Clinical trial • Phase II • Gastroenterology

BALINATUNFIB for Crohn's disease

Phase II trial of BALINATUNFIB for Crohn's disease.

Overview

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

Key dates

Initial CTIS Submission Date
25-09-2024
First CTIS Authorization Date
31-01-2025

Trial design

Randomised, open-label, placebo (match placebo to test product). dose and schedule for placebo not specified. (active investigational product: balinatunfib [sar441566] - dose-ranging arms but specific doses/schedules not specified in available data.)-controlled Phase II trial across 55 sites in Poland, France, Italy and others.

Randomised
Yes
Open Label
Yes
Comparator
Placebo (Match placebo to test product). Dose and schedule for placebo not specified. (Active investigational product: Balinatunfib [SAR441566] - dose-ranging arms but specific doses/schedules not specified in available data.)
Target Sample Size
375

Eligibility

Recruits 375 No vulnerable populations selected (isVulnerablePopulationSelected: false). Trial enrols adults aged 18 to 75. Informed consent is obtained via the subject information and informed consent form (ICF) documents (L1-sis-icf) provided; no assent process for minors is described..

Pregnancy Exclusion
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.
Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). Trial enrols adults aged 18 to 75. Informed consent is obtained via the subject information and informed consent form (ICF) documents (L1-sis-icf) provided; no assent process for minors is described.

Inclusion criteria

  • {"criterion_text":"- Male or female participants aged 18 to 75 years at the time of signing the ICF\n- Confirmed diagnosis of CD for at least 3 months prior to Baseline\n- Confirmed diagnosis of moderate to severe CD as assessed by: o\tCrohn’s Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader o\t stool frequency (SF), abdominal pain (AP) score\n- History of prior exposure to standard treatment (5-ASA, steroids, immunomodulators or antibiotics) or advanced therapies (biologics or small molecules), but having inadequate response to, loss or response to or intolerance to at least one of these therapies\n- \tOn stable doses of standard treatments prior to screening (oral 5-ASA compounds, oral corticosteroids, thiopurines (eg. AZA, 6-MP), or MTX)\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 active UC, indeterminate colitis or short bowel syndrome\n- Participants with CD isolated to the stomach, duodenum, jejunum, or peri anal region, without colonic or ileal involvement\n- Participants with following ongoing known complications of CD: fistula, abscess, symptomatic stricture/stenosis, fulminant colitis, toxic megacolon, recent bowel resection within 3 months of screening or history of > 3 bowel resections\n- Participants with stool sample positive for infectious pathogens\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 colonic mucosal dysplasia or presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during colonoscopy at screening visit\n- Infection(s) requiring treatment with IV anti infectives within 30 days 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\n- Participants who received therapeutic enema or suppository, other than required for colonoscopy within 14 days prior to screening or during screening\n- Screening laboratory and other analyses show abnormal results"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Proportion of participants achieving endoscopic response","definition_or_measurement_approach":"Endoscopic response measured by endoscopic assessment (SES-CD) at the end of induction treatment; endoscopy assessments are centrally read/confirmed by a central reader as described in trial documents."}

Secondary endpoints

  • {"endpoint_text":"- Proportion of participants achieving clinical remission based on Crohn’s Disease Activity Index (CDAI)","definition_or_measurement_approach":"Clinical remission assessed by Crohn’s Disease Activity Index (CDAI)."}
  • {"endpoint_text":"- Proportion of participants achieving Patient-Reported Outcome (PRO-2) remission","definition_or_measurement_approach":"PRO-2 assessed using the patient-reported outcome measures (stool frequency and abdominal pain components)."}
  • {"endpoint_text":"- Proportion of participants achieving both clinical remission and endoscopic response","definition_or_measurement_approach":"Composite endpoint combining CDAI-based clinical remission and endoscopic response assessed at end of induction."}
  • {"endpoint_text":"- Proportion of participants achieving endoscopic remission based on centrally read SES-CD","definition_or_measurement_approach":"Endoscopic remission assessed by centrally read Simple Endoscopic Score for Crohn's disease (SES-CD)."}
  • {"endpoint_text":"- Proportion of participants achieving CDAI clinical response","definition_or_measurement_approach":"Clinical response assessed using CDAI criteria."}
  • {"endpoint_text":"- Proportion of participants achieving Inflammatory Bowel Disease Questionnaire (IBDQ) remission","definition_or_measurement_approach":"IBDQ remission assessed using the Inflammatory Bowel Disease Questionnaire scores."}
  • {"endpoint_text":"- Proportion of participants achieving IBDQ response","definition_or_measurement_approach":"IBDQ response assessed as predefined change/thresholds in IBDQ scores."}
  • {"endpoint_text":"- Change from baseline in the IBDQ scores","definition_or_measurement_approach":"Change from baseline in IBDQ total and/or domain scores at selected visits."}
  • {"endpoint_text":"- Plasma pre-dose concentrations of SAR441566 at selected visits","definition_or_measurement_approach":"PK measurement of SAR441566 pre-dose plasma concentrations at specified visits."}
  • {"endpoint_text":"- Plasma post-dose concentrations of SAR441566 at selected visits","definition_or_measurement_approach":"PK measurement of SAR441566 post-dose plasma concentrations at specified visits."}
  • {"endpoint_text":"- Number of participants experiencing any TEAEs.Any TEAEs, including any serious opportunistic infections, psoriasiform skin lesions or other immune mediated phenomena during double-blind (DB) induction and maintenance treatment period","definition_or_measurement_approach":"Safety endpoint capturing treatment-emergent adverse events (TEAEs) including serious opportunistic infections, psoriasiform skin lesions, and other immune-mediated events during the double-blind induction and maintenance periods."}
  • {"endpoint_text":"- Number of participants experiencing any TEAEs. Any TEAEs, including any serious opportunistic infections, psoriasiform skin lesions or other immune mediated phenomena during open-label treatment period","definition_or_measurement_approach":"Safety endpoint capturing TEAEs (including serious opportunistic infections, psoriasiform lesions, other immune-mediated phenomena) during the open-label treatment period."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
375
Recruitment Window Months
51
Consent Approach
Informed consent obtained from each participant via subject information and informed consent form (ICF) documents (L1-sis-icf). Participants are adults (18–75) and provide written informed consent; partner/pregnancy information forms exist for pregnancy-related handling. ICFs and subject information materials are available in multiple language/country-specific versions (examples: English, French, Italian, Dutch, Hungarian, Polish, Romanian, Spanish, Bulgarian, Czech, German, Croatian and others as supplied per country). No assent process for minors is described.

Methods

  • Digital marketing (landing page, digital marketing content) targeting potential patient participants (country-specific landing pages documented).
  • Printed materials: flyers, posters and trifold/patient brochures for patient-facing recruitment (country-specific versions).
  • Doctor-to-doctor (Dr-to-Dr) referral letters directed at healthcare professionals to refer eligible patients (country-specific versions).
  • Placebo fact sheets and patient-facing informational materials (country-specific placebo fact sheets and Q&A documents).
  • Video/script materials for patient information (e.g., placebo fact video script referenced).
  • Pre-screener / online landing page pre-screening tools (country-specific pre-screener/landing-page materials).
  • Secondary assessment and communication materials and closure content to manage recruitment flow (country-specific versions).
  • Global privacy and data protection materials for recruitment (country-specific privacy documents).

Geography

Total Number Of Sites
55
Total Number Of Participants
193

Poland

Earliest CTIS Part Ii Submission Date
22-01-2025
Latest Decision Or Authorization Date
31-03-2026
Processing Time Days
433
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Medrise Sp. z o.o.
Department Name
private clinic
Contact Person Name
Wit Danilkiewicz
Contact Person Email
wit.danilkiewicz@medrise.pl
Site Name
Bodyclinic Sp. z o.o. sp.k.
Department Name
private clinic
Contact Person Name
Piotr Gietka
Contact Person Email
piotrgietka@gmail.com
Site Name
Gastromed Sp. z o.o.
Department Name
private clinic
Contact Person Name
Marcin Zmudzinski
Contact Person Email
m.zmudek2@gmail.com
Site Name
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department Name
Klinika Gastroenterologii i Chorob Wewnetrznych
Contact Person Name
Grazyna Rydzewska - Wyszkowska
Site Name
Endoskopia Sp. z o.o.
Department Name
private clinic
Contact Person Name
Marek HORYNSKI
Contact Person Email
badanie.kliniczne@wp.pl

France

Earliest CTIS Part Ii Submission Date
21-01-2025
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
430
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Gastroenterology
Contact Person Name
Mathilde Barrau
Contact Person Email
mathilde.barrau@chu-etienne.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Service D'Hapto-Gastroenterologie et Transplantation
Contact Person Name
Romain Altwegg
Contact Person Email
r-altwegg@chu-montpellier.fr
Site Name
CHRU De Nancy
Department Name
Gastroenterology
Contact Person Name
Bénédicte Caron
Contact Person Email
b.caron@chru-nancy.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Gastroenterology
Contact Person Name
Adrien Nicolau
Contact Person Email
nicolau.a@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Gastroenterology
Contact Person Name
Cyrielle Gilletta
Contact Person Email
gilletta.c@chu-toulouse.fr

Italy

Earliest CTIS Part Ii Submission Date
08-01-2025
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
481
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
Policlinico San Donato S.p.A.
Department Name
Unità di Gastroenterologia ed Endoscopia Digestiva
Contact Person Name
Vito Annese
Contact Person Email
vito.annese@grupposandonato.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Unità Operativa di Gastroenterologia ed Endoscopia digestiva – IBD Unit
Contact Person Name
Silvio Danese
Contact Person Email
danese.silvio@hsr.it
Site Name
Azienda Ospedaliera di Padova
Department Name
Ematologia e Immunologia Cl
Contact Person Name
Edoardo Vincenzo Savarino
Contact Person Email
edoardosavarino@gmail.com
Site Name
Humanitas Mirasole S.p.A.
Department Name
Sez. Autonoma di Reumatologia
Contact Person Name
Alessandro Armuzzi
Contact Person Email
alessandro.armuzzi@hunimed.eu
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Unità Operativa di Gastroenterologia
Contact Person Name
Massimo Bellini
Contact Person Email
mbellini58@gmail.com
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Medicina Interna e Gastroenterologia
Contact Person Name
Antonio Gasbarrini
Contact Person Email
antonio.gasbarrini@unicatt.it
Site Name
Fondazione Policlinico Universitario Campus Bio-medico
Department Name
UOC Gastroenterologia
Contact Person Name
Michele Cicala
Contact Person Email
m.cicala@unicampus.it

Netherlands

Earliest CTIS Part Ii Submission Date
09-01-2025
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
459
Number Of Sites
4
Number Of Participants
11

Sites

Site Name
Amphia Hospital
Department Name
Vakgroep Maag-, Darm- en Leverziekten
Contact Person Name
Alexander Bodelier
Contact Person Email
abodelier@amphia.nl
Site Name
Radboud universitair medisch centrum Stichting
Department Name
Afdeling Maag-, Darm- en Leverziekten
Contact Person Name
Marjolijn Duijvestein
Site Name
Universitair Medisch Centrum Utrecht
Department Name
afdeling Geriatrie en Ephor
Contact Person Name
Herma Fidder
Contact Person Email
h.h.fidder@umcutrecht.nl
Site Name
Stichting Elisabeth-Tweesteden Ziekenhuis
Department Name
Maag-, darm,- en leverziekten / Gastroenterology and Hepatology
Contact Person Name
Maurice Lutgens
Contact Person Email
m.lutgens@etz.nl

Germany

Earliest CTIS Part Ii Submission Date
17-01-2025
Latest Decision Or Authorization Date
01-04-2026
Processing Time Days
439
Number Of Sites
6
Number Of Participants
38

Sites

Site Name
Philipps-Universitaet Marburg
Department Name
Medizinische Klinik II
Contact Person Name
Carsten Schmidt
Site Name
Tumorzentrum Nordthueringen GmbH
Department Name
Praxis Dr. Ibe
Contact Person Name
Michael Ibe
Site Name
St. Marien Und St. Annastiftskrankenhaus
Department Name
Klinik für Innere Medizin
Contact Person Name
Tanja Kuehbacher
Site Name
Dr. Thomas Brunk Gastroenterology
Department Name
medical practice
Contact Person Name
Thomas Brunk
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Gastroenterologie, Infektiologie und Rheumatologie
Contact Person Name
Britta Siegmund
Contact Person Email
britta.siegmund@charite.de
Site Name
Studiengesellschaft BSF UG (haftungsbeschraenkt)
Department Name
Gastroenterology
Contact Person Name
Lars FECHNER
Contact Person Email
dr.fechner@gastro-halle.de

Bulgaria

Earliest CTIS Part Ii Submission Date
07-01-2025
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
489
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Diagnostic-consultative center “Aleksandrovska” EOOD
Contact Person Name
Diana Stefanova-Petrova
Contact Person Email
prof.petrova@mail.gb
Site Name
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
Department Name
Gastroenterology
Contact Person Name
Lyubomir Kosturkov
Contact Person Email
kosturkov@mcmedicaplus.com
Site Name
Diagnostics And Consultation Center Convex Ltd.
Department Name
Gastroenterology
Contact Person Name
Plamen Penchev
Contact Person Email
penchev.dr@gmail.com
Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
Gastroenterology
Contact Person Name
Luben Milatchkov
Contact Person Email
lub26@hotmail.com

Czechia

Earliest CTIS Part Ii Submission Date
21-01-2025
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
433
Number Of Sites
6
Number Of Participants
18

Sites

Site Name
PreventaMed s.r.o.
Department Name
Outpatient Internal Medicine
Contact Person Name
Jiri Pumprla
Contact Person Email
pumprla@vilazdravi.cz
Site Name
Vojenska Nemocnice Brno
Department Name
Internal Medicine
Contact Person Name
David Stepek
Contact Person Email
dstepek@vnbrno.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Gastroenterology and Endoscopy
Contact Person Name
Stefan Konecny
Contact Person Email
koncny.stefan@fnbrno.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Gastroenterology
Contact Person Name
Zuzana Serclova
Contact Person Email
sercl@seznam.cz
Site Name
SurGal Clinic s.r.o.
Department Name
Gastroenterology
Contact Person Name
Jan Ulbrych
Contact Person Email
Ulbrych.jan@surgalclinic.cz
Site Name
Hepato-Gastroenterologie HK s.r.o.
Department Name
Gastroenterology
Contact Person Name
Tomas Vanasek

Croatia

Earliest CTIS Part Ii Submission Date
27-01-2025
Latest Decision Or Authorization Date
01-04-2026
Processing Time Days
429
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Poliklinika Solmed d.o.o.
Department Name
Clinical Research
Contact Person Name
Dominik Kralj
Site Name
Specijalna Bolnica Medico
Department Name
Gastroenterology
Contact Person Name
Davor Stimac
Contact Person Email
davor.stimac@medico.hr
Site Name
Poliklinika Borzan d.o.o.
Department Name
Internal Medicine
Contact Person Name
Vladimir Borzan
Contact Person Email
info@poliklinika-borzan.hr
Site Name
University Hospital Centre Zagreb
Department Name
Gastroenterology and Hepatology
Contact Person Name
Zeljko Krznaric
Contact Person Email
kbc-zagreb@kbc-zagreb-hr

Hungary

Earliest CTIS Part Ii Submission Date
22-11-2024
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
528
Number Of Sites
8
Number Of Participants
24

Sites

Site Name
University Of Szeged
Department Name
Department of Internal Medicine nr I.
Contact Person Name
Tamas Molnar
Contact Person Email
molnar.tamas@med.u-szeged.hu
Site Name
Heves Varmegyei Markhot Ferenc Oktatokorhaz Es Rendelointezet
Department Name
Department of Internal Medicine and Infectology
Contact Person Name
Nagy István
Contact Person Email
pettadoktor@gmail.com
Site Name
Semmelweis University
Department Name
Belgyogyaszati et Onkologiai Klinika
Contact Person Name
Ilias Akos
Contact Person Email
driliasakos@gmail.com
Site Name
Bekes Varmegyei Koezponti Korhaz
Department Name
IV. Internal Medicine-Gastroenterology
Contact Person Name
Marta Varga
Contact Person Email
drvargamarta@gmail.com
Site Name
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Department Name
Gastroenterology
Contact Person Name
Andras Kafony
Contact Person Email
kafony@gmail.com
Site Name
Semmelweis University
Department Name
Department of internal Medicine and Hematology
Contact Person Name
Zsolt Tulassay
Contact Person Email
tulassay.zsolt@semmelweis.hu
Site Name
Clinfan Kft.
Contact Person Name
Agnes Salamon
Contact Person Email
salamonagidr@gmail.com
Site Name
Clinexpert Gyoengyoes Kft.
Contact Person Name
Gyula Horvát
Contact Person Email
horvatgyula@gmail.com

Romania

Earliest CTIS Part Ii Submission Date
14-10-2024
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
574
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Elias University Emergency Hospital
Department Name
Gastroenterology
Contact Person Name
Adrian Saftoiu
Site Name
Cabinet Particular Policlinic Algomed S.R.L.
Department Name
Gastroenterology
Contact Person Name
Eugen-Adrian Goldis
Contact Person Email
goldisadi@yahoo.com
Site Name
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj
Department Name
Gastroenterology
Contact Person Name
Roxana Zaharie
Contact Person Email
zahariedeliaroxana@gmail.com
Site Name
Policlinica Gastromond, Regina Maria
Department Name
Gastroenterology
Contact Person Name
Diana Candescu
Contact Person Email
candescu.diana@yahoo.com

Spain

Earliest CTIS Part Ii Submission Date
14-01-2025
Latest Decision Or Authorization Date
01-04-2026
Processing Time Days
442
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Hospital Universitario La Paz
Department Name
Gastroenterology
Contact Person Name
Martin Arranz
Contact Person Email
martin.arranz.lapaz@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Gastroenterology
Contact Person Name
Federico Argüelles Arias

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.
Responsibilities
sponsorDuties code: 3 (operational/CRO responsibilities indicated)
Name
Labcorp Central Laboratory Services SARL
Responsibilities
central laboratory services
Name
Eresearchtechnology Inc.
Responsibilities
Cardiac Safety and related services
Name
Precision for Medicine GmbH
Responsibilities
sample handling / shipment (EPI_shipment contact)

Third parties

  • {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"sponsorDuties codes: [\"1\"]","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":"France","full_name":"Firalis","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Accellacare Limited","duties_or_roles":"Home Nursing","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Inato","duties_or_roles":"sponsorDuties codes: [\"2\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties codes: [\"3\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Discovery Life Sciences LLC","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Cardiac Safety; additional duties code present","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Precision for Medicine GmbH","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
Balinatunfib
Active Substance
BALINATUNFIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus: 1
Investigational Product Name
Match placebo to test product
Modality
Other

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