Plaque PsoriasisEarly Phase 1NCT01317017
Cell Responses to IFN-gamma
A Early Phase 1 study testing Actimmune in people with Plaque Psoriasis, run by Rockefeller University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Actimmune
- Type of treatment
- Injection or infusion
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to May 2011
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cellular Responses To Intradermal-Gamma (IFN-gamma) in Normal and Psoriatic Patients
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.
- Conditions
- Plaque Psoriasis
- Being tested
- Actimmune
- Keywords
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActimmuneDrug
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startJul 2010
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: Unable to isolate sufficient cells from the skin biopsy to perform study experiments.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Lowes, MD, Principal investigator, The Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317017
- Sponsor's protocol ID
- MLO-0717
- Status last verified
- Mar 2013
- First submitted
- 10 Mar 2011
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cellular Responses To Intradermal-Gamma (IFN-gamma) in Normal and Psoriatic Patients
- ClinicalTrials.gov ID
- NCT01317017
- Acronym / sponsor ID
- MLO-0717
- Conditions
- Plaque Psoriasis
- Keywords
- Psoriasis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to isolate sufficient cells from the skin biopsy to perform study experiments.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 16 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Actimmune* 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. | Drug | – |
Primary outcome
Function of dendritic cells from IFNg-injected skin
Time frame: 6 months
To perform an assay using dendritic cells from the biopsy as stimulator cells and T cells as responders.
1 secondary outcome
Flow cytometry analysis of circulating leukocyte populations
Time frame: 9 months
Results and safety
The study was stopped early (reason given: Unable to isolate sufficient cells from the skin biopsy to perform study experiments.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Lowes, MD principal investigator
The Rockefeller University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Actimmune in people with Plaque Psoriasis, run by Rockefeller University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to isolate sufficient cells from the skin biopsy to perform study experiments.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Function of dendritic cells from IFNg-injected skin (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2013; AzTrials last refreshed its copy on 28 Oct 2026.