Investigation of clinical efficacy and safety of intramuscular administration of autologous total IgG therapy in patients with chronic urticaria
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0006814
- Lead Sponsor
- Ajou University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
1. Patient is 19-75 years of age
2. Patients with antihistamine-resistant chronic urticaria, as defined by the following
- Patients who remain symptoms such hives and itching despite treatment with approved doses of second generation non-sedating antihistamines for more than 6 consecutive weeks before screening
- At screening, UAS7 score =16 and UCT score < 12
- [Only for (Part B) participants patients with sub-study] Patients who have received systemic corticosteroids or systemic immunosuppressants within the last 1 months prior to screening.
3. Provide signed informed consent
4. Suitability for autologous blood donation criteria
1) Body weight =32 kg (satisfying body weight limitation for planned sampling of 320 mL of venous blood volume)
2) Hemoglobin: = 11 g/d
1. Inducible urticaria (dermographism, cold urticaria, solar urticaria, cholinergic urticaria, contact urticaria, etc.)
2. Any other skin disease associated with chronic itching that might confound the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.)
3. History of anaphylaxis
4. Patients who have received anti-IgE therapy (e.g. omalizumab) within the last 3 months prior to baseline.
5. [Only for (Part A) participants patients] Patients who have received systemic corticosteroids, systemic immunosuppressants and intravenous immunoglobulins within the last 1 months prior to baseline.
6. [Only for (Part B) participants patients with sub-study] Patients who have received intravenous immunoglobulins within the last 1 months prior to baseline.
7. Patients who are unable to agree on their own (emergency patients, patients with mental disability, patients with limited capacity to consent due to stroke or delirium caused by diabetes), patients with severe disease whose expected survival duration is less than 3 months.
8. Pregnancy or planned pregnancy within 1 year
9. Subjects who participated on another investigational device or drug studies within 4 weeks prior to screening visit
10. In the investigator’s opinion, unable to comply with all clinic visits and study-related procedures
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes from baseline in Weekly Urticara Activity Score (UAS7)
- Secondary Outcome Measures
Name Time Method