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Metabolic Profiling of Immune Responses in Immune-mediated Diseases

Study Purpose

Background: The immune system is the part of the body that fights infection. Some people have immune deficiencies that cause skin rashes, make them get sick often with infections, or make it difficult for their skin to heal. Researchers want to learn more to better treat conditions that affect immune response. Objective: To learn about how the immune system and skin healing are related to each other. Eligibility: People ages 18-75 with primary immune deficiency, eczema, or psoriasis. Healthy volunteers are also needed. Design: Participants will be screened with a medical and medicine history and a physical exam. They may take a pregnancy test. Participants will discuss the medicines or supplements they take as well as skin products they use, such as soaps and lotions. Participants will have up to 4 skin biopsies taken from the forearm. A needle will inject an anesthetic into the skin where the biopsy will be done. A sharp tool that looks like a tiny cookie cutter will be used to remove a round plug of skin a bit smaller than the tip of a pencil. Participants will give at least 1 blood sample. Participants may have optional skin swab collection. A cotton swab will be used to swab the skin on the arm. Participants may have optional skin tape collection. A sticky strip of tape will be placed on the arm and then removed. Participants may give leftover samples taken as part of their regular medical care. Participation will last for about 4 days. Participants will have 2 visits that each last about 1 hour. They may be asked to repeat the study in the future.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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    INCLUSION CRITERIA:

    In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1.
Meets one of the following: 1. Has documentation of PID confirmed by genetic evaluation demonstrating a deleterious variant in the gene (or genes) known to be associated with immune deficiency (confirmed PID); or. 2. Has documented variant of undetermined significance in a gene (or genes) that is predicted to be deleterious in immune function by the investigators AND a clinical history of infections which are more frequent, more chronic, or more severe than normal (suspected PID); or. 3. Has physician-diagnosed psoriasis; or. 4. Has physician-diagnosed AD; or. 5. Does not have clinically apparent evidence of any monogenic or digenic immune defect, AD, or psoriasis (healthy volunteers). 2. Aged 18 to 75 years. 3. Willing to allow storage of blood, biopsy tissue, and bacterial and fungal cultures for future research. 4. Able to provide informed consent.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study: 1. Current or prior (within 3 months) anticoagulant or anti-platelet therapy (other than aspirin or non-steroidal anti-inflammatory drugs). 2. Current or prior (within 3 months) use of immunomodulatory drugs (eg, chemotherapy, steroids), except if approved by the principal investigator. 3. History of keloid formation. 4. Pregnancy, lactating, or breastfeeding. 5. Any condition that, in the opinion of the investigator, contraindicates participation in the study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04864886
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Ian A Myles, M.D.
Principal Investigator Affiliation National Institute of Allergy and Infectious Diseases (NIAID)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Primary Immunodeficiency, Psoriasis, Atopic Dermatitis, Immune-mediated Diseases
Study Website: View Trial Website
Additional Details

Study Description: This is an exploratory sample collection study enrolling adult healthy volunteers and patients with immune-mediated diseases to elucidate the metabolic signatures associated with immune-mediated diseases. We hypothesize that activation of, and responses to, specific immune pathways will require metabolic changes within cells, serum, and skin. Following screening and baseline procedures, including blood draw, participants will undergo skin biopsies. The skin biopsies will involve up to 4 biopsies: 2 initial punch biopsies 2 mm in diameter, optionally followed by 1 or 2 punch biopsies 3 (+/-1) days later using a 3-mm punch to encompass the initial biopsy site(s), capturing the tissue at 3 days of healing. In addition, skin swabs and tape strips may be collected to assess for microbial or host markers of epithelial repair. Peripheral blood will be collected with the initial biopsies to compare metabolic signatures in peripheral blood cells and serum with those in the skin. After day 1 (or 3, if the participant has that optional visit), participation in the study will be complete. Samples and data will be stored for future research use. Objectives: Primary Objectives: 1. Evaluate metabolic profiles in immune activation associated with known or suspected immune-mediated disorders. 2. Determine whether there are abnormalities in specific tissue repair pathways, such as epithelial to mesenchymal transition (EMT), that are associated with immune-mediated disorders. Secondary Objectives: Not applicable. Endpoints: Primary Endpoints: 1. Fold differences in metabolic pathways associated with immune pathways. 2. Fold differences in metabolic pathways related to wound healing. 3. Change in relative abundance of microbial skin taxa and/or skin metabolites associated with wound healing or immune-mediated disorders. Secondary Endpoints: Not applicable.

Arms & Interventions

Arms

: Healthy volunteers

Control group

: Patients with atopic dermatitis

Physician-diagnosed atopic dermatitis

: Patients with primary immunodeficiency

Confirmed by genetic diagnosis or suspected by genetic variant of unconfirmed significance and a history consistent with immunodeficiency

: Patients with psoriasis

Physician-diagnosed psoriasis

Interventions

Contact a Trial Team

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Bethesda, Maryland

Status

Recruiting

Address

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

Site Contact

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

prpl@cc.nih.gov

800-411-1222 #TTY8664111010

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