Evaluation of IL 12B Genetic Polymorphism (rs3213094)

NCT07128472 | Recruiting DMC

• 1 other identifier: SVU-MED-DVA021-4
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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.

  3 Months

Secondary Outcomes (1)

• Evaluate the effect of treatment with Humira

  3 Months

Study Arms (2)

Patients Group

ACTIVE COMPARATOR

About 20 patients with psoriasis and psoriatic arthritis.

Drug: Humira

Healthy Group

ACTIVE COMPARATOR

About 20 healthy control group.

Drug: Humira

Interventions

Humira DRUG

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.

Also known as: IL 12B genetic polymorphism (rs3213094)

Healthy Group; Patients Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

Qina University hospital, South Valley University Hospital

Qina, Egypt

RECRUITING

MeSH Terms

Conditions

Psoriasis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue 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

• Moustafa Adam Ali El Taieb, Professor

  Dermatology, Venereology and Andrology. Faculty of Medicine,Qena University

  STUDY CHAIR

• Eisa Mohammed Hegazy, Professor

  Dermatology, Venereology and Andrology. Qena Faculty of Medicine,South Valley University

  STUDY DIRECTOR

• Mohamed Hosny Hassan, Professor

  Medical Biochemistry Department,Qena Faculty of Medicine,south valley university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaa Ahmed Saad Ali Aweida, MSc

CONTACT

+201119814470; alaaahmed201666@gmail.com

Soheir Abdel-Hamid Ali, Lecturer

CONTACT

+201066877343; Soher.abdel-hamed@med.svu.edu.eg

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 at Dermatology , venereology and andrology, Faculty of medicine

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 19, 2025
• Study Start: August 1, 2025
• Primary Completion: January 20, 2026
• Study Completion: February 1, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

EG (1)