ln this study the effect of 1 novel compound on the development of psoriasis in the humanized mouse model isinvestigated. The efficacy is compared to a registered drug, Ustekinumab.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Effect on the psoriatic process is tested by histology and immuno-histochemical
techniques in the transplanted
biopsies. Main read-out is epidermal thickness.
Secondary outcome
Secretion of inflammatory mediators by cells from patients. Markers on cultured
cells from psoriasis patients. Possibly also inflammatory cells
in the skin tissue will be evaluated
Background summary
Psoriasis is a highly prevalent disease with great impact on the quality of
life of the patients. Current treatments are far
from ideal. The development of new compounds requires validation in an animal
model, however, many differences
exist between the skin of most animals and humans. TNO Life Sciences has
acquired
expertise in the past year in transplanting human psoriasis skin onto a mouse.
Thereby, we are able to perform
preclinical testing of compounds for psoriasis. Non-laesional skin is
transplanted onto a mouse and after engraftment
injection with autologous T-cells synchronizes the psoriatic process.
Scientific background information can be read in
Appendix 3. Since the study involves pre-clinical testing, patients will not
experience a direct benefìt from participation.
Study objective
ln this study the effect of 1 novel compound on the development of psoriasis in
the humanized mouse model is
investigated. The efficacy is compared to a registered drug, Ustekinumab.
Study design
A pharmaceutical company has asked TNO to test a potential new therapy for
psoriasis in our humanized mouse
model of psoriasis. Besides animal welfare approval, we also need medical
ethical clearance for obtaining skin
biopsies and blood from psoriasis patients. The skin will be transplanted onto
mice after which autologous T-cells
(isolated from the blood of patients) will be injected into the graft to
synchronize development of psoriasis. As indicated
in the study protocol (Appendix 1), 4 skin punch biopsies will be obtained from
non-lesional skin as well as 6 vials of
blood (ca. 8 ml each).
Study burden and risks
TNO has arranged insurance for the patients participating in this study.
However, medical risks are very low. A week
after obtaining skin and blood samples, the stitches will be removed at the
research center (PT&R) and a check will
take place. With the consent of the patient, the medical practitioner of each
patient will be notified about the
participation.
Postbus 2215
2301 CE Leiden
NL
Postbus 2215
2301 CE Leiden
NL
Listed location countries
Age
Inclusion criteria
Psoriasis patients: Adults (m/f) with a mild form of psoriasis vulgaris (PASI score of maximal 6). Patients are allowed to use local corticosteroids or ointments to prevent dry skin (see Appendix 2).
Exclusion criteria
These patients have not received light therapy or another form of systemic treatment (methotrexate,
cyclosporin A, anti-TNF treatments). Gender or age of the adults are not exclusion criteria (see Appendix 2).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40416.028.12 |