Sex differences in the modulation of immune and inflammatory networks by etoricoxib, a mechanistic and exploratory pilot study

Sex differences in the modulation of immune and inflammatory networks by etoricoxib, a mechanistic and exploratory pilot study - SeMINE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039342

Enrollment

Registered

2026-02-27

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers

Interventions

Group 1: Peripheral blood mononuclear cells (PBMCs) will be obtained from healthy donors who are matched with respect to sex, ethnicity, and age (±5 years) and are between 18 and 65 years of age. The

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Donors of PBMCs must meet the following criteria: – Generally healthy volunteers based on medical history - Men and women aged between 18 and 65 years - Body mass index (BMI) between 18 and 30 kg/m² - Non-smokers, with no other nicotine consumption

Exclusion criteria

Exclusion criteria: PBMCs from the following donors will not be used: - Female participants who are pregnant or breastfeeding. - Participants who experienced an acute inflammatory condition within two weeks prior to blood collection or who suffer from a chronic inflammatory disease. - Participants who have taken non-steroidal anti-inflammatory drugs (NSAIDs) or antibiotics within 7 days prior to blood collection, or who have applied medicated creams, including but not limited to paracetamol (acetaminophen), aspirin, ibuprofen, antibiotics, antihistamines, or steroid-based topical formulations. - Participants who have received a vaccination within 7 days prior to blood collection.

Design outcomes

Primary

Measure	Time frame
- Gene expression of the COX signaling pathway at single-cell resolution. Sex-specific differences in the COX pathway response of immune cells will be analyzed using single-cell RNA sequencing (scRNA-seq). This analysis aims to provide mechanistic insights into sex-specific immune responses and the immunomodulatory effects of nonsteroidal anti-inflammatory drugs (NSAIDs). - Co-expression patterns or activation of sex hormone–associated genes (e.g., estrogen receptors or androgen receptors) in response to pharmacological treatments. - Sex differences in cytokine and chemokine gene expression at single-cell resolution, with particular emphasis on proinflammatory mediators (e.g., IL-1ß, TNF-a) compared to anti-inflammatory mediators (e.g., IL-10).	—

Measure

Time frame

- Gene expression of the COX signaling pathway at single-cell resolution. Sex-specific differences in the COX pathway response of immune cells will be analyzed using single-cell RNA sequencing (scRNA-seq). This analysis aims to provide mechanistic insights into sex-specific immune responses and the immunomodulatory effects of nonsteroidal anti-inflammatory drugs (NSAIDs). - Co-expression patterns or activation of sex hormone–associated genes** (e.g., estrogen receptors or androgen receptors) in response to pharmacological treatments. - Sex differences in cytokine and chemokine gene expression at single-cell resolution**, with particular emphasis on proinflammatory mediators (e.g., IL-1ß, TNF-a) compared to anti-inflammatory mediators (e.g., IL-10).

—

Secondary

Measure	Time frame
- Integration of the results with protein-based assays (e.g., flow cytometry, Olink assay, ELISA, and mass spectrometry) to validate the scRNA-seq findings.	—

Countries

United Kingdom

Contacts

Public ContactTilo Großer

Universität Bielefeld

tilo.grosser@uni-bielefeld.de+49 521 106-86800

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026