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

NCT06729463 | Completed DMC

• 1 other identifier: Fatma Abdel-Monem
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Psoriasis; Psoriatic Arthritis

Outcome Measures

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

  3 months

Study Arms (3)

Group A: Humira Group

ACTIVE COMPARATOR

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

Group B: Cosentyx Group

ACTIVE COMPARATOR

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

Group C: control Group

PLACEBO COMPARATOR

About 10 Healthy participants and will take no medical treatment

Drug: Humira

Interventions

Humira DRUG

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

Also known as: Cosentyx

Group A: Humira Group; Group B: Cosentyx Group; Group C: control Group

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

South Valley Hospitals

Qina, Egypt

Location

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic

Interventions

Adalimumab; secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Eisa Mohammed Hegazy, Professor

  Dermatology, Venereology, and Andrology Department, Faculty of Medicine, South Valley University, Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Dermatology, Venereology and Andrology.

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 11, 2024
• Study Start: December 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 30, 2025
• Last Updated: August 14, 2025

Record last verified: 2024-12

Locations

EG (1)