Systemic Lupus Erythematosus Related Interstial Lung DiseaseNCT06713187
Interleukin23 in Systemic Lupus
A study testing interleukin 23 in people with Systemic Lupus Erythematosus Related Interstial Lung Disease, run by Sohag University at 2 sites in Egypt.
Trial summary
assement of interleukin 23 in serum of patients with systemic lupus erythematosus related interstial lung disease . Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus Related Interstial Lung Disease
- What is being tested?
- interleukin 23
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 May 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with systemic lupus erythematous and patients with systemic lupus erythematosus with interstial lung disease.
Who cannot join
- patients with chest conditions rather than interstial lung disease \&who receiving biological blocking antibodies\& those treated with immunosuppressive drugs.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Sohag university hospital
Sohag
Magdy M Ameen, Professor
- Recruiting
Sohag university
Sohag
Magdy M Ameen, Professor, 0934602963, ethics@med.sohag.edu.eg
About this study
Official title: Role of Interleukin 23 in Systemic Lupus Erythematosus Related Interstial Lung Disease
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.
- Being tested
- interleukin 23
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interleukin 23Biological
assessment of interleukin 23 in Sera of patients using ELIZA
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | Patients with systemic lupus erythematosus without interstial lung disease. Receives: Biological: interleukin 23 |
| group2 | Active comparator | Patients with systemic lupus erythematosus with interstial lung disease. Receives: Biological: interleukin 23 |
| group3 | Active comparator | healthy control groups Receives: Biological: interleukin 23 |
What is being measured
The primary outcome is the main question the study is designed to answer.
interleukin 23
level of interleukin 23 in Sera of patients with systemic lupus erythematosus using ELIZA
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start1 May 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus Erythematosus Related Interstial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khadiga Mahmoud Salem, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713187
- Sponsor's protocol ID
- Soh_Med__24_11_09MS
- Status last verified
- Nov 2024
- First submitted
- 27 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 20467470Haroon 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 36698375Sisto 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 37685766Senoo 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Interleukin 23 in Systemic Lupus Erythematosus Related Interstial Lung Disease
- ClinicalTrials.gov ID
- NCT06713187
- Acronym / sponsor ID
- Soh_Med__24_11_09MS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
assement of interleukin 23 in serum of patients with systemic lupus erythematosus related interstial lung disease .
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Biological: interleukin 23Patients with systemic lupus erythematosus without interstial lung disease. |
| group2 | Active comparator | Biological: interleukin 23Patients with systemic lupus erythematosus with interstial lung disease. |
| group3 | Active comparator | Biological: interleukin 23healthy control groups |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with systemic lupus erythematous and patients with systemic lupus erythematosus with interstial lung disease.
Key exclusion criteria (1 listed)
- patients with chest conditions rather than interstial lung disease \&who receiving biological blocking antibodies\& those treated with immunosuppressive drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interleukin 23assessment of interleukin 23 in Sera of patients using ELIZA | Biological | group 1, group2, group3 |
Primary outcome
interleukin 23
Time frame: 2 years
level of interleukin 23 in Sera of patients with systemic lupus erythematosus using ELIZA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Background: PubMed 20467470Yap 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.
- Background: PubMed 36698375Haroon 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.
- Background: PubMed 37685766Sisto 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.
- Background: PubMed 34524907Senoo 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interleukin 23 in people with Systemic Lupus Erythematosus Related Interstial Lung Disease, run by Sohag University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khadiga M Salem, resident doctor (01069152448, khadiga_mahmoud_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
interleukin 23 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06713187, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.