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Cell Responses to IFN-gamma

Primary Purpose

Plaque Psoriasis

Status

Terminated

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Actimmune

About this trial

This is an interventional basic science trial for Plaque Psoriasis focused on measuring Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Rockefeller University

Outcomes

Primary Outcome Measures

Function of dendritic cells from IFNg-injected skin

To perform an assay using dendritic cells from the biopsy as stimulator cells and T cells as responders.

Secondary Outcome Measures

Flow cytometry analysis of circulating leukocyte populations

Surface phenotype and intracellular cytokine staining will be performed to determine if a single dose of IFNg alters circulating leukocyte phenotype.

Full Information

NCT ID

NCT01317017

First Posted

March 10, 2011

Last Updated

March 4, 2013

Sponsor

Rockefeller University

1. Study Identification

Unique Protocol Identification Number

NCT01317017

Brief Title

Cell Responses to IFN-gamma

Official Title

Cellular Responses To Intradermal-Gamma (IFN-gamma) in Normal and Psoriatic Patients

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Terminated

Why Stopped

Unable to isolate sufficient cells from the skin biopsy to perform study experiments.

Study Start Date

July 2010 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rockefeller University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plaque Psoriasis

Keywords

Psoriasis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Actimmune

Intervention Description

All subjects will receive one intradermal injections of 0.25ml of IFN-g (Actimmune TM 100 micrograms/0.5ml), in normal appearing skin of both normal volunteers and psoriasis patients. Blood will be taken at baseline and day 1. A skin biopsy (6mm punch) will be taken at the injection site 24 hours later. Patients will return at one to two weeks for suture removal. Clinical assessments done at every visit. Patients will also be evaluated at each visit for any adverse events.

Primary Outcome Measure Information:

Title

Function of dendritic cells from IFNg-injected skin

Description

To perform an assay using dendritic cells from the biopsy as stimulator cells and T cells as responders.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Flow cytometry analysis of circulating leukocyte populations

Description

Surface phenotype and intracellular cytokine staining will be performed to determine if a single dose of IFNg alters circulating leukocyte phenotype.

Time Frame

9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michelle Lowes, MD

Organizational Affiliation

The Rockefeller University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rockefeller University

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

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Cell Responses to IFN-gamma

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