Clinical trial • Phase II • Gastroenterology
BALINATUNFIB for Ulcerative colitis
Phase II trial of BALINATUNFIB for Ulcerative colitis. Randomised, placebo (product name: "not the same excipients as test")-controlled. 230 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Ulcerative colitis
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 19-02-2025
- First CTIS Authorization Date
- 03-06-2025
Trial design
Randomised, placebo (product name: "not the same excipients as test")-controlled Phase II trial in Austria, Belgium, Bulgaria and others.
- Randomised
- Yes
- Comparator
- Placebo (product name: "Not the same excipients as Test")
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 230
- Trial Duration For Participant
- 364
Eligibility
Recruits 230 No vulnerable populations selected (isVulnerablePopulationSelected=false). All participants are adults aged 18 to 75 years; consent obtained via subject information and informed consent form documents (country-specific ICFs listed in the study documents)..
- Pregnancy Exclusion
- Female participants who is pregnant, breastfeeding, or is considering becoming pregnant during the study or within 3 months after the last dose of study drug
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected=false). All participants are adults aged 18 to 75 years; consent obtained via subject information and informed consent form documents (country-specific ICFs listed in the study documents).
Inclusion criteria
- {"criterion_text":"- Male or female participants aged 18 to 75 years inclusive, at the time of signing the informed consent\n- Participants who have clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy during the screening period\n- Active moderate-to-severe UC at screening as defined by a modified Mayo Score (mMS) of 5 to 9 (without the Physician global Assessment (PGA), with a minimum rectal bleeding (RB) subscore ≥1, a minimum stool frequency (SF) subscore ≥1, a mMES ≥2 confirmed by central reader, a minimum sum of all subscores of 5, and a disease extent >15 cm from the anal verge\n- ·\tMust have received prior treatment for UC (either “a” or “b” below or a combination of both “a” and “b”): a) History of no prior exposure to approved Advanced Therapy (AT), but having inadequate response to, loss of response to or intolerance to standard treatment with any of the following : 5-ASA, thiopurines (eg.6-MP, AZA), MTX, oral or intravenous (IV) corticosteroids or history of corticosteroid dependence (defined an inability to successfully taper corticosteroids without recurrence of UC) OR b) History of inadequate response to, loss of response to or intolerance to treatment with ≥1 approved AT such as a biologic agent (eg. TNF antagonists, anti-integrin other than natalizumab, anti-IL-12/23, anti-IL-23, or a small molecule (such as a JAKi or S1PRm) for UC\n- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies."}
Exclusion criteria
- {"criterion_text":"- Participants with active CD, indeterminate colitis, ischemic colitis, microscopic colitis\n- Screening laboratory and other analyses show abnormal results\n- Participants with the following ongoing known complications of UC: fulminant colitis, toxic megacolon, or any other manifestation that might require bowel surgery while enrolled in the study\n- Participant with prior colectomy, ostomy or ileoanal pouch, or anticipated colectomy during their participation in the study\n- Participants with fecal sample positive for ova or parasites, bacterial pathogens, or positive for Clostridium difficile B toxin in stools\n- Participants with active tuberculosis (TB) or a history of incompletely treated active TB or latent TB infection per local guidelines\n- Participants with Positive Hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) and/or hepatitis C virus antibody (HCVAb) at the screening visit\n- Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex\n- Participants with a known history of human immunodeficiency virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening\n- Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening\n- History of gastro-intestinal dysplasia other than completely removed low grade dysplasia OR presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during endoscopy by the time of the screening visit\n- If the participant has extensive colitis for ≥8 years or disease limited to left side of colon (ie, distal to splenic flexure) for >10 years, regardless of age, a colonoscopy within 1 year of the screening visit is required to survey for dysplasia. Participants with dysplasia or cancer identified on biopsies will be excluded.\n- Female participants who is pregnant, breastfeeding, or is considering becoming pregnant during the study or within 3 months after the last dose of study drug\n- Infection(s) requiring treatment with IV anti-infectives within 30 days prior to the screening visit or oral/intramuscular anti-infectives within 14 days prior to the screening visit\n- Participants requiring or receiving any parental nutrition and/or exclusive enteral nutrition\n- Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening\n- Participants who received fecal microbial transplantation within 30 days prior to screening\n- Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)\n- Participants who received IV corticosteroids within 14 days prior to screening or during screening period"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Proportion of participants achieving clinical remission at Week 12 by modified Mayo Score (mMS)","definition_or_measurement_approach":"Clinical remission at Week 12 assessed by modified Mayo Score (mMS)"}
Secondary endpoints
- {"endpoint_text":"- Proportion of participants achieving clinical response at Week 12 by modified Mayo Score (mMS)","definition_or_measurement_approach":"Clinical response at Week 12 assessed by modified Mayo Score (mMS)"}
- {"endpoint_text":"- Proportion of participants achieving clinical response at Week 12 by full Mayo score (MS)","definition_or_measurement_approach":"Clinical response at Week 12 assessed by full Mayo Score (MS)"}
- {"endpoint_text":"- Proportion of participants achieving clinical remission at Week 12 by full Mayo score (MS)","definition_or_measurement_approach":"Clinical remission at Week 12 assessed by full Mayo Score (MS)"}
- {"endpoint_text":"- Proportion of participants achieving the combination of patient-reported outcome 2 (PRO2) remission and endoscopic remission at Week 12","definition_or_measurement_approach":"Combination of PRO2 remission and endoscopic remission at Week 12"}
- {"endpoint_text":"- Proportion of participants achieving endoscopic remission at Week 12","definition_or_measurement_approach":"Endoscopic remission at Week 12 (endoscopy assessments)"}
- {"endpoint_text":"- Change from baseline in PRO2 from randomization to Week 12","definition_or_measurement_approach":"Change from baseline in PRO2 score measured from randomization to Week 12"}
- {"endpoint_text":"- Proportion of participants achieving endoscopic response at Week 12","definition_or_measurement_approach":"Endoscopic response at Week 12"}
- {"endpoint_text":"- Proportion of participants achieving endoscopic improvement at Week 12","definition_or_measurement_approach":"Endoscopic improvement at Week 12"}
- {"endpoint_text":"- Proportion of participants achieving HEMI at Week 12","definition_or_measurement_approach":"HEMI (histologic endoscopic mucosal improvement) at Week 12"}
- {"endpoint_text":"- Plasma predose concentrations of SAR441566 at selected visits","definition_or_measurement_approach":"Predose plasma concentrations of SAR441566 measured at selected visits"}
- {"endpoint_text":"- Plasma postdose concentrations of SAR441566 at selected visits","definition_or_measurement_approach":"Postdose plasma concentrations of SAR441566 measured at selected visits"}
- {"endpoint_text":"- Number of participants with any treatment-emergent adverse events (TEAEs) during induction and maintenance treatment period","definition_or_measurement_approach":"Count of participants with any TEAEs during induction and maintenance periods"}
- {"endpoint_text":"- Number of participants with any reatment-emergent adverse events (TEAEs) during open-label treatment period","definition_or_measurement_approach":"Count of participants with any TEAEs during the open-label treatment period"}
- {"endpoint_text":"- Proportion achieving Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 12","definition_or_measurement_approach":"IBDQ remission at Week 12 assessed by IBDQ"}
- {"endpoint_text":"- Proportion of participants achieving Inflammatory Bowel Disease Questionnaire (IBDQ) response at Week 12","definition_or_measurement_approach":"IBDQ response at Week 12 assessed by IBDQ"}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 230
- Recruitment Window Months
- 40
- Consent Approach
- Informed consent provided by adult participants (aged 18 to 75) using subject information and informed consent form documents. Country-specific ICFs and participant information materials are provided (multiple language versions listed among documents including English, French, German, Hungarian, Greek, Czech, Italian, Polish, Romanian, Bulgarian, Dutch, Croatian). Partner/pregnancy information and partner-pregnancy ICF documents are included where relevant.
Methods
- Doctor-to-doctor letters (HCP outreach materials listed in recruitment documents)
- Factsheets for HCPs and patients
- Posters and patient brochures (site posters/patient-facing brochures listed)
- Trifold/study brochures for patients
- Actigraphy information leaflets (for participants provided alongside recruitment materials)
- Sanofi study website prescreener / online prescreener (digital prescreener materials listed)
- Digital awareness materials / screenshots for individual recruitment (digital awareness document listed)
- Email-to-referral materials (email templates for referrals)
- Site-based recruitment via participating hospitals/clinics (local country site-level recruitment materials)
Geography
- Total Number Of Sites
- 46
- Total Number Of Participants
- 178
Austria
- Earliest CTIS Part Ii Submission Date
- 04-06-2025
- Latest Decision Or Authorization Date
- 27-03-2026
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Clinical Department for Gastroenterology and Hepatology
- Principal Investigator Name
- Walter Reinisch
- Principal Investigator Email
- walter.reinisch@meduniwien.ac.at
- Contact Person Name
- Walter Reinisch
- Contact Person Email
- walter.reinisch@meduniwien.ac.at
- Site Name
- Medical University Of Graz
- Department Name
- Division of Gastroenterology and Hepatology
- Principal Investigator Name
- Andreas Blesl
- Principal Investigator Email
- andreas.blesl@medunigraz.at
- Contact Person Name
- Andreas Blesl
- Contact Person Email
- andreas.blesl@medunigraz.at
- Site Name
- Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
- Department Name
- Clinic for Internal Medicine I, Gastroenterology-Hepatology, Nephrology, Metabolism and Diabetology
- 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
- 12-05-2025
- Latest Decision Or Authorization Date
- 11-03-2026
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- UZ Leuven
- Department Name
- "UZ Leuven UZ Leuven Campus Gasthuisberg"
- 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
- Universitair Ziekenhuis Gent
- Department Name
- "Universitair Ziekenhuis Gent UZ Gent (#1)"
- Principal Investigator Name
- Jeroen Geldof
- Principal Investigator Email
- Jeroen.Geldof@uzgent.be
- Contact Person Name
- Jeroen Geldof
- Contact Person Email
- Jeroen.Geldof@uzgent.be
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 14-05-2025
- Latest Decision Or Authorization Date
- 09-04-2026
- Number Of Sites
- 4
- Number Of Participants
- 26
Sites
- Site Name
- Medical Center Comac Medical Ltd.
- Principal Investigator Name
- Mario Markov
- Principal Investigator Email
- Mario.markov@comac-medical.com
- Contact Person Name
- Mario Markov
- Contact Person Email
- Mario.markov@comac-medical.com
- Site Name
- Medical Center Comac Medical Ltd.
- Principal Investigator Name
- Mario Markov
- Principal Investigator Email
- Mario.markov@comac-medical.com
- Contact Person Name
- Mario Markov
- Contact Person Email
- Mario.markov@comac-medical.com
- Site Name
- Multi-profile Hospital for Active Treatment Heart and Brain EAD
- Department Name
- Clinic of gastroenterology
- Principal Investigator Name
- Assoc. Prof. Milko Mirchev
- Principal Investigator Email
- dr.milko.mirchev@abv.bg
- Contact Person Name
- Assoc. Prof. Milko Mirchev
- Contact Person Email
- dr.milko.mirchev@abv.bg
- Site Name
- The medical centre Kanev Ltd.
- Principal Investigator Name
- Ruslan Kulinski
- Principal Investigator Email
- Kulinskimd81@gmail.com
- Contact Person Name
- Ruslan Kulinski
- Contact Person Email
- Kulinskimd81@gmail.com
Croatia
- Earliest CTIS Part Ii Submission Date
- 15-05-2025
- Latest Decision Or Authorization Date
- 17-03-2026
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- University Hospital Centre Zagreb
- Department Name
- Gastroenterology and Hepatology
- Principal Investigator Name
- Zeljko Krznaric
- Principal Investigator Email
- kbc-zagreb@kbc-zagreb-hr
- Contact Person Name
- Zeljko Krznaric
- Contact Person Email
- kbc-zagreb@kbc-zagreb-hr
- Site Name
- Poliklinika Borzan d.o.o.
- Department Name
- Internal Medicine
- Principal Investigator Name
- Vladimir Borzan
- Principal Investigator Email
- study@poliklinika-borzan.hr
- Contact Person Name
- Vladimir Borzan
- Contact Person Email
- study@poliklinika-borzan.hr
Czechia
- Earliest CTIS Part Ii Submission Date
- 19-05-2025
- Latest Decision Or Authorization Date
- 11-03-2026
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Nemocnice Slany
- Department Name
- Nemocnice Slany
- Principal Investigator Name
- Martin PETERKA
- Principal Investigator Email
- peterka.studie@seznam.cz
- Contact Person Name
- Martin PETERKA
- Contact Person Email
- peterka.studie@seznam.cz
- Site Name
- EndoArt s.r.o.
- Department Name
- EndoArt s.r.o.
- Principal Investigator Name
- Radka Koskova
- Principal Investigator Email
- info@endoart.cz
- Contact Person Name
- Radka Koskova
- Contact Person Email
- info@endoart.cz
- Site Name
- PreventaMed s.r.o.
- Department Name
- PreventaMed s.r.o.
- Principal Investigator Name
- Jiri Pumprla
- Principal Investigator Email
- pumprla@vilazdravi.cz
- Contact Person Name
- Jiri Pumprla
- Contact Person Email
- pumprla@vilazdravi.cz
France
- Earliest CTIS Part Ii Submission Date
- 08-05-2025
- Latest Decision Or Authorization Date
- 16-03-2026
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Gastroenterology
- Principal Investigator Name
- Cyrielle Gilletta
- Principal Investigator Email
- gilletta.c@chu-toulouse.fr
- Contact Person Name
- Cyrielle Gilletta
- Contact Person Email
- gilletta.c@chu-toulouse.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Gastroenterology
- 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
- CHRU De Nancy
- Department Name
- Gastroenterology
- Principal Investigator Name
- Bénédicte Caron
- Principal Investigator Email
- b.caron@chru-nancy.fr
- Contact Person Name
- Bénédicte Caron
- Contact Person Email
- b.caron@chru-nancy.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 14-05-2025
- Latest Decision Or Authorization Date
- 01-04-2026
- Number Of Sites
- 9
- Number Of Participants
- 26
Sites
- Site Name
- Studiengesellschaft BSF UG (haftungsbeschraenkt)
- Department Name
- "Studiengesellschaft BSF UG (haftungsbeschränkt) Gastroenterology"
- 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
- DRK Kliniken Berlin
- Department Name
- Clinic for Internal Medicine, Gastroenterology
- Principal Investigator Name
- Andreas Sturm
- Principal Investigator Email
- a.sturm@drk-kliniken-berlin.de
- Contact Person Name
- Andreas Sturm
- Contact Person Email
- a.sturm@drk-kliniken-berlin.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Center for internal Medicine, Internal Medicine I
- Principal Investigator Name
- Jochen Klaus
- Principal Investigator Email
- Jochen.Klaus@uniklinik-ulm.de
- Contact Person Name
- Jochen Klaus
- Contact Person Email
- Jochen.Klaus@uniklinik-ulm.de
- Site Name
- Sana Kliniken Duisburg GmbH
- Department Name
- MVZ for special medical care Prof. Friedrichs GmbH
- Principal Investigator Name
- Wolfgang Nitz
- Principal Investigator Email
- Wolfgang.Nitz@Sana.de
- Contact Person Name
- Wolfgang Nitz
- Contact Person Email
- Wolfgang.Nitz@Sana.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Internal Medicine I -Gastroenterologies, Gastrointestinal Oncologys, Hepatologies, Infectiologies
- Principal Investigator Name
- Karsten Bueringer
- Principal Investigator Email
- karsten.bueringer@med.uni-tuebingen.de
- Contact Person Name
- Karsten Bueringer
- Contact Person Email
- karsten.bueringer@med.uni-tuebingen.de
- Site Name
- Klinikum Ernst von Bergmann gGmbH
- Department Name
- Klinik für Gastroenterologie, Hepatologie, Infektiologie und Rheumatologie
- Principal Investigator Name
- Daniel C. Baumgart
- Principal Investigator Email
- daniel.baumgart@uni-potsdam.de
- Contact Person Name
- Daniel C. Baumgart
- Contact Person Email
- daniel.baumgart@uni-potsdam.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Clinic for Gastroenterology, Hepatology, Infectiology and Endocrinology
- 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
- Klinische Forschung Berlin-Mitte GmbH
- Department Name
- Klinische Forschung Berlin-Mitte
- Principal Investigator Name
- Hans-Peter Gmuender
- Principal Investigator Email
- hans.peter.gmuender@pratia.com
- Contact Person Name
- Hans-Peter Gmuender
- Contact Person Email
- hans.peter.gmuender@pratia.com
- Site Name
- Goethe University Frankfurt
- Department Name
- Medical Clinic 1:Gastroenterology and Hepatology, Pulmonology and Allergology, Endocrinology
- Principal Investigator Name
- Irina Blumenstein
- Principal Investigator Email
- blumenstein@em.uni-frankfurt.de
- Contact Person Name
- Irina Blumenstein
- Contact Person Email
- blumenstein@em.uni-frankfurt.de
Greece
- Earliest CTIS Part Ii Submission Date
- 10-03-2025
- Latest Decision Or Authorization Date
- 11-03-2026
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- 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
- 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
- 2nd 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
Hungary
- Earliest CTIS Part Ii Submission Date
- 09-04-2025
- Latest Decision Or Authorization Date
- 13-03-2026
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- Semmelweis University
- Department Name
- Department of Internal Medicine and Oncology
- Principal Investigator Name
- Iliás Ákos
- Principal Investigator Email
- driliasakos@gmail.com
- Contact Person Name
- Iliás Ákos
- Contact Person Email
- driliasakos@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 17-05-2025
- Latest Decision Or Authorization Date
- 17-03-2026
- Number Of Sites
- 10
- Number Of Participants
- 32
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- "UOC Gastroenterologia- Centro Malattie Infiammatorie Intestinali Medicina Interna"
- Principal Investigator Name
- Silvia Nardelli
- Principal Investigator Email
- silvia.nardelli@uniroma1.it
- Contact Person Name
- Silvia Nardelli
- Contact Person Email
- silvia.nardelli@uniroma1.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Dipartimento di Gastroenterologia
- Principal Investigator Name
- Alessandro Armuzzi
- Principal Investigator Email
- clinicaltrialsibd@humanitas.it
- Contact Person Name
- Alessandro Armuzzi
- Contact Person Email
- clinicaltrialsibd@humanitas.it
- Site Name
- Fondazione IRCCS San Gerardo Dei Tintori
- Department Name
- UOC Gastroenterologia- Centro Malattie Infiammatorie Intestinali Medicina Interna
- Principal Investigator Name
- Pietro Invernizzi
- Principal Investigator Email
- pietro.invernizzi@unimib.it
- Contact Person Name
- Pietro Invernizzi
- Contact Person Email
- pietro.invernizzi@unimib.it
- Site Name
- Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
- Department Name
- UOC di Gastroenterologia ed Endoscopia Digestiva
- 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 di Gastroenterologia ed 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
- IRCCS Ospedale Policlinico San Martino
- Department Name
- Unità Operativa Clinica Gastroenterologica
- Principal Investigator Name
- Giorgia Bodini
- Principal Investigator Email
- giorgia.bodini@unige.it
- Contact Person Name
- Giorgia Bodini
- Contact Person Email
- giorgia.bodini@unige.it
- Site Name
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
- Department Name
- UOC di Gastroenterologia ed Epatologia
- Principal Investigator Name
- Maria Cappello
- Principal Investigator Email
- maria.cappello@policlinico.pa.it
- Contact Person Name
- Maria Cappello
- Contact Person Email
- maria.cappello@policlinico.pa.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- DIPARTIMENTO DI MEDICINA CLINICA E CHIRURGIA
- 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 Ospedaliero Universitaria Pisana
- Department Name
- "Azienda Ospedaliera Università Pisana AOU Pisana UO Gastroenterologia Universitaria, Ospedale di C"
- Principal Investigator Name
- Massimo Bellini
- Principal Investigator Email
- massimo.bellini@unipi.it
- Contact Person Name
- Massimo Bellini
- Contact Person Email
- massimo.bellini@unipi.it
- Site Name
- Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
- Department Name
- S.C.Gastroenterologia
- Principal Investigator Name
- Davide Giuseppe Ribaldone
- Principal Investigator Email
- davidegiuseppe.ribaldone@unito.it
- Contact Person Name
- Davide Giuseppe Ribaldone
- Contact Person Email
- davidegiuseppe.ribaldone@unito.it
- Site Name
- Azienda Ospedaliera di Padova
- Department Name
- UOC Gastroenterologia
- Principal Investigator Name
- Edoardo Vincenzo Savarino
- Principal Investigator Email
- edoardo.savarino@unipd.it
- Contact Person Name
- Edoardo Vincenzo Savarino
- Contact Person Email
- edoardo.savarino@unipd.it
Romania
- Earliest CTIS Part Ii Submission Date
- 10-03-2025
- Latest Decision Or Authorization Date
- 14-04-2026
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila
- Department Name
- Sectia Gastroenterologie
- Principal Investigator Name
- Daniel Vasile Balaban
- Principal Investigator Email
- gastroenterologie@scumc.ro
- Contact Person Name
- Daniel Vasile Balaban
- Contact Person Email
- gastroenterologie@scumc.ro
- Site Name
- Policlinica Gastromond, Regina Maria
- Department Name
- Gastroenterologie
- Principal Investigator Name
- Diana Candescu
- Principal Investigator Email
- candescu.diana@yahoo.com
- Contact Person Name
- Diana Candescu
- Contact Person Email
- candescu.diana@yahoo.com
Poland
- Earliest CTIS Part Ii Submission Date
- 16-05-2025
- Latest Decision Or Authorization Date
- 13-03-2026
- Number Of Sites
- 4
- Number Of Participants
- 30
Sites
- Site Name
- Pracownia Badan Klinicznych Salus
- Department Name
- Pracownia Badan Klinicznych Salus
- Principal Investigator Name
- Natalia Żerkowska
- Principal Investigator Email
- natalia.zerkowska@pbks.com.pl
- Contact Person Name
- Natalia żerkowska
- Contact Person Email
- natalia.zerkowska@pbks.com.pl
- Site Name
- Medicome Sp. z o.o.
- Department Name
- Oświęcimskie Centrum Badań Klinicznych
- Principal Investigator Name
- Kobielusz-Gembala Iwona
- Principal Investigator Email
- iwonagembala@wp.pl
- Contact Person Name
- Kobielusz-Gembala Iwona
- Contact Person Email
- iwonagembala@wp.pl
- Site Name
- Centrum Medyczne Medyk Sp. z o.o.
- Department Name
- "Centrum Medycznym Medyk Przychodnia Al. Rejtana 53"
- Principal Investigator Name
- Rafal Filip
- Principal Investigator Email
- r.s.filip@wp.pl
- Contact Person Name
- Rafal Filip
- Contact Person Email
- r.s.filip@wp.pl
- Site Name
- Vivamed Sp. z o.o.
- Department 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
Sponsor
Primary sponsor
- Full Name
- Sanofi-Aventis Recherche & Developpement
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Contract research organisations
- Name
- Accellacare Limited
- Responsibilities
- Home Health Care / Nursing
- Name
- Labcorp Central Laboratory Services SARL
- Responsibilities
- sponsorDuties code: 4
- Name
- Endpoint Clinical Inc.
- Responsibilities
- sponsorDuties code: 3
- Name
- Eresearchtechnology Inc.
- Responsibilities
- sponsorDuties codes: 7 / Cardiac Safety
Third parties
- {"country":"France","full_name":"Inato","duties_or_roles":"sponsorDuties codes present (code: 2)","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Accellacare Limited","duties_or_roles":"Home Health Care / Nursing","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties code: 7","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":"Empatica Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Cardiac Safety","organisation_type":"Pharmaceutical company"}
- {"country":"Bulgaria","full_name":"Comac Medical Ltd.","duties_or_roles":"sponsorDuties codes: 12, 14, 5","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Inato","duties_or_roles":"sponsorDuties code: 2","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"sponsorDuties code: 5","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":"Czechia","full_name":"PHOENIX lekarensky velkoobchod s.r.o.","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Balinatunfib
- Active Substance
- BALINATUNFIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- prodAuthStatus=1 (as recorded in productDictionaryInfo)
- Investigational Product Name
- Not the same excipients as Test
- Modality
- Other
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