Clinical trial • Phase III • Immunology
icotrokinra for Inflammatory conditions
Phase III trial of icotrokinra for Inflammatory conditions. 64 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Inflammatory conditions
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 25-04-2025
- First CTIS Authorization Date
- 16-06-2025
Trial design
Phase III trial across 2 sites in Belgium.
- Target Sample Size
- 64
Eligibility
Recruits 64 Vulnerable populations not included; only healthy volunteers selected; no special consent or assent handling is mentioned in the available documents..
- Vulnerable Population
- Vulnerable populations not included; only healthy volunteers selected; no special consent or assent handling is mentioned in the available documents.
Recruitment
- Planned Sample Size
- 64
- Recruitment Window Months
- 13
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 64
Belgium
- Earliest CTIS Part Ii Submission Date
- 10-06-2025
- Latest Decision Or Authorization Date
- 03-03-2026
- Processing Time Days
- 266
- Number Of Sites
- 2
- Number Of Participants
- 64
Sites
- Site Name
- Janssen Pharmaceutica
- Department Name
- Clinical Pharmacology Unit
- Contact Person Name
- Ann Uyt den Houwen
- Contact Person Email
- auytdenh@its.jnj.com
- Site Name
- SGS Belgium
- Department Name
- SGS Clinical Pharmacology Unit
- Contact Person Name
- Katrin Van Leuven
- Contact Person Email
- Katrin.VanLeuven@sgs.com
Sponsor
Primary sponsor
- Full Name
- Janssen Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- icotrokinra
- Routes Of Administration
- oral (tablet)
- Route
- oral
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