Clinical trial • Phase III • Other
vedolizumab
Phase III trial of vedolizumab.
Overview
- Trial Therapeutic Area
- Other
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 22-08-2025
- First CTIS Authorization Date
- 13-11-2025
Trial design
Randomised, pb016 versus us-licensed entyvio® (vedolizumab) after subcutaneous administration; dose and schedule not specified in provided documents-controlled Phase III trial across 2 sites in Germany.
- Randomised
- Yes
- Comparator
- PB016 versus US-licensed Entyvio® (vedolizumab) after subcutaneous administration; dose and schedule not specified in provided documents
- Target Sample Size
- 132
Eligibility
Recruits 132 Vulnerable population selected: true (trial population: Healthy volunteers; no further details on consent/assent provided in the supplied documents).
- Vulnerable Population
- Vulnerable population selected: true (trial population: Healthy volunteers; no further details on consent/assent provided in the supplied documents)
Recruitment
- Planned Sample Size
- 132
- Recruitment Window Months
- 8
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 132
Germany
- Earliest CTIS Part Ii Submission Date
- 24-09-2025
- Latest Decision Or Authorization Date
- 07-04-2026
- Processing Time Days
- 195
- Number Of Sites
- 2
- Number Of Participants
- 132
Sites
- Site Name
- Klinikum Westend Haus 31, Spandauer Damm 130, Charlottenburg
- Department Name
- 001: Parexel Early Phase Unit Berlin
- Contact Person Name
- Thomas Körnicke
- Contact Person Email
- Thomas.Koernicke@parexel.com
- Site Name
- Klinikum Westend Haus 31, Spandauer Damm 130, Charlottenburg
- Department Name
- Parexel Early Phase Unit Berlin
- Contact Person Name
- Obada Al Hamdan
- Contact Person Email
- obada.alhamdan@parexel.com
Sponsor
Primary sponsor
- Full Name
- Polpharma Biologics S.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Poland
Investigational products
- Investigational Product Name
- PB016
- Modality
- Monoclonal antibody
- Routes Of Administration
- subcutaneous
- Route
- subcutaneous
- Investigational Product Name
- US-licensed Entyvio® (vedolizumab)
- Active Substance
- vedolizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- subcutaneous
- Route
- subcutaneous
- Authorisation Status
- US-licensed
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