NCT04864886

Metabolic Profiling of Immune Responses in Immune-mediated Diseases

Recruiting now Last updated 8 April 2026

What this trial tests

trial in Primary Immunodeficiency in 300 participants. Currently enrolling.

Timeline

10 August 2021

Primary endpoint
30 June 2027

30 June 2027

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	300
Start date	10 August 2021
Primary completion	30 June 2027
Estimated completion	30 June 2027
Sites	1 location across United States

Conditions studied

• Primary Immunodeficiency — all drugs for Primary Immunodeficiency →
• Psoriasis — all drugs for Psoriasis →
• Atopic Dermatitis — all drugs for Atopic Dermatitis →
• Immune-mediated Diseases — all drugs for Immune-mediated Diseases →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 75, any sex, with Primary Immunodeficiency or Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Topical Steroid Withdrawal Is a Targetable Excess of Mitochondrial NAD.
   Shobnam N, Ratley G, Saksena S, Yadav M, et al · · 2025 · cited 16× · PMID 40088241 · DOI 10.1016/j.jid.2024.11.026
2. Proteomic and Metabolomic Changes in Psoriasis Preclinical and Clinical Aspects.
   Radulska A, Pelikant-Małecka I, Jendernalik K, Dobrucki IT, et al · · 2023 · cited 7× · PMID 37298466 · DOI 10.3390/ijms24119507
3. Biomarkers Are Consistent With Patient-Reported Allergic Sensitization in Topical Steroid Withdrawal.
   Vijendra A, Shobnam N, Jordan J, Thota P, et al · · 2026 · cited 1× · PMID 40995891 · DOI 10.1111/all.70068
4. Skin imaging mass spectrometry of controls versus atopic dermatitis patients with and without <i>STAT3</i> mutations.
   Spathies J, Ratley G, D'Souza BN, Sun AA, et al · · 2025 · cited 1× · PMID 40510125 · DOI 10.1016/j.isci.2025.112644
5. Examining the Unanswered Questions in TSW: A Case Series of 16 Patients and Review of the Literature.
   Lu MY, Erickson A, Vijendra A, Ratley G, et al · · 2026 · PMID 41517611 · DOI 10.3390/jcm15010361