Clinical trial • Phase II • Immunology|Dermatology
RO7790121 for Moderate to severe atopic dermatitis
Phase II trial of RO7790121 for Moderate to severe atopic dermatitis.
Overview
- Trial Therapeutic Area
- Immunology|Dermatology
- Trial Disease
- Moderate to severe atopic dermatitis
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 13-12-2024
- First CTIS Authorization Date
- 22-04-2025
Trial design
Randomised, ro7790121 (solution for injection/infusion; route: subcutaneous injection) versus ro7790121 placebo. dose and schedule are not specified in the ctis record.-controlled Phase II trial in France, Germany, Italy and others.
- Randomised
- Yes
- Comparator
- RO7790121 (SOLUTION FOR INJECTION/INFUSION; route: SUBCUTANEOUS INJECTION) versus RO7790121 Placebo. Dose and schedule are not specified in the CTIS record.
- Target Sample Size
- 89
Eligibility
Recruits 89 Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms for specific populations are included in the CTIS documents (examples: 'L4_SIS and ICF_Pregnant Partner', 'L5_SIS and ICF_Infant Authorization', infant and pregnancy follow-up ICFs). The presence of Infant Authorization and Pregnant Partner ICFs indicates tailored consent/authorization documents for these groups; detailed consent/assent processes are not explicitly described in the CTIS JSON..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms for specific populations are included in the CTIS documents (examples: 'L4_SIS and ICF_Pregnant Partner', 'L5_SIS and ICF_Infant Authorization', infant and pregnancy follow-up ICFs). The presence of Infant Authorization and Pregnant Partner ICFs indicates tailored consent/authorization documents for these groups; detailed consent/assent processes are not explicitly described in the CTIS JSON.
Inclusion criteria
- {"criterion_text":"- Atopic Dermatitis-Specific AD diagnosis confirmed by a dermatologist according to the Hanifin/Rajka criteria at least 1 year prior to screening\n- Atopic Dermatitis-Specific Moderate to severe AD as defined by – EASI score ≥ 16 at screening and baseline visits, – IGA score ≥ 3 (5-point scale) at screening and baseline visits, and – AD involvement of ≥10% body surface area (BSA) at screening and baseline visits\n- Atopic Dermatitis-Specific At least once daily use of an additive-free, bland emollient for at least 7 days prior to the baseline visit and during the study"}
Exclusion criteria
- {"criterion_text":"- Atopic Dermatitis-Specific 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- Prohibited Medications IV, IM, IL, and oral corticosteroids (inhaled, ophthalmic drops, and nasal corticosteroids are allowed) within 4 weeks of the baseline visit and during the study\n- Prohibited Medications Topical treatment for AD including, but not limited to topical corticosteroids, topical calcineurin Inhibitors, topical PDE-4 inhibitors, , prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea or filaggrin within 7 days prior to the baseline visit and during the study\n- Infection or Infection Risk Any active infection or other active skin diseases that required treatment with parenteral anti-infectives within 4 weeks or oral anti-infective treatment within 2 weeks prior to baseline\n- Infection or Infection Risk Acquired or congenital immunodeficiency Prohibited Medications Systemic therapies that are also used in the treatment of AD, including, but not limited to methotrexate, cyclosporine, azathioprine, mycophenolate mofetil within 4 weeks of the baseline visit and during the study"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Proportion of participants who achieve eczema area and severity index-75 (EASI-75) response (≥ 75% improvement from baseline) Week 16","definition_or_measurement_approach":"EASI-75 response defined as ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI) measured at Week 16."}
Secondary endpoints
- {"endpoint_text":"- 1. Proportion of participants who achieve Investigator global assessment (IGA) score of clear (0) or almost clear (1) with ≥ 2-grade improvement at Week 16 and Week 32","definition_or_measurement_approach":"IGA score of 0 (clear) or 1 (almost clear) with ≥2-grade improvement measured at Week 16 and Week 32."}
- {"endpoint_text":"- 2. Proportion of participants who achieve EASI-75 response at Week 32","definition_or_measurement_approach":"EASI-75 response (≥75% improvement from baseline) measured at Week 32."}
- {"endpoint_text":"- 3. Proportion of participants who achieve EASI-90 response at Week 16 and Week 32","definition_or_measurement_approach":"EASI-90 response (≥90% improvement from baseline) measured at Weeks 16 and 32."}
- {"endpoint_text":"- 4. Percent change from baseline in EASI by visit","definition_or_measurement_approach":"Percent change from baseline in EASI score assessed at each visit."}
- {"endpoint_text":"- 5. Percent change from baseline in peak pruritus Numerical Rating Scale (NRS) score by visit","definition_or_measurement_approach":"Percent change from baseline in peak pruritus NRS score assessed by visit."}
- {"endpoint_text":"- 6. Change from baseline in Dermatology Quality of Life Index at Week 16, Week 32 and by visit","definition_or_measurement_approach":"Change from baseline in Dermatology Life Quality Index (DLQI) measured at Weeks 16 and 32 and at intermediate visits."}
- {"endpoint_text":"- 7. Proportion of EASI-75 responders at week 16","definition_or_measurement_approach":"Proportion achieving EASI-75 at Week 16 (same measure as primary endpoint, additional listing)."}
- {"endpoint_text":"- 8. Incidence and severity of the following: – Adverse events – Serious adverse events – Adverse events leading to study treatment discontinuation – Adverse events of special interest","definition_or_measurement_approach":"Safety endpoints summarising incidence and severity of adverse events, serious adverse events, AEs leading to discontinuation, and AEs of special interest as recorded during the study."}
- {"endpoint_text":"- 9. Change from baseline in selected vital signs","definition_or_measurement_approach":"Change from baseline in selected vital signs measured at scheduled visits."}
- {"endpoint_text":"- 10. Change from baseline in selected clinical laboratory test results","definition_or_measurement_approach":"Change from baseline in selected clinical laboratory test results assessed during study visits."}
- {"endpoint_text":"- 11. Serum concentration of RO7790121 at specified timepoints","definition_or_measurement_approach":"Pharmacokinetic measurement: serum concentration of RO7790121 at predefined timepoints."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 89
- Recruitment Window Months
- 24
- Consent Approach
- Informed consent forms and subject information sheets are provided; main adult ICFs and language-specific versions are present (examples: V2.0ITA, V2.0FRA, V2.0POL, ESP, DEU and English patient-facing documents). Specific ICFs for pregnant partners and an Infant Authorization form are included, and PGx (pharmacogenomics) consent forms are present. Consent is obtained from the participant; infant participation requires authorization (Infant Authorization document) and pregnancy follow-up uses a dedicated ICF. Detailed stepwise consent/assent procedures are not described in the CTIS JSON.
Methods
- Digital patient brochure / digital recruitment materials (CTIS documents: Digital Patient Brochure)
- Social media advertising and clinical trial posts (CTIS documents: Social Media and Clinical Trial Posts)
- Banner advertisements (CTIS documents: Banner Ads)
- Doctor-to-patient letters / Physician referral materials (CTIS documents: Doctor-to-Patient Letter; Physician Referral Letter/Brochure)
- Pre-enrolment information cards and patient posters (CTIS documents: Pre-Enrollment Info Card; Patient Poster)
- Physician referral brochures and site/clinic referral materials
Geography
- Total Number Of Sites
- 36
- Total Number Of Participants
- 71
France
- Earliest CTIS Part Ii Submission Date
- 07-02-2025
- Latest Decision Or Authorization Date
- 19-08-2025
- Processing Time Days
- 193
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- CHU Besancon
- Department Name
- Onco-dermatology
- Principal Investigator Name
- Francois AUBIN
- Principal Investigator Email
- faubin@chu-besancon.fr
- Contact Person Name
- Francois AUBIN
- Contact Person Email
- faubin@chu-besancon.fr
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Onco-dermatology
- Principal Investigator Name
- Anne-Benedicte DUVAL-MODESTE
- Principal Investigator Email
- anne-benedicte.duval-modeste@chu-rouen.fr
- Contact Person Name
- Anne-Benedicte DUVAL-MODESTE
- Contact Person Email
- anne-benedicte.duval-modeste@chu-rouen.fr
- 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
Germany
- Earliest CTIS Part Ii Submission Date
- 27-03-2025
- Latest Decision Or Authorization Date
- 22-01-2026
- Processing Time Days
- 332
- Number Of Sites
- 9
- Number Of Participants
- 15
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
- Thermalsole und Schwefelbad Bentheim GmbH
- Department Name
- Fachklinik Bad Bentheim , 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
- 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
- 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
- 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
- CRS Clinical Research Services Management GmbH
- Principal Investigator Name
- Abir Alatrach
- Principal Investigator Email
- abir.alatrach@crs-group.de
- Contact Person Name
- Abir Alatrach
- Contact Person Email
- abir.alatrach@crs-group.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR (Luebeck)
- Department Name
- Institue for Inflammation Medicine
- Principal Investigator Name
- Diamant Thaci
- Principal Investigator Email
- Diamant.Thaci@uksh.de
- Contact Person Name
- Diamant Thaci
- Contact Person Email
- Diamant.Thaci@uksh.de
- Site Name
- Hms GmbH
- Department Name
- Dermatology
- Principal Investigator Name
- Sebastian Zimmer
- Principal Investigator Email
- sebastian.zimmer@hautmedizin-saar.de
- Contact Person Name
- Sebastian Zimmer
- Contact Person Email
- sebastian.zimmer@hautmedizin-saar.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR (Kiel)
- Department Name
- Department of Dermatology
- Principal Investigator Name
- Sascha Gerdes
- Principal Investigator Email
- sgerdes@dermatology.uni-kiel.de
- Contact Person Name
- Sascha Gerdes
- Contact Person Email
- sgerdes@dermatology.uni-kiel.de
Italy
- Earliest CTIS Part Ii Submission Date
- 14-02-2025
- Latest Decision Or Authorization Date
- 22-08-2025
- Processing Time Days
- 189
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Dermatologia
- Principal Investigator Name
- Silvia Ferrucci
- Principal Investigator Email
- silvia.ferrucci@policlinico.mi.it
- Contact Person Name
- Silvia Ferrucci
- Contact Person Email
- silvia.ferrucci@policlinico.mi.it
- 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 Delle Marche
- Department Name
- SOD CLINICA DI DERMATOLOGIA
- 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
- 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
Spain
- Earliest CTIS Part Ii Submission Date
- 13-02-2025
- Latest Decision Or Authorization Date
- 27-01-2026
- Processing Time Days
- 379
- Number Of Sites
- 8
- Number Of Participants
- 13
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
- 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
- pherranzp@gmail.com
- Contact Person Name
- Pedro Herranz Pinto
- Contact Person Email
- pherranzp@gmail.com
- Site Name
- Hospital General Universitario Dr. Balmis
- Department Name
- Onco-dermatology
- Principal Investigator Name
- Francois AUBIN
- Principal Investigator Email
- faubin@chu-besancon.fr
- Contact Person Name
- Francois AUBIN
- Contact Person Email
- faubin@chu-besancon.fr
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Dermatology
- Principal Investigator Name
- María Ángeles Flórez Menéndez
- Principal Investigator Email
- angeles.florez.menendez@sergas.es
- Contact Person Name
- María Ángeles Flórez Menéndez
- Contact Person Email
- angeles.florez.menendez@sergas.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Dermatology
- Principal Investigator Name
- Esther Serra Baldric
- Principal Investigator Email
- eserra@santpau.cat
- Contact Person Name
- Esther Serra Baldric
- Contact Person Email
- eserra@santpau.cat
- 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
- Hospital Marina Baixa De La Vila Joiosa
- Department Name
- Dermatology
- Principal Investigator Name
- Francisco Javier Mataix Diaz
- Principal Investigator Email
- mataixdiaz@hotmail.com
- Contact Person Name
- Francisco Javier Mataix Diaz
- Contact Person Email
- mataixdiaz@hotmail.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 Inc.
- Responsibilities
- Global CRO
- Name
- CRS Clinical Research Services Management GmbH
- Responsibilities
- Listed as a clinical research services organisation in site listings (responsibilities not specified in sponsor thirdParties list)
Third parties
- {"country":"United Kingdom","full_name":"Q2q Communications Limited","duties_or_roles":"Meeting Organizer","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Electronic Patient Reported Outcomes vendor","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Global CRO","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Mapi Research Trust","duties_or_roles":"Translational Services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Photography","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central laboratory services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Data management / analytics (code 3)","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
- Investigational (no marketing authorisation stated in CTIS record)
- Investigational Product Name
- RO7790121 Placebo
- Modality
- Other
- Authorisation Status
- Not applicable (placebo)
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