@uzleuven.be

Bulgaria

Earliest CTIS Part Ii Submission Date
02-02-2026
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
39
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Diagnostic-Consultative Center Alexandrovska EOOD
Principal Investigator Name
Diana Stefanova
Principal Investigator Email
prof.petrova@mail.bg
Contact Person Name
Diana Stefanova
Contact Person Email
prof.petrova@mail.bg
Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
Clinic of Gastroenterology
Principal Investigator Name
Luben Milachkov
Principal Investigator Email
Lub26@hotmail.com
Contact Person Name
Luben Milachkov
Contact Person Email
Lub26@hotmail.com
Site Name
Diagnostics And Consultation Center Convex Ltd.
Principal Investigator Name
Plamen PENCHEV
Principal Investigator Email
penchev.dr@gmail.com
Contact Person Name
Plamen PENCHEV
Contact Person Email
penchev.dr@gmail.com
Site Name
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
Department Name
First Department of Internal Diseases
Principal Investigator Name
Lyubomir Kosturkov
Principal Investigator Email
kosturkov@mcmedicaplus.com
Contact Person Name
Lyubomir Kosturkov
Contact Person Email
kosturkov@mcmedicaplus.com

Croatia

Earliest CTIS Part Ii Submission Date
04-03-2026
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
12
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Poliklinika Borzan d.o.o.
Principal Investigator Name
Vladimir Borzan
Principal Investigator Email
vborzan@hotmail.com
Contact Person Name
Vladimir Borzan
Contact Person Email
vborzan@hotmail.com
Site Name
Poliklinika Bates
Principal Investigator Name
Zeljko CABRIJAN
Principal Investigator Email
zcabrijan@gmail.com
Contact Person Name
Zeljko CABRIJAN
Contact Person Email
zcabrijan@gmail.com
Site Name
University Hospital Centre Zagreb
Department Name
Gastroenterology Department
Principal Investigator Name
Zeljko Krznaric
Principal Investigator Email
zeljko.krznaric1@zg.t-com.hr
Contact Person Name
Zeljko Krznaric
Contact Person Email
zeljko.krznaric1@zg.t-com.hr
Site Name
Poliklinika Solmed d.o.o.
Principal Investigator Name
Dominik Kralj
Principal Investigator Email
dominik.kralj@solmed-clinic.com
Contact Person Name
Dominik Kralj
Site Name
Specijalna Bolnica Medico
Principal Investigator Name
Davor STIMAC
Principal Investigator Email
davor.stimac@medico.hr
Contact Person Name
Davor STIMAC
Contact Person Email
davor.stimac@medico.hr

Czechia

Earliest CTIS Part Ii Submission Date
20-11-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
109
Number Of Sites
8
Number Of Participants
15

Sites

Site Name
Vojenska Nemocnice Brno
Department Name
Gastroenterologie
Principal Investigator Name
David Stepek
Principal Investigator Email
dstepek@vnbrno.cz
Contact Person Name
David Stepek
Contact Person Email
dstepek@vnbrno.cz
Site Name
SurGal Clinic s.r.o.
Department Name
Gastroenterologie
Principal Investigator Name
Jan Ulbrych
Principal Investigator Email
recepce@surgalclinic.cz
Contact Person Name
Jan Ulbrych
Contact Person Email
recepce@surgalclinic.cz
Site Name
EndoArt s.r.o.
Department Name
Gastroenterologie
Principal Investigator Name
Radka Koskova
Principal Investigator Email
mudr.koskova@seznam.cz
Contact Person Name
Radka Koskova
Contact Person Email
mudr.koskova@seznam.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Gastroenterologie
Principal Investigator Name
Zuzana Šerclová
Principal Investigator Email
zuzana.serclova@fnkv.cz
Contact Person Name
Zuzana Šerclová
Contact Person Email
zuzana.serclova@fnkv.cz
Site Name
PreventaMed s.r.o.
Department Name
Gastroenterologie
Principal Investigator Name
Jiri Pumprla
Principal Investigator Email
pumprla@vilazdravi.cz
Contact Person Name
Jiri Pumprla
Contact Person Email
pumprla@vilazdravi.cz
Site Name
Hepato-Gastroenterologie HK s.r.o.
Department Name
Gastroenterologie
Principal Investigator Name
Miroslava Volfova
Principal Investigator Email
miroslava.volfova@hepato-gastro.com
Contact Person Name
Miroslava Volfova
Site Name
Fakultni Nemocnice Brno
Department Name
Gastroenterologie
Principal Investigator Name
Štefan Konečný
Principal Investigator Email
konecny.stefan@fnbrno.cz
Contact Person Name
Štefan Konečný
Contact Person Email
konecny.stefan@fnbrno.cz
Site Name
Fakultni Nemocnice Brno (additional site listed)
Department Name
Gastroenterologie
Principal Investigator Name
Marjolijn Duijvestein
Principal Investigator Email
marjolijn.duijvestein@radboudumc.nl
Contact Person Name
Marjolijn Duijvestein

France

Earliest CTIS Part Ii Submission Date
08-12-2025
Latest Decision Or Authorization Date
11-03-2026
Processing Time Days
93
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Service d'Hépato-Gastroentérologie
Principal Investigator Name
Adrien Nicolau
Principal Investigator Email
nicolau.a@chu-nice.fr
Contact Person Name
Adrien Nicolau
Contact Person Email
nicolau.a@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Gastroentérologie
Principal Investigator Name
Mathilde Barrau
Principal Investigator Email
mathilde.barrau@chu-st-etienne.fr
Contact Person Name
Mathilde Barrau
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Service d'Hépato-Gasroentérologie et Transplantation
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
Centre Hospitalier Universitaire De Toulouse
Department Name
Gastroentérologie et Nutrition
Principal Investigator Name
Cyrielle Giletta De Saint Joseph
Principal Investigator Email
gilletta.c@chu-toulouse.fr
Contact Person Name
Cyrielle Giletta De Saint Joseph
Contact Person Email
gilletta.c@chu-toulouse.fr
Site Name
CHRU De Nancy
Department Name
Unité d'investigation clinique - Gastroentérologie
Principal Investigator Name
Benedicte Caron
Principal Investigator Email
b.caron@chru-nancy.fr
Contact Person Name
Benedicte Caron
Contact Person Email
b.caron@chru-nancy.fr

Germany

Earliest CTIS Part Ii Submission Date
13-02-2026
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
24
Number Of Sites
1
Number Of Participants
15

Sites

Site Name
CED Studienzentrum Karlshorst, Dr. med., Thomas Brunk, Gastroenterologie Berlin
Department Name
Dr. med. Thomas Brunk Gastroenterologie Berlin, CED Studienzentrum Karlshorst
Principal Investigator Name
Thomas Brunk
Principal Investigator Email
thomas.brunk@gastroenterologie-brunk.de
Contact Person Name
Thomas Brunk

Greece

Earliest CTIS Part Ii Submission Date
20-11-2025
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
110
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
University General Hospital Of Heraklion
Department Name
Department of Gastroenterology
Principal Investigator Name
Ioannis Koutroubakis
Principal Investigator Email
ikoutroub@med.uoc.gr
Contact Person Name
Ioannis Koutroubakis
Contact Person Email
ikoutroub@med.uoc.gr
Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
Second Department of Gastroenterology
Principal Investigator Name
Konstantinos Triantafyllou
Principal Investigator Email
ktriant@med.uoa.gr
Contact Person Name
Konstantinos Triantafyllou
Contact Person Email
ktriant@med.uoa.gr
Site Name
Evaggelismos Hospital
Department Name
Gastroenterology Department
Principal Investigator Name
Nikolaos Viazis
Principal Investigator Email
nikos.viazis@gmail.com
Contact Person Name
Nikolaos Viazis
Contact Person Email
nikos.viazis@gmail.com

Hungary

Earliest CTIS Part Ii Submission Date
12-01-2026
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
92
Number Of Sites
8
Number Of Participants
14

Sites

Site Name
Heves Varmegyei Markhot Ferenc Oktatokorhaz Es Rendelointezet
Department Name
Belgyogyaszati-Infektologiai Centrum Belgyogyaszati Osztaly
Principal Investigator Name
Istvan NAGY
Principal Investigator Email
pettadoktor@gmail.com
Contact Person Name
Istvan NAGY
Contact Person Email
pettadoktor@gmail.com
Site Name
Semmelweis University (Szentkiralyi Utca 46)
Department Name
Belgyógyászati és Hematológiai Klinika
Principal Investigator Name
Zsolt Tulassay
Principal Investigator Email
tulassay.zsolt@semmelweis.hu
Contact Person Name
Zsolt Tulassay
Contact Person Email
tulassay.zsolt@semmelweis.hu
Site Name
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Department Name
Gasztroenterologiai Osztaly
Principal Investigator Name
Andras Kafony
Principal Investigator Email
kafony@gmail.com
Contact Person Name
Andras Kafony
Contact Person Email
kafony@gmail.com
Site Name
Bekes Varmegyei Koezponti Korhaz
Department Name
4. Belgyogyaszat-Gasztroenterologia, Hepatologia
Principal Investigator Name
Marta Varga
Principal Investigator Email
drvargamarta@gmail.com
Contact Person Name
Marta Varga
Contact Person Email
drvargamarta@gmail.com
Site Name
University Of Szeged
Department Name
Belgyogyaszati Klinika Nyugati Telephely
Principal Investigator Name
Molnár Tamás
Principal Investigator Email
molnar.tamas@med.u-szeged.hu
Contact Person Name
Molnár Tamás
Contact Person Email
molnar.tamas@med.u-szeged.hu
Site Name
Clinfan Kft.
Principal Investigator Name
Agnes Salamon
Principal Investigator Email
salamon.clinfan@gmail.com
Contact Person Name
Agnes Salamon
Contact Person Email
salamon.clinfan@gmail.com
Site Name
Semmelweis University (Koranyi Sandor Utca 2/a)
Department Name
Belgyógyászati és Onkológiai Klinika Klinikai Farmakológiai Részleg
Principal Investigator Name
Akos Ilias
Principal Investigator Email
ilias.akos@semmelweis.hu
Contact Person Name
Akos Ilias
Contact Person Email
ilias.akos@semmelweis.hu
Site Name
Clinexpert Gyoengyoes Kft.
Principal Investigator Name
Gyula Horvat
Principal Investigator Email
horvatgyula@gmail.com
Contact Person Name
Gyula Horvat
Contact Person Email
horvatgyula@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
10-02-2026
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
28
Number Of Sites
12
Number Of Participants
21

Sites

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
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Department Name
S.C. di Gastroenterologia
Principal Investigator Name
Marco Orsello
Principal Investigator Email
marco.orsello@ospedale.al.it
Contact Person Name
Marco Orsello
Contact Person Email
marco.orsello@ospedale.al.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Unità Clinica Gastroenterologia e Endoscopia digestiva
Principal Investigator Name
Silvio Danese
Principal Investigator Email
danese.silvio@hsr.it
Contact Person Name
Silvio Danese
Contact Person Email
danese.silvio@hsr.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Malattie Infiammatorie Croniche Intestinali
Principal Investigator Name
Alessandro Armuzzi
Principal Investigator Email
alessandro.armuzzi@hunimed.eu
Contact Person Name
Alessandro Armuzzi
Contact Person Email
alessandro.armuzzi@hunimed.eu
Site Name
Azienda Ospedaliero Universitaria Federico II Di Napoli
Department Name
Unità di Fisiopatologia nutrizionale e digestione
Principal Investigator Name
Giovanni Sarnelli
Principal Investigator Email
sarnelli@unina.it
Contact Person Name
Giovanni Sarnelli
Contact Person Email
sarnelli@unina.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
S.C. Gastroenterologia U
Principal Investigator Name
Davide Ribaldone
Principal Investigator Email
davidegiuseppe.ribaldone@unito.it
Contact Person Name
Davide Ribaldone
Site Name
Azienda Ospedaliera di Padova
Department Name
UOC Gastroenterologia
Principal Investigator Name
Edoardo Savarino
Principal Investigator Email
edoardosavarino@gmail.com
Contact Person Name
Edoardo Savarino
Contact Person Email
edoardosavarino@gmail.com
Site Name
Policlinico San Donato S.p.A.
Department Name
UO Gastroenterologia e endoscopia digestiva
Principal Investigator Name
Vito Annese
Principal Investigator Email
vito.annese@grupposandonato.it
Contact Person Name
Vito Annese
Contact Person Email
vito.annese@grupposandonato.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UO Gastroenterologia Universitaria
Principal Investigator Name
Massimo Bellini
Principal Investigator Email
bellinistudiclinici@gmail.com
Contact Person Name
Massimo Bellini
Contact Person Email
bellinistudiclinici@gmail.com
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Medicina Interna
Principal Investigator Name
Manuela MERLI
Principal Investigator Email
manuela.merli@uniroma1.it
Contact Person Name
Manuela MERLI
Contact Person Email
manuela.merli@uniroma1.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Medicina Interna
Principal Investigator Name
Giorgia Bodini
Principal Investigator Email
bodini.giorgia@gmail.com
Contact Person Name
Giorgia Bodini
Contact Person Email
bodini.giorgia@gmail.com
Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
UOC Gastroenterologia
Principal Investigator Name
Maria Cappello
Principal Investigator Email
maria.cappello@policlinico.pa.it
Contact Person Name
Maria Cappello

Romania

Earliest CTIS Part Ii Submission Date
13-02-2026
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
31
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
POLICLINICA GASTROMOND – REGINA MARIA
Department Name
Dept. of Gastroenterology
Principal Investigator Name
Diana CANDESCU
Principal Investigator Email
Candescu.diana@yahoo.com
Contact Person Name
Diana CANDESCU
Contact Person Email
Candescu.diana@yahoo.com
Site Name
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj
Department Name
Gastroenterologie II
Principal Investigator Name
Roxana Zaharie
Principal Investigator Email
zahariedeliaroxana@gmail.com
Contact Person Name
Roxana Zaharie
Contact Person Email
zahariedeliaroxana@gmail.com
Site Name
Cabinet Particular Policlinic Algomed S.R.L.
Department Name
Gastroenterology
Principal Investigator Name
Adrian Goldis
Principal Investigator Email
goldisadi@yahoo.com
Contact Person Name
Adrian Goldis
Contact Person Email
goldisadi@yahoo.com
Site Name
Elias University Emergency Hospital
Department Name
Clinic of Gastroenterology
Principal Investigator Name
Adrian Saftoiu
Principal Investigator Email
adriansaftoiu@gmail.com
Contact Person Name
Adrian Saftoiu
Contact Person Email
adriansaftoiu@gmail.com
Site Name
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila
Department Name
Gastroenterology
Principal Investigator Name
Vasile Daniel Balaban
Principal Investigator Email
vbalaban@yahoo.com
Contact Person Name
Vasile Daniel Balaban
Contact Person Email
vbalaban@yahoo.com

Spain

Earliest CTIS Part Ii Submission Date
10-02-2026
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
27
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Hospital Universitario La Paz
Department Name
Servicio de Aparato Digestivo
Principal Investigator Name
Maria Dolores Martin Arranz
Principal Investigator Email
mmartinarranz@salud.madrid.org
Contact Person Name
Maria Dolores Martin Arranz
Contact Person Email
mmartinarranz@salud.madrid.org
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Servicio de Aparato Digestivo
Principal Investigator Name
Federico Argüelles-Arias
Principal Investigator Email
farguelles@telefonica.net
Contact Person Name
Federico Argüelles-Arias
Contact Person Email
farguelles@telefonica.net

Netherlands

Earliest CTIS Part Ii Submission Date
03-03-2026
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
6
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Amphia Hospital
Department Name
MDL
Principal Investigator Name
Alexander Bodelier
Principal Investigator Email
a.bodelier@amphia.nl
Contact Person Name
Alexander Bodelier
Contact Person Email
a.bodelier@amphia.nl
Site Name
Stichting Elisabeth-Tweesteden Ziekenhuis
Department Name
MDL
Principal Investigator Name
Maurice Lutgens
Principal Investigator Email
m.lutgens@etz.nl
Contact Person Name
Maurice Lutgens
Contact Person Email
m.lutgens@etz.nl
Site Name
Radboud universitair medisch centrum Stichting
Department Name
MDL
Principal Investigator Name
Marjolijn Duijvestein
Principal Investigator Email
marjolijn.duijvestein@radboudumc.nl
Contact Person Name
Marjolijn Duijvestein

Poland

Earliest CTIS Part Ii Submission Date
03-02-2026
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
69
Number Of Sites
10
Number Of Participants
18

Sites

Site Name
Medicome Sp. z o.o.
Principal Investigator Name
Iwona Kobielusz-Gembala
Principal Investigator Email
iwonagembala@wp.pl
Contact Person Name
Iwona Kobielusz-Gembala
Contact Person Email
iwonagembala@wp.pl
Site Name
Medrise Sp. z o.o.
Principal Investigator Name
Wit Danilkiewicz
Principal Investigator Email
wit.danilkiewicz@medrise.pl
Contact Person Name
Wit Danilkiewicz
Contact Person Email
wit.danilkiewicz@medrise.pl
Site Name
Pracownia Badan Klinicznych Salus
Principal Investigator Name
Natalia Zerkowska
Principal Investigator Email
natalia.zerkowska@pbks.com.pl
Contact Person Name
Natalia Zerkowska
Contact Person Email
natalia.zerkowska@pbks.com.pl
Site Name
Vivamed Sp. z o.o.
Principal Investigator Name
Robert Petryka
Principal Investigator Email
robert@petrykamed.com
Contact Person Name
Robert Petryka
Contact Person Email
robert@petrykamed.com
Site Name
Endoskopia Sp. z o.o.
Principal Investigator Name
Marek Horynski
Principal Investigator Email
badanie.kliniczne@wp.pl
Contact Person Name
Marek Horynski
Contact Person Email
badanie.kliniczne@wp.pl
Site Name
Medical Network Sp. z o.o.
Department Name
WIP Warsaw IBD Point Profesor Kierkus
Principal Investigator Name
Jaroslaw Kierkus
Principal Investigator Email
j.kierkus@med-net.pl
Contact Person Name
Jaroslaw Kierkus
Contact Person Email
j.kierkus@med-net.pl
Site Name
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department Name
Klinika Gastroenterologii i Chorob Wewnetrznych
Principal Investigator Name
Grazyna Rydzewska-Wyszkowska
Principal Investigator Email
grazyna.rydzewska@pimmswia.gov.pl
Contact Person Name
Grazyna Rydzewska-Wyszkowska
Site Name
Gastromed Sp. z o.o.
Principal Investigator Name
Marcin Zmudzinski
Principal Investigator Email
m.zmudek2@gmail.com
Contact Person Name
Marcin Zmudzinski
Contact Person Email
m.zmudek2@gmail.com
Site Name
Centrum Medyczne Medyk Sp. z o.o.
Principal Investigator Name
Rafal Filip
Principal Investigator Email
r.filip.medyk@gmail.com
Contact Person Name
Rafal Filip
Contact Person Email
r.filip.medyk@gmail.com
Site Name
Bodyclinic Sp. z o.o. sp.k.
Principal Investigator Name
Piotr Gietka
Principal Investigator Email
kontakt@bodyclinic.pl
Contact Person Name
Piotr Gietka
Contact Person Email
kontakt@bodyclinic.pl

Sponsor

Primary sponsor

Full Name
Sanofi-Aventis Recherche & Developpement
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Contract research organisations

Name
Endpoint Clinical Inc.
Name
Eresearchtechnology Inc.
Responsibilities
Cardiac Safety; Clinical Outcomes Assessment Instrument (eCOA)
Name
Labcorp Central Laboratory Services SARL
Responsibilities
Central Laboratory
Name
ESMS Global Limited
Responsibilities
Centralized 24-Hour Emergency System: eSMS
Name
Alimentiv Inc.
Responsibilities
Central Medical Reading or Imaging Reading

Third parties

  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central Laboratory","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"Central Medical Reading or Imaging Reading","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Cardiac Safety; Clinical Outcomes Assessment Instrument (eCOA)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Balinatunfib
Active Substance
BALINATUNFIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Investigational Product Name
Not the same excipients as test
Modality
Other
Routes Of Administration
ORAL
Route
ORAL

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