ln this study the effect of 2 novel compounds on the development of psoriasis in the humanized mouse model is investigated. The efficacy is compared to one registered drug, namely Stelera.
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
CK16 expression in epidermal layer. 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 Earth, Environment and
Life Sciences has acquired expertise in the past year in transplanting human
psoriasis skin onto a mouse. Thereby, we are able to perform pre-clinical
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 2 novel compounds on the development of psoriasis
in the humanized mouse model is investigated. The efficacy is compared to one
registered drug, namely Stelera.
Study design
A pharmaceutical company has asked TNO to test a 2 potential new therapies 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 5 vials of blood (ca. 10 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 | NL36891.028.11 |