Clinical trial • Phase I • Immunology
OM336 for Sjogren's syndrome|Idiopathic inflammatory myopathy
Phase I trial of OM336 for Sjogren's syndrome|Idiopathic inflammatory myopathy. open-label. 31 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Sjogren's syndrome|Idiopathic inflammatory myopathy
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 18-12-2025
- First CTIS Authorization Date
- 21-04-2026
Trial design
open-label Phase I trial across 1 site in Czechia.
- Open Label
- Yes
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 31
Recruitment
- Planned Sample Size
- 31
- Recruitment Window Months
- 25
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 31
Czechia
- Earliest CTIS Part Ii Submission Date
- 16-02-2026
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 64
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- Revmatologicky Ustav
- Department Name
- Vědeckovýzkumné centrum
- Contact Person Name
- Jiří Vencovský
- Contact Person Email
- vencovsky@revma.cz
Sponsor
Primary sponsor
- Full Name
- Ouro Medicines Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Investigational products
- Investigational Product Name
- OM336
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