Efficacy and Safety of Histamine Human Immunoglobulin in the Treatment of Chronic Spontaneous Urticaria (CSU)

Launched by HANGZHOU GRAND BIOLOGIC PHARMACEUTICAL, INC. · Jan 31, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for people with chronic spontaneous urticaria (CSU), a condition that causes itchy hives without a known reason. The treatment being studied is called histamine human immunoglobulin, also known as ShuYangMinNing. The main goal of the study is to find out if this treatment is effective and safe for patients suffering from CSU.

To participate in the trial, you must be at least 18 years old and have had urticaria symptoms in the week before joining. You should also have been taking standard antihistamines regularly for at least two weeks without enough relief from your symptoms. However, this trial is not open to everyone. For example, pregnant or nursing women, those with certain serious health conditions, or individuals with a history of severe allergies or drug abuse will not be eligible. If you join the trial, you’ll undergo assessments to monitor your health and the effectiveness of the treatment. Overall, this study aims to explore a promising option for managing CSU symptoms and improving patients' quality of life.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent must be obtained before any assessment is performed；
• • 2. Age ≥ 18 years；
• • 3. Meet the diagnostic criteria of chronic spontaneous urticaria from《Guideline for diagnosis and treatment of urticaria in China（2022）》and follow the doctor's advice；the patient had urticaria symptoms in the previous week before enrollment, and UAS7 score(range 0-42) ≥ 7;
• • 4. Patients with uncontrolled urticaria are regularly treated with standard single-dose antihistamines regularly for 2 weeks before screening;
• Exclusion Criteria:
• • 1. Pregnant or nursing (lactating) women;
• • 2. Patients with malignant tumors, severe liver and kidney diseases, hematological disorders, autoimmune diseases(such as systemic lupus erythematosus, Sjogren's syndrome, dermatomyositis, myositis, systemic vasculitis, systemic sclerosis, rheumatoid arthritis, spondyloarthropathy or other rheumatic immune diseases evaluated by the physician that are not suitable for inclusion), chronic serious infections, diabetic peripheral neuropathy, psychosis, and other diseases or medical histories that may affect normal efficacy evaluation and/or subject safety evaluation；
• • 3. History of drug or alcohol abuse;
• • 4. Patients who discontinue systemic use of glucocorticoids and other immunosuppressants(such as cyclosporin A, wilfordii , etc.) that affect immune function for less than 4 weeks;Patients who discontinue systemic use of biologics (e.g., omalizumab) for less than 3 months;
• • 5. Patients with symptoms of urticaria and/or angioedema, Including but not limited to urticaria vasculitis, serum sickness like reaction, bullous pemphigoid, mastocytosis, neutrophilic urticaria dermatosis, Schnitzler syndrome, autoinflammatory response syndromes (e.g., tumor necrosis factor receptor-associated periodic fever syndrome, familial Mediterranean fever, mevaldate kinase deficiency, etc.);or other chronic itchy skin conditions, such as atopic dermatitis, dermatitis herpetiformis, and pruritus senile;
• • 6. Allergic to human immunoglobulin;
• • 7. History of other severe allergic reactions;
• • 8. Patients with pathological arrhythmias and a history of organic heart disease; Patients with known or suspected QT prolongation; or patients who are unable to discontinue medications that cause QT prolongation during the trial；
• • 9. Subjects whom the investigator considers unsuitable for other reasons.