ln this study effect of 3 novel compounds on the development of psoriasis in the humanized mouse model isinvestigated. The efficacy is compared to one registered drug, namely Remicade(R).
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
Serum markers in blood of transplanted mice will be studied together with
markers on cultured cells from psoriasis
patients. Possibly also inflammatory markers 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 effect of 3 novel compounds on the development of psoriasis in
the humanized mouse model is
investigated. The efficacy is compared to one registered drug, namely
Remicade(R).
Study design
A pharmaceutical company has asked TNO to test a 3 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.
\Mth the consent of the patient, the medical practicioner of each patient will
be notified about the participation.
Inflammation and Immunology RU, 200 Cambridge Park Drive
Cambridge, MA 02140
GB
Inflammation and Immunology RU, 200 Cambridge Park Drive
Cambridge, MA 02140
GB
Listed location countries
Age
Inclusion criteria
Psoriasis patients: Adults (m/f) with a mild form of psoriasis vulgaris (PASI score of maximal 6). Patients areallowed to use local corticosteroids or ointments to prevent dry skin (see Appendix 2).
Exclusion criteria
Psoriasis patients: 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 | NL36398.028.11 |