Clinical trial • Phase II • Immunology

FYB202 for Chronic inflammatory diseases | Psoriasis | Crohn's disease | Psoriatic arthropathy

Phase II trial of FYB202 for Chronic inflammatory diseases | Psoriasis | Crohn's disease | Psoriatic arthropathy.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Chronic inflammatory diseases | Psoriasis | Crohn's disease | Psoriatic arthropathy
Trial Stage
Phase II

Key dates

Initial CTIS Submission Date
15-07-2025
First CTIS Authorization Date
03-11-2025

Trial design

Prefilled syringe presentation of FYB202 versus Autoinjector presentation of FYB202 (dose and schedule not specified)-controlled Phase II trial across 1 site in Poland.

Comparator
Prefilled syringe presentation of FYB202 versus Autoinjector presentation of FYB202 (dose and schedule not specified)
Target Sample Size
160

Recruitment

Planned Sample Size
160
Recruitment Window Months
8

Geography

Total Number Of Sites
1
Total Number Of Participants
160

Poland

Earliest CTIS Part Ii Submission Date
13-10-2025
Latest Decision Or Authorization Date
27-02-2026
Processing Time Days
137
Number Of Sites
1
Number Of Participants
160

Sites

Site Name
Biokinetica S.A.
Department Name
Przychodnia Józefów
Contact Person Name
Monika Tomaszewska-Kiecana
Contact Person Email
monika.kiecana@biokinetica.com

Sponsor

Primary sponsor

Full Name
Fresenius Kabi SwissBioSim GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Investigational products

Investigational Product Name
FYB202

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