Clinical trial • Phase II • Immunology | Musculoskeletal

RO7790121 for Rheumatoid arthritis (moderate to severe)

Phase II trial of RO7790121 for Rheumatoid arthritis (moderate to severe).

Overview

Trial Therapeutic Area
Immunology | Musculoskeletal
Trial Disease
Rheumatoid arthritis (moderate to severe)
Trial Stage
Phase II
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
01-08-2025
First CTIS Authorization Date
23-11-2025

Trial design

Randomised, ro7790121 placebo (placebo comparator); no dose or schedule specified in the provided ctis data-controlled Phase II trial in Belgium, France, Germany and others.

Randomised
Yes
Comparator
RO7790121 placebo (placebo comparator); no dose or schedule specified in the provided CTIS data
Target Sample Size
97
Trial Duration For Participant
98

Eligibility

Recruits 97 Vulnerable population selected. Subject information and informed consent forms and authorisation documents are listed for infants and pregnant partners (e.g. 'L1_ICF_Infant Authorisation', 'L1_ICF_Pregnant Partner Authorisation', 'L1_Infant ICF' variants). Specific consent/assent procedures or who provides consent (parent/guardian) are not detailed in the provided data..

Vulnerable Population
Vulnerable population selected. Subject information and informed consent forms and authorisation documents are listed for infants and pregnant partners (e.g. 'L1_ICF_Infant Authorisation', 'L1_ICF_Pregnant Partner Authorisation', 'L1_Infant ICF' variants). Specific consent/assent procedures or who provides consent (parent/guardian) are not detailed in the provided data.

Inclusion criteria

  • {"criterion_text":"- Have moderate to severe active RA defined by the presence of ≥ 6 swollen joints and ≥ 6 tender joints at screening and baseline (based on 66/68-joint count)\n- Agreement to adhere to the contraception requirements\n- Diagnosis of RA for ≥ 3 months and also fulfills the 2010 American College of Rheumatology (ACR)/ European Alliance of Associations for Rheumatology (EULAR) classification criteria for RA\n- Demonstrated an inadequate response or loss of response to or intolerance to one or more TNF/JAK inhibitor(s)"}

Exclusion criteria

  • {"criterion_text":"- Class IV RA according to ACR revised response criteria\n- Any major surgery within 6 weeks prior to screening or a major surgery planned during the study\n- History of organ transplant\n- Acquired or congenital immunodeficiency"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from baseline in DAS28-CRP at Week 14","definition_or_measurement_approach":"Change from baseline in Disease Activity Score-28 C-Reactive Protein (DAS28-CRP) at Week 14"}

Secondary endpoints

  • {"endpoint_text":"- ACR20 response rate at Week 14","definition_or_measurement_approach":"ACR20 response rate at Week 14 (American College of Rheumatology 20 response)"}
  • {"endpoint_text":"- ACR50 response rate at Week 14","definition_or_measurement_approach":"ACR50 response rate at Week 14"}
  • {"endpoint_text":"- ACR70 response rate at Week 14","definition_or_measurement_approach":"ACR70 response rate at Week 14"}
  • {"endpoint_text":"- Change from baseline in DAS28-ESR at Week 14","definition_or_measurement_approach":"Change from baseline in DAS28-ESR at Week 14"}
  • {"endpoint_text":"- Change from baseline in SDAI score at Week 14","definition_or_measurement_approach":"Change from baseline in SDAI score at Week 14"}
  • {"endpoint_text":"- Change from baseline in CDAI score at Week 14","definition_or_measurement_approach":"Change from baseline in CDAI score at Week 14"}
  • {"endpoint_text":"- Change from baseline in SF-36 score at Week 14","definition_or_measurement_approach":"Change from baseline in SF-36 score at Week 14"}
  • {"endpoint_text":"- Incidence and severity of the following: - Adverse events - Serious adverse events - Adverse events leading to study treatment discontinuation - Adverse events of special interest - Change from baseline in selected vital signs - Change from baseline in selected clinical laboratory test results","definition_or_measurement_approach":"Incidence and severity of listed safety events and changes from baseline in selected vital signs and clinical laboratory results"}
  • {"endpoint_text":"- Serum concentration of RO7790121 at specified timepoints","definition_or_measurement_approach":"Serum concentration (PK) of RO7790121 measured at specified timepoints"}

Recruitment

Planned Sample Size
97
Recruitment Window Months
19
Consent Approach
Informed consent obtained using Main ICF; additional ICFs exist for infant authorisation and pregnant partner authorisation. ICFs and participant information documents are available in multiple languages as provided (examples in English, French, Dutch, Polish, Italian, German, Spanish). Specific assent procedures and exact consent-signing roles are not detailed in the provided data.

Methods

  • Clinic posters (country-specific clinic posters listed in recruitment documents)
  • Participant information sheets and recruitment materials (country-specific Participant Information Sheet documents listed)
  • Thank you/consideration letters (country-specific documents listed)
  • Recruitment arrangements documents submitted per country (K1/K2 recruitment arrangements files listed)

Geography

Total Number Of Sites
33
Total Number Of Participants
63

Belgium

Earliest CTIS Part Ii Submission Date
22-10-2025
Latest Decision Or Authorization Date
25-11-2025
Processing Time Days
34
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
UZ Leuven
Department Name
Rheumatology
Contact Person Name
Barbara Neerinckx
Contact Person Email
barbara.neerinckx@uzleuven.be
Site Name
Hopital Erasme
Department Name
Rheumatology and Physical Medicine
Contact Person Name
Joëlle Margaux
Contact Person Email
joelle.margaux@hubruxelles.be

France

Earliest CTIS Part Ii Submission Date
24-10-2025
Latest Decision Or Authorization Date
25-11-2025
Processing Time Days
32
Number Of Sites
5
Number Of Participants
6

Sites

Site Name
Centre Hospitalier Regional De Marseille
Department Name
Rhumatologie
Contact Person Name
Thao PHAM
Contact Person Email
thao.pham@ap-hm.fr
Site Name
Hopital Cochin Saint Vincent De Paul
Department Name
Rhumatologie
Contact Person Name
Jérôme Avouac
Contact Person Email
jerome.avouac@inserm.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Rhumatologie
Contact Person Name
Jacques Morel
Contact Person Email
j-morel@chu-montpellier.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Rhumatologie
Contact Person Name
Jacques-Eric Gottenberg
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Rhumatologie
Contact Person Name
Arnaud Constantin
Contact Person Email
constantin.a@chu-toulouse.fr

Germany

Earliest CTIS Part Ii Submission Date
23-10-2025
Latest Decision Or Authorization Date
25-11-2025
Processing Time Days
33
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Department Name
Rheumazentrum Ruhrgebiet
Contact Person Name
Ioana Andreica
Site Name
Studienambulanz Rheumazentrum Ratingen GbR
Department Name
1. Medizinische Klinik
Contact Person Name
Siegfried Wassenberg
Contact Person Email
studien@rhzr.de
Site Name
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Department Name
Hamburger Rheuma Forschungszentrum II
Contact Person Name
Daniela Andrea Everding
Contact Person Email
studienzentrum@hotmail.com
Site Name
Staedtisches Klinikum Dresden
Department Name
1. Medizinische Klinik
Contact Person Name
Olaf Nestler

Italy

Earliest CTIS Part Ii Submission Date
24-10-2025
Latest Decision Or Authorization Date
24-11-2025
Processing Time Days
31
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
Rheumatology
Contact Person Name
Andreina Manfredi
Site Name
Humanitas Mirasole S.p.A.
Department Name
Division of Rheumatology and Metabolism
Contact Person Name
Elisa Gremese
Contact Person Email
elisa.gremese@hunimed.eu
Site Name
Azienda Ospedaliera di Padova
Department Name
Department of Medicine
Contact Person Name
Margherita Zen
Contact Person Email
margherita.zen@unipd.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Rheumatology
Contact Person Name
Maria Antonietta D'Agostino

Poland

Earliest CTIS Part Ii Submission Date
03-11-2025
Latest Decision Or Authorization Date
25-11-2025
Processing Time Days
22
Number Of Sites
8
Number Of Participants
30

Sites

Site Name
Reumed Sp. z o.o.
Department Name
Zespół Poradni Specjalistycznych REUMED filia nr 1 Wallenroda
Contact Person Name
Robert Zwolak
Contact Person Email
zwolakr@wp.pl
Site Name
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
Department Name
Twoja Przychodnia NCM
Contact Person Name
Małgorzata Miakisz
Contact Person Email
ncm@twojaprzychodnia.com
Site Name
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
Department Name
Centrum Kliniczno – Badawcze J. Brzezicki,B. Górnikiewicz-Brzezicka Lekarze Spółka Partnerska
Contact Person Name
Jan Brzezicki
Contact Person Email
kontakt@ckb.elblag.pl
Site Name
Klinika Reuma Park Sp. z o.o. S.K.
Department Name
Centrum Medyczne Reuma Park
Contact Person Name
Janusz Jaworski
Contact Person Email
januszjaworski@ymail.com
Site Name
Malopolskie Badania Kliniczne Sp. z o.o.
Department Name
Małopolskie Badania Kliniczne Sp. z o.o.
Contact Person Name
Bogdan Batko
Contact Person Email
b.batko@mbk.clinic
Site Name
Reumatop Grzegorz Rozumek Karin Pistorius Sp. j.
Department Name
Reumatop Grzegorz Rozumek Karin Pistorius Sp. j.
Contact Person Name
Grzegorz Rozumek
Contact Person Email
klinika@reumatop.pl
Site Name
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Department Name
Centrum Wsparcia Badań Klinicznych
Contact Person Name
Brygida Kwiatkowska
Contact Person Email
cwbk@spartanska.pl
Site Name
BIF-MED
Department Name
NZOZ Bif-Med S.C. Arkadiusz Wawiernia, Mariola Roykiewicz, Rafał Roykiewicz
Contact Person Name
Hanna Mastalerz
Contact Person Email
hannamastalerz@wp.pl

Denmark

Earliest CTIS Part Ii Submission Date
10-11-2025
Latest Decision Or Authorization Date
23-11-2025
Processing Time Days
13
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Region Hovedstaden
Department Name
Department of Rheumatology
Contact Person Name
Bjarke Brandt Hansen
Site Name
Region Sjaelland
Department Name
Rheumatological Department
Contact Person Name
Ada Colic
Contact Person Email
adco@regionsjaelland.dk

Spain

Earliest CTIS Part Ii Submission Date
31-10-2025
Latest Decision Or Authorization Date
26-11-2025
Processing Time Days
26
Number Of Sites
8
Number Of Participants
7

Sites

Site Name
Hospital Quironsalud Infanta Luisa
Department Name
rheumatology
Contact Person Name
Nadia Abdel-Kader Martin
Contact Person Email
abdelmartin@hotmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
rheumatology
Contact Person Name
Jose Javier Perez Venegas
Contact Person Email
perez.venegas@gmail.com
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
rheumatology
Contact Person Name
Francisco Javier Blanco Garcia
Contact Person Email
fblagar@sergas.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
rheumatology
Contact Person Name
Antonio Fernandez Nebro
Contact Person Email
afnebro@gmail.com
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
rheumatology
Contact Person Name
Eva Maria Pérez Pampín
Site Name
Hospital Universitari Vall D Hebron
Department Name
rheumatology
Contact Person Name
Maria America Lopez Lasanta
Site Name
Hospital Universitario Reina Sofia
Department Name
rheumatology
Contact Person Name
Alejandro Escudero Contreras
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
rheumatology
Contact Person Name
Jose María Alvaro-Gracia
Contact Person Email
jalvarogracia@gmail.com

Sponsor

Primary sponsor

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

Contract research organisations

Name
IQVIA Limited
Responsibilities
Study Management Provider
Name
Icon Clinical Research Limited
Responsibilities
COA translation services
Name
Pharmaceutical Product Development LLC
Responsibilities
Central Laboratory Provider
Name
Labcorp Central Laboratory Services SARL
Responsibilities
Central Laboratory Provider
Name
Q2 Solutions LLC
Responsibilities
Central Laboratory Provider
Name
Eresearchtechnology Inc.
Responsibilities
Clinical Outcome Assessment (eCOA, ePRO) Provider
Name
Perceptive Informatics Inc.
Responsibilities
IxRS Provider

Third parties

  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"COA translations for VAS scales","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Clinical Outcome Assessment (eCOA, ePRO) Provider","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Study Management Provider","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Qualitymetric Incorporated LLC","duties_or_roles":"COA licensing and translations for the SF-36v2","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"IxRS Provider","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"COA translation services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Central Laboratory Provider","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Mapi Research Trust","duties_or_roles":"COA licensing","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central Laboratory Provider","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"Central Laboratory Provider","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
RO7790121
Active Substance
RO7790121
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Investigational Product Name
RO7790121 placebo
Modality
Other

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