In this study the efficacy of a novel monoclonal antibody on the development of psoriasis in the humanized mouse model will be investigated.This experimental compound will be compared with 2 registered drugs, i.e. Humira en Stelara.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The effect of treatment on the psoriatic process is tested by histological and
immuno-histochemical techniques in the transplanted biopsies. The 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.
Markers of inflammation in serum or RNA isolated from blood cells and in the
skin.
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.
The department Biosciences at TNO 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 benefit
from participation.
Study objective
In this study the efficacy of a novel monoclonal antibody on the development of
psoriasis in the humanized mouse model will be investigated.
This experimental compound will be compared with 2 registered drugs, i.e.
Humira en Stelara.
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
along with 50 cc of blood.
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 practicioner of
each patient will be notified about the participation.
175 Briar Ridge Rd
Ridgefield, CT 06877
US
175 Briar Ridge Rd
Ridgefield, CT 06877
US
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
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 considered as 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 | NL34992.028.10 |