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CompletedNCT06729463Updated Aug 14, 2025

IKBKB Gene Polymorphism (Single Nucleotide Polymorphism) (SNP) in Psoriatic and Psoriatic Arthritis Patients

An interventional study of Humira in Psoriasis and Psoriatic Arthritis, sponsored by South Valley University. Completed at 1 site in Egypt. Open to participants aged 16 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-14.

Sponsored by South Valley University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
16 Years to 60 Years
Sex
All
01

Study summary

Psoriasis is a chronic inflammatory skin disease characterized by scaly indurated erythema. It impairs patients' quality of life enormously.

Psoriasis refers to a persistent inflammatory illness of the skin and joints. It also impacts roughly 2%-3% of the inhabitants of the universe

Read the detailed description

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.

Psoriatic arthritis, which is characterized by dactylitis and enthesis, is closely associated with psoriasis. Up to 30-40% of patients with psoriasis will develop PsA, with an average of 10 years between psoriasis and PsA . The overlapping of genetic variations and inflammatory mediators involved in psoriasis and PsA implies a common pathogenic mechanism between the two diseases.

Psoriasis is a chronic relapsing disease, which often necessitates a long-term therapy. Mild to moderate psoriasis can be treated topically with a combination of glucocorticoids, vitamin D analogues, and phototherapy. Moderate to severe psoriasis often requires systemic treatment. The presence of comorbidities such as psoriasis arthritis is also highly relevant in treatment selection.

Oral treatments include traditional agents such as methotrexate, acitretin, cyclosporine, and the advanced small molecule apremilast, which is a phosphodiesterase 4 inhibitor. Oral treatments include traditional agents such as methotrexate, acitretin, cyclosporine, and the advanced small molecule apremilast, which is a phosphodiesterase 4 inhibitor.

The American Academy of Dermatology-National Psoriasis Foundation guidelines recommend biologics as an option for first-line treatment of moderate to severe plaque psoriasis because of their efficacy in treating it and acceptable safety profiles.

Specifically, inhibitors to tumour necrosis factor α (TNF-α) include etanercept, adalimumab, certolizumab, and infliximab. Other biologics inhibit cytokines such as the p40 subunit of the cytokines IL-12 and IL-13 (ustekinumab), IL-17 (secukinumab, ixekizumab, bimekizumab, and brodalumab), and the p19 subunit of IL-23 (guselkumab, tildrakizumab, risankizumab, and mirikizumab). Biologics that inhibit TNF-α, p40IL-12/23, and IL-17 are also approved for the treatment of psoriatic arthritis.

The NF-κB pathway would play an important role in psoriasis. In this way, the NF-κB is regarded as a mediator between immunity and the keratinocyte alteration characteristic of psoriasis .

This role is also supported by the fact that the blockade of the NF-κB binding sites would reduce the expression of several proinflammatory cytokines implicated in psoriasis. The transcriptional activity of NF-κB is regulated by several cytoplasmic inhibitors. Among these nuclear inhibitors, IκBKB (encoded by NFKBIZ) would play a prominent role in the pathogenesis of psoriasis.

IκBKB(Inhibitor of nuclear factor-kappa B subunit ζ ) is induced by several proinflammatory molecules. In particular, its expression is regulated by IL-17A and might contribute to the activation of Th17-mediated pathways. Therefore, IκBζ( IκBKB) plays an important role in the pathogenesis of psoriatic disease through IL-17-mediated mechanisms.

Recently, genome-wide association studies (GWAS) have found a significant association between psoriasis and single-nucleotide polymorphisms (SNPs) within NFKB1, NFKBIA, and NFKBIZ

02

Conditions studied

  • Psoriasis
  • Psoriatic Arthritis
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 50 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

South Valley University is the lead sponsor of 147 studies on the registry; 46 are open to participants now.

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

04

Who can participate

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

Inclusion criteria

  • Patients between the ages of 16 and 60 years proved having psoriasis diagnosed clinically for at least 6 months and who have a severity grade of moderate to 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 or without psoriatic arthritis

Exclusion criteria

Exclusion Criteria:

  • Patient receiving immune suppressive drugs.
  • Patients having malignancy.
  • Pregnant or lactating female.
  • Patients having liver disease ( Hepatitis)
  • Patients having comorbid and/or uncontrolled renal, cardiac, vascular, and hepatic diseases or symptoms.
  • Active infection or human immunodeficiency virus (HIV)
  • Tuberculosis
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Group A: Humira Group

    About 20 patients suffering from psoriasis disease and they will take Humira vials about 40 mg every two weeks by subcutaneous injection for 3 months

    Drug: Humira

  • Active comparator
    Group B: Cosentyx Group

    About 20 patients suffering from severe psoriasis will take Cosentyx vials by intravenous infusion as : 1-Loading dose about(300 mg) then decreasing the dose to be 150 mg every month for 3 months.

    Drug: Humira

  • Placebo comparator
    Group C: control Group

    About 10 Healthy participants and will take no medical treatment

    Drug: Humira

Interventions

  • DrugHumira

    Assess the pharmacogenetic association between IKBKB gene polymorphism (SNPs) in psoriatic patients taking systemic biologic therapy

    Also known as: Cosentyx

06

What researchers measure

Primary outcomes

  1. Treatment of the Psoriasis disease

    Evaluation the clinical efficacy of biological therapy in patients of psoriasis and assessing the relation between the drug response and IKBKB mutation

    Time frame: 3 months

07

Study locations

1 site
  • South Valley Hospitals
    Qina, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2025, 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
NCT06729463
Lead sponsor
South Valley University
Responsible party
Fatma Abdel-monem Mahmoud (Resident of Dermatology, Venereology and Andrology., South Valley University) — Principal investigator
First posted
Dec 11, 2024
Start date
Dec 1, 2024
Primary completion
Mar 1, 2025
Completion
Mar 30, 2025
Last update
Aug 14, 2025

Study contacts

Eisa Mohammed Hegazy, Professor
study chair · Dermatology, Venereology, and Andrology Department, Faculty of Medicine, South Valley University, Egypt

Oversight

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

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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