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RecruitingNCT06713187Updated Dec 3, 2024

Interleukin23 in Systemic Lupus

An interventional study of interleukin 23 in Systemic Lupus Erythematosus Related Interstial Lung Disease, sponsored by Sohag University. Recruiting at 2 sites in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-03.

Sponsored by Sohag University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the detailed description

for all patients detailed history taken clinical and rhumatological examination will be assessed and SLEDAI score will be collected from the case record of the patients\&laboratory investigation included 1_erythrocytic sedimentation rate.2_complete blood count.3_interleukin23 .4_complement 3\&4.5_Antinuclear Antibodies.6_Anti double stranded antibodies.7_full basic biochemical test(24 urine protien)8_high resolution computed tomography.

02

Conditions studied

  • Systemic Lupus Erythematosus Related Interstial Lung Disease
03

In context

Lead sponsor

Sohag University is the lead sponsor of 1,220 studies on the registry; 629 are open to participants now.

Browse Sohag University studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients with chest conditions rather than interstial lung disease \&who receiving biological blocking antibodies\& those treated with immunosuppressive drugs.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    group 1

    Patients with systemic lupus erythematosus without interstial lung disease.

    Biological: interleukin 23

  • Active comparator
    group2

    Patients with systemic lupus erythematosus with interstial lung disease.

    Biological: interleukin 23

  • Active comparator
    group3

    healthy control groups

    Biological: interleukin 23

Interventions

  • Biologicalinterleukin 23

    assessment of interleukin 23 in Sera of patients using ELIZA

06

What researchers measure

Primary outcomes

  1. interleukin 23

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

    Time frame: 2 years

07

Study locations

2 of 2 sites recruiting
  • Sohag university hospital
    Sohag, Egypt
    • Magdy M Ameen, Professor · Contact
    Recruiting
  • Sohag university
    Sohag, Egypt
    Recruiting
08

References and documents

Publications

  • 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. PubMed 20467470 ↗
  • 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. PubMed 36698375 ↗
  • 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. PubMed 37685766 ↗
  • 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. PubMed 34524907 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06713187
Lead sponsor
Sohag University
Responsible party
khadiga Mahmoud Salem (resident doctor at clinical pathology department, Sohag University) — Principal investigator
First posted
Dec 3, 2024
Start date
May 1, 2025 (estimated)
Primary completion
Aug 1, 2025 (estimated)
Completion
Jun 1, 2026 (estimated)
Last update
Dec 3, 2024

Study contacts

Khadiga M Salem, resident doctor
Contact
khadiga_mahmoud_post@med.sohag.edu.eg
01069152448

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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