Clinical trial • Phase III • Gastroenterology|Immunology

RO7790121 for Crohn's disease (moderately to severely active)

Phase III trial of RO7790121 for Crohn's disease (moderately to severely active).

Overview

Trial Therapeutic Area
Gastroenterology|Immunology
Trial Disease
Crohn's disease (moderately to severely active)
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
03-12-2024
First CTIS Authorization Date
14-04-2025

Trial design

Randomised, open-label, ro7790121 (investigational product; iv infusion) versus ro7790121 placebo (placebo arm); dose and schedule not specified in provided data-controlled Phase III trial in Bulgaria, Italy, Germany and others.

Randomised
Yes
Open Label
Yes
Comparator
RO7790121 (investigational product; IV infusion) versus RO7790121 Placebo (placebo arm); dose and schedule not specified in provided data
Biomarker Stratified
True, TL1A (tumor necrosis factor-like ligand 1A) biomarker-defined subgroups
Target Sample Size
204

Eligibility

Recruits 204 Vulnerable populations are selected. Study documentation includes assent forms for adolescents (e.g. 'L1 SIS and ICF Assent 16-17 yrs' and 'Assent 12-17 years' documents), parental/informed consent forms for parents (parental ICFs) and infant information ICFs. Consent framework: adults provide informed consent via ICF; where minors are addressed in local documents, parental consent plus assent (age-appropriate) is provided. Country- and site-specific ICF/assent/parental materials are included in the submission..

Vulnerable Population
Vulnerable populations are selected. Study documentation includes assent forms for adolescents (e.g. 'L1 SIS and ICF Assent 16-17 yrs' and 'Assent 12-17 years' documents), parental/informed consent forms for parents (parental ICFs) and infant information ICFs. Consent framework: adults provide informed consent via ICF; where minors are addressed in local documents, parental consent plus assent (age-appropriate) is provided. Country- and site-specific ICF/assent/parental materials are included in the submission.

Inclusion criteria

  • {"criterion_text":"- Age ≥ 18 to ≤ 80 years at the time of signing Informed Consent Form"}
  • {"criterion_text":"- General Inclusion Criteria Bodyweight ≥ 40 kg"}
  • {"criterion_text":"- Crohn's Disease-Specific Inclusion Criteria Confirmed diagnosis of CD with supportive clinical, endoscopic and histopathological evidence"}
  • {"criterion_text":"- Crohn's Disease-Specific Inclusion Criteria Moderately to severely active CD, meeting all of the following: - SES-CD of ≥ 6 (or ≥ 4 for isolated ileal disease) - CDAI ≥ 220 and ≤ 450"}
  • {"criterion_text":"- Crohn's Disease-Specific Inclusion Criteria Involvement of ileum and/or colon, with at least four colonic segments traversable by an endoscope or a pediatric endoscope, or three segments (colon and/or ileum) for patients who have undergone a bowel resection among the following segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum."}
  • {"criterion_text":"- Crohn's Disease-Specific Inclusion Criteria Screening for colorectal cancer (CRC) during or prior to screening for all participants (performed according to local standards)  With risk factors for bowel cancer a surveillance ileocolonoscopy must be performed within 12 months prior to screening.  For all other patients, must be up to date with CRC surveillance (according to CRC risks and local standards)  Screening ileocolonoscopy can be used for CRC surveillance (following local guidelines) and results must be available prior to randomization Any adenomatous polyps must be completely removed according to routine practice prior to their first dose of study drug."}

Exclusion criteria

  • {"criterion_text":"- Inflammatory Bowel Disease Exclusion Criteria Participant with a history of ≥ 3 bowel resections > 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum"}
  • {"criterion_text":"- Inflammatory Bowel Disease Exclusion Criteria Diagnosis of short gut or short bowel syndrome"}
  • {"criterion_text":"- Medical History Exclusion Criteria Any major surgery within 6 weeks prior to screening or a major surgery planned during the study"}
  • {"criterion_text":"- Significant uncontrolled medical comorbidity (such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders [excluding CD]), psychiatric, or other condition that in the opinion of the investigator, would confound the study results, compromise patient safety, interfere with the potential participant's provision of informed consent, or compliance with trial procedures"}
  • {"criterion_text":"- Infection or Infection Risk Exclusion Criteria Any clinically significant infection < 4 weeks prior to randomization that has not resolved, and/or that required hospitalization, and/or IV antibiotics o Any clinically significant infection that was opportunistic in nature is not permitted within 3 months prior to randomization"}
  • {"criterion_text":"- Infection or Infection Risk Exclusion Criteria Confirmation of HIV infection (e.g., positive HIV test) at screening"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. Clinical remission, defined as Crohn's disease activity index (CDAI) < 150","definition_or_measurement_approach":"Clinical remission defined as Crohn's disease activity index (CDAI) < 150"}
  • {"endpoint_text":"- 2. Endoscopic response, defined as decrease in Simple Endoscopic Score for Crohn's disease (SES-CD) from baseline≥ 50%","definition_or_measurement_approach":"Endoscopic response defined as ≥50% decrease in Simple Endoscopic Score for Crohn's disease (SES-CD) from baseline"}

Secondary endpoints

  • {"endpoint_text":"- 1. Symptomatic remission,","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 2. Endoscopic remission,","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 3. Ulcer-free endoscopy,","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 4. Average of daily number of liquid or very soft stools in the past week (SF), from baseline","definition_or_measurement_approach":"Change from baseline in average daily number of liquid or very soft stools over the previous week"}
  • {"endpoint_text":"- 5. Average of daily abdominal pain scores in the past week (APS) from baseline","definition_or_measurement_approach":"Change from baseline in average daily abdominal pain scores (APS) over the previous week"}
  • {"endpoint_text":"- 6. Bowel urgency, from baseline","definition_or_measurement_approach":"Change from baseline in bowel urgency"}
  • {"endpoint_text":"- 7. Fatigue, as measured by Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F), from baseline","definition_or_measurement_approach":"Change from baseline in FACIT-F score"}
  • {"endpoint_text":"- 8. Inflammatory Bowel Disease Questionnaire (IBDQ) score, from baseline","definition_or_measurement_approach":"Change from baseline in IBDQ score"}
  • {"endpoint_text":"- 9. Among biomarker-defined subgroups of participants: Clinical remission","definition_or_measurement_approach":"Analysis of clinical remission within biomarker-defined subgroups"}
  • {"endpoint_text":"- 10. Among biomarker-defined subgroups of participants: Endoscopic response","definition_or_measurement_approach":"Analysis of endoscopic response within biomarker-defined subgroups"}
  • {"endpoint_text":"- 11. Clinical response, defined as a decrease in CDAI from baseline","definition_or_measurement_approach":"Clinical response defined as decrease in CDAI from baseline"}
  • {"endpoint_text":"- 12. Symptomatic response,","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 13. Overall change in CD symptoms, as measured by PGIC, from baseline","definition_or_measurement_approach":"Change from baseline measured by Patient Global Impression of Change (PGIC)"}
  • {"endpoint_text":"- 14. Overall severity in CD symptoms, as measured by Patient Global Impression of Severity (PGIS), from baseline","definition_or_measurement_approach":"Change from baseline measured by Patient Global Impression of Severity (PGIS)"}
  • {"endpoint_text":"- 15. General well-being, from baseline","definition_or_measurement_approach":"Change from baseline in general well-being"}
  • {"endpoint_text":"- 16. Incidence and severity of the following: Adverse events","definition_or_measurement_approach":"Incidence and severity as recorded/reported during study"}
  • {"endpoint_text":"- 17. Incidence and severity of the following: Serious adverse events","definition_or_measurement_approach":"Incidence and severity as recorded/reported during study"}
  • {"endpoint_text":"- 18. Incidence and severity of the following: Adverse events leading to study treatment discontinuation","definition_or_measurement_approach":"Incidence and severity as recorded/reported during study"}
  • {"endpoint_text":"- 19. Incidence and severity of the following: Adverse events of special interest","definition_or_measurement_approach":"Incidence and severity as recorded/reported during study"}
  • {"endpoint_text":"- 20. Presence of draining fistulas","definition_or_measurement_approach":"Presence/absence assessment of draining fistulas"}

Recruitment

Digital Remote Recruitment
True, includes social media posts, digital flyers, and patient database letters as recruitment channels
Planned Sample Size
204
Recruitment Window Months
70
Consent Approach
Informed consent obtained using subject information sheets and Informed Consent Forms (ICFs) for adults. Where minors are addressed in submitted materials, parental/guardian informed consent and age-appropriate assent forms are provided (examples: 'Assent 16-17 yrs', 'Assent 12-17 years', parental ICFs, infant information ICF). Consent/assent materials are provided in English and local language versions for Member States (country-specific ICFs and translations listed across submission documents).

Methods

  • Patient-facing recruitment materials: posters and flyers (K2_recruitment material_Patient Poster, K2_Recruitment materials)
  • Social media posts / digital outreach (K4_Social Media Posts_IBD)
  • Patient database letters / database outreach (Patient database letter referenced in recruitment materials)
  • Communication to doctors / GP letters (e.g. 'General Practitioner Letter', 'Communication to Doctors')
  • Patient information brochures and leaflets (K2_recruitment material leaftlet, patient information brochures)

Geography

Total Number Of Sites
72
Total Number Of Participants
225

Bulgaria

Earliest CTIS Part Ii Submission Date
02-04-2025
Latest Decision Or Authorization Date
16-04-2025
Processing Time Days
14
Number Of Sites
3
Number Of Participants
30

Sites

Site Name
Second Multiprofile Hospital For Active Treatment Sofia EAD
Department Name
Gastroenterology
Principal Investigator Name
Nikolay Tsonev
Principal Investigator Email
dr.n.tsonev@abv.bg
Contact Person Name
Nikolay Tsonev
Contact Person Email
dr.n.tsonev@abv.bg
Site Name
Medical Center St. Ivan Rilski Chudotvorets 2010 EOOD
Department Name
-
Principal Investigator Name
Nikolay Stoynov
Principal Investigator Email
s.toncheva@rdservices.org
Contact Person Name
Nikolay Stoynov
Contact Person Email
s.toncheva@rdservices.org
Site Name
Diagnostics And Consultation Center Convex Ltd.
Department Name
-
Principal Investigator Name
Plamen Penchev
Principal Investigator Email
lilly@convex.bg
Contact Person Name
Plamen Penchev
Contact Person Email
lilly@convex.bg

Italy

Earliest CTIS Part Ii Submission Date
26-03-2025
Latest Decision Or Authorization Date
16-04-2025
Processing Time Days
21
Number Of Sites
8
Number Of Participants
19

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Gastroenterologia
Principal Investigator Name
Lucrezia Laterza
Principal Investigator Email
lucrezia.laterza@policlinicogemelli.it
Contact Person Name
Lucrezia Laterza
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Gastroenterologia
Principal Investigator Name
Chiara Ricci
Principal Investigator Email
gastroenterologia@asst-spedalicivili.it
Contact Person Name
Chiara Ricci
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Gastroenterologia
Principal Investigator Name
Fernando Rizzello
Principal Investigator Email
fernando.rizzello@unibo.it
Contact Person Name
Fernando Rizzello
Contact Person Email
fernando.rizzello@unibo.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Gastroenterologia
Principal Investigator Name
Virginia Solitano
Principal Investigator Email
solitano.virginia1@hsr.it
Contact Person Name
Virginia Solitano
Contact Person Email
solitano.virginia1@hsr.it
Site Name
Azienda Sanitaria Locale Matera
Department Name
Gastroenterologia interventistica
Principal Investigator Name
Marina Rizzi
Principal Investigator Email
Marina.Rizzi@asmbasilicata.it
Contact Person Name
Marina Rizzi
Contact Person Email
Marina.Rizzi@asmbasilicata.it
Site Name
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Department Name
Gastroenterologia
Principal Investigator Name
Michele Cicala
Principal Investigator Email
m.cicala@policlinicocampus.it
Contact Person Name
Michele Cicala
Contact Person Email
m.cicala@policlinicocampus.it
Site Name
Policlinico San Donato S.p.A.
Department Name
Gastroenterologia ed 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
IRCCS Ospedale Sacro Cuore Don Calabria
Department Name
Gastroenterologia
Principal Investigator Name
Angela Variola
Principal Investigator Email
angela.variola@sacrocuore.it
Contact Person Name
Angela Variola
Contact Person Email
angela.variola@sacrocuore.it

Germany

Earliest CTIS Part Ii Submission Date
25-03-2025
Latest Decision Or Authorization Date
22-04-2025
Processing Time Days
28
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Abteilung Innere Medizin IV
Principal Investigator Name
Annika Gauss
Contact Person Name
Annika Gauss
Site Name
Gastroenterologische Spezialpraxis-Berlin-Karlshorst
Department Name
Facharztpraxis für Gastroenterologie
Principal Investigator Name
Thomas Brunk
Principal Investigator Email
karlshorst@gastroenterologie-brunk.de
Contact Person Name
Thomas Brunk
Site Name
Klinikum Ernst von Bergmann gGmbH
Department Name
Department of Gastroenterology, Infectious Diseases ans Rheumatology
Principal Investigator Name
Daniel Baumgart
Principal Investigator Email
daniel.baumgart@charite.de
Contact Person Name
Daniel Baumgart
Contact Person Email
daniel.baumgart@charite.de

Croatia

Earliest CTIS Part Ii Submission Date
01-04-2025
Latest Decision Or Authorization Date
22-04-2025
Processing Time Days
21
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Poliklinika Borzan d.o.o.
Department Name
Poliklinika Borzan
Principal Investigator Name
Vladimir Borzan
Principal Investigator Email
study@poliklinika-borzan.hr
Contact Person Name
Vladimir Borzan
Contact Person Email
study@poliklinika-borzan.hr
Site Name
KBC Zagreb
Department Name
Zavod za gastroenterologiju i hepatologiju
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
Site Name
Klinička bolnica Dubrava
Department Name
Zavod za gastroenterologiju, hepatologiju i kliničku prehranu
Principal Investigator Name
Željko Čabrijan
Principal Investigator Email
zcabrija@kbd.hr
Contact Person Name
Željko Čabrijan
Contact Person Email
zcabrija@kbd.hr

France

Earliest CTIS Part Ii Submission Date
04-04-2025
Latest Decision Or Authorization Date
14-04-2025
Processing Time Days
10
Number Of Sites
11
Number Of Participants
49

Sites

Site Name
University Hospital Of Clermont-Ferrand
Department Name
Hépato-gastro-entérologie
Principal Investigator Name
Anthony BUISSON
Principal Investigator Email
a_buisson@chu-clermontferrand.fr
Contact Person Name
Anthony BUISSON
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Hépato-gastro-entérologie
Principal Investigator Name
Astrid De Maissin
Principal Investigator Email
recherche.clinique@chd-vendee.fr
Contact Person Name
Astrid De Maissin
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Hépato-gastro-entérologie
Principal Investigator Name
Sophie GEYL
Principal Investigator Email
sophie.geyl@chu-limoges.fr
Contact Person Name
Sophie GEYL
Contact Person Email
sophie.geyl@chu-limoges.fr
Site Name
Centre Medico Chirurgical Ambroise Pare Hartmann
Department Name
Institut des MICI
Principal Investigator Name
Carmen Stefanescu
Principal Investigator Email
carmen.stefanescu@institutdesmici.fr
Contact Person Name
Carmen Stefanescu
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hépato-gastro-entérologie
Principal Investigator Name
Mathieu Uzzan
Principal Investigator Email
mathieu.uzzan@aphp.fr
Contact Person Name
Mathieu Uzzan
Contact Person Email
mathieu.uzzan@aphp.fr
Site Name
Hospices Civils De Lyon
Department Name
Hépato-gastro-entérologie
Principal Investigator Name
Stéphane Nancey
Principal Investigator Email
stephane.nancey@chu-lyon.fr
Contact Person Name
Stéphane Nancey
Contact Person Email
stephane.nancey@chu-lyon.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Hépato-gastro-entérologie
Principal Investigator Name
Driffa Moussata
Principal Investigator Email
d.moussata@chu-tours.fr
Contact Person Name
Driffa Moussata
Contact Person Email
d.moussata@chu-tours.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Hépato-gastro-entérologie
Principal Investigator Name
Maria Nachury
Principal Investigator Email
direction-recherche@chu-lille.fr
Contact Person Name
Maria Nachury
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Hépato-gastro-entérologie
Principal Investigator Name
Anne Bozon
Principal Investigator Email
aan-bozon@chu-montpellier.fr
Contact Person Name
Anne Bozon
Contact Person Email
aan-bozon@chu-montpellier.fr
Site Name
CHRU De Nancy
Department Name
Hépato-gastro-entérologie
Principal Investigator Name
Bénédicte Caron
Principal Investigator Email
protocoles-mici@chru-nancy.fr
Contact Person Name
Bénédicte Caron
Contact Person Email
protocoles-mici@chru-nancy.fr
Site Name
Hopital Saint Louis
Department Name
Hépato-gastro-entérologie
Principal Investigator Name
Joelle Bonnet
Principal Investigator Email
joelle.bonnet@aphp.fr
Contact Person Name
Joelle Bonnet
Contact Person Email
joelle.bonnet@aphp.fr

Portugal

Earliest CTIS Part Ii Submission Date
27-03-2025
Latest Decision Or Authorization Date
15-04-2025
Processing Time Days
19
Number Of Sites
5
Number Of Participants
5

Sites

Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Serviço de Gastrenterologia
Principal Investigator Name
Tiago Leal
Principal Investigator Email
2ca@ccabraga.org
Contact Person Name
Tiago Leal
Contact Person Email
2ca@ccabraga.org
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Serviço de Gastrenterologia
Principal Investigator Name
Sofia Saraiva
Principal Investigator Email
ana.saraiva@ulssm.min-saude.pt
Contact Person Name
Sofia Saraiva
Contact Person Email
ana.saraiva@ulssm.min-saude.pt
Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
Serviço de Gastroenterologia
Principal Investigator Name
Susana Lopes
Principal Investigator Email
centro.investigacao@chsj.min-saude.pt
Contact Person Name
Susana Lopes
Site Name
Unidade Local De Saude De Entre O Douro E Vouga E.P.E.
Department Name
Serviço de Gastrenterologia
Principal Investigator Name
Rute Cerqueira
Principal Investigator Email
alice.coelho@chedv.min-saude.pt
Contact Person Name
Rute Cerqueira
Site Name
Unidade Local De Saude De Viseu Dao-Lafoes E.P.E.
Department Name
Serviço de Gastroenterologia
Principal Investigator Name
Paula Ministro
Principal Investigator Email
4342@hstviseu.min-saude.pt
Contact Person Name
Paula Ministro
Contact Person Email
4342@hstviseu.min-saude.pt

Austria

Earliest CTIS Part Ii Submission Date
26-03-2025
Latest Decision Or Authorization Date
22-04-2025
Processing Time Days
27
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Klinikum Wels-Grieskirchen GmbH
Department Name
Department of Internal Medicine I
Principal Investigator Name
Harald Hofer
Principal Investigator Email
interne1.Studienzentrum@klinikum-wegr.at
Contact Person Name
Harald Hofer
Site Name
Ordensklinikum Linz GmbH
Department Name
Department of internal medicine IV
Principal Investigator Name
Matus Gregus
Principal Investigator Email
gastroenterologie@ordensklinikum.at
Contact Person Name
Matus Gregus

Poland

Earliest CTIS Part Ii Submission Date
14-03-2025
Latest Decision Or Authorization Date
30-04-2025
Processing Time Days
47
Number Of Sites
15
Number Of Participants
33

Sites

Site Name
Amicare Sp. z o.o. S.K.
Principal Investigator Name
Hubert Zatorski
Principal Investigator Email
office@amicare.pl
Contact Person Name
Hubert Zatorski
Contact Person Email
office@amicare.pl
Site Name
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Principal Investigator Name
Monika Augustyn
Principal Investigator Email
trials@plejady.com.pl
Contact Person Name
Monika Augustyn
Contact Person Email
trials@plejady.com.pl
Site Name
Eb Group Sp. z o.o.
Department Name
Centrum Zdrowia MDM
Principal Investigator Name
Marek Woynarowski
Principal Investigator Email
bk@czmdm.pl
Contact Person Name
Marek Woynarowski
Contact Person Email
bk@czmdm.pl
Site Name
EMC Instytut Medyczny S.A.
Department Name
PL Certus Szpital Nr 1, PL Certus Ambulatorium
Principal Investigator Name
Pawel Szablowski
Principal Investigator Email
kinga.kieronczyk@emc-sa.pl
Contact Person Name
Pawel Szablowski
Contact Person Email
kinga.kieronczyk@emc-sa.pl
Site Name
Planetmed Sp. z o.o.
Principal Investigator Name
Barbara Woźniak-Stolarska
Principal Investigator Email
basiastolarska@interia.pl
Contact Person Name
Barbara Woźniak-Stolarska
Contact Person Email
basiastolarska@interia.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
Clinical Research Center Sp. z o.o. Medic-R sp.k.
Principal Investigator Name
Marcin Hańczewski
Principal Investigator Email
agnieszka.kmieciak@cr-center.pl
Contact Person Name
Marcin Hańczewski
Site Name
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
Principal Investigator Name
Patryk Korga
Principal Investigator Email
patryk.korga@kermed.pl
Contact Person Name
Patryk Korga
Contact Person Email
patryk.korga@kermed.pl
Site Name
Mz Badania Slowik Zymla Sp. j.
Principal Investigator Name
Maciej Żymła
Principal Investigator Email
mzbadania@gmail.com
Contact Person Name
Maciej Żymła
Contact Person Email
mzbadania@gmail.com
Site Name
Osrodek Badan Klinicznych Bd Research Sp. z o.o.
Principal Investigator Name
Jerzy Kruszewski
Principal Investigator Email
sekretariat@bdresearch.com.pl
Contact Person Name
Jerzy Kruszewski
Contact Person Email
sekretariat@bdresearch.com.pl
Site Name
Piotr Walczak Gabinet Endoskopii Przewodu Pokarmowego
Principal Investigator Name
Piotr Walczak
Principal Investigator Email
gabinet@endoskopia.net.pl
Contact Person Name
Piotr Walczak
Contact Person Email
gabinet@endoskopia.net.pl
Site Name
Gastromed Kralisz Romatowski Stachurska Sp. j.
Principal Investigator Name
Jacek Romatowski
Principal Investigator Email
biuro@gastromed.info
Contact Person Name
Jacek Romatowski
Contact Person Email
biuro@gastromed.info
Site Name
Centrum Medyczne Oporow
Department Name
Centrum Medyczne Oporow
Principal Investigator Name
Radosław Kempinski
Principal Investigator Email
badania@cmoporow.com
Contact Person Name
Radosław Kempinski
Contact Person Email
badania@cmoporow.com
Site Name
Endoskopia Sp. z o.o.
Principal Investigator Name
Dariusz Kleczkowski
Principal Investigator Email
badanie.kliniczne@wp.pl
Contact Person Name
Dariusz Kleczkowski
Contact Person Email
badanie.kliniczne@wp.pl
Site Name
Promed P.Lach R.Glowacki Sp. j.
Department Name
Centrum Medyczne Promed
Principal Investigator Name
Danuta Owczarek
Principal Investigator Email
badania.kliniczne@cmpromed.pl
Contact Person Name
Danuta Owczarek
Contact Person Email
badania.kliniczne@cmpromed.pl

Slovakia

Earliest CTIS Part Ii Submission Date
28-03-2025
Latest Decision Or Authorization Date
14-04-2025
Processing Time Days
17
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Fakultna Nemocnica S Poliklinikou Nove Zamky
Department Name
Gastroenterologické a hepatologické centrum
Principal Investigator Name
Juraj Ďurina
Principal Investigator Email
juraj.durina@nspnz.sk
Contact Person Name
Juraj Ďurina
Contact Person Email
juraj.durina@nspnz.sk
Site Name
KM Management spol. s r.o.
Department Name
Gastroenterologická ambulancia
Principal Investigator Name
Miloš Greguš
Principal Investigator Email
gregus.studie@gmail.com
Contact Person Name
Miloš Greguš
Contact Person Email
gregus.studie@gmail.com
Site Name
Abawi spol. s r.o.
Department Name
Gastroenterologická ambulancia
Principal Investigator Name
Habib Narwan
Principal Investigator Email
abawisro@gmail.com
Contact Person Name
Habib Narwan
Contact Person Email
abawisro@gmail.com

Romania

Earliest CTIS Part Ii Submission Date
02-04-2025
Latest Decision Or Authorization Date
22-04-2025
Processing Time Days
20
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Tvm Med Serv S.R.L.
Department Name
Gastroenterologie
Principal Investigator Name
Alina Tantau
Principal Investigator Email
contact@doctortantau.ro
Contact Person Name
Alina Tantau
Contact Person Email
contact@doctortantau.ro

Czechia

Earliest CTIS Part Ii Submission Date
26-03-2025
Latest Decision Or Authorization Date
15-04-2025
Processing Time Days
20
Number Of Sites
5
Number Of Participants
24

Sites

Site Name
Fakultni Nemocnice Ostrava
Department Name
Interní a kardiologická klinika
Principal Investigator Name
Pavel Svoboda
Principal Investigator Email
pavel.svoboda@fno.cz
Contact Person Name
Pavel Svoboda
Contact Person Email
pavel.svoboda@fno.cz
Site Name
Krajska zdravotni a.s.
Department Name
Gastroenterologické oddělení
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 (IBD)
Principal Investigator Name
Milan Likáš
Principal Investigator Email
milan.lukas@email.cz
Contact Person Name
Milan Likáš
Contact Person Email
milan.lukas@email.cz
Site Name
Hepato-Gastroenterologie HK s.r.o.
Department Name
hepato-gastro enterologie
Principal Investigator Name
Tomáš Vaňásek
Principal Investigator Email
tomas.vanasek@hepato-gastro.com
Contact Person Name
Tomáš Vaňásek
Site Name
Institute For Clinical And Experimental Medicine
Department Name
klinika hepatogastroenterologie
Principal Investigator Name
Martin Vašátko
Principal Investigator Email
martin.vasatko@ikem.cz
Contact Person Name
Martin Vašátko
Contact Person Email
martin.vasatko@ikem.cz

Belgium

Earliest CTIS Part Ii Submission Date
12-03-2025
Latest Decision Or Authorization Date
30-04-2025
Processing Time Days
49
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
Gastro-enterology
Principal Investigator Name
Olivier Dewit
Principal Investigator Email
clinicaltrialcenter@saintluc.uclouvain.be
Contact Person Name
Olivier Dewit
Site Name
CHU Saint Pierre
Department Name
Gastro-enterology
Principal Investigator Name
Vinciane Muls
Principal Investigator Email
vinciane.muls@stpierre-bru.be
Contact Person Name
Vinciane Muls
Contact Person Email
vinciane.muls@stpierre-bru.be
Site Name
UZ Brussel
Department Name
Gastro-enterology
Principal Investigator Name
Liv Vandermeulen
Principal Investigator Email
gastro.clinicaltrials@uzbrussel.be
Contact Person Name
Liv Vandermeulen

Spain

Earliest CTIS Part Ii Submission Date
07-02-2025
Latest Decision Or Authorization Date
14-04-2025
Processing Time Days
66
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Aparato Digestivo
Principal Investigator Name
María Isabel Vera Mendoza
Principal Investigator Email
farmacologia_clinica@idiphim.org
Contact Person Name
María Isabel Vera Mendoza
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Gastroenterología
Principal Investigator Name
Ignacio Marin Jimenez
Principal Investigator Email
drnachomarin@hotmail.com
Contact Person Name
Ignacio Marin Jimenez
Contact Person Email
drnachomarin@hotmail.com
Site Name
Hospital Universitario Fundacion Alcorcon
Department Name
Gastroenterología
Principal Investigator Name
Pilar López Serrano
Principal Investigator Email
plopezserrano@salud.madrid.org
Contact Person Name
Pilar López Serrano
Contact Person Email
plopezserrano@salud.madrid.org
Site Name
Hospital Universitario De Fuenlabrada
Department Name
Aparato Digestivo
Principal Investigator Name
Fernando Bermejo San José
Principal Investigator Email
fernando.bermejo@salud.madrid.org
Contact Person Name
Fernando Bermejo San José
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Gastroenterología
Principal Investigator Name
Yolanda Ber Nieto
Principal Investigator Email
ybernieto@gmail.com
Contact Person Name
Yolanda Ber Nieto
Contact Person Email
ybernieto@gmail.com

Hungary

Earliest CTIS Part Ii Submission Date
28-03-2025
Latest Decision Or Authorization Date
22-04-2025
Processing Time Days
25
Number Of Sites
5
Number Of Participants
7

Sites

Site Name
Central Hospital Of Northern Pest Military Hospital
Department Name
Gasztroenterológia
Principal Investigator Name
Tibor Gyokeres
Principal Investigator Email
gyokereshonvedstudy@gmail.com
Contact Person Name
Tibor Gyokeres
Contact Person Email
gyokereshonvedstudy@gmail.com
Site Name
Semmelweis University
Department Name
Transzplantacios és Gasztroenterologiai Klinika
Principal Investigator Name
Pal Miheller
Principal Investigator Email
pmiheller@gmail.com
Contact Person Name
Pal Miheller
Contact Person Email
pmiheller@gmail.com
Site Name
Vas-Oxy Kft.
Department Name
Vas-Oxy Egészségügyi Korlátolt Felelősségű Társaság
Principal Investigator Name
Krisztina Sarang
Principal Investigator Email
dr.sarang.k@gmail.com
Contact Person Name
Krisztina Sarang
Contact Person Email
dr.sarang.k@gmail.com
Site Name
Endomedix Kft.
Department Name
Budapest
Principal Investigator Name
Alajos Takáts
Principal Investigator Email
takats.alajos@endomedix.hu
Contact Person Name
Alajos Takáts
Contact Person Email
takats.alajos@endomedix.hu
Site Name
Geomedical Kft.
Department Name
Gasztroenterológia
Principal Investigator Name
Gábor Hegede
Principal Investigator Email
gab.heg@freemail.hu
Contact Person Name
Gábor Hegede
Contact Person Email
gab.heg@freemail.hu

Sponsor

Primary sponsor

Full Name
F. Hoffmann-La Roche AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
Global CRO

Third parties

  • {"country":"United States","full_name":"Pathai Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translations","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"Central Imaging","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Mobile Nursing","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Global CRO","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
RO7790121
Active Substance
RO7790121
Modality
Peptide/protein/enzyme
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
prodAuthStatus: 1
Investigational Product Name
RO7790121 Placebo

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