Clinical trial • Phase II • Dermatology|Immunology
RO7790121 for Atopic dermatitis
Phase II trial of RO7790121 for Atopic dermatitis. 76 participants.
Overview
- Trial Therapeutic Area
- Dermatology|Immunology
- Trial Disease
- Atopic dermatitis
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 31-07-2025
- First CTIS Authorization Date
- 13-11-2025
Trial design
Phase II trial in Germany, Italy, Spain and others.
- Target Sample Size
- 76
Eligibility
Recruits 76 Vulnerable population selected. Country-specific subject information and informed consent forms available including documents titled 'L4_SIS and ICF_Infant Authorization_san' and 'L3_SIS and ICF_Pregnant Partner_san' (and multiple country-specific ICFs listed for FR/IT/ES/PL). Infant Authorization and Pregnant Partner consent forms are included among the published ICFs, indicating specific consent procedures/documents for infants and pregnant partners (parental/guardian authorisation documents present)..
- Vulnerable Population
- Vulnerable population selected. Country-specific subject information and informed consent forms available including documents titled 'L4_SIS and ICF_Infant Authorization_san' and 'L3_SIS and ICF_Pregnant Partner_san' (and multiple country-specific ICFs listed for FR/IT/ES/PL). Infant Authorization and Pregnant Partner consent forms are included among the published ICFs, indicating specific consent procedures/documents for infants and pregnant partners (parental/guardian authorisation documents present).
Inclusion criteria
- {"criterion_text":"- Ability and willingness to comply with all aspects of the protocol including completion of the efficacy assessments (EASI and IGA), clinical outcome assessment instruments (DLQI, POEM), and safety and PK sample collections for the duration of the study\n- Agreement to adhere to the contraception requirements\n- Completed the treatment period of the parent study"}
Exclusion criteria
- {"criterion_text":"- Evidence of other skin conditions that would interfere with the assessment of AD, including, but not limited to, for example cutaneous T-cell lymphoma, allergic contact dermatitis\n- Withdrawal of consent and/or premature discontinuation from parent study\n- Any permanent discontinuation of study drug in parent study\n- Use of a prohibited therapy during the parent study\n- Investigator determination that treatment discontinuation is in the best interest of the participant\n- History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of afimkibart"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence and severity of adverse events, serious adverse events, adverse events leading to study treatment discontinuation, adverse events of special interest","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Change and percent change from baseline (in parent study) in Eczema Area and Severity Index (EASI) score at each visit","definition_or_measurement_approach":"Change and percent change from parent study baseline in EASI score measured at each visit"}
- {"endpoint_text":"- Proportion of participants with EASI50/75/90 at each visit","definition_or_measurement_approach":"Proportion of participants achieving ≥50/75/90% improvement in EASI at each visit"}
- {"endpoint_text":"- Proportion of participants achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) of clear (0) or almost clear (1) with more than or equal to 2-grade improvement from baseline (in the parent study) at each visit","definition_or_measurement_approach":"Proportion of participants with vIGA-AD = 0 or 1 and ≥2-grade improvement from parent-study baseline at each visit"}
- {"endpoint_text":"- Change from parent baseline (in the parent study) in Participant-Oriented Eczema Measure (POEM) at each visit","definition_or_measurement_approach":"Change from parent-study baseline in POEM score measured at each visit"}
- {"endpoint_text":"- Change from parent baseline (in the parent study) in Dermatology Life Quality Index (DLQI) at each visit","definition_or_measurement_approach":"Change from parent-study baseline in DLQI score measured at each visit"}
- {"endpoint_text":"- Change from baseline (in the parent study) in selected clinical laboratory test results","definition_or_measurement_approach":"Change from parent-study baseline in selected clinical laboratory parameters (specific tests not detailed here)"}
- {"endpoint_text":"- Change from baseline in selected vital signs","definition_or_measurement_approach":"Change from baseline in selected vital signs measured at scheduled visits"}
- {"endpoint_text":"- Serum concentration of afimkibart at specified timepoints","definition_or_measurement_approach":"Serum concentration (PK) of afimkibart measured at specified timepoints"}
- {"endpoint_text":"- Incidence and titres of ADA and NAb","definition_or_measurement_approach":"Incidence and titres of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) measured per immunogenicity assays"}
Recruitment
- Planned Sample Size
- 76
- Recruitment Window Months
- 93
- Consent Approach
- Country-specific subject information and informed consent forms are provided (published ICFs listed for France, Italy, Spain, Poland and versions in multiple languages). Documents include main ICFs, pregnancy ICFs, pregnant-partner ICFs and an 'Infant Authorization' form. Consent is via the provided subject information and informed consent forms; infant-specific authorization and pregnant-partner forms are included indicating parental/partner-specific consent documentation. Languages available in the submitted documents include English, French, Italian, Spanish and Polish (country-specific ICF versions are listed).
Geography
- Total Number Of Sites
- 30
- Total Number Of Participants
- 49
Germany
- Earliest CTIS Part Ii Submission Date
- 10-10-2025
- Latest Decision Or Authorization Date
- 13-11-2025
- Processing Time Days
- 34
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- Dermatologikum Hamburg GmbH
- Principal Investigator Name
- Peter Weisenseel
- Principal Investigator Email
- p.weisenseel@dermatologikum.de
- Contact Person Name
- Peter Weisenseel
- Contact Person Email
- p.weisenseel@dermatologikum.de
- Site Name
- Deutsches Rotes Kreuz Gemeinnuetzige Krankenhaus GmbH Sachsen
- Department Name
- Hautklinik
- Principal Investigator Name
- Martin Kaatz
- Principal Investigator Email
- kaatz.martin@drk-khs.de
- Contact Person Name
- Martin Kaatz
- Contact Person Email
- kaatz.martin@drk-khs.de
- Site Name
- Thermalsole und Schwefelbad Bentheim GmbH
- Department Name
- Klinisches Studienzentrum
- Principal Investigator Name
- Athanasios Tsianakas
- Principal Investigator Email
- a.tsianakas@fk-bentheim.de
- Contact Person Name
- Athanasios Tsianakas
- Contact Person Email
- a.tsianakas@fk-bentheim.de
- Site Name
- Harzklinikum Dorothea Christiane Erxleben GmbH
- Department Name
- Klinik für Dermatologie & Allergologie
- Principal Investigator Name
- Christiane Schreck
- Principal Investigator Email
- christiane.schreck@harzklinikum.com
- Contact Person Name
- Christiane Schreck
- Contact Person Email
- christiane.schreck@harzklinikum.com
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Klinik für Dermatologie und Venerologie
- Principal Investigator Name
- Kilian Eyerich
- Principal Investigator Email
- kilian.eyerich@uniklinik-freiburg.de
- Contact Person Name
- Kilian Eyerich
- Contact Person Email
- kilian.eyerich@uniklinik-freiburg.de
Italy
- Earliest CTIS Part Ii Submission Date
- 24-10-2025
- Latest Decision Or Authorization Date
- 20-11-2025
- Processing Time Days
- 27
- Number Of Sites
- 4
- Number Of Participants
- 5
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Dermatologia
- Principal Investigator Name
- Ketty Peris
- Principal Investigator Email
- ketty.peris@unicatt.it
- Contact Person Name
- Ketty Peris
- Contact Person Email
- ketty.peris@unicatt.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
- Department Name
- UOC Dermatologia
- Principal Investigator Name
- Giuseppe Micali
- Principal Investigator Email
- gmicalitrial@gmail.com
- Contact Person Name
- Giuseppe Micali
- Contact Person Email
- gmicalitrial@gmail.com
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- Department of clinical and Molecular Science
- Principal Investigator Name
- Oriana Simonetti
- Principal Investigator Email
- oriana.simonetti@ospedaliriuniti.marche.it
- Contact Person Name
- Oriana Simonetti
- Contact Person Email
- oriana.simonetti@ospedaliriuniti.marche.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Dermatology
- Principal Investigator Name
- Silvia Mariel Ferrucci
- Principal Investigator Email
- silvia.ferrucci@policlinico.mi.it
- Contact Person Name
- Silvia Mariel Ferrucci
- Contact Person Email
- silvia.ferrucci@policlinico.mi.it
Spain
- Earliest CTIS Part Ii Submission Date
- 31-10-2025
- Latest Decision Or Authorization Date
- 17-11-2025
- Processing Time Days
- 17
- Number Of Sites
- 7
- Number Of Participants
- 8
Sites
- Site Name
- Clinica Universidad De Navarra (Pamplona)
- Department Name
- Dermatology
- Principal Investigator Name
- Rafael Salido Vallejo
- Principal Investigator Email
- rsalidov@unav.es
- Contact Person Name
- Rafael Salido Vallejo
- Contact Person Email
- rsalidov@unav.es
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Dermatology
- Principal Investigator Name
- Juan Alberto Ruano Ruiz
- Principal Investigator Email
- juanruanoruiz@mac.com
- Contact Person Name
- Juan Alberto Ruano Ruiz
- Contact Person Email
- juanruanoruiz@mac.com
- Site Name
- Clinica Universidad De Navarra (Madrid)
- Department Name
- Dermatology
- Principal Investigator Name
- Rafael Salido Vallejo
- Principal Investigator Email
- rsalidov@unav.es
- Contact Person Name
- Rafael Salido Vallejo
- Contact Person Email
- rsalidov@unav.es
- Site Name
- Hospital Universitario La Paz
- Department Name
- Dermatology
- Principal Investigator Name
- Pedro Herranz Pinto
- Principal Investigator Email
- pedro.herranz@salud.madrid.org
- Contact Person Name
- Pedro Herranz Pinto
- Contact Person Email
- pedro.herranz@salud.madrid.org
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Dermatology
- Principal Investigator Name
- Esther Serra Baldrich
- Principal Investigator Email
- eserra@santpau.cat
- Contact Person Name
- Esther Serra Baldrich
- Contact Person Email
- eserra@santpau.cat
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Dermatology
- Principal Investigator Name
- Maria Angeles Florez Menendez
- Principal Investigator Email
- angeles.florez.menendez@sergas.es
- Contact Person Name
- Maria Angeles Florez Menendez
- Contact Person Email
- angeles.florez.menendez@sergas.es
- Site Name
- Clinica Universidad De Navarra (additional site)
- Department Name
- Dermatology
- Principal Investigator Name
- Rafael Salido Vallejo
- Principal Investigator Email
- rsalidov@unav.es
- Contact Person Name
- Rafael Salido Vallejo
- Contact Person Email
- rsalidov@unav.es
Poland
- Earliest CTIS Part Ii Submission Date
- 24-10-2025
- Latest Decision Or Authorization Date
- 21-11-2025
- Processing Time Days
- 28
- Number Of Sites
- 12
- Number Of Participants
- 23
Sites
- Site Name
- Pratia S.A. (Gdynia)
- Department Name
- Centrum Medyczne Pratia Gdynia
- Principal Investigator Name
- Dominika Bielińska-Warężak
- Principal Investigator Email
- dbielinska@pratia.pl
- Contact Person Name
- Dominika Bielińska-Warężak
- Contact Person Email
- dbielinska@pratia.pl
- Site Name
- Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski, Paweł Brzewski S.C.
- Principal Investigator Name
- Paweł Brzewski
- Principal Investigator Email
- brzewski@sgd-polska.com
- Contact Person Name
- Paweł Brzewski
- Contact Person Email
- brzewski@sgd-polska.com
- Site Name
- Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
- Principal Investigator Name
- Małgorzata Dyczek
- Principal Investigator Email
- malgorzata.dyczek@dobrylekarz.com.pl
- Contact Person Name
- Małgorzata Dyczek
- Contact Person Email
- malgorzata.dyczek@dobrylekarz.com.pl
- Site Name
- Pratia S.A. (Katowice)
- Department Name
- Centrum Medyczne Pratia Katowice
- Principal Investigator Name
- Santa Vanaga-Besser
- Principal Investigator Email
- svbesser.pratia@gmail.com
- Contact Person Name
- Santa Vanaga-Besser
- Contact Person Email
- svbesser.pratia@gmail.com
- Site Name
- Medical Network Sp. z o.o.
- Department Name
- Medical Network Spółka z o. o. WIP Warsaw IBD Point
- Principal Investigator Name
- Agnieszka Kardynał
- Principal Investigator Email
- agnieszka.kardynal@gmail.com
- Contact Person Name
- Agnieszka Kardynał
- Contact Person Email
- agnieszka.kardynal@gmail.com
- Site Name
- Dermoklinika Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak
- Principal Investigator Name
- Joanna Narbutt
- Principal Investigator Email
- joanna.narbutt@dermoklinika.pl
- Contact Person Name
- Joanna Narbutt
- Contact Person Email
- joanna.narbutt@dermoklinika.pl
- Site Name
- Klinika Ambroziak Sp. z o.o.
- Department Name
- Klinika Ambroziak Dermatologia
- Principal Investigator Name
- Monika Kałowska
- Principal Investigator Email
- principalkalowska@klinikaambroziak.pl
- Contact Person Name
- Monika Kałowska
- Contact Person Email
- principalkalowska@klinikaambroziak.pl
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o. (Warsaw)
- Department Name
- MICS Centrum Medyczne Warszawa Chłodna
- Principal Investigator Name
- Joanna Kolinek
- Principal Investigator Email
- joannakolinek@medycynakliniczna.pl
- Contact Person Name
- Joanna Kolinek
- Contact Person Email
- joannakolinek@medycynakliniczna.pl
- Site Name
- Royalderm Agnieszka Nawrocka
- Principal Investigator Name
- Witold Owczarek
- Principal Investigator Email
- witold.owczarek@dermedicus.pl
- Contact Person Name
- Witold Owczarek
- Contact Person Email
- witold.owczarek@dermedicus.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
- Department Name
- Klinika Dermatologii i Dermatologii Onkologicznej
- Principal Investigator Name
- Adam Reich
- Principal Investigator Email
- adamandrzejreich@gmail.com
- Contact Person Name
- Adam Reich
- Contact Person Email
- adamandrzejreich@gmail.com
- Site Name
- Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Królicki
- Principal Investigator Name
- Katarzyna Turek-Urasińska
- Principal Investigator Email
- katarzyna.urasinska@wp.pl
- Contact Person Name
- Katarzyna Turek-Urasińska
- Contact Person Email
- katarzyna.urasinska@wp.pl
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o. (Torun)
- Department Name
- MICS Centrum Medyczne Toruń
- Principal Investigator Name
- Aleksandra Badzian
- Principal Investigator Email
- aleksandra.badzian@mics.medicover.com
- Contact Person Name
- Aleksandra Badzian
- Contact Person Email
- aleksandra.badzian@mics.medicover.com
France
- Earliest CTIS Part Ii Submission Date
- 14-11-2025
- Latest Decision Or Authorization Date
- 30-01-2026
- Processing Time Days
- 77
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Dermatology
- Principal Investigator Name
- Marie JACHIET
- Principal Investigator Email
- marie.jachiet@aphp.fr
- Contact Person Name
- Marie JACHIET
- Contact Person Email
- marie.jachiet@aphp.fr
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Onco-dermatology
- Principal Investigator Name
- Anne-Bénédicte DUVAL-MODESTE
- Principal Investigator Email
- anne-benedicte.duval-modeste@chu-rouen.fr
- Contact Person Name
- Anne-Bénédicte DUVAL-MODESTE
- Contact Person Email
- anne-benedicte.duval-modeste@chu-rouen.fr
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
- CRO
Third parties
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"IxRS Provider","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Lilly Corporate Center","duties_or_roles":"Other Third Party Duty","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Clario Medical Imaging Inc.","duties_or_roles":"Clinical Outcome Assessment (eCOA, ePRO) Provider","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Cardiff University","duties_or_roles":"Other Third Party Duty","organisation_type":"Educational Institution"}
- {"country":"France","full_name":"Mapi Research Trust","duties_or_roles":"Other Third Party Duty","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central Laboratory Provider","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- RO7790121
- Active Substance
- RO7790121
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- prodAuthStatus=1
- Investigational Product Name
- RO7790121 placebo/diluent
- Modality
- Other
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