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NCT Number: NCT07675837

Inducible Co-stimulator Gene With Systemic Lupus Erythematosus

The aim of this study is to investigate the association between ICOS gene polymorphism and susceptibility to systemic lupus erythematosus (SLE), as well as its impact on disease severity.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Systemic lupus erythematosus (SLE) is a chronic, multiorgan, systemic autoimmune disease that affects almost all tissue and organ systems, has a varied clinical appearance, and fluctuates in severity among people and over time. The global incidence of SLE has been estimated at 5.14 per 100,000 person-years with mortality rates ranging from 6.7 to 37.8 %, with women five times more likely to be affected than men. The pathogenesis of SLE is complex and involves cells of both innate and adaptive immunity. The distinguishing feature of SLE is the production of autoantibodies, with the formation of immune complexes , and result in the inflammatory response of the immune system.Costimulatory signals, which include ligands and receptors and their interactions involving multiple types of signal information, are essential for the initiation, maintenance, and regulation of immune reactions. When costimulatory factors malfunction, complex abnormal immune responses with biological effects and ultimately clinical autoimmune diseases result. Inducible co-stimulator (ICOS) is the third member of the CD28/cytotoxic T-lymphocyte associated antigen-4 family and is involved in the proliferation and activation of T cells. The inducible T cell co-stimulator (ICOS) is expressed on T cells following peptide:MHC engagement with CD28 co-stimulation. The interaction of ICOS with its sole ligand the Inducible T-cell co-stimulatory ligand (ICOSL; also known as B7-related protein-1 or ICOSL) triggers key activities of T cells including cytokine production and differentiation into the T follicular helper (Tfh) cell lineage over effector lineages. Inducible T-cell co-stimulator (ICOS)-deficient people are unable to produce T follicular helper (Tfh) cells, which are CD4 T cells that migrate into B cell follicles and promote germinal centre (GC) reactions, according to research on human patients and mice models.

In this study, we aim to explore the possible association between potentially functional SNP rs11889031 of the ICOS gene and SLE in the Egyptian population.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with SLE based on 2019 EULAR/ACR Male or female. willing to provide written informed consent for participation and genetic testing

Exclusion criteria

  • Other autoimmune diseases or chronic inflammatory disorders. Malignancy. Pregnancy or breastfeeding. Inability to provide informed consent.

Treatment and study plan

Primary outcomes

  1. ICOS gene polymorphism and SLE

    Time frame: 6 month

    association between ICOS gene polymorphism and SLE susceptibility

Secondary outcomes

  1. systemic lupus erythematosus (SLE) Assessment

    Time frame: 6 month

    the impact of the ICOS gene polymorphism on disease severity and activity using the Systemic Lupus Erythematosus Disease Activity Index Index (SLEDAI).

Study contacts

Contact information is provided by the study sponsor or research team.

Dina Fetouh Abdel-latif, MSc

CONTACT

[email protected]

+201283364643

Soheir abdel- Hamid Ali, lecturer

CONTACT

[email protected]

+201066877343

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

Association of ICOS Gene Polymorphism With Susceptibility and Severity of Systemic Lupus Erythematosus.

Acronym: ICOS/SLE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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