Clinical trial • Phase I • Immunology
PIT565 for Rheumatoid arthritis
Phase I trial of PIT565 for Rheumatoid arthritis. open-label, none/not specified-controlled, adaptive. 40 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Rheumatoid arthritis
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 27-03-2025
- First CTIS Authorization Date
- 22-07-2025
Trial design
open-label, none/not specified-controlled, adaptive Phase I trial across 13 sites in France, Germany, Hungary and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- Yes
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 40
Eligibility
Recruits 40 Vulnerable population selected (isVulnerablePopulationSelected = true); no details on consent or assent handling provided in the available record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true); no details on consent or assent handling provided in the available record.
Recruitment
- Planned Sample Size
- 40
- Recruitment Window Months
- 24
Geography
- Total Number Of Sites
- 13
- Total Number Of Participants
- 40
France
- Earliest CTIS Part Ii Submission Date
- 09-05-2025
- Latest Decision Or Authorization Date
- 22-07-2025
- Processing Time Days
- 74
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Bicetre Hospital
- Department Name
- 2001:Rheumatology
- Principal Investigator Name
- Xavier Mariette
- Principal Investigator Email
- xavier.mariette@aphp.fr
- Contact Person Name
- Xavier Mariette
- Contact Person Email
- xavier.mariette@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- 2003:Rheumatology
- Principal Investigator Name
- Jerome Avouac
- Principal Investigator Email
- jerome.avouac@aphp.fr
- Contact Person Name
- Jerome Avouac
- Contact Person Email
- jerome.avouac@aphp.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- 2002:Rheumatology
- Principal Investigator Name
- Divi Cornec
- Principal Investigator Email
- divi.cornec@chu-brest.fr
- Contact Person Name
- Divi Cornec
- Contact Person Email
- divi.cornec@chu-brest.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 23-06-2025
- Latest Decision Or Authorization Date
- 22-07-2025
- Processing Time Days
- 29
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- 1002:I. Medizinische Klinik und Poliklinik
- Principal Investigator Name
- Julia Weinmann-Menke
- Principal Investigator Email
- Julia.weinmann-menke@unimedizin-mainz.de
- Contact Person Name
- Julia Weinmann-Menke
- Contact Person Email
- Julia.weinmann-menke@unimedizin-mainz.de
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- 1001:Klinik für Innere Medizin III, Rheumatologie/Osteologie
- Principal Investigator Name
- Alexander Pfeil
- Principal Investigator Email
- Alexander.Pfeil@med.uni-jena.de
- Contact Person Name
- Alexander Pfeil
- Contact Person Email
- Alexander.Pfeil@med.uni-jena.de
Hungary
- Earliest CTIS Part Ii Submission Date
- 04-07-2025
- Latest Decision Or Authorization Date
- 23-07-2025
- Processing Time Days
- 19
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- University Of Szeged
- Department Name
- 5001 : Phase I unit
- Principal Investigator Name
- Róbert Takács
- Principal Investigator Email
- takacs.robert@med.u-szeged.hu
- Contact Person Name
- Róbert Takács
- Contact Person Email
- takacs.robert@med.u-szeged.hu
- Site Name
- Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
- Department Name
- 50002:Phase I unit
- Principal Investigator Name
- Bernadette Rojkovich
- Principal Investigator Email
- rojkovich.b@gmail.com
- Contact Person Name
- Bernadette Rojkovich
- Contact Person Email
- rojkovich.b@gmail.com
Romania
- Earliest CTIS Part Ii Submission Date
- 23-06-2025
- Latest Decision Or Authorization Date
- 28-07-2025
- Processing Time Days
- 35
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Arensia Clinics S.R.L.
- Department Name
- 6001: Internal Medicin
- Principal Investigator Name
- Mihai Abobului
- Principal Investigator Email
- mihai.abobului.ext@arensia-em.com
- Contact Person Name
- Mihai Abobului
- Contact Person Email
- mihai.abobului.ext@arensia-em.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Cluj
- Department Name
- 6002: Rheumatology
- Principal Investigator Name
- Daniela Fodor
- Principal Investigator Email
- daniela.fodor.ext@arensia-em.com
- Contact Person Name
- Daniela Fodor
- Contact Person Email
- daniela.fodor.ext@arensia-em.com
Spain
- Earliest CTIS Part Ii Submission Date
- 04-07-2025
- Latest Decision Or Authorization Date
- 24-07-2025
- Processing Time Days
- 20
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- 8001:Rheumatology
- Principal Investigator Name
- Eva Perez Pampin
- Principal Investigator Email
- eva.perez.pampin@sergas.es
- Contact Person Name
- Eva Perez Pampin
- Contact Person Email
- eva.perez.pampin@sergas.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- 8002:Rheumatology
- Principal Investigator Name
- Maria Lopez Lasanta
- Principal Investigator Email
- maria.lopezlasanta@vallhebron.cat
- Contact Person Name
- Maria Lopez Lasanta
- Contact Person Email
- maria.lopezlasanta@vallhebron.cat
Netherlands
- Earliest CTIS Part Ii Submission Date
- 11-07-2025
- Latest Decision Or Authorization Date
- 22-07-2025
- Processing Time Days
- 11
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- Centre for Human Drug Research
- Department Name
- 9001: Internal Medicine
- Principal Investigator Name
- Naomi Klarenbeek
- Principal Investigator Email
- nklarenbeek@chdr.nl
- Contact Person Name
- Naomi Klarenbeek
- Contact Person Email
- nklarenbeek@chdr.nl
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 23-06-2025
- Latest Decision Or Authorization Date
- 25-07-2025
- Processing Time Days
- 32
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Multispecialty hospital for active treatment Sveta Sofia EOOD
- Department Name
- 1101: Department of Internal Diseases
- Principal Investigator Name
- Silviya Naydenova
- Principal Investigator Email
- silviya.naydenova.ext@arensia-em.com
- Contact Person Name
- Silviya Naydenova
- Contact Person Email
- silviya.naydenova.ext@arensia-em.com
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- PIT565
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