None listed
Conditions
Interventions
Procedure/Surgery : Autologous total IgG purified from the autologous plasma will be administered to the patients by intramuscular injection, once a week for 8 weeks (total 9 injections) from baseline
Sponsors
Ajou University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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/dL
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in Weekly Urticara Activity Score (UAS7) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in Weekly Urticara Activity Score (UAS7);Changes from baseline in Urticaria Control Test (UCT) ;Changes from baseline in physician severity score assessment ;Change from baseline in the weekly number of hives score ;Change from baseline in weekly Itch severity;Number of participants who experience an adverse events (AEs) and Serious Adverse Events (SAEs) ;Number of participants with abnormal serum chemistry results and blood test results due to clinical study;Change from baseline in serum concentrations of biological parameters (immunoglobulin, cytokine, D-dimer etc.);Change from baseline in lymphocyte fraction by flow cytometry analysis of peripheral blood mononuclear cells;Change from baseline in Chronic urticaria quality of life questionnaire (CU-QoI);Change from baseline in subjective index of satisfaction (Visual Analogue Scale; VAS) ;Change from baseline in medication requirement ;Number of participants with complete response using the urticaria activity score over 7 days (UAS7=0);Number of participants with disease control (UAS7<=6) | — |
Countries
Korea, Republic of
Contacts
Public ContactDong-Ho Nahm
Ajou University Hospital
Outcome results
None listed