Clinical trial • Phase II • Immunology
Human IgG1 monoclonal antibody against human IL-1 beta and human IL-18 for Still's disease
Phase II trial of Human IgG1 monoclonal antibody against human IL-1 beta and human IL-18 for Still's disease. open-label, none/not specified-controlled.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Still's disease
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody | Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 04-07-2025
- First CTIS Authorization Date
- 28-10-2025
Trial design
open-label, none/not specified-controlled Phase II trial across 17 sites in France, Germany, Netherlands and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 15
- Trial Duration For Participant
- 1269
Eligibility
Recruits 15 paediatric patients.
- Pregnancy Exclusion
- Pregnant or breastfeeding women
- Vulnerable Population
- Vulnerable population selected: the study includes paediatric participants (age ≥1). Consent/assent handling documented: parent/legal guardian informed consent forms and parent/legal guardian ICFs are provided; child assent and adolescent assent forms are provided. Country-specific ICF/assent documents are included in multiple languages (English, French, German, Dutch, Spanish, Italian) according to the uploaded documents.
Inclusion criteria
- {"criterion_text":"- Age ≥ 1 with a diagnosis of Still’s disease\n- Active disease\n- Need for glucocorticoids (prednisone or equivalent)"}
Exclusion criteria
- {"criterion_text":"- Ongoing or previous treatment with immunomodulatory drugs as outlined in the protocol’s Prohibited therapies section, except a limited number of patients that have previously received MAS825 through a managed access program.\n- Glucocorticoid dose exceeding a certain threshold or requiring IV pulsed glucocorticoid therapy\n- Any conditions or significant medical problems which, in the opinion of the investigator, places the patient at unacceptable risk for MAS825 therapy.\n- History of ongoing, chronic or possibly recurrent infection(s) (e.g. HIV, TB, HCV, HBV) and/or symptoms and signs, in the judgement of the investigator, of clinically significant active bacterial, fungal, or viral infections.\n- Live vaccinations within a certain period prior to MAS825 treatment.\n- History of malignancy of any organ system, including post-transplant lymphoproliferative disorder (other than adequately treated localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within a certain period, regardless of whether there is evidence of local recurrence or metastases.\n- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or to any of the excipients.\n- Pregnant or breastfeeding women\n- Women of child-bearing potential who do not agree to comply with required contraceptive use."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Clinical response defined by achieving a composite endpoint","definition_or_measurement_approach":"Not specified in the provided record."}
Secondary endpoints
- {"endpoint_text":"- Adverse events and serious adverse events. Safety measures including vital signs, ECG and laboratory assessments throughout the study","definition_or_measurement_approach":"Not specified in the provided record."}
- {"endpoint_text":"- Clinical response defined by achieving a composite endpoint","definition_or_measurement_approach":"Not specified in the provided record."}
- {"endpoint_text":"- Change in physician´s assessment. Change in laboratory features of Macrophage Activation Syndrome","definition_or_measurement_approach":"Not specified in the provided record."}
- {"endpoint_text":"- Glucocorticoid dose compared to baseline","definition_or_measurement_approach":"Not specified in the provided record."}
- {"endpoint_text":"- Change from baseline in patient/parent assessment of physical function","definition_or_measurement_approach":"Not specified in the provided record."}
- {"endpoint_text":"- Clinically inactive disease whilst on non‑treatment dose corticosteroid at any time during the study","definition_or_measurement_approach":"Not specified in the provided record."}
Recruitment
- Planned Sample Size
- 15
- Recruitment Window Months
- 41
- Consent Approach
- Informed consent is documented with adult main ICFs for adult participants; for paediatric participants parent/legal guardian informed consent forms are provided and child/adolescent assent forms are provided. Country- and language-specific ICFs and assent forms are included (documents in English, French, German, Dutch, Spanish, Italian). There are also follow-up ICFs for pregnant participants/partners where applicable.
Geography
- Total Number Of Sites
- 17
- Total Number Of Participants
- 15
France
- Earliest CTIS Part Ii Submission Date
- 29-09-2025
- Latest Decision Or Authorization Date
- 01-12-2025
- Processing Time Days
- 63
- Number Of Sites
- 7
- Number Of Participants
- 7
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- 3005: Internal Medecine
- Principal Investigator Name
- Sophie GEORGIN-LAVIALLE
- Principal Investigator Email
- Sophie.georgin@aphp.fr
- Contact Person Name
- Sophie GEORGIN-LAVIALLE
- Contact Person Email
- Sophie.georgin@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- 3003: Pediatric
- Principal Investigator Name
- Eric HACHULLA
- Principal Investigator Email
- Eric.hachulla@chru-lille.fr
- Contact Person Name
- Eric HACHULLA
- Contact Person Email
- Eric.hachulla@chru-lille.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- 3002:Rhumatologie
- Principal Investigator Name
- Marie-Lise TRUCHETET
- Principal Investigator Email
- Marie-elise.truchetet@chu-bordeaux.fr
- Contact Person Name
- Marie-Lise TRUCHETET
- Contact Person Email
- Marie-elise.truchetet@chu-bordeaux.fr
- Site Name
- Bicetre Hospital
- Department Name
- 3006:Immunology-Hematology and Rhumatology
- Principal Investigator Name
- Isabelle KONE PAUT
- Principal Investigator Email
- Isabelle.kone-paut@bct.aphp.fr
- Contact Person Name
- Isabelle KONE PAUT
- Contact Person Email
- Isabelle.kone-paut@bct.aphp.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- 3001:Pediatric Rhumatology
- Principal Investigator Name
- Alexandre BELOT
- Principal Investigator Email
- Alexandre.belot@chu-lyon.fr
- Contact Person Name
- Alexandre BELOT
- Contact Person Email
- Alexandre.belot@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- 3003:Internal Medicine
- Principal Investigator Name
- Eric HACHULLA
- Principal Investigator Email
- Eric.hachulla@chru-lille.fr
- Contact Person Name
- Eric HACHULLA
- Contact Person Email
- Eric.hachulla@chru-lille.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- 3004:Immuno-Hematology-Pediatric Rhumatology
- Principal Investigator Name
- Pierre QUARTIER-DIT-Maire
- Principal Investigator Email
- pierre.quartier@aphp.fr
- Contact Person Name
- Pierre QUARTIER-DIT-Maire
- Contact Person Email
- pierre.quartier@aphp.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 18-09-2025
- Latest Decision Or Authorization Date
- 23-01-2026
- Processing Time Days
- 127
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- Universitaet Muenster
- Department Name
- 4002:Klinik für Pädiatrische Rheumatologie und Immunologie
- Principal Investigator Name
- Dirk Foll
- Principal Investigator Email
- dfoell@uni-muenster.de
- Contact Person Name
- Dirk Foll
- Contact Person Email
- dfoell@uni-muenster.de
- Site Name
- Asklepios Klinik Sankt Augustin GmbH
- Department Name
- 4003:Kinderklinik
- Principal Investigator Name
- Gerd Horneff
- Principal Investigator Email
- g.horneff@asklepios.com
- Contact Person Name
- Gerd Horneff
- Contact Person Email
- g.horneff@asklepios.com
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- 4001:Med. Klinik V, Klinik für Haematologie, Onkologie, Rheumatologie
- Principal Investigator Name
- Norbert Blank
- Principal Investigator Email
- Norbert.blank@med.uni-heidelberg.de
- Contact Person Name
- Norbert Blank
- Contact Person Email
- Norbert.blank@med.uni-heidelberg.de
Netherlands
- Earliest CTIS Part Ii Submission Date
- 16-10-2025
- Latest Decision Or Authorization Date
- 02-12-2025
- Processing Time Days
- 47
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- 6001:Rheumatology & clinical immunology
- Principal Investigator Name
- Bas Vastert
- Principal Investigator Email
- B.Vastert@umcutrecht.nl
- Contact Person Name
- Bas Vastert
- Contact Person Email
- B.Vastert@umcutrecht.nl
Spain
- Earliest CTIS Part Ii Submission Date
- 26-09-2025
- Latest Decision Or Authorization Date
- 23-01-2026
- Processing Time Days
- 119
- Number Of Sites
- 3
- Number Of Participants
- 2
Sites
- Site Name
- Hospital Sant Joan De Deu Barcelona
- Department Name
- #7003: Reumatología pediátrica
- Principal Investigator Name
- Jordi Anton Lopez
- Principal Investigator Email
- jordi.anton@sjd.es
- Contact Person Name
- Jordi Anton Lopez
- Contact Person Email
- jordi.anton@sjd.es
- Site Name
- Hospital Universitario La Paz
- Department Name
- #7001: Medicina Interna
- Principal Investigator Name
- Angel Robles Marhuenda
- Principal Investigator Email
- aroblesmarhuenda@gmail.com
- Contact Person Name
- Angel Robles Marhuenda
- Contact Person Email
- aroblesmarhuenda@gmail.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- #7002: Reumatología pediátrica
- Principal Investigator Name
- Lucia LaCruz Perez
- Principal Investigator Email
- lacruz_lucper@gva.es
- Contact Person Name
- Lucia LaCruz Perez
- Contact Person Email
- lacruz_lucper@gva.es
Italy
- Earliest CTIS Part Ii Submission Date
- 24-07-2025
- Latest Decision Or Authorization Date
- 06-03-2026
- Processing Time Days
- 225
- Number Of Sites
- 3
- Number Of Participants
- 2
Sites
- Site Name
- IRCCS Istituto Giannina Gaslini
- Department Name
- #5003: U.O.C. Clinica Pediatrica e Reumatologia
- Principal Investigator Name
- Roberta Caorsi
- Principal Investigator Email
- robertacaorsi@gaslini.org
- Contact Person Name
- Roberta Caorsi
- Contact Person Email
- robertacaorsi@gaslini.org
- Site Name
- Ospedale Pediatrico Bambino Gesu
- Department Name
- #5001: U.O.C. Reumatologia
- Principal Investigator Name
- Claudia Bracaglia
- Principal Investigator Email
- claudia.bracaglia@opgb.net
- Contact Person Name
- Claudia Bracaglia
- Contact Person Email
- claudia.bracaglia@opgb.net
- Site Name
- Azienda Ospedaliera Universitaria Meyer IRCCS
- Department Name
- #5002: U.O. Reumatologia
- Principal Investigator Name
- Gabriele Simonini
- Principal Investigator Email
- gabriele.simonini@meyer.it
- Contact Person Name
- Gabriele Simonini
- Contact Person Email
- gabriele.simonini@meyer.it
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Parexel International (IRL) Limited
- Responsibilities
- sponsorDuties codes: [12]
- Name
- IQVIA Limited
- Responsibilities
- sponsorDuties codes: [1]
- Name
- Icon Clinical Research Limited
- Responsibilities
- sponsorDuties codes: [1]
- Name
- Syneos Health Inc.
- Responsibilities
- sponsorDuties codes: [1]
- Name
- 4g Clinical LLC
- Responsibilities
- sponsorDuties codes: [3]
Third parties
- {"country":"Switzerland","full_name":"Novartis Pharma AG","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Somalogic Operating Co. Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Eurofins Central Laboratory B.V.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"Denmark","full_name":"Eurofins Genomics Europe AgriGenomics Products & Services A/S","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: [12]","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Provision of ancillary supplies to site (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: [1]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [6]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [1]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"France","full_name":"SGS France","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"Illingworth Research Group Limited","duties_or_roles":"sponsorDuties codes: [13]","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: [1]","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- MAS825
- Active Substance
- Human IgG1 monoclonal antibody against human IL-1 beta and human IL-18
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS | SUBCUTANEOUS | INTRAMUSCULAR
- Route
- INTRAVENOUS | SUBCUTANEOUS | INTRAMUSCULAR
- Investigational Product Name
- Glucocorticoids (auxiliary product)
- Active Substance
- Glucocorticoids (ATC H02AB)
- Modality
- Small molecule
- Routes Of Administration
- UNKNOWN USE
- Route
- UNKNOWN
- Combination Treatment
- Yes
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