Clinical trial • Phase I • Immunology
PIT565 for Systemic lupus erythematosus
Phase I trial of PIT565 for Systemic lupus erythematosus. open-label, none/not specified-controlled, adaptive. 12 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Systemic lupus erythematosus
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 17-05-2024
- First CTIS Authorization Date
- 09-09-2024
Trial design
open-label, none/not specified-controlled, adaptive Phase I trial across 10 sites in Bulgaria, Germany, Spain and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True, ascending dose (dose-escalation) study with step-up doses to assess safety, tolerability and pharmacokinetics; detailed escalation rules, interim analyses, and stopping rules not provided in the CTIS record.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 12
Eligibility
Recruits 12 Vulnerable population selected; no details on consent or assent handling provided in the CTIS record..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent handling provided in the CTIS record.
Recruitment
- Planned Sample Size
- 12
- Recruitment Window Months
- 32
Geography
- Total Number Of Sites
- 10
- Total Number Of Participants
- 32
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 12-08-2024
- Latest Decision Or Authorization Date
- 16-09-2024
- Processing Time Days
- 35
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Medical Center Comac Medical Ltd.
- Department Name
- #1004
- Contact Person Name
- Rumen Stoilov
- Contact Person Email
- rmstoilov@abv.bg
Germany
- Earliest CTIS Part Ii Submission Date
- 12-08-2024
- Latest Decision Or Authorization Date
- 12-09-2024
- Processing Time Days
- 31
- Number Of Sites
- 3
- Number Of Participants
- 16
Sites
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- 1002: I. Medizinische Klinik und Poliklinik
- Contact Person Name
- Julia Weinmann-Menke
- Contact Person Email
- Julia.weinmann-menke@unimedizin-mainz.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- 1014:Klinik für Nephrologie und Infektiologie
- Contact Person Name
- Sebastian Dolff
- Contact Person Email
- Sebastian.dolff@uk-essen.de
- Site Name
- Charite Research Organisation GmbH
- Department Name
- 1001
- Contact Person Name
- Stanislav Ignatenko
- Contact Person Email
- Stanislav.ignatenko@charite-research.org
Spain
- Earliest CTIS Part Ii Submission Date
- 28-03-2024
- Latest Decision Or Authorization Date
- 19-09-2024
- Processing Time Days
- 175
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- #1006: Rheumatology
- Contact Person Name
- Eva Maria Perez Pampin
- Contact Person Email
- eva.perez.pampin@sergas.es
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- #1013; Rheumatology
- Contact Person Name
- Maria Jesus Garcia Villanueva
- Contact Person Email
- machusgv@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- #1005: Rheumatology
- Contact Person Name
- Josefina Cortes Hernandez
- Contact Person Email
- fina.cortes@vhir.org
Netherlands
- Earliest CTIS Part Ii Submission Date
- 30-08-2024
- Latest Decision Or Authorization Date
- 12-09-2024
- Processing Time Days
- 13
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Centre for Human Drug Research
- Department Name
- #1003: Internal Medicine
- Contact Person Name
- Naomi Klarenbeek
- Contact Person Email
- nklarenbeek@chdr.nl
Hungary
- Earliest CTIS Part Ii Submission Date
- 14-07-2025
- Latest Decision Or Authorization Date
- 22-08-2025
- Processing Time Days
- 39
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Semmelweis University
- Department Name
- 1011: Belgyógyászati és Onkológiai Klinika, Klinikai Farmakológiai részleg
- Contact Person Name
- István Takács
- Contact Person Email
- takacs.istvan@semmelweis.hu
- Site Name
- University Of Szeged
- Department Name
- 1010: Szent-Györgyi Albert Klinikai Központ, Klinikai Farmakológiai Központ, Fázis I. vizsgálóhely
- Principal Investigator Name
- Róbert Takács
- Contact Person Name
- Róbert Takács
- Contact Person Email
- takacs.robert@med.u-szeged.hu
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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