Cell Responses to IFN-gamma

Rockefeller University

Status and phase

Terminated

Early Phase 1

Conditions

Plaque Psoriasis

Treatments

Drug: Actimmune

Study type

Interventional

Funder types

Other

Identifiers

NCT01317017

MLO-0717

Details and patient eligibility

About

IFN-gamma is a central player in the development of psoriasis lesions, which can be involved a variety of cellular processes in the skin. Dendritic cells are important cells in driving inflammation in psoriasis through the induction of T cells that produce IL-17 in psoriasis. Injecting IFN-g into the skin can increase the numbers of T cells and also inflammatory DCs that produce cytokines involved in IL-17 production. Thus, the investigators hypothesize that the dendritic cells present in the skin after IFN-g injection polarize IL-17-producing T cells.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Signed informed consent
Normal volunteers with no evidence of skin disease OR diagnosis of plaque type psoriasis for at least 6 months
18 years of age or greater
For women of childbearing potential or in men whose partners may become pregnant, willingness to use an acceptable method of contraception to prevent pregnancy for the duration of the study. Acceptable methods of contraception include use of a condom; abstinence; use by sexual partner of oral implantable or injectable contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap; or a sterile sexual partner

Exclusion criteria

Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
Clinically significant psoriasis flare during screening or on the first treatment day
Hypersensitivity to IFN-g or E. coli derivatives
Pre-existing, uncontrolled myelosuppression, cardiac disease, seizure disorders, compromised central nervous system function or multiple sclerosis
History of malignancy, clinically significant renal insufficiency, poorly controlled medical conditions that would increase the risks
Presence of malignancy within the past 5 years, including lymphoproliferative disorders. Subjects with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled.
Pregnancy or lactation. As the risk of IFN-g in pregnancy is unknown, pregnant women will be excluded from the study.
Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug