Clinical trial • Phase III • Haematology | Rare Disease
DEPEMOKIMAB for Hypereosinophilic syndrome
Phase III trial of DEPEMOKIMAB for Hypereosinophilic syndrome.
Overview
- Trial Therapeutic Area
- Haematology | Rare Disease
- Trial Disease
- Hypereosinophilic syndrome
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 02-07-2024
- First CTIS Authorization Date
- 01-08-2024
Trial design
Randomised, placebo comparator arms: 'placebo for depemokimab injection' (matching subcutaneous injection) and 'placebo for prednisolone' (matching oral prednisolone). standard of care prednisolone is allowed/used (prednisolone oral, up to 40 mg daily per product information). specific depemokimab dose and schedule not stated in the available ctis records.-controlled Phase III trial across 31 sites in Belgium, Czechia, Denmark and others.
- Randomised
- Yes
- Comparator
- Placebo comparator arms: 'Placebo for Depemokimab Injection' (matching subcutaneous injection) and 'Placebo for Prednisolone' (matching oral prednisolone). Standard of care prednisolone is allowed/used (PREDNISOLONE oral, up to 40 mg daily per product information). Specific depemokimab dose and schedule not stated in the available CTIS records.
- Target Sample Size
- 84
- Trial Duration For Participant
- 364
Eligibility
Recruits 84 The trial selects vulnerable populations flag is true in the registry. Consent requirement: participants must be capable of giving signed informed consent as described in protocol Section 10.1. All participants must provide signed informed consent themselves (no provision for assent of minors; minimum age for participation is ≥18 years)..
- Pregnancy Exclusion
- Pregnancy
- Vulnerable Population
- The trial selects vulnerable populations flag is true in the registry. Consent requirement: participants must be capable of giving signed informed consent as described in protocol Section 10.1. All participants must provide signed informed consent themselves (no provision for assent of minors; minimum age for participation is ≥18 years).
Inclusion criteria
- {"criterion_text":"- Participant must be ≥18 years of age, at the time of signing the informed consent."}
- {"criterion_text":"- Participants who are ≥40 kg at Screening Visit 1."}
- {"criterion_text":"- Participants who have a documented diagnosis of HES prior to Visit 2. HES diagnosis is based on: • blood eosinophilia of >1,500 eosinophils/μL on at least 2 occasions at ≥1 month interval, without a discernible non haematological secondary cause, and • signs or symptoms of organ involvement and/or dysfunction that can be directly related to eosinophilia"}
- {"criterion_text":"- Flare history: A history of 2 or more HES flares within the past 12 months prior to Visit 1. Historical HES flares are defined as documented HES-related worsening of clinical symptoms or blood eosinophil counts requiring an addition or escalation in OCS or cytotoxic/immunosuppressive therapy. At least 1 HES flare within the past 12 months must not be related to a decrease in HES therapy during the 4 weeks prior to the flare."}
- {"criterion_text":"- Male or female participants • A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: • Is a woman of non-childbearing potential (WONCBP) as defined in protocol Section 10.4, Appendix 4 OR • Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in, Section 10.4, Appendix 4, from at least 14 days prior to the first dose of study intervention until at least 30 weeks after the last administered dose of study intervention. The Investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention."}
- {"criterion_text":"- Capable of giving signed informed consent as described in protocol Section 10.1 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol."}
Exclusion criteria
- {"criterion_text":"- HES disease manifestations which in the opinion of the Investigator may put the participant at unacceptable risk from study participation or confound interpretation of efficacy or safety data. Specific consideration should be given to the participant's ability to comply with protocol requirements, including the list of prohibited therapies; exclusion criteria no. 13 - 16."}
- {"criterion_text":"- COVID-19: Participants that, according to the Investigator's medical judgment, are likely to have active COVID-19 infection should be excluded. Participants with known COVID-19 positive contacts within the past 14 days must be excluded for at least 14 days following the exposure during which the participant must remain symptom-free."}
- {"criterion_text":"- Other concurrent medical conditions that may affect the participant's safety: Participants who have known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological, respiratory, cardiac or any other system abnormalities that are not associated with HES and are uncontrolled with standard treatment."}
- {"criterion_text":"- Hypersensitivity: Participants with an allergy/ intolerance to a monoclonal antibody or biologic, or any of the excipients of the investigational product in protocol Section 6.1."}
- {"criterion_text":"- Monoclonal antibodies (mAb) targeting IL-5/5R: Participants who have a previous documented failure with anti-IL-5/5R therapy, based on investigator's discretion."}
- {"criterion_text":"- mAbs: Participants who have received mAb within 30 days or 5 halflives, whichever is longer, prior to Visit 1 (other than approved mAbs for the treatment of COVID-19). If a participant has been treated with and responsive to biologics for HES, the participant should not stop the treatment for study eligibility purpose."}
- {"criterion_text":"- Non oral systemic corticosteroids: Participants who have received intravenous, intramuscular, or subcutaneous corticosteroids within 4- weeks prior to Visit 2."}
- {"criterion_text":"- Investigational medications/clinical study: • Participants who have received treatment with an investigational agent within 30 days or 5 drug half-lives whichever is longer, prior to Visit 1. The term \"investigational\" applies to any drug not approved for sale in the country in which it is being used or investigational formulations of marketed products. • Participants who are currently participating in any other interventional clinical study."}
- {"criterion_text":"- FIP1L1-PDGFRα Status: Participants who test positive for the FIP1L1-PDGFRα fusion gene (i.e., participants with the myeloid-variant HES are excluded). Blood sampling is required for all participants at Screening (Visit 1) for this test unless the documented result is available."}
- {"criterion_text":"- ECG Assessment: QTcF ≥450 msec or QTcF ≥480 msec for participants with Bundle Branch Block at Screening Visit 1."}
- {"criterion_text":"- OCS responsiveness: Participants who are not responsive to OCS based on clinical response or blood eosinophil counts in the opinion of the Investigator."}
- {"criterion_text":"- Infection: • Participants with chronic or ongoing active infections requiring systemic treatment. • Participants with a pre-existing parasitic infestation within 6 months prior to Visit 1."}
- {"criterion_text":"- Alcohol/Substance Abuse"}
- {"criterion_text":"- Pregnancy"}
- {"criterion_text":"- Participants who have known evidence of lack of adherence to controller medications and/or ability to follow physician’s recommendations."}
- {"criterion_text":"- Immunodeficiency: Participants with a known immunodeficiency (e.g., HIV), other than that explained by the use of oral corticosteroid (OCS) or other therapy taken for HES."}
- {"criterion_text":"- Malignancy: • Participants with a history of or current lymphoma. • Participants with current malignancy or previous history of cancer in remission for less than 5 years prior to Visit 1. Participants that had localized carcinoma (i.e., basal or squamous cell) of the skin which was resected for cure will not be excluded. • Participants with a haematologic malignancy with hypereosinophilia in which HES is not the primary diagnosis, e.g., chronic myeloid leukaemia, myelodysplastic syndrome, chronic eosinophilic leukaemia-not otherwise specified."}
- {"criterion_text":"- Liver disease: • Cirrhosis or current unstable liver or biliary disease per Investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, persistent jaundice. NOTE: Stable non cirrhotic chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B or C) is acceptable if participant otherwise meets entry criteria."}
- {"criterion_text":"- Cardiovascular: Participants who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment."}
- {"criterion_text":"- Vasculitis: Participants with current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at Screening will be evaluated and current vasculitis must be excluded prior to randomization."}
- {"criterion_text":"- Eosinophilia of unknown significance: Hypereosinophila with no clinical symptoms and/or proof of organ dysfunction."}
- {"criterion_text":"- Clinical diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Frequency of HES flares during the 52-week study intervention period","definition_or_measurement_approach":"Number (frequency) of HES flares occurring during the 52-week intervention period; measured as count of flares over the 52-week study intervention period."}
Secondary endpoints
- {"endpoint_text":"- Time to first HES flare (days)","definition_or_measurement_approach":"Measured in days from randomisation/first dose to occurrence of first HES flare."}
- {"endpoint_text":"- At least one HES flare during the 52-week study intervention period","definition_or_measurement_approach":"Binary outcome indicating whether the participant experienced ≥1 HES flare during the 52-week intervention period."}
- {"endpoint_text":"- Change from Baseline to Week 52 in Brief Fatigue Inventory (BFI) item 3 weekly average score.","definition_or_measurement_approach":"Change from baseline to Week 52 in weekly average score of BFI item 3."}
- {"endpoint_text":"- Change from Baseline to Week 24 in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a score","definition_or_measurement_approach":"Change from baseline to Week 24 in PROMIS Fatigue SF 7a score as reported by participant questionnaires."}
Recruitment
- Registry Or Advocacy Recruitment
- True, Patient advocacy groups (PAG) materials are explicitly listed (advocacy_PAG patient FAQ brochure, PAG enewsletter, site_to_PAG_intro_letter).
- Digital Remote Recruitment
- True, the presence of website prescreener documents, patient website materials and vendor platform/eCOA/telemedicine (Science 37, eCOA/eSource) indicates digital/remote recruitment and remote data capture methods.
- Planned Sample Size
- 84
- Recruitment Window Months
- 61
- Consent Approach
- Informed consent must be signed by the participant (participants must be ≥18 and 'capable of giving signed informed consent' per protocol Section 10.1). Subject information and ICF documents (L1_SIS and ICF_Main and versions) are available in multiple country/language-specific versions (document lists include English, Spanish, Romanian, Czech, Danish, German, Greek, Italian, Polish and Belgian language versions including French/Dutch). No assent process for minors is described (minimum age 18).
Methods
- Site-based recruitment using patient brochures, doctor-to-patient letters and site materials (K2_Recruitment material_dr_to_pt_letter; K2 patient brochure) – target: patients with HES attending participating hospitals (country-specific site materials present).
- Patient advocacy group (PAG) engagement and materials (advocacy_PAG_patient_FAQ_brochure, PAG enewsletter, site_to_PAG_intro_letter) – target: patient advocacy organisations and their members/contacts in multiple countries.
- Website prescreener and online study prescreener materials (K2_Recruitment material_website_prescreener; Recruitment Arrangement_prescreener_EN) – digital prescreening to identify potentially eligible participants.
- Study webpages / patient website materials (K2_Recruitment material_patient_website) – online information for prospective participants.
- Local language patient-facing materials and lay person slide decks / flipcharts / flowcharts to support site recruitment and patient understanding (multiple K2 materials, flowchart, flipchart, study_overview_slide_deck).
- Visit reminder cards and study visit guides for participants (visit_reminder_card, study_visit_guide) to support retention and attendance.
- Healthcare professional outreach via study overview slide decks and doctor-to-patient letters to referring clinicians (K2_Recruitment material_study_overview_slide_deck; dr_to_pt_letter).
- Telemedicine / remote platform support (vendor platform and eCOA/diary, eSource, telemedicine listed among vendor responsibilities) to enable remote assessments and e-consent/patient-reported outcomes.
Geography
- Total Number Of Sites
- 31
- Total Number Of Participants
- 36
Belgium
- Latest Decision Or Authorization Date
- 01-08-2024
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Hopital Erasme
- Department Name
- Internal Medicine
- Principal Investigator Name
- Florence Roufosse
- Principal Investigator Email
- froufoss@ulb.ac.be
- Contact Person Name
- Florence Roufosse
- Contact Person Email
- froufoss@ulb.ac.be
Czechia
- Latest Decision Or Authorization Date
- 01-08-2024
- Number Of Sites
- 4
- Number Of Participants
- 1
Sites
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Ustav klinicke imunologie a alergologie
- Principal Investigator Name
- Irena Krcmova
- Principal Investigator Email
- irena.krcmova@fnhk.cz
- Contact Person Name
- Irena Krcmova
- Contact Person Email
- irena.krcmova@fnhk.cz
- Site Name
- Krajska zdravotni a.s.
- Department Name
- Oddeleni klinicke imunologie a alergologie
- Principal Investigator Name
- Dalibor Jilek
- Principal Investigator Email
- dalibor.jilek@kcrz.eu
- Contact Person Name
- Dalibor Jilek
- Contact Person Email
- dalibor.jilek@kcrz.eu
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Interni hematologicka a onkologicka klinika
- Principal Investigator Name
- Michael Doubek
- Principal Investigator Email
- doubek.michael@fnbrno.cz
- Contact Person Name
- Michael Doubek
- Contact Person Email
- doubek.michael@fnbrno.cz
- Site Name
- Fakultni Thomayerova nemocnice
- Department Name
- Ambulance bronchialni obstrukce
- Principal Investigator Name
- Lucie Heribanova
- Principal Investigator Email
- Lucie.heribanova@ftn.cz
- Contact Person Name
- Lucie Heribanova
- Contact Person Email
- Lucie.heribanova@ftn.cz
Denmark
- Latest Decision Or Authorization Date
- 05-08-2024
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Odense University Hospital
- Department Name
- Hæmatologisk Afdeling X
- Principal Investigator Name
- Gunhild Nynke Thomsen
- Principal Investigator Email
- Gunhild.nynke.thomsen@rsyd.dk
- Contact Person Name
- Gunhild Nynke Thomsen
- Contact Person Email
- Gunhild.nynke.thomsen@rsyd.dk
Germany
- Latest Decision Or Authorization Date
- 07-08-2024
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Klinikum Bad Bramstedt GmbH
- Department Name
- Klinik fuer Rheumatologie und Immunologie
- Principal Investigator Name
- Ina Koetter
- Principal Investigator Email
- ina.koetter@klinikumbb.de
- Contact Person Name
- Ina Koetter
- Contact Person Email
- ina.koetter@klinikumbb.de
- Site Name
- Universitaetsklinikum Mannheim GmbH
- Department Name
- Universitaetsmedizin Mannheim, III. Med. Klinik, Haematologie und Onkologie
- Principal Investigator Name
- Juliana Schwaab
- Principal Investigator Email
- Juliana.Schwaab@medma.uni-heidelberg.de
- Contact Person Name
- Juliana Schwaab
- Contact Person Email
- Juliana.Schwaab@medma.uni-heidelberg.de
Greece
- Latest Decision Or Authorization Date
- 23-10-2024
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Evaggelismos Hospital
- Department Name
- Hematology-Lymphomas Dept. and BMT Unit
- Principal Investigator Name
- Maria Pagoni
- Principal Investigator Email
- marianpagoni@yahoo.com
- Contact Person Name
- Maria Pagoni
- Contact Person Email
- marianpagoni@yahoo.com
Italy
- Latest Decision Or Authorization Date
- 05-08-2024
- Number Of Sites
- 9
- Number Of Participants
- 6
Sites
- Site Name
- Universita' Vita-salute S. Raffaele
- Department Name
- Unit of Immunology, Rheumatology, Allergy and Rare Diseases
- Principal Investigator Name
- Lorenzo Dagna
- Principal Investigator Email
- dagna.lorenzo@unisr.it
- Contact Person Name
- Lorenzo Dagna
- Contact Person Email
- dagna.lorenzo@unisr.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- U.O.C. of Hematology and Bone
- Principal Investigator Name
- Fabrizio Pane
- Principal Investigator Email
- fabrizio.pane@unina.it
- Contact Person Name
- Fabrizio Pane
- Contact Person Email
- fabrizio.pane@unina.it
- Site Name
- Azienda Ospedaliero-Universitaria Maggiore Della Carita
- Department Name
- SCDU Hematology
- Principal Investigator Name
- Andrea Patriarca
- Principal Investigator Email
- andrea.patriarca@unipo.it
- Contact Person Name
- Andrea Patriarca
- Contact Person Email
- andrea.patriarca@unipo.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- U.O. Hematology
- Principal Investigator Name
- Cristina Papayannidis
- Principal Investigator Email
- cristina.papayannidis@unibo.it
- Contact Person Name
- Cristina Papayannidis
- Contact Person Email
- cristina.papayannidis@unibo.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- UOC Hematology
- Principal Investigator Name
- Elena Chiara
- Principal Investigator Email
- c.elena@smatteo.pv.it
- Contact Person Name
- Elena Chiara
- Contact Person Email
- c.elena@smatteo.pv.it
- Site Name
- Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
- Department Name
- UOC Internal Medicine
- Principal Investigator Name
- Francesco Cinetto
- Principal Investigator Email
- francesco.cine@gmail.com
- Contact Person Name
- Francesco Cinetto
- Contact Person Email
- francesco.cine@gmail.com
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Internal Medicine
- Principal Investigator Name
- Simonetta Friso
- Principal Investigator Email
- simonetta.friso@univr.it
- Contact Person Name
- Simonetta Friso
- Contact Person Email
- simonetta.friso@univr.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- +390630157803
- Principal Investigator Name
- Maria Antonietta D’Agostino
- Principal Investigator Email
- mariaantonietta.dagostino@policlinicogemelli.it
- Contact Person Name
- Maria Antonietta D’Agostino
- Contact Person Email
- mariaantonietta.dagostino@policlinicogemelli.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
- Department Name
- Department of Medical sciences and surgical specialties, Hematology Section
- Principal Investigator Name
- Alessandra Romano
- Principal Investigator Email
- sandrina.romano@gmail.com
- Contact Person Name
- Alessandra Romano
- Contact Person Email
- sandrina.romano@gmail.com
Romania
- Latest Decision Or Authorization Date
- 02-08-2024
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Spitalul Clinic Colentina Bucuresti
- Department Name
- Hematology
- Principal Investigator Name
- Georgeta Daniela Georgescu
- Principal Investigator Email
- dana1601@yahoo.com
- Contact Person Name
- Georgeta Daniela Georgescu
- Contact Person Email
- dana1601@yahoo.com
- Site Name
- Spitalul Clinic Colentina Bucuresti
- Department Name
- Hematology
- Principal Investigator Name
- Viola Maria Popov
- Principal Investigator Email
- violamariap@gmail.com
- Contact Person Name
- Viola Maria Popov
- Contact Person Email
- violamariap@gmail.com
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Hematology
- Principal Investigator Name
- Mihnea Tudor Zdrenghea
- Principal Investigator Email
- mzdrenghea@umfcluj.ro
- Contact Person Name
- Mihnea Tudor Zdrenghea
- Contact Person Email
- mzdrenghea@umfcluj.ro
Spain
- Latest Decision Or Authorization Date
- 02-08-2024
- Number Of Sites
- 8
- Number Of Participants
- 6
Sites
- Site Name
- Hospital Universitario Virgen De Las Nieves
- Department Name
- Hematology
- Principal Investigator Name
- Concepción Morales
- Principal Investigator Email
- concepcion.morales.sspa@juntadeandalucia.es
- Contact Person Name
- Concepción Morales
- Contact Person Email
- concepcion.morales.sspa@juntadeandalucia.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Hematology
- Principal Investigator Name
- Georgina Espigol
- Principal Investigator Email
- gespigol@clinic.cat
- Contact Person Name
- Georgina Espigol
- Contact Person Email
- gespigol@clinic.cat
- Site Name
- Hospital Universitario Infanta Leonor
- Department Name
- Hematology
- Principal Investigator Name
- Jose Angel Hernandez Rivas
- Principal Investigator Email
- jahernandezr@salud.madrid.org
- Contact Person Name
- Jose Angel Hernandez Rivas
- Contact Person Email
- jahernandezr@salud.madrid.org
- Site Name
- Hospital Unviersitario Miguel Servet
- Department Name
- Hematology
- Principal Investigator Name
- Gonzalo Caballero
- Principal Investigator Email
- gcaballeron@salud.aragon.es
- Contact Person Name
- Gonzalo Caballero
- Contact Person Email
- gcaballeron@salud.aragon.es
- Site Name
- Hospital Universitario HLA Moncloa
- Department Name
- Hematology
- Principal Investigator Name
- Concepcion Alaez Uson
- Principal Investigator Email
- concha.alaez@gmail.com
- Contact Person Name
- Concepcion Alaez Uson
- Contact Person Email
- concha.alaez@gmail.com
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Hematology
- Principal Investigator Name
- Jesus María Hernandez Rivas
- Principal Investigator Email
- jmhr@usal.es
- Contact Person Name
- Jesus María Hernandez Rivas
- Contact Person Email
- jmhr@usal.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Hematology
- Principal Investigator Name
- Elvira Mora
- Principal Investigator Email
- Mora_elv@gva.es
- Contact Person Name
- Elvira Mora
- Contact Person Email
- Mora_elv@gva.es
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Hematology
- Principal Investigator Name
- Aranzazu Alonso
- Principal Investigator Email
- aranzazu.alonso@quironsalud.es
- Contact Person Name
- Aranzazu Alonso
- Contact Person Email
- aranzazu.alonso@quironsalud.es
Poland
- Latest Decision Or Authorization Date
- 04-08-2024
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
- Department Name
- Oddzial Kliniczny Chorob Wewnetrznych, Astmy i Alergii
- Principal Investigator Name
- Marta Kołacińska-Flont
- Principal Investigator Email
- marta.kolacinska-flont@umed.lodz.pl
- Contact Person Name
- Marta Kołacińska-Flont
- Contact Person Email
- marta.kolacinska-flont@umed.lodz.pl
- Site Name
- Wojewodzki Szpital Specjalistyczny Im. Sw. Rafala W Czerwonej Gorze
- Department Name
- Oddzial IV Alergologiczny
- Principal Investigator Name
- Piotr Lacwik
- Principal Investigator Email
- lacwik@gmail.com
- Contact Person Name
- Piotr Lacwik
- Contact Person Email
- lacwik@gmail.com
Sponsor
Primary sponsor
- Full Name
- Glaxosmithkline Research & Development Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Contract research organisations
- Name
- Syneos Health Inc.
- Responsibilities
- Vendor management
- Name
- Science 37 Inc.
- Responsibilities
- Platform and eCOA/diary, eSource, eCOA, Telemedicine
- Name
- WCG Clinical Inc.
- Responsibilities
- Study questionnaire licensing and translations
- Name
- eResearchTechnology GmbH
- Responsibilities
- ECG analysis; eCoA/Cardiac safety
Third parties
- {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Qualitymetric Incorporated LLC","duties_or_roles":"Study questionnaire licensing and translations","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Corevitas LLC","duties_or_roles":"Participant optional feedback questionnaire","organisation_type":"Pharmaceutical company"}
- {"country":"Romania","full_name":"Syneos Health Romania S.R.L.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"ECG analysis; eCoA/Cardiac safety","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Illingworth Research Group Limited","duties_or_roles":"Patient Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Greece","full_name":"Syneos Health Hellas Single Member S.A.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Study questionnaire licensing and translations","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Science 37 Inc.","duties_or_roles":"Platform and eCOA/diary, eSource, eCOA, Telemedicine","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Primera Analytical Solutions Corp.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Vendor management","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Flatiron Health Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Acetaminophen Toxicity Diagnostics LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Long term storage of the samples: optional exploratory serum/urine/whole blood RNA biomarker samples","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Depemokimab (solution for injection)
- Active Substance
- DEPEMOKIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous use
- Route
- Subcutaneous
- Authorisation Status
- Authorised (PRD5046670) as sponsor product entry in CTIS
- Investigational Product Name
- Placebo for Depemokimab Injection
- Modality
- Other
- Investigational Product Name
- Placebo for Prednisolone
- Modality
- Other
- Investigational Product Name
- Prednisolone (auxiliary / standard of care)
- Active Substance
- PREDNISOLONE
- Modality
- Small molecule
- Routes Of Administration
- Oral use
- Route
- Oral
- Authorisation Status
- Marketed product (product entry with EU substance number SUB10018MIG)
- Frequency
- Up to 40 mg daily (max daily dose amount listed as 40 mg)
- Maximum Dose
- 40 mg daily
- Combination Treatment
- Yes
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