NCT06713187

Brief Summary

assement of interleukin 23 in serum of patients with systemic lupus erythematosus related interstial lung disease .

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started May 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
May 2025Jun 2026

First Submitted

Initial submission to the registry

November 27, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 3, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

November 27, 2024

Last Update Submit

November 27, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • interleukin 23

    level of interleukin 23 in Sera of patients with systemic lupus erythematosus using ELIZA

    2 years

Study Arms (3)

group 1

ACTIVE COMPARATOR

Patients with systemic lupus erythematosus without interstial lung disease.

Biological: interleukin 23

group2

ACTIVE COMPARATOR

Patients with systemic lupus erythematosus with interstial lung disease.

Biological: interleukin 23

group3

ACTIVE COMPARATOR

healthy control groups

Biological: interleukin 23

Interventions

interleukin 23BIOLOGICAL

assessment of interleukin 23 in Sera of patients using ELIZA

group 1group2group3

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients with systemic lupus erythematous and patients with systemic lupus erythematosus with interstial lung disease.

You may not qualify if:

  • patients with chest conditions rather than interstial lung disease \&who receiving biological blocking antibodies\& those treated with immunosuppressive drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sohag university hospital

Sohag, Egypt

RECRUITING

Sohag university

Sohag, Egypt

RECRUITING

Related Publications (4)

  • Yap DY, Lai KN. Cytokines and their roles in the pathogenesis of systemic lupus erythematosus: from basics to recent advances. J Biomed Biotechnol. 2010;2010:365083. doi: 10.1155/2010/365083. Epub 2010 May 6.

    PMID: 20467470BACKGROUND
  • Haroon MM, Hegazy GA, Hassanien MA, Shaker O, Hussein WH. Significance of Interleukin 23 in Systemic Lupus Patients: Relation to Disease Activity and Damage Indices. Biologics. 2023 Jan 18;17:1-9. doi: 10.2147/BTT.S389021. eCollection 2023.

    PMID: 36698375BACKGROUND
  • Sisto M, Lisi S. Interleukin-23 Involved in Fibrotic Autoimmune Diseases: New Discoveries. J Clin Med. 2023 Sep 1;12(17):5699. doi: 10.3390/jcm12175699.

    PMID: 37685766BACKGROUND
  • Senoo S, Taniguchi A, Itano J, Oda N, Morichika D, Fujii U, Guo L, Sunami R, Kanehiro A, Tokioka F, Yoshimura A, Kiura K, Maeda Y, Miyahara N. Essential role of IL-23 in the development of acute exacerbation of pulmonary fibrosis. Am J Physiol Lung Cell Mol Physiol. 2021 Nov 1;321(5):L925-L940. doi: 10.1152/ajplung.00582.2020. Epub 2021 Sep 15.

    PMID: 34524907BACKGROUND

MeSH Terms

Interventions

Interleukin-23

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Central Study Contacts

Khadiga M Salem, resident doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at clinical pathology department

Study Record Dates

First Submitted

November 27, 2024

First Posted

December 3, 2024

Study Start

May 1, 2025

Primary Completion

August 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

December 3, 2024

Record last verified: 2024-11

Locations