Clinical trial • Phase II • Gastroenterology

RO7837195 for Moderately to severely active ulcerative colitis

Phase II trial of RO7837195 for Moderately to severely active ulcerative colitis.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Moderately to severely active ulcerative colitis
Trial Stage
Phase II
Drug Modality
Bispecific antibody

Key dates

Initial CTIS Submission Date
28-05-2025
First CTIS Authorization Date
03-10-2025

Trial design

Randomised, placebo (matching placebo arm for ro7837195); dose and schedule not specified in the available metadata-controlled Phase II trial across 44 sites in France, Poland, Czechia and others.

Randomised
Yes
Comparator
Placebo (matching placebo arm for RO7837195); dose and schedule not specified in the available metadata
Target Sample Size
140

Eligibility

Recruits 140 Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms for infants and other groups are present in the document list (e.g., 'L1_2025-520690-39_Infant Info ICF_san', 'L1_SIS and ICF_Infant Health Autorization_san', country-specific ICFs). Specific consent/assent procedures and detailed handling are not described in the available metadata..

Pregnancy Exclusion
Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required
Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms for infants and other groups are present in the document list (e.g., 'L1_2025-520690-39_Infant Info ICF_san', 'L1_SIS and ICF_Infant Health Autorization_san', country-specific ICFs). Specific consent/assent procedures and detailed handling are not described in the available metadata.

Inclusion criteria

  • {"criterion_text":"- Diagnosis of UC established at least 3 months prior to screening, confirmed by clinical and endoscopic evidence during screening\n- Evidence of UC extending a minimum of 15 cm from the anal verge as determined by baseline endoscopy (flexible sigmoidoscopy or colonoscopy) performed during screening\n- Colonoscopy within 2 years prior to screening or willingness to undergo colonoscopy in lieu of a flexible sigmoidoscopy at screening\n- Moderately to severely active UC, defined as a modified Mayo Score (mMS) of 5-9 including an endoscopic subscore of ≥ 2 during the screening period\n- Agreement to adhere to the contraception requirements\n- Prior advanced therapy failure and/or conventional therapy failure"}

Exclusion criteria

  • {"criterion_text":"- Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required\n- Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC\n- History of or current ileostomy or colostomy\n- Diagnosis of Crohn’s disease or indeterminate colitis\n- Suspicion of ischemic colitis, radiation colitis, or microscopic colitis\n- Diagnosis of toxic megacolon within 12 months prior to screening"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Clinical remission at Week 12, with clinical remission defined as mMS of ≤ 2, with Mayo subscores meeting the following criteria: – Stool frequency subscore ≤ 1 – Rectal bleeding subscore = 0 Endoscopy subscore ≤ 1 (score of 1 modified to exclude friability)","definition_or_measurement_approach":"Clinical remission assessed at Week 12 using the modified Mayo Score (mMS) with component Mayo subscores: stool frequency ≤1, rectal bleeding =0, and Mayo endoscopy subscore ≤1 (score of 1 modified to exclude friability)."}

Secondary endpoints

  • {"endpoint_text":"- Clinical response at Week 12, with clinical response defined as meeting both of the following sets of criteria: – Decrease from baseline in the mMS of ≥ 2 and ≥ 30% reduction from baseline - Decrease in Mayo rectal bleeding subscore of ≥ 1 or absolute rectal bleeding subscore of ≤1","definition_or_measurement_approach":"Clinical response at Week 12 defined by decrease from baseline in mMS of ≥2 and ≥30% and decrease in Mayo rectal bleeding subscore of ≥1 or absolute rectal bleeding subscore ≤1."}
  • {"endpoint_text":"- Endoscopic improvement at Week 12, with endoscopic improvement defined as a Mayo endoscopy subscore of ≤1 (score of 1 modified to exclude friability)","definition_or_measurement_approach":"Endoscopic assessment at Week 12 using Mayo endoscopy subscore; improvement defined as subscore ≤1 (score of 1 modified to exclude friability)."}
  • {"endpoint_text":"- Endoscopic remission at Week 12, with endoscopic remission defined as a Mayo endoscopy subscore of 0","definition_or_measurement_approach":"Endoscopic remission at Week 12 defined as Mayo endoscopy subscore = 0."}
  • {"endpoint_text":"- Incidence and severity of adverse events, with severity determined according to the National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0) grading scale","definition_or_measurement_approach":"Safety assessed by incidence and severity of adverse events graded by NCI CTCAE v5.0."}
  • {"endpoint_text":"- Change from baseline in selected vital signs","definition_or_measurement_approach":"Change from baseline in prespecified vital sign measurements (timepoints not specified in metadata)."}
  • {"endpoint_text":"- Change from baseline in selected clinical laboratory test results","definition_or_measurement_approach":"Change from baseline in prespecified clinical laboratory parameters (specific tests/timepoints not provided in metadata)."}
  • {"endpoint_text":"- Serum concentration of RO7837195 at specified timepoints","definition_or_measurement_approach":"Pharmacokinetic assessment: serum concentrations of RO7837195 measured at predefined study timepoints."}
  • {"endpoint_text":"- Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study","definition_or_measurement_approach":"Immunogenicity assessment measuring prevalence of anti-drug antibodies at baseline and incidence during the study (assay specifics not provided in metadata)."}

Recruitment

Planned Sample Size
140
Recruitment Window Months
31
Consent Approach
Subject information and informed consent forms are provided in multiple country/language versions (documents include main ICFs and country-specific ICFs: France, Poland, Czechia, Germany, Italy, etc.). Infant-specific information/ICF documents are present. The metadata lists functional contact(s) and ICF documents but does not detail the step-by-step consent or assent procedures or specify age cut-offs for assent in the available fields.

Geography

Total Number Of Sites
44
Total Number Of Participants
84

France

Earliest CTIS Part Ii Submission Date
26-08-2025
Latest Decision Or Authorization Date
03-10-2025
Processing Time Days
38
Number Of Sites
4
Number Of Participants
7

Sites

Site Name
Hospices Civils De Lyon
Department Name
Gastroenterology
Contact Person Name
Stéphane Nancey
Contact Person Email
stephane.nancey@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Gastroenterology
Contact Person Name
Xavier Roblin
Site Name
Centre Medico Chirurgical Ambroise Pare Hartmann
Department Name
Gastroenterology
Contact Person Name
Carmen Stefanescu
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Gastroenterology
Contact Person Name
Anthony Buisson

Poland

Earliest CTIS Part Ii Submission Date
21-08-2025
Latest Decision Or Authorization Date
07-10-2025
Processing Time Days
47
Number Of Sites
25
Number Of Participants
51

Sites

Site Name
Centrum Medyczne Lukamed JOANNA ŁUKA
Contact Person Name
Artur Sołtysiak
Contact Person Email
artursoltysiak@lukamed.com
Site Name
Medon Clinical Research Sp. z o.o.
Department Name
Site Name: Medon Clinical Research/ Address: Zygmunta Modzelewskiego 6/LU1, 02-679 Warszawa
Contact Person Name
Anna Bochenek Mularczyk
Contact Person Email
anna.bochenek@medoncr.com
Site Name
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Department Name
Site Name: Centrum Medyczne Plejady/Ul. Tadeusza Szafrana 5D/ U2-U5, 30-363 Kraków
Contact Person Name
Monika Augustyn
Contact Person Email
amonika@interia.pl
Site Name
Termedia Sp. z o.o.
Department Name
Site: NZOZ Zespół Poradni Specjalistycznych "Termedica"/os. Bolesława Chrobrego 101 60-681 Poznań
Contact Person Name
Maciej Mazur
Contact Person Email
m.mazur@cbktermedica.pl
Site Name
Solumed Centrum Medyczne Sp. z o.o.
Department Name
Site Name: Solumed Centrum Medyczne/ Jana Henryka Dąbrowskiego 77A, 60-529 Poznań
Contact Person Name
Magdalena Andrzejewska
Site Name
EMC Instytut Medyczny S.A.
Department Name
Gastroenterology
Contact Person Name
Piotr Szablowski
Contact Person Email
szapi@mp.pl
Site Name
Etg Zamosc Sp. z o.o.
Department Name
Site Name: ETG Zamosc/ Ul. Gęsia 3, 22-400 Zamość
Contact Person Name
Katarzyna Wójcik
Contact Person Email
k.wojcik@etg-network.com
Site Name
Eb Group Sp. z o.o.
Department Name
Site Name: Centrum Zdrowia MDM/ ul. Inflancka 4A, 00-189 Warszawa
Contact Person Name
Piotr Liszka Dalecki
Contact Person Email
piotr.liszka-dalecki@czmdm.pl
Site Name
Manermed Sp. z o.o.
Department Name
Site Name: Centrum Medyczne Medis/ ul. Garbary 5/L-4, 85-229 Bydgoszcz
Contact Person Name
Maria Kłopocka
Contact Person Email
mariaklopocka@cm-medis.pl
Site Name
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department Name
Klinika Gastroenterologii i Chorób Wewnętrznych
Contact Person Name
Grażyna Rydzewska Wyszkowska
Site Name
Centrum Medyczne Clw-Med Aneta Cichomska I Joanna Luka-Wendrowska Sp. j.
Contact Person Name
Dariusz Gajda
Contact Person Email
dariuszgajda@lukamed.com
Site Name
Osrodek Badan Klinicznych Clinsante s.c. Ewa Galczak-Nowak Malgorzata
Contact Person Name
Michał Wiatr
Contact Person Email
michalwiatr2019@gmail.com
Site Name
Velocity Skierniewice Sp. z o.o.
Contact Person Name
Dariusz Jastrzębski
Site Name
Centrum Medyczne Oporow
Contact Person Name
Radosław Kempiński
Site Name
Twoja Przychodnia Opolskie Centrum Medyczne
Contact Person Name
Marzena Kwinto
Contact Person Email
mkwinto@opolemed.com
Site Name
Medical Network Sp. z o.o.
Department Name
Site Name: WIP Warsaw IBD Point Profesor Kierkus/ ul. Płowiecka 103, 04-501 Warszawa
Contact Person Name
Jarosław Kierkuś
Contact Person Email
j.kierkus@med-net.pl
Site Name
Mz Badania Slowik Zymla Sp. j.
Contact Person Name
Maciej Żymła
Contact Person Email
mzbadania@gmail.com
Site Name
Allmedica Badania Kliniczne Sp. z o.o. sp.k.
Contact Person Name
Mikołaj Krzyżanowski
Contact Person Email
mikolaj.krzyzanowski@gmail.com
Site Name
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
Department Name
Site Name: Twoja Przychodnia PCM/ Ul. Marcelińska 92, 60-324 Poznań
Contact Person Name
Ewa Furmanowska Ladorska
Site Name
Clinical Research Center Sp. z o.o. Medic-R sp.k.
Department Name
Site:Clinical Research Center Sp. z o.o., Medic-R Sp. k/ ul. Feliksa Nowowiejskiego 5,61-731 Poznań
Contact Person Name
Marcin Hańczewski
Contact Person Email
marcin.hanczewski@cr-center.pl
Site Name
Vita Longa Sp. z o.o.
Department Name
Site Name: NZOZ "Vita Longa" Sp. z o.o./ ul. Uniczowska 6, 40-748 Katowice
Contact Person Name
Przemysław Ramos
Site Name
Wsd Medi Clinical Sp. z o.o.
Department Name
Site Name: WSD MEDI/ Site Address: Al. Jana Rodowicza "Anody" 22/U4, 02-786 Warszawa
Contact Person Name
Michał Krogulecki
Site Name
Provita Poliklinika Sp. z o.o.
Contact Person Name
Marek Bugajski
Contact Person Email
marek.bugajski@gmail.com
Site Name
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Department Name
Site: TWOJA PRZYCHODNIA Szczecińskie Centrum Medyczne/ ul. Juliusza Słowackiego 19, 71-434 Szczecin
Contact Person Name
Beata Gawdis Wojnarska
Contact Person Email
scm@twojaprzychodnia.com
Site Name
Vistamed & Vertigo Sp. z o.o.
Department Name
Site Name: VISTAMED/ ul. Racławicka 105/1B, 53-149 Wrocław
Contact Person Name
Bernardeta Fryśna
Contact Person Email
b.frysna@vistamed.pl

Czechia

Earliest CTIS Part Ii Submission Date
11-06-2025
Latest Decision Or Authorization Date
07-10-2025
Processing Time Days
118
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Nemocnice Slany
Department Name
Gastroenterology
Contact Person Name
Martin Peterka
Contact Person Email
peterka.studie@seznam.cz
Site Name
Clinoxus s.r.o.
Department Name
Gastroenterology
Contact Person Name
Petr Hrabák
Contact Person Email
petr.hrabak@vfn.cz
Site Name
PreventaMed s.r.o.
Department Name
Gastroenterology
Contact Person Name
Jiří Pumprla
Contact Person Email
pumprla@vilazdravi.cz

Germany

Earliest CTIS Part Ii Submission Date
08-08-2025
Latest Decision Or Authorization Date
08-10-2025
Processing Time Days
61
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik und Poliklinik für Innere Medizin I
Contact Person Name
Arne Kandulski
Contact Person Email
arne.kandulski@ukr.de
Site Name
Goethe University Frankfurt
Department Name
Medizinische Klinik 1
Contact Person Name
Irina Blumenstein

Italy

Earliest CTIS Part Ii Submission Date
05-09-2025
Latest Decision Or Authorization Date
03-10-2025
Processing Time Days
28
Number Of Sites
10
Number Of Participants
16

Sites

Site Name
Azienda Ospedaliera di Padova
Department Name
Department of Surgery, Oncology and Gastroenterology and Gastro
Contact Person Name
Edoardo Vicenzo Savirino
Contact Person Email
edoardo.savarino@unipd.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Internal Medicine and Gastroenterology
Contact Person Name
Antonio Gasbarrini
Contact Person Email
antonio.gasbarrini@unicatt.it
Site Name
Azienda Socio Sanitaria Territoriale Rhodense
Department Name
UO Gastroenterologia ed Endoscopia Digestiva
Contact Person Name
Simone Saibeni
Contact Person Email
saibo@tiscali.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
S.C. General Medicine 1
Contact Person Name
Antonio Di Sabatino
Contact Person Email
a.disabatino@smatteo.pv.it
Site Name
Policlinico San Donato S.p.A.
Department Name
Gastroeneterology
Contact Person Name
Vito Annese
Contact Person Email
vito.annese@grupposandonato.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Unità Malattie Infiammatorie Croniche Intestinali
Contact Person Name
Alessadro Armuzzi
Contact Person Email
alessandro.armuzzi@hunimed.eu
Site Name
Fondazione Poliambulanza
Department Name
UO Gastroenterologia ed Endoscopia Digestiva
Contact Person Name
Paola Cesaro
Contact Person Email
paola.cesaro@poliambulanza.it
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
S.C. Gastroenterologia
Contact Person Name
Marco Daperno
Contact Person Email
mdaperno@gmail.com
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Gastroeneterology and Gastrointestinal Endoscopic unit
Contact Person Name
Silvio Danese
Contact Person Email
danese.silvio@hsr.it
Site Name
IRCCS Ospedale Sacro Cuore Don Calabria
Department Name
Gastroeneterology - IBD Unit
Contact Person Name
Angela Variola
Contact Person Email
angela.variola@sacrocuore.it

Sponsor

Primary sponsor

Full Name
Genentech Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Iqvia Inc.
Responsibilities
CRO Vendor

Third parties

  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"CRO Vendor","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"ePRO Vendor","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"IxRS Vendor","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"Imaging Vendor","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
RO7837195
Active Substance
RO7837195
Modality
Bispecific antibody
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Investigational Product Name
RO7837195 (placebo/control)

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