PsoriasisNCT07086924
Genetic Variation in TRAF3IP2 (rs13190932)
A study testing Methotrexate in people with Psoriasis and Psoriatic Arthritis, run by South Valley University at 1 site in Egypt.
Trial summary
Psoriasis is an immune-mediated inflammatory disease that is highly prevalent worldwide, affecting approximately 2-3% of the world population. It is characterized by red, scaly plaques that can appear on various parts of the body, causing significant physical and psychological burden to affected individuals. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Psoriatic Arthritis
- What is being tested?
- Methotrexate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 10 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 -70years .
- the severity of cutaneous affection is categorized according to PASI score into PASI 7-12 (moderate severity), and PASI > 12 (severe severity). (15)Confirmed diagnosis: Psoriasis vulgaris (PsV) or psoriatic arthritis (PsA) diagnosed by the Dermatologist or the Rheumatologist.
- Willingness to participate: Signed informed consent.
- Initiating methotrexate (MTX) therapy: For prospective cohort.
- Availability for follow-up: Patients must be willing and able to attend scheduled visit.
Who cannot join
- Patients with other autoimmune conditions (e.g., rheumatoid arthritis, systemic lupus erythematosus).
- Pregnancy and lactation.
- Patients currently undergoing immunosuppressive or systemic therapies.
- Patients with known genetic disorders affect immune system function.
- Patients with liver or kidney impairment.
- Patients with allergy or contraindication to methotrexate.
- Patients with active or uncontrolled infections, including chronic infections like tuberculosis.
- Previous genetic analysis Patients who have previously undergone genetic analysis for the TRAF3IP2 gene polymorphism (rs13190932).
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
Qena Hospital
Qina
Mohamed Hosny Hassan, Professor, +201098473605, mohammedhosnyhassaan@med.svu.edu.eg
Ebtehal Alaa El-Din Kotop Mohamed, Lecturer, +201066798383, Ebtehal_alaa@med.svu.edu.eg
About this study
Official title: Genetic Variation in TRAF3IP2 (rs13190932) and Its Association With Psoriasis, Psoriatic Arthritis, and Treatment Outcome With Methotrexate
Psoriasis is an immune-mediated inflammatory disease that is highly prevalent worldwide, affecting approximately 2-3% of the world population.
It is characterized by red, scaly plaques that can appear on various parts of the body, causing significant physical and psychological burden to affected individuals.
The Pathogenesis of PsA involves a complex interplay of genetic, immunological, and environmental factors.Genetic studies have identified several susceptibility loci, including HLA-Cw6 and IL23R, which are shared with psoriasis. Additionally, the presence of certain alleles, such as HLA-B27, is associated with a more severe disease course and a higher likelihood of axial involvement.
Read the detailed description
Psoriatic arthritis (PsA) is a chronic systemic inflammatory arthritis that involves both peripheral joints and axial skeleton associated with psoriasis. The extra-articular manifestations and comorbidities are also very common. PsA develops in up to 30% of patients with psoriasis, accounting for an estimated 0.3-1.0% of the general population.
The exact aetiopathogenesis of psoriasis is not completely explained. Pathological mechanism involves skin inflammation and hyperproliferation of keratinocytes induced innate and adaptive immune cells. Genetic, immunological and environmental factors are considered the most important aetiologies . Anti-psoriatic topical preparations, such as those containingcorticosteroids or vitamin D3 analogs (usually calcipotriol [Cal]), are the mainstay of treatment of mild-to-moderate plaque psoriasis. Phototherapy and systemic drugs (administered orally or by injection or infusion) are reserved for more severe or refractory psoriasis.
Methotrexate (MTX) has remained the backbone of the treatment for moderate to severe psoriasis ever since its first use nearly half a century ago. Over the years, its high efficacy, low cost, relative ease of administration and usefulness in concomitant psoriatic arthritis have contributed in making MTX the drug of choice in managing severe psoriasis. Although the majority of patients achieve remission of disease activity with MTX, a significant proportion may experience mild and transient adverse effects. From time to time, various guidelines on the use of MTX have correctly and adequately stressed the need for strict monitoring of haematological and hepatic adverse events.
Characterizing psoriatic arthritis (PsA), mainly as an immune-mediated disease that is also affected by barrier proteins. One new PsA and psoriasis-susceptibility gene, TRAF3IP2, codes for the adaptor protein ACT1 (nuclear factor-κB activator 1), a regulator of the NF-κB pathway involved in IL-17 signaling. We were able to identify the common coding variant p.Asp10Aspn as the disease-causing allele with evidence from association findings at single nucleotide polymorphism (SNP) and haplotype levels, as well as binding studies of ACT1 with its interaction partner TRAF6.
TRAF3 is one of the most versatile members of the TRAF family. It is an intracellular protein that primarily acts as an adaptor protein with a large variety of binding partners. TRAF3 interacting protein 2 (TRAF3IP2), also called CIKS or Act1, is a key intermediate in the normal inflammatory response and is involved in the pathogenesis of various autoimmune and inflammatory diseases .Furthermore, TRAF3IP2 is a protein acting downstream of the IL-17 receptor that binds to and stabilizes mRNAs encoding key inflammatory proteins.
- Conditions
- Psoriasis, Psoriatic Arthritis
- Being tested
- Methotrexate
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Also called Genetic variation in TRAF3IP2
Assessing the response of psoriasis and psoriatic arthritis to Methotrexate. and also Assessing the pharmacogenetic association between TRAF3IP2 ( rs13190932 ) gene Polymorphism in psoriatic and psoriatic arthritis patients taking Methotrexate.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | About 30 patients suffering from psoriasis Receives: Drug: Methotrexate |
| Group B | Active comparator | About 10 patients suffering from psoriatic arthritis Receives: Drug: Methotrexate |
| Group C | Experimental | About 10 healthy control group Receives: Drug: Methotrexate |
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 methotrexate 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
Evalaute the effect of treatment with Methotrexate
Evaluate the effect of treatment with methotrexate therapy (15 mg per week) on the level of serum TRAF3IP2( rs13190932 ) gene Polymorphism 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 posted25 Jul 2025
- Study start1 Jun 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion10 Jun 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fawzia Mohamed Abdelzaher Mohamed, South Valley University
- Investigators
- Eisa Mohammed Hegazy, Professor, Study chair, Dermatology,Venereology,and Andrology Department,Faculty of Medicine,South Valley University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086924
- Sponsor's protocol ID
- Genetic variation in TRAF3IP2
- Status last verified
- Jun 2025
- First submitted
- 18 Jul 2025
- Last updated
- 25 Jul 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 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Variation in TRAF3IP2 (rs13190932) and Its Association With Psoriasis, Psoriatic Arthritis, and Treatment Outcome With Methotrexate
- ClinicalTrials.gov ID
- NCT07086924
- Acronym / sponsor ID
- Genetic variation in TRAF3IP2
- Conditions
- Psoriasis, Psoriatic Arthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 10 Jun 2026 (estimated)
- First posted
- 25 Jul 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 an immune-mediated inflammatory disease that is highly prevalent worldwide, affecting approximately 2-3% of the world population.
It is characterized by red, scaly plaques that can appear on various parts of the body, causing significant physical and psychological burden to affected individuals.
The Pathogenesis of PsA involves a complex interplay of genetic, immunological, and environmental factors.Genetic studies have identified several susceptibility loci, including HLA-Cw6 and IL23R, which are shared with psoriasis. Additionally, the presence of certain alleles, such as HLA-B27, is associated with a more severe disease course and a higher likelihood of axial involvement.
Detailed description
Psoriatic arthritis (PsA) is a chronic systemic inflammatory arthritis that involves both peripheral joints and axial skeleton associated with psoriasis. The extra-articular manifestations and comorbidities are also very common. PsA develops in up to 30% of patients with psoriasis, accounting for an estimated 0.3-1.0% of the general population.
The exact aetiopathogenesis of psoriasis is not completely explained. Pathological mechanism involves skin inflammation and hyperproliferation of keratinocytes induced innate and adaptive immune cells. Genetic, immunological and environmental factors are considered the most important aetiologies . Anti-psoriatic topical preparations, such as those containingcorticosteroids or vitamin D3 analogs (usually calcipotriol [Cal]), are the mainstay of treatment of mild-to-moderate plaque psoriasis. Phototherapy and systemic drugs (administered orally or by injection or infusion) are reserved for more severe or refractory psoriasis.
Methotrexate (MTX) has remained the backbone of the treatment for moderate to severe psoriasis ever since its first use nearly half a century ago. Over the years, its high efficacy, low cost, relative ease of administration and usefulness in concomitant psoriatic arthritis have contributed in making MTX the drug of choice in managing severe psoriasis. Although the majority of patients achieve remission of disease activity with MTX, a significant proportion may experience mild and transient adverse effects. From time to time, various guidelines on the use of MTX have correctly and adequately stressed the need for strict monitoring of haematological and hepatic adverse events.
Characterizing psoriatic arthritis (PsA), mainly as an immune-mediated disease that is also affected by barrier proteins. One new PsA and psoriasis-susceptibility gene, TRAF3IP2, codes for the adaptor protein ACT1 (nuclear factor-κB activator 1), a regulator of the NF-κB pathway involved in IL-17 signaling. We were able to identify the common coding variant p.Asp10Aspn as the disease-causing allele with evidence from association findings at single nucleotide polymorphism (SNP) and haplotype levels, as well as binding studies of ACT1 with its interaction partner TRAF6.
TRAF3 is one of the most versatile members of the TRAF family. It is an intracellular protein that primarily acts as an adaptor protein with a large variety of binding partners. TRAF3 interacting protein 2 (TRAF3IP2), also called CIKS or Act1, is a key intermediate in the normal inflammatory response and is involved in the pathogenesis of various autoimmune and inflammatory diseases .Furthermore, TRAF3IP2 is a protein acting downstream of the IL-17 receptor that binds to and stabilizes mRNAs encoding key inflammatory proteins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: MethotrexateAbout 30 patients suffering from psoriasis |
| Group B | Active comparator | Drug: MethotrexateAbout 10 patients suffering from psoriatic arthritis |
| Group C | Experimental | Drug: MethotrexateAbout 10 healthy control group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 -70years .
- the severity of cutaneous affection is categorized according to PASI score into PASI 7-12 (moderate severity), and PASI > 12 (severe severity). (15)Confirmed diagnosis: Psoriasis vulgaris (PsV) or psoriatic arthritis (PsA) diagnosed by the Dermatologist or the Rheumatologist.
- Willingness to participate: Signed informed consent.
- Initiating methotrexate (MTX) therapy: For prospective cohort.
- Availability for follow-up: Patients must be willing and able to attend scheduled visit.
Key exclusion criteria (8 listed)
- Patients with other autoimmune conditions (e.g., rheumatoid arthritis, systemic lupus erythematosus).
- Pregnancy and lactation.
- Patients currently undergoing immunosuppressive or systemic therapies.
- Patients with known genetic disorders affect immune system function.
- Patients with liver or kidney impairment.
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 |
|---|---|---|
| MethotrexateAlso: Genetic variation in TRAF3IP2Assessing the response of psoriasis and psoriatic arthritis to Methotrexate. and also Assessing the pharmacogenetic association between TRAF3IP2 ( rs13190932 ) gene Polymorphism in psoriatic and psoriatic arthritis patients taking Methotrexate. | Drug | Group A, Group B, Group C |
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 methotrexate 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.
Evalaute the effect of treatment with Methotrexate
Time frame: 3 months
Evaluate the effect of treatment with methotrexate therapy (15 mg per week) on the level of serum TRAF3IP2( rs13190932 ) gene Polymorphism on the Participants whom suffering from Psoriasis and Psoriatic arthritis.
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 25 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Psoriatic Arthritis (PsA)
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.
Eisa Mohammed Hegazy, Professor study chair
Dermatology,Venereology,and Andrology Department,Faculty of Medicine,South Valley University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methotrexate in people with Psoriasis and Psoriatic Arthritis, 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 5 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 25 Jul 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 Fawzia Mohamed Abd Elzaher, MSC (+201001238064, drfawzia11111995@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). The study lists 2 primary outcomes in all. 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 25 Jul 2025.