Clinical trial • Phase III • Gastroenterology
vixarelimab for Ulcerative colitis | Moderate to severe ulcerative colitis
Phase III trial of vixarelimab for Ulcerative colitis | Moderate to severe ulcerative colitis. 24 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Ulcerative colitis | Moderate to severe ulcerative colitis
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 18-10-2024
- First CTIS Authorization Date
- 18-12-2024
Trial design
Phase III trial across 1 site in Germany.
- Target Sample Size
- 24
Eligibility
Recruits 24 No vulnerable population selected (isVulnerablePopulationSelected:false). Consent/assent procedures and language-specific materials are not specified in the CTIS record..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected:false). Consent/assent procedures and language-specific materials are not specified in the CTIS record.
Recruitment
- Planned Sample Size
- 24
- Recruitment Window Months
- 18
- Consent Approach
- Not specified in CTIS record
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 24
Germany
- Earliest CTIS Part Ii Submission Date
- 29-11-2024
- Latest Decision Or Authorization Date
- 04-04-2025
- Processing Time Days
- 126
- Number Of Sites
- 1
- Number Of Participants
- 24
Sites
- Site Name
- Charite Research Organisation GmbH
- Contact Person Name
- Stanislav Ignatenko
- Contact Person Email
- info@cro-studien.de
- Number Of Participants
- 24
Sponsor
Primary sponsor
- Full Name
- Genentech Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Charite Research Organisation GmbH
- Responsibilities
- Site organisation / local contact (trial site)
Investigational products
- Investigational Product Name
- Vixarelimab
- Active Substance
- vixarelimab
- Modality
- Monoclonal antibody
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