PsoriasisNCT07128472
Evaluation of IL 12B Genetic Polymorphism (rs3213094)
A study testing Humira in people with Psoriasis, run by South Valley University at 1 site in Egypt.
Trial summary
Psoriasis is a skin disorder that is chronic proliferative and inflammatory in nature. Extensor surfaces, scalp, and lumbosacral area are covered in erythematous plaques with silvery scales. The disease can also impair the eyes and joints. It has no cure. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Humira
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 1 Feb 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients having psoriasis diagnosed clinically for at least 6 months and who have a severity grade of severe, defined as a Psoriasis Area and Severity Index (PASI) score greater than 10, and involvement of greater than 10% of the body surface area (BSA) with psoriatic arthritis.
Who cannot join
- Patients with other autoimmune or inflammatory conditions (e.g., rheumatoid arthritis, lupus).
- Pregnancy and lactation.
- Patients currently undergoing any treatment other than Humira.
- Patients with known genetic disorders affect immune system function.
- Patients were undergoing any treatment other than Humira in the last 6 months.
- Patients with active infections, including tuberculosis or chronic viral infections (e.g., hepatitis B or C, HIV).
- Patients with contraindication to Humira.
- Renal \&Vascular diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Qina University hospital, South Valley University Hospital
Qina
Ebtehal Alaa El-Din Kotop Mohamed, Lecturer, +201066798383, Ebtehal_alaa@med.svu.edu.eg
Shimaa Saber Ahmed, M.D, +201099283315, shimaasaber063@gmail.com
About this study
Official title: Evaluation of IL 12B Genetic Polymorphism (rs3213094) in Patient With Psoriasis and Psoriatic Arthritis in Response to Humira
Psoriasis is a skin disorder that is chronic proliferative and inflammatory in nature. Extensor surfaces, scalp, and lumbosacral area are covered in erythematous plaques with silvery scales. The disease can also impair the eyes and joints. It has no cure. Because of their low quality of life, many psoriasis patients experience depression. In addition to the cutaneous manifestations, it is associated with an increased risk of psoriatic arthritis, depression and cardiovascular disease.
Read the detailed description
Psoriasis is known to be affecting 3% to 4% of the general population worldwide. While the prevalence of psoriasis in Egypt ranges 0.19-3% Psoriatic arthritis (PsA) most commonly develops in 20-30% of psoriatic patients with preceding psoriasis or develops concomitantly with psoriasis, and it manifests all features of arthritis, including enthesitis.
The pathogenesis of psoriasis is multifactorial, involving a complex interplay between genetic predisposition, immune system dysregulation, and environmental triggers. Central to the disease process is the activation of T-cells, particularly Th1, Th17, and Th22 subsets, which release pro-inflammatory cytokines such as tumor necrosis factor-alpha (TNF-α), interleukin-17 (IL-17), and interleukin-22 (IL-22)
. These cytokines drive the abnormal growth and differentiation of keratinocytes and induce the inflammatory cascade that results in the characteristic skin lesions. Genetic factors, including polymorphisms in genes related to the immune system, such as HLA-Cw6.Additionally, environmental factors like infections, stress, and trauma (Koebner phenomenon) can exacerbate or trigger the onset of the disease.
The Psoriasis Area and Severity Index (PASI) is a widely used tool for assessing the severity of psoriasis and evaluating treatment efficacy. It combines the extent of skin involvement and the degree of erythema, scaling, and thickness across four body regions: the head, upper limbs, trunk, and lower limbs. Each region is assigned a score for surface area involvement (0-6) and for each symptom (0-4), which are then combined to yield an overall PASI score ranging from 0 to 72. Higher scores indicate more severe disease. Typically, a PASI score below 10 suggests mild psoriasis, while scores between 10 and 20 indicate moderate severity, and scores above 20 reflect severe psoriasis. PASI serves as a critical endpoint to gauge disease burden.
Interleukin-12B (IL12B) encodes the p40 subunit shared by both IL-12 and IL-23, cytokines that are pivotal in the differentiation of naive T-cells into Th1 and Th17 cells, respectively. The IL-12/IL-23 axis is well-established in contributing to the immune pathology seen in psoriasis. Genetic studies have shown that polymorphisms within the IL12B gene are associated with an increased risk of psoriasis.
Single nucleotide polymorphisms (SNPs) are the most common type of genetic variation in humans. SNP rs3213094, located within the IL12B gene, has been identified as a potentially significant variant that could alter the expression or function of the cytokines involved in immune responses. Previous studies have suggested that SNP rs3213094 within the IL12B gene is associated with psoriasis, although the strength of this association varies across different populations.
Humira (adalimumab) is a monoclonal antibody targeting TNF-α, widely used for treating moderate-to-severe psoriasis and PsA. It works by neutralizing the activity of TNF-α, thereby reducing inflammation, decreasing keratinocyte proliferation, and alleviating joint symptoms. However, individual responses to Humira can vary significantly, with some patients experiencing limited or no therapeutic benefits
- Conditions
- Psoriasis
- Being tested
- Humira
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HumiraDrug
Also called IL 12B genetic polymorphism (rs3213094)
Assess the response of psoriasis and psoriatic arthritis to Humira and also Assessing the pharmacogenetic association between IL 12B genetic polymorphism (rs3213094) in psoriatic and psoriatic arthritis patients taking Humira.
| Study group | Role | What they receive |
|---|---|---|
| Patients Group | Active comparator | About 20 patients with psoriasis and psoriatic arthritis. Receives: Drug: Humira |
| Healthy Group | Active comparator | About 20 healthy control group. Receives: Drug: Humira |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of Psoriasis and Psoriatic Arthritis
Treatment the patients whom suffering from Psoriasis and Psoriatic arthritis and Assessment of clinical improvement to Humira therapy according to: PASI score into PASI 50: means 50% reduction in PASI score - an acceptable measure of efficacy for secondary endpoints in psoriasis clinical trials PASI 75: means 75% reduction in PASI score - standard efficacy measure used in most psoriasis clinical studies1 PASI 90: means 90% reduction in PASI score (almost clear skin) PASI 100: means Completely clear skin.
Measured: 3 Months
Secondary outcomes (1)
Evaluate the effect of treatment with Humira
Evaluate the effect of treatment with Humira therapy on the level of serum IL12B genetic polymorphism (rs3213094) on the Participants whom suffering from Psoriasis and Psoriatic arthritis.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Aug 2025
- Primary completion20 Jan 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Ahmed Saad Ali Aweida, South Valley University
- Investigators
- Moustafa Adam Ali El Taieb, Professor, Study chair, Dermatology, Venereology and Andrology. Faculty of Medicine,Qena UniversityEisa Mohammed Hegazy, Professor, Study director, Dermatology, Venereology and Andrology. Qena Faculty of Medicine,South Valley UniversityMohamed Hosny Hassan, Professor, Principal investigator, Medical Biochemistry Department,Qena Faculty of Medicine,south valley university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128472
- Sponsor's protocol ID
- SVU-MED-DVA021-4
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of IL 12B Genetic Polymorphism (rs3213094) in Patient With Psoriasis and Psoriatic Arthritis in Response to Humira
- ClinicalTrials.gov ID
- NCT07128472
- Acronym / sponsor ID
- SVU-MED-DVA021-4
- Conditions
- Psoriasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 20 Jan 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 19 Aug 2025 (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.
Psoriasis is a skin disorder that is chronic proliferative and inflammatory in nature. Extensor surfaces, scalp, and lumbosacral area are covered in erythematous plaques with silvery scales. The disease can also impair the eyes and joints. It has no cure. Because of their low quality of life, many psoriasis patients experience depression. In addition to the cutaneous manifestations, it is associated with an increased risk of psoriatic arthritis, depression and cardiovascular disease.
Detailed description
Psoriasis is known to be affecting 3% to 4% of the general population worldwide. While the prevalence of psoriasis in Egypt ranges 0.19-3% Psoriatic arthritis (PsA) most commonly develops in 20-30% of psoriatic patients with preceding psoriasis or develops concomitantly with psoriasis, and it manifests all features of arthritis, including enthesitis.
The pathogenesis of psoriasis is multifactorial, involving a complex interplay between genetic predisposition, immune system dysregulation, and environmental triggers. Central to the disease process is the activation of T-cells, particularly Th1, Th17, and Th22 subsets, which release pro-inflammatory cytokines such as tumor necrosis factor-alpha (TNF-α), interleukin-17 (IL-17), and interleukin-22 (IL-22)
. These cytokines drive the abnormal growth and differentiation of keratinocytes and induce the inflammatory cascade that results in the characteristic skin lesions. Genetic factors, including polymorphisms in genes related to the immune system, such as HLA-Cw6.Additionally, environmental factors like infections, stress, and trauma (Koebner phenomenon) can exacerbate or trigger the onset of the disease.
The Psoriasis Area and Severity Index (PASI) is a widely used tool for assessing the severity of psoriasis and evaluating treatment efficacy. It combines the extent of skin involvement and the degree of erythema, scaling, and thickness across four body regions: the head, upper limbs, trunk, and lower limbs. Each region is assigned a score for surface area involvement (0-6) and for each symptom (0-4), which are then combined to yield an overall PASI score ranging from 0 to 72. Higher scores indicate more severe disease. Typically, a PASI score below 10 suggests mild psoriasis, while scores between 10 and 20 indicate moderate severity, and scores above 20 reflect severe psoriasis. PASI serves as a critical endpoint to gauge disease burden.
Interleukin-12B (IL12B) encodes the p40 subunit shared by both IL-12 and IL-23, cytokines that are pivotal in the differentiation of naive T-cells into Th1 and Th17 cells, respectively. The IL-12/IL-23 axis is well-established in contributing to the immune pathology seen in psoriasis. Genetic studies have shown that polymorphisms within the IL12B gene are associated with an increased risk of psoriasis.
Single nucleotide polymorphisms (SNPs) are the most common type of genetic variation in humans. SNP rs3213094, located within the IL12B gene, has been identified as a potentially significant variant that could alter the expression or function of the cytokines involved in immune responses. Previous studies have suggested that SNP rs3213094 within the IL12B gene is associated with psoriasis, although the strength of this association varies across different populations.
Humira (adalimumab) is a monoclonal antibody targeting TNF-α, widely used for treating moderate-to-severe psoriasis and PsA. It works by neutralizing the activity of TNF-α, thereby reducing inflammation, decreasing keratinocyte proliferation, and alleviating joint symptoms. However, individual responses to Humira can vary significantly, with some patients experiencing limited or no therapeutic benefits
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients Group | Active comparator | Drug: HumiraAbout 20 patients with psoriasis and psoriatic arthritis. |
| Healthy Group | Active comparator | Drug: HumiraAbout 20 healthy control group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients having psoriasis diagnosed clinically for at least 6 months and who have a severity grade of severe, defined as a Psoriasis Area and Severity Index (PASI) score greater than 10, and involvement of greater than 10% of the body surface area (BSA) with psoriatic arthritis.
Key exclusion criteria (8 listed)
- Patients with other autoimmune or inflammatory conditions (e.g., rheumatoid arthritis, lupus).
- Pregnancy and lactation.
- Patients currently undergoing any treatment other than Humira.
- Patients with known genetic disorders affect immune system function.
- Patients were undergoing any treatment other than Humira in the last 6 months.
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 |
|---|---|---|
| HumiraAlso: IL 12B genetic polymorphism (rs3213094)Assess the response of psoriasis and psoriatic arthritis to Humira and also Assessing the pharmacogenetic association between IL 12B genetic polymorphism (rs3213094) in psoriatic and psoriatic arthritis patients taking Humira. | Drug | Healthy Group, Patients Group |
Primary outcome
Treatment of Psoriasis and Psoriatic Arthritis
Time frame: 3 Months
Treatment the patients whom suffering from Psoriasis and Psoriatic arthritis and Assessment of clinical improvement to Humira therapy according to: PASI score into PASI 50: means 50% reduction in PASI score - an acceptable measure of efficacy for secondary endpoints in psoriasis clinical trials PASI 75: means 75% reduction in PASI score - standard efficacy measure used in most psoriasis clinical studies1 PASI 90: means 90% reduction in PASI score (almost clear skin) PASI 100: means Completely clear skin.
1 secondary outcome
Evaluate the effect of treatment with Humira
Time frame: 3 Months
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 19 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Psoriasis
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Recruiting
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Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
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RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
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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.
Moustafa Adam Ali El Taieb, Professor study chair
Dermatology, Venereology and Andrology. Faculty of Medicine,Qena University
Eisa Mohammed Hegazy, Professor study director
Dermatology, Venereology and Andrology. Qena Faculty of Medicine,South Valley University
Mohamed Hosny Hassan, Professor principal investigator
Medical Biochemistry Department,Qena Faculty of Medicine,south valley university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Humira in people with Psoriasis, run by South Valley University at 1 site 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 8 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 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Alaa Ahmed Saad Ali Aweida, MSc (+201119814470, alaaahmed201666@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment of Psoriasis and Psoriatic Arthritis (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2025.